Hohlfeld Et Al-2021-Cochrane Database of Systematic Reviews

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Cochrane Database of Systematic Reviews

Circumcision devices versus standard surgical techniques in
adolescent and adult male circumcisions (Review)
Hohlfeld A, Ebrahim S, Shaik MZ, Kredo T
Hohlfeld A, Ebrahim S, Shaik MZ, Kredo T.

Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions.
Cochrane Database of Systematic Reviews 2021, Issue 3. Art. No.: CD012250.
DOI: 10.1002/14651858.CD012250.pub2.
www.cochranelibrary.com

Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions (Review)
Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Trusted evidence.
Informed decisions.

Library Better health. Cochrane Database of Systematic Reviews
TABLE OF CONTENTS
HEADER......................................................................................................................................................................................................... 1
ABSTRACT..................................................................................................................................................................................................... 1
PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2
SUMMARY OF FINDINGS.............................................................................................................................................................................. 4
BACKGROUND.............................................................................................................................................................................................. 6
OBJECTIVES.................................................................................................................................................................................................. 7
METHODS..................................................................................................................................................................................................... 7
Figure 1.................................................................................................................................................................................................. 9
Figure 2.................................................................................................................................................................................................. 10
Figure 3.................................................................................................................................................................................................. 11
RESULTS........................................................................................................................................................................................................ 13
Figure 4.................................................................................................................................................................................................. 16
Figure 5.................................................................................................................................................................................................. 17
Figure 6.................................................................................................................................................................................................. 18
Figure 7.................................................................................................................................................................................................. 19
Figure 8.................................................................................................................................................................................................. 20
DISCUSSION.................................................................................................................................................................................................. 21
AUTHORS' CONCLUSIONS........................................................................................................................................................................... 23
ACKNOWLEDGEMENTS................................................................................................................................................................................ 24
REFERENCES................................................................................................................................................................................................ 25
CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 29
DATA AND ANALYSES.................................................................................................................................................................................... 61
Analysis 1.1. Comparison 1: Circumcision devices versus standard surgical techniques, Outcome 1: Serious adverse events....... 63
Analysis 1.2. Comparison 1: Circumcision devices versus standard surgical techniques, Outcome 2: Moderate adverse events..... 64
Analysis 1.3. Comparison 1: Circumcision devices versus standard surgical techniques, Outcome 3: Mild adverse events........... 65
Analysis 1.4. Comparison 1: Circumcision devices versus standard surgical techniques, Outcome 4: Operative time (minutes)..... 66
Analysis 1.5. Comparison 1: Circumcision devices versus standard surgical techniques, Outcome 5: Pain during the first 24 hours 66
(VAS means)...........................................................................................................................................................................................
Analysis 1.6. Comparison 1: Circumcision devices versus standard surgical techniques, Outcome 6: Pain during the first 7 days 67
(VAS means)...........................................................................................................................................................................................
Analysis 1.7. Comparison 1: Circumcision devices versus standard surgical techniques, Outcome 7: Pain during erection (VAS 67
means)...................................................................................................................................................................................................
Analysis 1.8. Comparison 1: Circumcision devices versus standard surgical techniques, Outcome 8: Participant satisfaction...... 68
ADDITIONAL TABLES.................................................................................................................................................................................... 69
APPENDICES................................................................................................................................................................................................. 76
HISTORY........................................................................................................................................................................................................ 81
CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 81
DECLARATIONS OF INTEREST..................................................................................................................................................................... 81
SOURCES OF SUPPORT............................................................................................................................................................................... 81
DIFFERENCES BETWEEN PROTOCOL AND REVIEW.................................................................................................................................... 81
NOTES........................................................................................................................................................................................................... 82
Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions (Review) i
Informed decisions.

[Intervention Review]
Circumcision devices versus standard surgical techniques in adolescent

and adult male circumcisions
Ameer Hohlfeld1, Sumayyah Ebrahim2, Muhammed Zaki Shaik2, Tamara Kredo1
1Cochrane South Africa, South African Medical Research Council, Cape Town, South Africa. 2School of Clinical Medicine, Department of
Surgery, University of KwaZulu-Natal, Durban, South Africa
Contact address: Ameer Hohlfeld, ameer.hohlfeld@mrc.ac.za, hhlste001@gmail.com.
Editorial group: Cochrane Urology Group.

Publication status and date: New, published in Issue 3, 2021.
Citation: Hohlfeld A, Ebrahim S, Shaik MZ, Kredo T. Circumcision devices versus standard surgical techniques in adolescent and adult
male circumcisions. Cochrane Database of Systematic Reviews 2021, Issue 3. Art. No.: CD012250. DOI: 10.1002/14651858.CD012250.pub2.
ABSTRACT
Background
Medical circumcisions are among the most common surgical procedures performed in males. The usual indications are phimosis (inability
to completely retract the foreskin and expose the glans due to a congenital or acquired constriction of the prepuce), paraphimosis (when
the foreskin is not pulled back over the glans after retraction resulting in a tight constricting band which causes swelling of the distal penis
and acute discomfort), balanoposthitis (erythema and edema of the prepuce and glans) and balanitis (inflammation is confined to the
glans; the foreskin is usually non-retractile). Circumcision devices have been developed to shorten the operative time, simplify techniques,
and improve safety and cosmetic outcomes. The devices generally aim to crush the foreskin while simultaneously creating hemostasis,
the foreskin is then excised or allowed to slough off. Their use is supposedly safer and easier to replicate than the standard dissection
techniques. There are at least 20 devices for male circumcision on the market, yet their effectiveness has not been reviewed to date.
Objectives
To assess the effects of device-based circumcisions compared with standard surgical techniques in adolescent and adult males (10 years
old and above).
Search methods
We performed a comprehensive search with no restrictions to the language of publication or publication status. We searched the Cochrane
Library, MEDLINE (PubMed), Embase, Web of Science, trials registries, grey literature sources and conference proceedings up to 16 April
2020.
Selection criteria
We included randomized controlled trials of device-based circumcisions (crush or ligature circumcision devices) compared to standard
surgical dissection-based circumcision conducted by health professionals in a medical setting.
Data collection and analysis

At least two review authors independently assessed study eligibility and extracted data from the included studies. We classified adverse
events into serious, moderate or mild. We reported study results as risk ratios (RR) or mean differences (MD) using 95% confidence intervals
(CI) and a random-effects model. We used the GRADE approach to evaluate the overall certainty of the evidence for each outcome.
Main results
Eighteen trials met the inclusion criteria. Trials were conducted in China, South Africa, Kenya and Zambia, Mozambique, Rwanda, Uganda
and Zimbabwe.
Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions (Review) 1
Informed decisions.

Primary outcomes
Serious adverse events: there were no serious adverse events in either treatment arm (11 trials, 3472 participants).
Moderate adverse events: there may be a slight increase in moderate adverse events when devices are used compared to standard
surgical techniques (RR 1.31, 95% CI 0.55 to 3.10; I2= 68%; 10 trials, 3370 participants; low-certainty evidence); this corresponds to 8 more
(ranging from 15 fewer to 84 more) moderate adverse events per 1000 participants. We downgraded the certainty of the evidence for study
limitations and imprecision.
Secondary outcomes
Mild adverse events: we are uncertain about the difference in mild adverse events between groups when devices are used compared
to standard surgical techniques (RR 1.09, 95% CI 0.44 to 2.72; I2 = 91%; 10 trials, 3370 participants; very low-certainty evidence). We
downgraded the certainty of the evidence for study limitations, imprecision and unexplained inconsistency.
Operative time: operative time is probably about 17 minutes shorter when using a device rather than standard surgical techniques,
which constitutes a clinically meaningful decrease in a procedure (MD –17.26 minutes, 95% CI –19.96 to –14.57; I2 = 99%; 14 trials, 4812
participants; moderate-certainty evidence). We downgraded the certainty of the evidence for serious study limitations. The standard
surgical technique generally takes about 24 minutes.
There may be less postoperative pain during the first 24 hours when circumcision devices are used compared to standard surgical
techniques (measured using a visual analog scale [VAS]; MD 1.30 cm lower, 95% CI 2.37 lower to 0.22 lower; I2 = 99%; 9 trials, 3022
participants; low-certainty evidence). We downgraded the certainty of the evidence for study limitations and unexplained heterogeneity.
There may be little or no difference in postoperative pain experienced during the first seven days when compared with standard surgical
techniques (measured using a VAS; MD 0.11 cm higher, 95% CI 0.89 lower to 1.11 higher; I2 = 94%; 4 trials, 1430 participants; low-certainty
evidence). We downgraded the certainty of the evidence for study limitations and unexplained inconsistency. A higher score on the VAS
indicates greater pain.
Participants may slightly prefer circumcision devices compared to standard surgical techniques (RR 1.19, 95% CI 1.04 to 1.37; I2 = 97%;
15 trials, 4501 participants; low-certainty evidence). We downgraded the certainty of the evidence for study limitations and unexplained
inconsistency. We recorded satisfaction as a dichotomous outcome. Higher rates reflected greater satisfaction.
Authors' conclusions
We found that there were no serious adverse events reported when using a circumcision device compared to standard surgical techniques,
but they may slightly increase moderate adverse effects, and it is unclear whether there is a difference in mild adverse effects. Use of
circumcision devices probably reduces the time of the procedure by about 17 minutes, a clinically meaningful time saving. For patients,
use of the circumcision device may result in lower pain scores during the first 24 hours and patients may be slightly more satisfied with
it compared with standard surgical techniques. Clinicians, patients and policymakers can use these results in conjunction with their own
contextual factors to inform the approach that best suits their healthcare settings. High-quality trials evaluating this intervention are
needed to provide further certainty regarding the rates of adverse effects and postoperative pain of using devices compared to standard
approaches.
PLAIN LANGUAGE SUMMARY
Are circumcision devices safer or faster when compared to standard surgical circumcisions for males older than 10 years?
Background
Male circumcisions have been performed for many centuries and are one of the most common surgical procedures in males. Medical
doctors usually perform circumcisions by removing the foreskin found on the penis in a surgical procedure. Some doctors use circumcision
devices specifically designed for medical male circumcisions. It is believed that they may save time, and be simpler and safer circumcision
methods. But, it is unclear from research evidence whether males circumcised with these devices have better health outcomes.
Study characteristics
After a wide search of the literature, we found 18 clinical trials including 5246 males. We looked at information from trials that compared
surgical and device-based circumcision procedures. We compared the complications (negative experiences) that patients had after the
circumcision; the amount of time a healthcare provider took to do the circumcision; patient's pain during the day after the procedure and
one week afterwards; and the amount of satisfaction patients felt with the procedure.
Key results
There was probably little to no difference in serious complications (negative effects) such as admission to hospital or permanent damage
to the penis in any trial whether men had a standard surgical circumcision or used a circumcision device.
Informed decisions.

There may be slightly more moderate complications that require additional treatment such as stitches or antibiotics for those circumcised
with devices, but further evidence may help us understand this better.
We are unsure whether or not there is a difference in mild complications such as minor bleeding that requires added treatment, but further
evidence may help us understand this better.
The average duration for the standard surgical procedure is about 24 minutes (ranging from 15 minutes to 31 minutes), compared to the
use of circumcision devices that has an average duration of about 7 minutes (ranging from 3 minutes to 13 minutes). Therefore, the review
found that using a circumcision device saved about 17 minutes compared to standard surgical circumcision.
There may be less pain during the first 24 hours in patients who were circumcised with the device compared to standard surgical
circumcision. There may be little or no difference in pain in the first seven days after circumcision for patients who were circumcised with
the device compared to those circumcised with standard surgical methods.
We found that patients were slightly more satisfied when circumcised with a device compared to those that received a standard surgical
circumcision procedure.
Conclusions
Overall, our review found that circumcision devices may have slightly more complications than standard surgery, such as requiring
antibiotics or stitches. We also found that procedures done with circumcision devices probably take less time to complete. Patients may feel
less pain in the first 24 hours after a circumcision procedure when a device is used compared to the standard surgery. Patients may slightly
prefer the use of a device compared to standard surgery. When deciding whether to use a device, these results should be kept in mind
alongside consideration of the local context such as costs and access to trained healthcare workers in different healthcare settings. Further
trials can help us to understand the benefits and harms with more certainty, particularly about complications and postoperative pain.
SUMMARY OF FINDINGS

Summary of findings 1. Circumcision devices compared to standard surgical techniques in adolescent and adult male circumcisions
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Circumcision devices compared to standard surgical techniques in adolescent and adult male circumcisions
Patient or population: adolescent and adult male circumcisions

Setting: outpatient
Intervention: circumcision devices
Better health.
Informed decisions.
Trusted evidence.
Comparison: standard surgical techniques
Outcomes № of partici- Certainty of Relative effect Anticipated absolute effects* (95% CI) Comments
pants the evidence (95% CI)
(studies) (GRADE) Risk with stan- Risk difference with
dard surgical circumcision de-
techniques vices
Serious ad- 3472 ⊕⊕⊕⊝ Not pooled Study population No serious adverse events reported. There is
verse events (11 RCTs) Moderate a ,b probably little to no difference between circum-
Not pooled Not pooled cision devices and standard surgical approaches.
Moderate ad- 3370 ⊕⊕⊝⊝ RR 1.31 Study population There is may be a slight increase in moderate ad-
verse events (10 RCTs) Low a ,c (0.55 to 3.10) verse effects when using circumcision devices
27 per 1000 8 more per 1000 compared to surgical techniques.
(12 fewer to 57 more)
Mild adverse 3370 ⊕⊝⊝⊝ RR 1.09 Study population We are uncertain whether devices or surgery are
events (10 RCTs) Very low a ,c,d (0.44 to 2.72) different with respect to mild adverse effects.
114 per 1000 10 more per 1000
(64 fewer to 195
more)

Operative time 4812 ⊕⊕⊕⊝ — The mean oper- MD 17.26 lower Use of circumcision devices probably reduces op-
(minutes) (14 RCTs) Moderate a ,e ative time (min- (19.96 lower to 14.57 erative time by about 17 minutes compared to
utes) was 0 lower) standard surgical techniques which take on aver-
age 24 minutes.
Pain during the 3022 ⊕⊕⊝⊝ — The mean pain MD 1.3 lower There may be less pain during the first 24 hours
first 24 hours (9 RCTs) Low a ,d during the first (2.37 lower to 0.22 after procedure when using circumcision devices
(VAS means) 24 hours (VAS lower)f compared to standard surgical techniques.
means) was 0
4

Pain during 1430 ⊕⊕⊝⊝ — The mean pain MD 0.11 higher There may be little to no difference between
the first 7 days (4 RCTs) Low a ,d during the first 7 (0.89 lower to 1.11 circumcision devices and standard surgical ap-
(VAS means) days (VAS means) higher)f proaches for pain during the first 7 days.
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was 0
Participant 4501 ⊕⊕⊝⊝ RR 1.19 Study population Participants may slightly prefer the device com-
satisfaction (15 RCTs) Low a ,d (1.04 to 1.37) pared to standard surgical techniques.
751 per 1000 143 more per 1000
(30 more to 278
Better health.
Informed decisions.
Trusted evidence.
more)g
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and
its 95% CI).
CI: confidence interval; MD: mean difference; RCT: randomised controlled trial; RR: risk ratio VAS: visual analogue scale.
GRADE Working Group grades of evidence

High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is
substantially different.
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
aDowngraded one level for serious study limitations: poor reporting on sequence generation and allocation concealment, and detection bias due to lack of blinding of outcome
assessors.
bThere were no reports of serious adverse events in any of the 11 trials reporting this outcome for either comparison. Thus, the best estimate of the risk ratio would thus be one
as there is probably no difference regardless of method for circumcision.
cDowngraded one level for serious imprecision: the confidence intervals were wide including appreciable benefit and harm with low numbers of events in each arm.
dDowngraded one level for serious inconsistency: there was considerable unexplained heterogeneity.
eNot downgraded for inconsistency: despite statistical heterogeneity, there was a consistent finding of reduced operation time in the intervention group of approximately 10
minutes or more compared to standard surgical methods.
fA higher score on the VAS indicates greater pain. Pain was considered clinically significant if there was a minimally clinical important difference of 1.0 cm on the 10-cm VAS.

gParticipant satisfaction (cosmesis) was recorded as a dichotomous outcome. We extracted participants' satisfaction with their circumcision using a device and standard surgical
circumcision. Trials measured this using three different approaches. The first approach was a two-point scale, participants indicated that they were 'satisfied' or 'unsatisfied' with
their procedure. The second was a three-point scale, participants indicated that they were 'very satisfied,' 'satisfied' or 'not satisfied.' We combined 'very satisfied' and 'satisfied.'
The third was a five-point scale, participants indicated that they were 'extremely dissatisfied,' 'dissatisfied,' 'neutral,' 'satisfied' or 'extremely satisfied.' We combined responses
'satisfied' or 'extremely satisfied.' Higher rates reflected greater satisfaction.

5

Informed decisions.

BACKGROUND techniques are the traditional forceps-guided technique, the dorsal

slit technique and the inner ring-outer ring (sleeve) techniques.
Description of the condition
Adverse events may include bleeding, hematoma, wound infection,
Circumcisions have been recorded in Egypt as early as 2300 wound disruption and penile injury. The WHO's Framework
BC (Auvert 2005; WHO/UNAIDS 2007), and are among the most for Clinical Evaluation of Devices for Adult Male Circumcision
common surgical procedures performed in males (Malone 2007). provides standardized definitions for grading adverse events as
The usual indications for surgical or dissection technique-based mild, moderate or severe (WHO 2012; WHO 2013a). In brief,
circumcision are the following foreskin conditions. Phimosis adverse events are categorized as mild if they require little or
(inability to completely retract the foreskin and expose the glans no intervention (e.g. mild wound disruption or slight bleeding),
due to a congenital or acquired constriction of the prepuce) moderate if they require active treatment (e.g. antibiotics or
(WHO/UNAIDS 2007), which causes swelling, including difficult suturing) or severe if they require transfusion or hospitalization or
painful erections, candidiasis and numerous sexually transmissible result in permanent damage (Millard 2013).
infections (Morris 2017). Paraphimosis (when the foreskin is not
pulled back over the glans after retraction resulting in a tight How the intervention might work
constricting band that causes swelling of the distal penis and acute
discomfort) (Malone 2007). Balanoposthitis (erythema and edema Circumcision devices have been developed to shorten the
of the prepuce and glans) and balanitis (inflammation is confined operative time, simplify techniques, and improve safety and
to the glans; the foreskin is usually non-retractile) (Malone 2007). cosmetic outcomes (Peng 2008). Device-based techniques
Circumcisions are also performed for hygiene, personal, cultural, generally provide protection to the glans, reliably circumcise
ritual or religious reasons (in Jewish, Muslim and traditional African adequate foreskin and provide crush hemostasis. This technique
cultures) (WHO/UNAIDS 2007), and decrease the risk of sexually is supposedly safer and easier to replicate than the standard
transmitted infections (STIs) and HIV transmission (Siegfried 2009). dissection techniques (Bakare 2008). Device-based techniques
Importantly, voluntary medical male circumcision (VMMC) is a also allow for task-shifting, as nurses and other non-physician
key World Health Organization (WHO) HIV preventive intervention healthcare providers may safely perform them, thus allowing for
(WHO/UNAIDS 2011). The results of three randomized controlled rapid scale-up of VMMC for HIV prevention in resource-constrained
trials (RCTs) conducted in Africa showed that VMMC decreased settings (Ridzon 2016; WHO 2013b). It is important to note
the risk of female-to-male sexual transmission by approximately that the use of device-based techniques is precluded in men
60% (Auvert 2005; Bailey 2007; Gray 2007). Globally, the prevalence with penile anatomic abnormalities, chronic paraphimosis and
of circumcision among males 15 years or older is estimated active genital infection (Mutabazi 2012; Peng 2008). The shorter
to be 36.7% (95% confidence interval [CI] 31.4 to 42.0) (Morris procedure duration and other advantages described would then
2016). In Southern Africa, prevalence varies: 15.1% in Botswana, be appropriate for men with normal penile anatomy, seeking
8.2% in Swaziland, 12.8% in Zambia and 9.2% in Zimbabwe, circumcision for hygiene, personal, religious reasons or to prevent
with higher prevalence in Namibia (25.5%), Malawi (21.6%), South HIV and other STIs.
Africa (44.7%) and Lesotho (52.0%) (Morris 2016). The Joint United
Nations Programme on HIV and AIDS (UNAIDS) and WHO have
Why it is important to do this review
prioritized 16 countries in southern and East Africa for scale-up of For policymakers, there are several factors that form part of the
VMMC as well as the roll-out of routine medical circumcision for requirements that need to be taken into consideration when
newborn boys (WHO/UNAIDS 2013). HIV prevention programs in introducing a circumcision device to low-resource settings. First,
these countries performed over 22 million circumcisions between ease of use (with a short procedure time), easy and practical
2008 and 2018 (UNAIDS 2019). removal, and it should be suitable for mid-level providers to use.
Second, it should be low cost or affordably priced, thus, having a
Description of the intervention cost advantage over standard surgical procedures. Third, it needs
The basis of circumcision devices (irrespective of the individual to meet regulatory and marketing criteria that support high-quality
type of device) is crushing of the foreskin at the proposed clinical data on its safety and effectiveness, and preferably is used
tissue apposition line and simultaneously obtaining hemostasis. in age groups relevant for the country intending to use it (WHO
The foreskin is then excised or allowed to slough off by 2012). Currently, research indicates that available circumcision
ischemic necrosis. The crushed apposed edges can then be suture devices have the potential to reduce the complexity and duration
reinforced, glued or are sometimes left to heal (Alanis 2004). There of the male circumcision procedure; however, the high number
are at least 20 identified devices for male circumcisions (Bakare of circumcisions performed can be demanding on both human
2008; WHO 2012). The three commonly used devices are the Gomco and financial resources. One study reported a median duration of
clamp, the Mogen clamp and the Plastibell (WHO/UNAIDS 2007). 30 minutes which ranged from 18 minutes to 63 minutes (Krieger
The WHO has prequalified two adult devices: PrePex in 2013 and 2005). Therefore, an effective, safe, inexpensive and easy-to-use
Shang Ring (SR) in 2015 (WHO 2019). Circumcision devices can be device would assist in easing any burden (Bakare 2008; Millard
further classified as ligature devices (i.e. they allow the foreskin 2013; WHO 2012). With more types of devices being manufactured,
to slough off by ischemic necrosis with no suturing apposition albeit with the same mechanism, it is important to categorically
needed) or crush devices (i.e. they provide crushing hemostasis compare the efficacy of circumcision devices with the dissection
and simultaneous apposition, the foreskin is excised and edges technique. To date, the WHO Medical Circumcision Technical
are suture re-enforced) (WHO 2013a). The dissection techniques Advisory Group has published guidelines on the use of PrePex and
involve using sharp dissection, cautery or ligation of bleeding SR devices with recommendations made based on comparative
vessels and suturing to apposed edges. The types of dissection and non-comparative studies (WHO 2013a; WHO 2014). This
Cochrane Review compared standard surgical techniques with
Informed decisions.

circumcision devices regarding benefits and harms and followed within the intraoperative and early postoperative period (30
the methodologic standards of a Cochrane Review, together with days).
the application of GRADE and generation of a 'Summary of findings'
table. Secondary outcomes
• Mild adverse events require little or no intervention (e.g.
OBJECTIVES slight wound disruption, minor bleeding and occur within the
To assess the effects of device-based circumcisions compared with intraoperative and early postoperative period [30 days]).
standard surgical techniques in adolescent and adult males (10 • Operative time measured in minutes. An operative time longer
years old and above). than 10 minutes was considered a clinically important difference
from a surgical perspective. In three trials, we combined
METHODS two reported subgroups into a single group (Lv 2014; Miao
2015; Sokal 2014). We referred to the Cochrane Handbook for
Criteria for considering studies for this review Systematic Reviews of Interventions Section 7.7.3.8 on combining
groups to guide us and used the formulae in Table 7.7a to
Types of studies
combine the numbers into a single sample size, mean and
We included RCTs regardless of their publication status or the standard deviation (SD) for each group. Lv 2014 and Miao 2015
language of publication. reported mean operative times separately for both circumcision
device groups and the surgical group. Sokal 2014 had two trial
Types of participants sites, one in Kenya and one in Zambia. The operative times
We included trials that included males, ages 10 years and older were reported separately for both groups located at both trial
(adolescent and adult males), as they are the target of massive locations. Thus, we combined the means, SDs and sample sizes
circumcision campaigns in HIV prevention initiatives using devices. in the circumcision device groups and for the surgical groups
Since neonates and infants are almost exclusively circumcised from Kenya and Zambia.
using devices, and for religious reasons, we excluded them from • Postoperative pain measured using the visual analog scale (VAS)
this review. The Characteristics of included studies table describes centimeter (cm) scale. Minimal clinically important difference
detailed specific exclusion criteria for both dissection and device- (MCID) for pain in circumcisions is undefined in the literature;
based circumcisions. however, it has been defined for other types of postoperative
pain where a change of 10 mm in the 100 mm VAS is considered
Types of interventions the MCID (Myles 2017). All included trials in our review used
a 10-point VAS where '0' corresponded to 'no pain at all' and
Experimental interventions
'10' to 'worst pain imaginable' (WHO 2013a). In the absence
Device-based circumcision (crush or ligature circumcision devices): of definitive data on the MCID of pain after circumcision using
crush devices such as the SR, circular stapler, Gomco clamp and VAS, we considered an MCID of 1.0 cm on a 10-cm VAS scale as
Unicirc provide crushing hemostasis through tight compression of clinically significant for this review. A higher score on the VAS
the foreskin between hard surfaces and simultaneous apposition, indicated greater pain. Pain was evaluated in four categories:
the foreskin is excised and edges are suture reinforced. Injection of pain during the first 24 hours, pain during the first seven
local anesthesia is required for pain control as the device crushes days, pain during erection and pain during device removal.
the foreskin on placement, and tissue is excised immediately after These time points were considered most comparable, allowing
device placement. In contrast, with ligature devices such as PrePex, for comparisons between circumcision devices and standard
there is slow compression of the foreskin between an elastic ring surgical circumcision. Two trials had three interventions arms
and a hard surface that allows the foreskin to slough off by ischemic consisting of two crush circumcision device arms and a surgical
necrosis with no suturing apposition needed. Such devices can be arm (Lv 2014; Miao 2015). To analyze the outcome pain during
used without injected local anesthetic (WHO 2013a). the first 24 hours for Miao 2015 and pain during the first seven
days for Lv 2014, we combined the two circumcision device arms
Comparator interventions into a single group. We referred to the Cochrane Handbook for
Dissection-based circumcision, any recognized dissection Systematic Reviews of Interventions Section 7.7.3.8 on combining
technique (forceps-guided method, dorsal slit method or the sleeve groups to guide us and used the formulae in Table 7.7a to
method) conducted by health professionals in a medical setting. combine the numbers into a single sample size, mean and SD for
each group.
Types of outcome measures • Participant satisfaction (cosmesis) recorded as a dichotomous
outcome. We extracted participants' satisfaction with their
Based on perceived patient-importance, we distinguished between
circumcision using circumcision devices and standard surgical
primary and secondary outcomes.
circumcision. Trials measured this using three different
Primary outcomes approaches. The first approach was a two-point scale,
participants indicated that they were 'satisfied' or 'unsatisfied'
• Serious adverse events defined as events requiring a blood with their procedure. The second was a three-point scale,
transfusion, hospitalization or resulting in permanent damage participants indicated that they were 'very satisfied,' 'satisfied'
(e.g. penile injury occurring within the intraoperative and early or 'not satisfied.' We combined 'very satisfied' and 'satisfied.'
postoperative period [30 days]). The third was a five-point scale, participants indicated that they
• Moderate adverse events defined as events requiring active were 'extremely dissatisfied,' 'dissatisfied,' 'neutral,' 'satisfied'
treatment such as suturing, antibiotics, and surgical hemostasis
Informed decisions.

or 'extremely satisfied.' We combined responses 'satisfied' or We provided the search strategies for the Cochrane Library,
'extremely satisfied.' MEDLINE, Embase, Web of Science and ClinicalTrials.gov in
• Inadequate removal of the foreskin. Appendix 2.
Method and timing of outcome measurement Searching other resources

See 'Definitions and timing of outcome measurement' in Appendix We tried to identify other potentially eligible trials or ancillary
1. publications by searching the reference lists of retrieved included
trials, reviews, meta-analyses and health technology assessment
Search methods for identification of studies reports. We attempted to contact the authors of trials for trial data
(Lagarde 2009; Kanyago 2013), but were unsuccessful with Lagarde
We performed a comprehensive literature search with no
2009. We searched abstract proceedings of relevant meetings such
restrictions to the language of publication or publication status.
as the American Urological Association, the European Association
We repeated the search three months before the anticipated
of Urology and the Society of Sexual Medicine from 2013 to 2021 for
publication of the review.
relevant studies.
Electronic searches
Data collection and analysis
We conducted electronic searches for RCTs using the key search
terms for circumcision, device and individual device names (e.g. We used reference management software (e.g. EndNote) to identify
Gomco, Mogen, Plastibell) (Appendix 2). We excluded studies of and remove potential duplicate studies. Three review authors (MZS,
neonates and infants, and used the Cochrane RCT maximizing filter SE, AH) independently scanned the abstract and title of remaining
(Lefebvre 2011). records to determine which studies were potentially eligible.
We searched the following databases, using the key search terms Selection of studies
with added Boolean operators. Three review authors (MZS, SE, AH) read the full texts of
all potentially relevant records, mapped records to trials, and
• The Cochrane Library: to 16 April 2020: classified studies as included studies, excluded studies or
* Cochrane Database of Systematic Reviews (CDSR); ongoing studies in accordance with the criteria for each as
* Cochrane Central Register of Controlled Trials (CENTRAL); provided in the Cochrane Handbook for Systematic Reviews of
* Database of Abstracts of Reviews of Effects (DARE); Interventions (Higgins 2011a). We resolved any discrepancies
* Health Technology Assessment Database (HTA). through consensus or with input from a fourth review author
• MEDLINE (PubMed): to 16 April 2020. (TK). If the resolution of disagreement was not possible, we
planned to designate the study as 'awaiting classification' and
• Embase was searched on 16 August 2016, but was not searched we would have contacted the study authors for clarification,
on 16 April 2020 as the license was not renewed.
but this did not happen. However, we found 12 non-English
• Web of Science (WOS) Core Collection was searched on 16 April language articles that required feedback on whether they met our
2020. eligibility criteria. Where possible we contacted trial authors to
obtain full texts and to review the eligibility of their studies for
We also searched the following for planned, ongoing or not yet
this review; none responded to our requests. We then contacted
published studies:
Chinese language-speaking colleagues via Cochrane Task Exchange
• ClinicalTrials.gov (www.clinicaltrials.gov/): to 16 April 2020; (taskexchange.cochrane.org/), who found the published full-text
articles and assessed their eligibility based on title and abstract
• WHO International Clinical Trials Registry Platform (ICTRP)
and, where necessary, assessed eligibility based on full-text
search portal (apps.who.int/trialsearch/), a meta-register of
assessment. We then documented reasons for all excluded studies
studies with links to numerous other trials registers. The search
in the Characteristics of excluded studies table. We presented
was conducted on 4 May 2018 and repeated on 16 April 2020.
an adapted PRISMA flow diagram reporting the process of study
selection (Figure 1) (Liberati 2009).

Informed decisions.

Figure 1. Study flow diagram.
Informed decisions.

Data extraction and management obtained the number of events and totals for populations from 2 ×
2 tables for dichotomous outcomes. For continuous outcomes, we
We developed a pilot-tested data extraction form.
obtained means and SDs.
For studies that fulfilled the inclusion criteria, three review authors
We settled disagreements through discussion. If necessary, we
(MZS, SE, AH) independently extracted the following information,
consulted the fourth review author (TK). We provided information,
which is provided in the Characteristics of included studies table.
including trial identifier, from potentially relevant ongoing studies
• Study design. in the Characteristics of ongoing studies table. We attempted to
contact authors of included studies to obtain missing data required
• Study dates (if dates were not available then this was reported
for our analysis or to clarify ambiguous outcomes reported.
as such).
• Study setting and country. Assessment of risk of bias in included studies
• Participant inclusion and exclusion criteria.
Three review authors (MZS, SE, AH) independently assessed the
• Participant details and baseline demographics. risk of bias of each included study. We resolved disagreements by
• Number of participants by study and by study arm. consensus or by consulting a fourth review author (TK).
• Details of relevant experimental and comparator interventions
such as device type, name and method of dissection. We assessed risk of bias using the Cochrane 'Risk of bias'
assessment tool (Higgins 2011b). The tool recommends that the
• Definitions of relevant outcomes, method and timing of
following domains are assessed.
outcome measurement, and any relevant subgroups.
• Study funding sources. • Random sequence generation (selection bias).
• Declarations of interest by primary trial authors. • Allocation concealment (selection bias).
• Blinding of participants and personnel (performance bias).
Dealing with duplicate and companion publications
• Blinding of outcome assessment (detection bias).
When there were duplicate publications, companion documents • Incomplete outcome data (attrition bias).
or multiple reports of a primary study, we maximized the yield
• Selective reporting (reporting bias).
of information by mapping all publications to unique studies and
collated all available data in one data extraction form. We used the • Other sources of bias.
complete dataset aggregated across all known publications and
The 'Risk of bias' domains were judged at 'low risk,' 'high risk' or
noted one of the studies as the primary reference. We collated the
'unclear risk' and individual bias items were described according
reports of the same study so that each study, rather than each
to the Cochrane Handbook for Systematic Reviews of Interventions
report, was the unit of interest for the review, and such studies had
(Higgins 2011b). We produced a 'Risk of bias' graph (Figure 2) and
a single identifier with multiple references.
summary figure (Figure 3) to illustrate these findings.
We extracted outcome data that were relevant to this Cochrane
Review to calculate summary statistics and measure variance. We

Figure 2. Risk of bias graph: review authors' judgments about each risk of bias item presented as percentages
across all included studies.
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel (performance bias): All outcomes
Blinding of outcome assessment (detection bias): Subjective outcomes (severe adverse events, moderate adverse events, minor adverse events, pain, patient satisfaction)
Blinding of outcome assessment (detection bias): Objective outcomes (operative time)
Incomplete outcome data (attrition bias): All outcomes
Selective reporting (reporting bias)
Other bias
0% 25% 50% 75% 100%
Low risk of bias Unclear risk of bias High risk of bias


Library
Cochrane
Better health.
Trusted evidence.
Informed decisions.

Blinding of participants and personnel (performance bias): All outcomes
Blinding of outcome assessment (detection bias): Subjective outcomes (severe adverse events, moderate adverse events, minor adverse events, pain, patient satisfaction)
Blinding of outcome assessment (detection bias): Objective outcomes (operative time)
Figure 3. Risk of bias summary: review authors' judgments about each risk of bias item for each included study.
11

Blinding of participants and personnel (performance bias): All
Blinding of outcome assessment (detection bias): Subjective o
Blinding of outcome assessment (detection bias): Objective o
Informed decisions.


Figure 3. (Continued)

Other bias
Huo 2015 + ? ? - + + ? +
Jin 2015 ? - ? - + + ? +
Kanyago 2013 ? + ? - + - + +
Lagarde 2009 ? ? ? ? - ? -
Li 2010 - ? ? - + + ? +
Li 2014 ? ? ? - + + ? +
Lv 2014 + ? ? - + + ? +
Miao 2015 ? ? ? - + + ? +
Millard 2013 + ? ? - + + ? +
Millard 2014 + + ? - + + + +
Mutabazi 2012 + + ? - + + + +
Pang 2015 ? ? ? - + + - +
Ren 2014 ? ? ? - + + - +
Shenje 2016 + + ? - + + + +
Sokal 2014 + + ? - + + + +
Tshimanga 2016 + ? ? - + + - +
Wang 2014 + ? ? - + + ? +
Wang 2017 + ? ? - + + ? +

We evaluated the risk of bias separately for performance Measures of treatment effect
bias (blinding of participants and personnel) and detection
We reported dichotomous data as risk ratios (RRs) with 95%
bias (blinding of outcome assessment). We grouped outcomes
CIs. We assessed the dichotomous outcomes based on the
according to whether they were measured subjectively or
number of events and the number of people in the comparison
objectively when reporting findings in the 'Risk of bias' tables.
and intervention groups. We reported continuous data as mean
We evaluated attrition bias (incomplete outcome data) for all
differences (MDs) with 95% CIs unless different studies used
outcomes.
different measures to assess the same outcome, in which case we
For risk of bias assessment, we defined the following endpoints as expressed data as standardized mean differences (SMDs) with 95%
subjective outcomes. CIs.
• Serious adverse events. Unit of analysis issues

• Moderate adverse events. The unit of analysis was the individual participant. We did not
• Mild adverse events. identify eligible trials using cross-over or cluster-RCT designs.
• Pain during the first 24 hours (VAS means).
Dealing with missing data
• Pain during the first seven days (VAS means).
• Participant satisfaction (cosmesis). Missing data were obtained from the study authors in one trial
(Kanyago 2013). We performed an intention-to-treat (ITT) analyses.
• Inadequate foreskin removal.
Attrition rates, e.g. dropouts, losses to follow-up and withdrawals
We defined the following endpoint as an objective outcome. were investigated and reasons for missing data were critically
appraised.
• Operative times.
Informed decisions.

Assessment of heterogeneity • Restricting the analysis to very long or extensive studies to

establish the extent to which they dominate the results.
In the event of substantial unexplained heterogeneity, we reported
a narrative description of results. Summary of findings and assessment of the certainty of the
evidence
We assessed heterogeneity (inconsistency) through visual
inspection of the forest plots to assess the amount of overlap of CIs We used the GRADE approach to present the overall quality of
and the I2 statistic (which quantifies inconsistency across studies) the evidence for each outcome, which takes into account five
to identify the impact of heterogeneity on the meta-analysis criteria related to internal validity (risk of bias, inconsistency,
(Higgins 2002; Higgins 2003). The I2 statistic was interpreted as imprecision, publication bias) and external validity (directness of
follows. results) (Guyatt 2008). For each comparison, three review authors
(MZS, SE, AH) independently rated the certainty of the evidence
• 0% to 40%: may not be important. for each outcome as 'high,' 'moderate,' 'low' or 'very low' using
• 30% to 60%: may indicate moderate heterogeneity. GRADEpro GDT (GRADEpro GDT). We resolved any discrepancies by
• 50% to 90%: may indicate substantial heterogeneity. consensus, or by discussion with a fourth review author (TK). For
• 75% to 100%: considerable heterogeneity. the comparison: device versus surgical circumcision, we presented
a summary of the evidence for the main outcomes in 'Summary of
When there was heterogeneity, we examined individual study and findings' table. This summary provides key information about the
subgroup characteristics for possible reasons. best estimate of the magnitude of the effect in relative terms and
absolute differences for each relevant comparison of alternative
Assessment of reporting biases management strategies; the number of participants and studies
that address each main outcome; and the rating of the overall
Where possible, we assessed study protocols for selective outcome
confidence in effect estimates for each outcome (Guyatt 2011;
reporting.
Schünemann 2011). If meta-analysis was not possible, we provided
Where there were 10 trials that investigated a particular outcome, a narrative summary.
we used funnel plots to assess small-study effects. Several
We reported the following outcomes in the 'Summary of findings'
explanations can be offered for the asymmetry of a funnel plot,
table.
including true heterogeneity of effect with respect to trial size, poor
methodologic design (and hence bias of small trials), chance and • Serious adverse events.
publication bias.
• Moderate adverse events.
Data synthesis • Mild adverse events.
As specified in the protocol, we proceeded to conduct meta- • Operative time (minutes).
analyses where the trials were methodologically similar and the • Pain during the first 24 hours (VAS means in centimeters).
population, interventions and controls homogeneous enough to • Pain during the first seven days (VAS means in centimeters).
combine their data. We synthesized data using a random-effects • Participant satisfaction (cosmesis).
meta-analysis. We performed statistical analyses according to the
statistical guidelines in the Cochrane Handbook for Systematic RESULTS
Reviews of Interventions (Higgins 2011c). For dichotomous
outcomes, we used the Mantel-Haenszel method; for continuous Description of studies
outcomes, we used the inverse variance method. We used Review
For a detailed description of the included studies see the
Manager 5 software to perform the analyses (Review Manager
Characteristics of included studies table. Studies that did not
2014).
satisfy our selection criteria are described in the Characteristics of
Subgroup analysis and investigation of heterogeneity excluded studies table.
We expected the following characteristic to introduce clinical Results of the search

heterogeneity, and, therefore, we carried out a subgroup analysis
We identified 596 records from electronic and supplementary
to investigate interactions.
searches and two additional records through reference lists. After
• Type of circumcision device (crush devices versus ligature removing duplicates, three review authors (MZS and SE, AH)
devices). screened 535 titles and abstracts and excluded 507 records. Thus,
there were 28 articles in the full-text screening stage. We excluded
We used the test for subgroup differences in Review Manager 5 to nine trials with reasons and one trial is ongoing. We included 18
compare subgroup analyses when there was a sufficient number of trials in the final review. The flow of trials identified to be included
included studies (Review Manager 2014). in the review is summarized in a flow chart (Figure 1).
Sensitivity analysis Included studies

We performed a sensitivity analysis to assess the influence of the The 18 included trials are described in detail in the Characteristics
following factors (when applicable) on effect sizes. of included studies table. All included trials were randomized at the
individual participant level. There were 10 trials conducted in China
• Restricting the analysis by considering risk of bias, by excluding (Huo 2015; Jin 2015; Li 2010; Li 2014; Lv 2014; Miao 2015; Pang 2015;
studies at 'high risk' or 'unclear risk.' Ren 2014; Wang 2014; Wang 2017), three in South Africa (Lagarde
Informed decisions.

2009; Millard 2014; Shenje 2016), two multi-country trials in Kenya Millard 2013; Millard 2014; Pang 2015; Ren 2014; Wang 2014; Wang
and Zambia (Sokal 2014) and in Malawi and Zimbabwe (Tshimanga 2017).
2016), one trial in Mozambique (Millard 2013), one in Rwanda
(Mutabazi 2012), and one in Uganda (Kanyago 2013). Twelve trials Outcomes
stated that the interventions were conducted in hospital settings Lagarde 2009 did not clearly report their outcomes. We contacted
(Huo 2015; Jin 2015; Kanyago 2013; Li 2010; Li 2014; Lv 2014; Miao the authors of this trial to request trial data, with no response.
2015; Mutabazi 2012; Pang 2015; Ren 2014; Wang 2014; Wang 2017), Thus, the outcomes were not included in the analysis in this review.
and six trials were conducted in outpatient settings (Lagarde 2009; Six trials were written in Chinese; two first-language Chinese
Millard 2013; Millard 2014; Shenje 2016; Sokal 2014; Tshimanga researchers translated these (Huo 2015; Li 2010; Li 2014; Miao 2015;
2016). Most trials had two arms, except Lv 2014 and Miao 2015, Pang 2015; Ren 2014). Both researchers indicated that the adverse
which had three arms comparing two intervention arms both event results were not clearly described. Thus, we extracted only
consisting of crush devices to a standard surgical technique. operative time, pain and patient satisfaction from the publications.
We attempted to obtain clarity from the contact authors, however,
Participants
we are yet to receive a response.
The 18 studies included 5246 participants. The included sample
sizes ranged from 56 participants (Pang 2015) to 942 (Lv 2014). None of the participants in the included trials reported serious
Nine trials included males older than 18 years (Jin 2015; Lagarde adverse events, thus no meta-analysis could be performed. Ten
2009; Lv 2014; Millard 2013; Millard 2014; Mutabazi 2012; Sokal 2014; trials including 3370 participants reported moderate adverse
Tshimanga 2016; Wang 2017), five trials included males older than events (Jin 2015; Kanyago 2013; Lv 2014; Millard 2013; Millard 2014;
12 years (Kanyago 2013; Li 2010; Pang 2015; Shenje 2016; Wang Mutabazi 2012; Shenje 2016; Sokal 2014; Tshimanga 2016; Wang
2014). We considered the two trials that included males older than 2014). One trial did not clearly report moderate adverse events
seven years to be eligible (Miao 2015; Ren 2014); with participants for us to include into the analysis; we contacted the authors to
in the Miao 2015 trial having a mean age of 22.5 (SD 5.7) years with clarify their findings but received no response (Wang 2017). Ten
ages ranging from nine years to 56 years. Ren 2014 trial participants trials including 3370 participants reported mild adverse events (Jin
had a mean age of 24 years ranging from seven years to 56 years. 2015; Kanyago 2013; Lv 2014; Millard 2013; Millard 2014; Mutabazi
Both trials had mean ages higher than 10 years including wide age 2012; Shenje 2016; Sokal 2014; Tshimanga 2016; Wang 2014). Wang
ranges. We assumed that these trials likely did not include many 2017 did not clearly report mild adverse events for us to include
participants younger than 10 years. Furthermore, every attempt into the analysis; we contacted the authors for clarity but received
was made to contact trial authors, we are still awaiting a response. no response. Twelve trials reported pain during the first 24 hours
Finally, the age range for two trials was not clearly described, but by VAS using centimeters as the unit of measurement (Huo 2015;
the mean age was above 26 years (Huo 2015; Li 2014). Twelve trials Jin 2015; Kanyago 2013; Li 2010; Li 2014; Miao 2015; Millard 2013;
included participants with genital conditions such as redundant Millard 2014; Mutabazi 2012; Shenje 2016; Sokal 2014; Wang 2017).
prepuce, phimosis and scarred frenulum (Huo 2015; Jin 2015; Li However, only nine of these trials reported mean pain scores (Huo
2010; Lv 2014; Miao 2015; Millard 2013; Millard 2014; Pang 2015; Ren 2015; Jin 2015; Kanyago 2013; Li 2014; Li 2010; Miao 2015; Millard
2014; Sokal 2014; Wang 2014; Wang 2017). The remaining six trials 2013; Millard 2014; Mutabazi 2012). These were thus included in the
included healthy male participants (Kanyago 2013; Lagarde 2009; analyses. A further four trials reported VAS scores during the first
Li 2014; Mutabazi 2012; Shenje 2016; Tshimanga 2016). seven days after circumcision (Kanyago 2013; Lv 2014; Millard 2013;
Millard 2014). Two trials reported pain during erection (Mutabazi
Interventions 2012; Sokal 2014).
The types of devices compared to standard surgical procedures Seventeen trials reported operative time (Huo 2015; Jin 2015;
can be broadly classified into two categories: 16 trials used crush- Kanyago 2013; Li 2010; Li 2014; Lv 2014; Miao 2015; Millard 2013;
based devices (Huo 2015; Jin 2015; Kanyago 2013; Lagarde 2009; Millard 2014; Mutabazi 2012; Pang 2015; Ren 2014; Shenje 2016;
Li 2010; Li 2014; Lv 2014; Miao 2015; Millard 2013; Millard 2014; Sokal 2014; Tshimanga 2016; Wang 2014; Wang 2017); of these,
Pang 2015; Ren 2014; Shenje 2016; Sokal 2014; Wang 2014; Wang 14 trials reported their operative times as a mean value and were
2017), and two trials used ligature-based devices (Mutabazi 2012; included in the analyses (Huo 2015; Jin 2015; Kanyago 2013; Li
Tshimanga 2016). Two trials trained doctors and nurses to conduct 2010; Li 2014; Lv 2014; Miao 2015; Millard 2013; Mutabazi 2012; Pang
the procedures (Sokal 2014; Tshimanga 2016), 10 trials trained only 2015; Ren 2014; Sokal 2014; Tshimanga 2016; Wang 2014). Fifteen
doctors to the procedures (Huo 2015; Jin 2015; Kanyago 2013; trials measured the proportion of participant's satisfaction with the
Lagarde 2009; Lv 2014; Millard 2013; Millard 2014; Mutabazi 2012; circumcision (Huo 2015; Jin 2015; Kanyago 2013; Li 2010; Li 2014;
Shenje 2016; Wang 2014), and six trials did not specify the providers Lv 2014; Millard 2013; Millard 2014; Mutabazi 2012; Pang 2015; Ren
(Li 2010; Li 2014; Miao 2015; Pang 2015; Ren 2014; Wang 2017; 2014; Shenje 2016; Tshimanga 2016; Wang 2014; Wang 2017).
Wang 2017). Seven trials stated that the healthcare professional
conducting procedures were trained or had experience in using Excluded studies
the tested circumcision devices (Huo 2015; Lagarde 2009; Lv 2014;
We excluded nine studies, see Characteristics of excluded
Mutabazi 2012; Shenje 2016; Sokal 2014; Tshimanga 2016). One trial
studies table. Five studies had an ineligible study design (Awori
clearly stated that the surgeons had no prior experience in using the
2016; Feldblum 2014; Lei 2015; Liang 2012; Yu 2014), two
experimental circumcision device (Kanyago 2013). It was unclear in
studies compared two application methods of the same device
the remaining 10 trials whether the healthcare professionals had
(Cheng 2012; Feldblum 2016), one study compared two surgical
prior experience or had received the relevant training in using the
circumcision methods (Decastro 2010), and one study was a
tested circumcision devices (Jin 2015; Li 2010; Li 2014; Miao 2015;
retracted article previously published in another journal (Yue 2012).
Informed decisions.

Studies awaiting classification differential attrition, with 25% losses to follow-up without reasons
in the intervention group and was, therefore, at high risk of bias;
There are no studies awaiting classification.
authors assumed that participants in the surgical group who did not
Ongoing trials return had high satisfaction and no minor or major complications.
In Lagarde 2009, there was also higher and differential attrition in
We found one ongoing trial that has completed recruiting the intervention group, which we judged at high risk of bias for this
participants (ChiCTR-TRC-13003428; see Characteristics of ongoing domain.
studies table).
Selective reporting
Risk of bias in included studies
Six trials had study protocols or registry records (Kanyago 2013;
The judgments for the risk of bias of the 18 included studies are Millard 2014; Mutabazi 2012; Shenje 2016; Sokal 2014; Tshimanga
summarized in Figure 2 and Figure 3. 2016). Five of them reported outcomes according to those
prespecified and were, therefore, at low risk of bias. Tshimanga
Allocation 2016 reported pain, which was not specified in the registry record;
Random sequence generation this resulted in high risk of selective outcome reporting. We did
not find protocols for the remaining 12 trials. Two trials seemed as
Ten trials reported adequate random sequence generation (Huo though pain was meant to have been reported but was not (high risk
2015; Lv 2014; Millard 2013; Millard 2014; Mutabazi 2012; Shenje of bias; Pang 2015; Ren 2014). The remaining 10 trials had unclear
2016; Sokal 2014; Tshimanga 2016; Wang 2014; Wang 2017). risk of selective outcome reporting (Huo 2015; Jin 2015; Lagarde
Seven trials did not report clearly on the method for sequence 2009; Li 2010; Li 2014; Lv 2014; Miao 2015; Millard 2013; Wang 2014;
generation and were at unclear risk of bias (Jin 2015; Kanyago 2013; Wang 2017).
Lagarde 2009; Li 2014; Miao 2015; Pang 2015; Ren 2014). One trial
randomized participants according to day/date of clinic visit and Other potential sources of bias
was at high risk of bias (Li 2010).
One trial had a potentially high risk of bias due to early stopping
Allocation concealment and the trial not meeting its planned sample size for the primary
outcome (power) (Lagarde 2009).
Five trials had adequate allocation concealment (Kanyago 2013;
Millard 2014; Mutabazi 2012; Shenje 2016; Sokal 2014). Twelve Effects of interventions
trials had unclear reporting of allocation concealment (Huo 2015;
Lagarde 2009; Li 2010; Li 2014; Lv 2014; Miao 2015; Millard 2013; See: Summary of findings 1 Circumcision devices compared
Pang 2015; Ren 2014; Tshimanga 2016; Wang 2014; Wang 2017). to standard surgical techniques in adolescent and adult male
For Jin 2015, the baseline characteristics of participants were not circumcisions
similar across the study groups: there were more participants with
See: Summary of findings 1 for circumcision devices versus
phimosis in the surgical group compared to the device group.
standard surgical techniques.
Therefore, we judged this study at high risk of selection bias.
Twelve trials reported adverse events (Jin 2015; Kanyago 2013;
Blinding
Lagarde 2009; Lv 2014; Millard 2013; Millard 2014; Mutabazi 2012;
Blinding of participants and personnel Shenje 2016; Sokal 2014; Tshimanga 2016; Wang 2014; Wang 2017).
Results from one trial were not clearly reported and thus not
The nature of the surgical intervention precludes the blinding of analyzed ( Lagarde 2009); we attempted to obtain trial data from
participants and personnel. Therefore, all studies were at unclear the authors. See Table 1 for a description of adverse events from
risk of performance bias. the trials whose data on adverse events could not be used in the
Blinding of outcome assessment analyses (Huo 2015; Lagarde 2009; Li 2010; Li 2014; Miao 2015; Pang
2015; Ren 2014). For a description of the methods and timing for
We differentiated between subjective and objective outcomes for outcome assessment, refer to Appendix 1.
which blinding of outcome assessors would be relevant. Subjective
outcomes were serious, moderate and mild adverse events; pain Primary outcomes
and participant satisfaction. We judged all trials at high risk Serious adverse events
of detection bias for the subjective outcomes. Assessment of
operative time was a more objective outcome; despite the lack of Eleven trials reported serious adverse effects (Jin 2015; Kanyago
blinding with respect to surgical interventions, we judged all trials 2013; Lv 2014; Millard 2013; Millard 2014; Mutabazi 2012; Shenje
measuring this outcome at low risk of bias. One trial did not report 2016; Sokal 2014; Tshimanga 2016; Wang 2014; Wang 2017). There
on operative time (Lagarde 2009). was moderate-certainty evidence that there is probably little or
no difference in serious adverse events comparing devices with
Incomplete outcome data standard surgical techniques for circumcision. There were no
Sixteen trials reported low levels of attrition, less than 10% (Huo serious adverse events reported in either group (3472 participants,
2015; Jin 2015; Li 2010; Li 2014; Lv 2014; Miao 2015; Millard 2013; 0 events). We downgraded the evidence one level for methodologic
Millard 2014; Mutabazi 2012; Pang 2015; Ren 2014; Shenje 2016; limitations due to potential risk of bias for poor reporting on
Sokal 2014; Tshimanga 2016; Wang 2014; Wang 2017). In addition sequence generation and allocation concealment in several trials,
where attrition was equal between groups and well described, and lack of blinding of the outcome assessors. None of the 11 trials
we judged that domain as low risk of bias. Kanyago 2013 had
Informed decisions.

reported serious adverse events, thus we were unable to calculate slightly more moderate adverse events when devices are used
an effect size estimate for this outcome. compared to standard surgical techniques (RR 1.31, 95% CI 0.55
to 3.10; I2= 68%; 3370 participants; low-certainty evidence; Figure
Moderate adverse events 4). This represents eight more moderate adverse events per 1000
Ten trials reported moderate adverse effects (Jin 2015; Kanyago people circumcised with a device (95% CI from 12 fewer to 57 more).
2013; Lv 2014; Millard 2013; Millard 2014; Mutabazi 2012; Shenje We downgraded the certainty of the evidence due to serious risk of
2016; Sokal 2014; Tshimanga 2016; Wang 2014). There may be bias and imprecision.

Figure 4. Forest plot of comparison: 1 Circumcision devices versus standard surgical techniques, outcome: 1.2
Moderate adverse events.
Circumcision devices Surgical technique Risk Ratio Risk Ratio Risk of Bias
Study or Subgroup Events Total Events Total Weight M-H, Random, 95% CI M-H, Random, 95% CI A B C D E F G
1.2.1 Crush devices

Jin 2015 7 441 16 438 18.4% 0.43 [0.18 , 1.05] ? - ? - + ? +
Kanyago 2013 23 73 5 65 18.2% 4.10 [1.65 , 10.15] ? + ? - - + +
Lv 2014 10 628 0 314 6.6% 10.52 [0.62 , 178.89] + ? ? - + ? +
Millard 2013 13 100 4 100 16.7% 3.25 [1.10 , 9.63] + ? ? - + ? +
Millard 2014 20 100 8 50 19.4% 1.25 [0.59 , 2.64] + + ? - + + +
Shenje 2016 1 50 0 25 5.6% 1.53 [0.06 , 36.25] + + ? - + + +
Sokal 2014 0 200 2 200 6.0% 0.20 [0.01 , 4.14] + + ? - + + +
Wang 2014 0 60 0 60 Not estimable + ? ? - + ? +
Subtotal (95% CI) 1652 1252 91.0% 1.60 [0.67 , 3.80]
Total events: 74 35
Heterogeneity: Tau² = 0.75; Chi² = 18.13, df = 6 (P = 0.006); I² = 67%
Test for overall effect: Z = 1.06 (P = 0.29)
1.2.2 Ligature devices

Mutabazi 2012 1 150 3 76 9.0% 0.17 [0.02 , 1.60] + + ? - + + +
Tshimanga 2016 0 160 0 80 Not estimable + ? ? - + - +
Subtotal (95% CI) 310 156 9.0% 0.17 [0.02 , 1.60]
Total events: 1 3
Heterogeneity: Not applicable
Total (95% CI) 1962 1408 100.0% 1.31 [0.55 , 3.10]

Total events: 75 38
Heterogeneity: Tau² = 0.86; Chi² = 21.60, df = 7 (P = 0.003); I² = 68% 0.001 0.1 1 10 1000
Test for overall effect: Z = 0.60 (P = 0.55) Favors devices Favors surgery
Test for subgroup differences: Chi² = 3.34, df = 1 (P = 0.07), I² = 70.1%
Risk of bias legend

(A) Random sequence generation (selection bias)
(B) Allocation concealment (selection bias)
(C) Blinding of participants and personnel (performance bias): All outcomes
(D) Blinding of outcome assessment (detection bias): Subjective outcomes (severe adverse events, moderate adverse events, minor adverse events, pain, patient satisfaction)
(E) Incomplete outcome data (attrition bias): All outcomes
(F) Selective reporting (reporting bias)
(G) Other bias

Secondary outcomes There is uncertainty about the difference in mild adverse events
between groups when devices were used compared to standard
Mild adverse events
surgical techniques (RR 1.09, 95% CI 0.44 to 2.72; I2 = 91%; 10
Ten trials reported mild adverse events (Jin 2015; Kanyago 2013; Lv trials, 3370 participants; very low-certainty evidence; Figure 5). We
2014; Millard 2013; Millard 2014; Mutabazi 2012; Shenje 2016; Sokal downgraded the certainty of the evidence for serious risk of bias,
2014; Tshimanga 2016; Wang 2014). unexplained heterogeneity and imprecision.

Informed decisions.

Figure 5. Forest plot of comparison: 1 Circumcision devices versus standard surgical techniques, outcome: 1.3 Mild
adverse events.
1.3.1 Crush devices

Jin 2015 5 441 18 438 12.4% 0.28 [0.10 , 0.74] ? - ? - + ? +
Kanyago 2013 19 73 7 65 13.0% 2.42 [1.09 , 5.38] ? + ? - - + +
Lv 2014 103 628 105 314 14.3% 0.49 [0.39 , 0.62] + ? ? - + ? +
Millard 2013 69 100 14 100 13.9% 4.93 [2.98 , 8.15] + ? ? - + ? +
Millard 2014 27 100 5 50 12.7% 2.70 [1.11 , 6.59] + + ? - + + +
Shenje 2016 0 50 1 25 5.3% 0.17 [0.01 , 4.03] + + ? - + + +
Sokal 2014 8 200 5 200 12.0% 1.60 [0.53 , 4.81] + + ? - + + +
Wang 2014 0 60 0 60 Not estimable + ? ? - + ? +
Subtotal (95% CI) 1652 1252 83.6% 1.21 [0.43 , 3.37]
Total events: 231 155
Heterogeneity: Tau² = 1.59; Chi² = 90.50, df = 6 (P < 0.00001); I² = 93%

Mutabazi 2012 3 150 5 76 10.8% 0.30 [0.07 , 1.24] + + ? - + + +
Tshimanga 2016 2 160 0 80 5.6% 2.52 [0.12 , 51.78] + ? ? - + - +
Subtotal (95% CI) 310 156 16.4% 0.57 [0.08 , 3.87]
Total events: 5 5
Total (95% CI) 1962 1408 100.0% 1.09 [0.44 , 2.72]

Heterogeneity: Tau² = 1.50; Chi² = 92.90, df = 8 (P < 0.00001); I² = 91% 0.02 0.1 1 10 50
Test for subgroup differences: Chi² = 0.46, df = 1 (P = 0.50), I² = 0%
Risk of bias legend

(G) Other bias

Operative time 14.57; I2 = 99%; 14 trials, 4812 participants; moderate-certainty
evidence; Figure 6). We downgraded the certainty of the evidence
Fourteen trials reported operative time (Huo 2015; Jin 2015;
one level for serious risk of bias. Despite the high statistical
Kanyago 2013; Li 2010; Li 2014; Lv 2014; Miao 2015; Millard 2013;
inconsistency (I2 = 99%), all times indicated a reduction in
Mutabazi 2012; Pang 2015; Ren 2014; Sokal 2014; Tshimanga 2016;
procedure duration when a device was used compared to
Wang 2014).
the standard surgical technique; therefore, we elected not to
There is probably a clinically relevant 17 minute reduction in downgrade for inconsistency. Furthermore, we considered an
operative time when using a device compared to standard operative time less than 10 minutes to be clinically important.
surgical techniques (MD –17.26 minutes, 95% CI –19.96 to –

Informed decisions.

Operative time (minutes).
Circumcision devices Surgical technique Mean Difference Mean Difference Risk of Bias
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Random, 95% CI IV, Random, 95% CI A B C D E F G
1.4.1 Crush devices

Huo 2015 7.1 1.4 120 22.6 4.6 60 7.1% -15.50 [-16.69 , -14.31] + ? ? + + ? +
Jin 2015 6.8 3.1 441 24.2 3.2 438 7.2% -17.40 [-17.82 , -16.98] ? - ? + + ? +
Kanyago 2013 8.7 6.9 73 23.2 5.5 65 6.9% -14.50 [-16.57 , -12.43] ? + ? + - + +
Li 2010 4.7 1.3 402 25.6 8.3 322 7.2% -20.90 [-21.82 , -19.98] - ? ? + + ? +
Li 2014 4.02 0.69 129 30.8 4.05 120 7.2% -26.78 [-27.51 , -26.05] ? ? ? + + ? +
Lv 2014 6.75 3.66 628 21.4 5.8 314 7.2% -14.65 [-15.35 , -13.95] + ? ? + + ? +
Miao 2015 6.88 2.19 184 28.36 4.22 92 7.2% -21.48 [-22.40 , -20.56] ? ? ? + + ? +
Millard 2013 12.8 2.7 83 22.5 6.6 81 7.1% -9.70 [-11.25 , -8.15] + ? ? + + ? +
Pang 2015 3.9 0.8 28 31.2 3.9 28 7.1% -27.30 [-28.77 , -25.83] ? ? ? + + - +
Ren 2014 8.2 1.6 136 30.4 4.7 84 7.2% -22.20 [-23.24 , -21.16] ? ? ? + + - +
Sokal 2014 7.2 2 197 20.3 4.8 201 7.2% -13.10 [-13.82 , -12.38] + + ? + + + +
Wang 2014 7.6 4.5 60 23.6 4.4 60 7.1% -16.00 [-17.59 , -14.41] + ? ? + + ? +
Subtotal (95% CI) 2481 1865 85.6% -18.31 [-21.05 , -15.57]
Test for overall effect: Z = 13.10 (P < 0.00001)

Mutabazi 2012 3.1 1.1 150 15.4 3.1 76 7.2% -12.30 [-13.02 , -11.58] + + ? + + + +
Tshimanga 2016 4.8 1.2 160 14.6 4.2 80 7.2% -9.80 [-10.74 , -8.86] + ? ? + + - +
Subtotal (95% CI) 310 156 14.4% -11.07 [-13.52 , -8.62]
Total (95% CI) 2791 2021 100.0% -17.26 [-19.96 , -14.57]

Test for overall effect: Z = 12.55 (P < 0.00001) -20 -10 0 10 20
Test for subgroup differences: Chi² = 14.91, df = 1 (P = 0.0001), I² = 93.3% Favors devices Favors surgery
Risk of bias legend

(D) Blinding of outcome assessment (detection bias): Objective outcomes (operative time)
(G) Other bias

Postoperative pain There may be less pain if circumcision devices are used compared
to standard surgical techniques for postoperative pain during the
See Table 2 for narrative reports of pain from each trial.
first 24 hours (MD –1.30 cm, 95% CI –2.37 to –0.22; I2 = 99%; 3022
Pain during the first 24 hours participants; low-certainty evidence; Figure 7). We downgraded the
certainty of the evidence for serious methodologic limitations and
Nine trials reported pain during the first 24 hours after circumcision serious unexplained heterogeneity. Lv 2014 reported this outcome
(Huo 2015; Jin 2015; Kanyago 2013; Li 2010; Li 2014; Miao 2015; but we did not include the data in this analysis because they
Millard 2013; Millard 2014; Mutabazi 2012); all used a VAS to measured pain intraoperatively.
evaluate pain severity.

Informed decisions.

Figure 7. Forest plot of comparison: 1 Circumcision devices versus standard surgical techniques, outcome: 1.5 Pain
during the first 24 hours (VAS means).
Circumcision devices Surgical technique Mean Difference Mean Difference Risk of Bias
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Random, 95% CI IV, Random, 95% CI A B C D E F G
1.5.1 Crush devices

Huo 2015 1.9 1.3 120 5.2 1.7 60 11.1% -3.30 [-3.79 , -2.81] + ? ? - + ? +
Jin 2015 4 0.9 441 5.8 1 438 11.4% -1.80 [-1.93 , -1.67] ? - ? - + ? +
Kanyago 2013 2 2.5 73 3 2.2 65 10.7% -1.00 [-1.78 , -0.22] ? + ? - - + +
Li 2010 1.83 0.86 402 5.27 1.74 322 11.3% -3.44 [-3.65 , -3.23] - ? ? - + ? +
Li 2014 1.84 1.02 129 4.99 1.36 120 11.3% -3.15 [-3.45 , -2.85] ? ? ? - + ? +
Miao 2015 2.52 0.98 184 1.82 0.75 92 11.3% 0.70 [0.49 , 0.91] ? ? ? - + ? +
Millard 2013 3.3 2.7 100 3.3 2.4 100 10.9% 0.00 [-0.71 , 0.71] + ? ? - + ? +
Millard 2014 4.2 2.7 100 3.1 2.4 50 10.6% 1.10 [0.25 , 1.95] + + ? - + + +
Subtotal (95% CI) 1549 1247 88.7% -1.38 [-2.56 , -0.20]

Mutabazi 2012 0.3 0.8 150 0.9 1.5 76 11.3% -0.60 [-0.96 , -0.24] + + ? - + + +
Subtotal (95% CI) 150 76 11.3% -0.60 [-0.96 , -0.24]
Total (95% CI) 1699 1323 100.0% -1.30 [-2.37 , -0.22]

Test for overall effect: Z = 2.36 (P = 0.02) -4 -2 0 2 4
Risk of bias legend

(G) Other bias

Pain during the first seven days inconsistency and imprecision (wide CIs due to few studies
Four trials reported pain during the first seven days after reporting this outcome, which may be due to selective outcome
circumcision by mean and SDs using a VAS (Kanyago 2013; Lv 2014; reporting).
Millard 2013; Millard 2014). Pain during device removal
There may be little or no difference in postoperative pain during the This outcome only applies to participants where surgeons used
first seven days when compared with standard surgical techniques circumcision devices. Two trials reported pain during device
(MD 0.11 cm, 95% CI –0.89 to 1.11; I2 = 94%; 1430 participants; low- removal (Mutabazi 2012; Tshimanga 2016). One reported moderate
certainty evidence). We downgraded the certainty of the evidence transient pain levels (VAS score: 2 cm to 6 cm) in 93.6% of the
for serious methodologic limitations, and serious unexplained participants (Tshimanga 2016). One recorded a mean VAS of 4.7 cm
heterogeneity. during removal (Mutabazi 2012).
Two trials did not report outcomes during this period (Jin 2015; Participant satisfaction (cosmesis)
Mutabazi 2012), and five others did not use VAS scores or used other
Participant satisfaction (cosmesis) was a dichotomous outcome.
summary statistics (Shenje 2016; Sokal 2014; Tshimanga 2016;
We extracted participants' satisfaction with their circumcision
Wang 2014; Wang 2017).
using a device or standard surgery. Trials measured this using three
Pain during erection different approaches. The first approach was a two-point scale,
participants indicated that they were 'satisfied' or 'unsatisfied'
Three trials reported pain during erection (Mutabazi 2012; Sokal with their procedure. The second was a three-point scale,
2014; Tshimanga 2016), but only two trials could be included in participants indicated that they were 'very satisfied,' 'satisfied'
the meta-analysis (Mutabazi 2012; Sokal 2014); Tshimanga 2016 or 'not satisfied.' We combined 'very satisfied' and 'satisfied.'
reported the number and percentages of participants experiencing The third was a five-point scale, participants indicated that
a given pain level at categories of the VAS score (0, 2, 4, 6, 8). they were 'extremely dissatisfied,' 'dissatisfied,' 'neutral,' 'satisfied'
or 'extremely satisfied.' We combined responses 'satisfied' and
There is uncertainty about pain during erection in those who
'extremely satisfied.' Higher rates reflected greater satisfaction. See
were circumcised with a device compared to standard surgical
Table 3 with narrative reports of participant satisfaction from each
techniques (MD –0.74 cm, 95% CI –4.57 to 3.08; I2 = 99%; 2 trials,
trial.
626 participants; very low-certainty evidence). We downgraded the
certainty of the evidence for study limitations (lack of blinding),
Informed decisions.

Fifteen trials reported participant satisfaction (Huo 2015; Jin 2015; 95% CI 1.04 to 1.37; I2 = 97%; 4501 participants; low-certainty
Kanyago 2013; Li 2010; Li 2014; Lv 2014; Millard 2013; Millard 2014; evidence; Figure 8). The absolute effect is 143 more participants per
Mutabazi 2012; Pang 2015; Ren 2014; Shenje 2016; Tshimanga 2016; 1000 population were satisfied with circumcision devices (95% CI
Wang 2014; Wang 2017). from 30 more to 278 more). We downgraded the certainty of the
evidence for serious risk of bias and unexplained inconsistency.
Participants may slightly prefer circumcision devices compared to
standard surgical techniques for participant satisfaction (RR 1.19,

Participant satisfaction.
1.8.1 Crush devices

Huo 2015 114 120 51 60 7.0% 1.12 [1.00 , 1.25] + ? ? - + ? +
Jin 2015 402 441 395 438 7.2% 1.01 [0.97 , 1.05] ? - ? - + ? +
Kanyago 2013 54 73 39 65 6.0% 1.23 [0.97 , 1.57] ? + ? - - + +
Li 2010 400 402 224 322 7.2% 1.43 [1.33 , 1.54] - ? ? - + ? +
Li 2014 127 129 109 120 7.2% 1.08 [1.02 , 1.15] ? ? ? - + ? +
Lv 2014 484 628 66 314 6.2% 3.67 [2.95 , 4.56] + ? ? - + ? +
Millard 2013 95 100 99 100 7.2% 0.96 [0.91 , 1.01] + ? ? - + ? +
Millard 2014 93 100 48 50 7.1% 0.97 [0.90 , 1.05] + + ? - + + +
Pang 2015 27 28 20 28 6.0% 1.35 [1.06 , 1.72] ? ? ? - + - +
Ren 2014 133 136 74 84 7.1% 1.11 [1.02 , 1.21] ? ? ? - + - +
Shenje 2016 44 50 23 25 6.7% 0.96 [0.82 , 1.12] + + ? - + + +
Wang 2014 58 60 60 60 7.2% 0.97 [0.91 , 1.02] + ? ? - + ? +
Wang 2017 50 51 39 51 6.7% 1.28 [1.10 , 1.50] + ? ? - + ? +
Subtotal (95% CI) 2318 1717 88.8% 1.20 [1.03 , 1.40]

Mutabazi 2012 91 150 55 76 6.4% 0.84 [0.69 , 1.01] + + ? - + + +
Tshimanga 2016 74 160 23 80 4.7% 1.61 [1.10 , 2.36] + ? ? - + - +
Subtotal (95% CI) 310 156 11.2% 1.14 [0.57 , 2.28]
Total (95% CI) 2628 1873 100.0% 1.19 [1.04 , 1.37]

Test for overall effect: Z = 2.44 (P = 0.01) Favors surgery Favors devices
Risk of bias legend

(G) Other bias

Inadequate removal of foreskin Moderate adverse events
None of the studies reported inadequate removal of the foreskin. Subgroup analyses strongly favored ligature-based devices (RR
0.17, 95% CI 0.02 to 1.60) over crush-based devices (RR 1.60, 95%
Subgroup analyses CI 0.67 to 3.80) (Analysis 1.2). The test for interaction did not meet
We attempted to do preplanned subgroup analyses for the statistical significance (P = 0.07).
use crush-based versus ligature-based devices for all outcomes.
Mild adverse events
Serious adverse events Effects size for both subgroups were similar (Analysis 1.3).
No effect size could be calculated for either group and there was
therefore no suggestion of a subgroup effect (Analysis 1.1).
Informed decisions.

Operative time From the included studies, the mean duration for the standard
surgical procedure was 24 minutes (ranging from 15 minutes to
Operative time favored crush-based devices (MD –18.31 minutes,
31 minutes). The procedure is reduced by about 17 minutes (95%
95% CI –21.05 to –15.57) over ligature-based devices (MD –11.07
CI –20 to –15; moderate-certainty evidence) when a device is
minutes, 95% CI –13.52 to -8.62) (Analysis 1.4). The test for
used rather than the standard surgical method. For the outcome
interaction was significant (P = 0.0001) supporting the notion that
pain, there may be less pain postoperatively within the first
this may not be a chance finding.
24 hours when a circumcision device was used (low-certainty
Pain evidence). Furthermore, there may be little or no difference in
postoperative pain during the first seven days when compared
Pain during the first 24 hours with standard surgical techniques (very low-certainty evidence).
Pain during the first 24 hours after circumcision favored crush- Participant satisfaction may be slightly greater when a circumcision
based devices (MD –1.38, 95% CI –2.56 to –0.20) over ligature-based device is used compared to standard surgical techniques (low-
devices (MD –0.60, 95% CI –0.96 to –0.24) (Analysis 1.5), but the test certainty evidence).
for interaction did not meet statistical significance (P = 0.21).
Overall completeness and applicability of evidence
Pain during the first seven days
In our review process, we identified 18 trials addressing the review
We were unable to conduct any subgroup analyses. question. Most trials used crush circumcision devices rather than
ligature devices. It is of note that the trials were conducted
Pain during erection exclusively in China and countries in sub-Saharan Africa, which
We were unable to conduct any subgroup analyses. may affect the applicability of our findings to other high-income
settings. However, there is no reason why these devices would
Participant satisfaction work differently in such a setting, except that the health system
and training of professionals who perform these procedures may
Effects size for both subgroups were similar (Analysis 1.8).
differ from resource-constrained settings. Low- to middle-income
Sensitivity analyses countries generally have fewer specialist doctors trained to perform
surgical circumcisions. All the included trials comprised medically
We were unable to conduct any predefined sensitivity analyses trained doctors with varying levels of experience performing the
since all studies were similar with regard to overall risk of bias and device-based circumcisions. Two trials also included nurses who
length of follow-up. carried out the device-based procedures, suggesting that this task
could potentially be shifted to nurses thus saving on costs in the
DISCUSSION long term. Insights into the level of health practitioner required for
these procedures and feasibility of task shifting or sharing would
Summary of main results require further evaluation in trials/VMMC programs where this is
See Summary of findings 1. being initiated.
Male medical circumcision conducted in health facilities by trained We attempted to obtain clarity from the contact authors.
healthcare providers is considered a relatively safe procedure that Consequently, we summarized the reported adverse events in
has been practiced for many years (WHO 2012). We conducted a Table 1.
comprehensive search for trials of circumcision devices compared
to standard surgical procedures for boys older than 10 years and Another area for research not covered by this review would be
men to evaluate the differences in adverse events, pain, operative circumcisions conducted in line with cultural norms in which
time and participant satisfaction. We included 18 trials, with 5246 traditional healers may perform the procedure. Therefore, it
participants, the majority were older than 10 years. The trials were is not clear how these crush and ligature devices would be
conducted in lower- and middle-income countries including China implemented outside the health system, within more traditional
(one trial), South Africa (three trials), Rwanda (one trial), Kenya (one settings. This was outside of the scope of the review, which
trial), Zimbabwe (one trial), Malawi (one trial), Mozambique (one considered procedures done by health professionals, but may have
trial) and Zambia (one trial). The devices we evaluated fell into one important implications for implementation across other settings.
of two types, either the crush device or ligature devices (WHO 2012). Our main primary and secondary outcomes were adverse events.
In our review, we found that when a circumcision device is used We extracted data from 11 trials for adverse events. Six included
compared to a standard surgical technique, there are probably no studies were reported in Chinese and required translation (Huo
more serious adverse events such as hospitalization or permanent 2015; Li 2010; Li 2014; Miao 2015; Pang 2015; Ren 2014), and
damage (moderate-certainty evidence). There may be slightly more we were unable to extract adverse event data from these trials.
moderate adverse events that require an intervention such as Further, one South African trial did not report adverse events in
suturing or antibiotics (low-certainty evidence). We are uncertain enough detail for us to extract data (Lagarde 2009). Overall, we
whether there is a difference in mild adverse events that require found that there were no serious adverse events reported in any
little intervention such as minor bleeding (very low-certainty of the trials of 5246 participants. There were also very low rates
evidence). The certainty of the evidence for adverse events was of moderate and minor adverse events reported. In many respects
downgraded due to low event rates and, therefore, imprecision and this is reassuring, as these adverse outcomes may not be common.
possible outcome assessment bias. However, most trials were powered to consider the outcome
operative time and, therefore, would have been underpowered to
answer these clinically relevant questions about harms. The result
Informed decisions.

was that the certainty of our evidence ranged from moderate to very • Imprecision: we downgraded analyses with wide CIs, including
low and further suitably powered trials would provide insight into appreciable benefit, and harm with low numbers of events in
adverse events rates. each arm were downgraded.
• Publication bias: there was no reason to downgrade for any
The included studies had differing eligibility criteria, as some outcomes when assessing the potential for publication bias
included participants with genital conditions, whereas others using the funnel plots.
only included healthy participants. There were also two studies
that included males under 10 years old (Miao 2015; Ren 2014). • Selective reporting bias: trials with a protocol registration were
evaluated for selective reporting.
The circumcision device mechanisms and surgical procedures
also differed across studies. Also, device-based techniques for
Potential biases in the review process
circumcisions may not be appropriate in men with certain penile
anatomic abnormalities such as a tight phimosis. Postoperative We adhered to rigorous Cochrane standards to minimize bias in the
wound/infection control and pain management were not clearly process of conducting and reporting this review. There is a broad
described, which may have skewed the results for these outcomes. range of names given to circumcision devices in this field, which
Furthermore, the adverse events were generally similarly reported, could lead to overlooked trials during our search. Special effort
except for the six Chinese language studies. Continuous outcomes was made to conduct an exhaustive search which included hand-
such as pain and operative time were reported as medians instead searching of reference lists and conference abstract proceedings.
of means in some studies making the data difficult to incorporate Additionally, our search may not have identified 'negative' studies,
in meta-analyses. and articles written in the Chinese language. A further limitation of
this review was the inability to search Embase during the second
We did not compare different circumcision devices, as this was out search in May 2018 as the license had expired. Furthermore, CINAHL
of the scope of this review. Furthermore, we did not include an was not searched, although this was planned in the protocol. Last,
assessment of resource use, costs or cost-effectiveness. Economic the WHO has classified these devices into three categories; clamp,
data are important for decision-makers to guide decisions on ligature and elastic collar compression. When writing the protocol,
whether circumcision devices work better but they also need to this third category of devices was categorized as a ligature-based
decide on whether approving new methods may lead to a more device, and thus we did not incorporate this as a search term in
efficient use of resources. This is especially important in resource- our search strategy. Furthermore, in August 2019, Professor Millard
limited settings where the included trials of this review were noted in an email correspondence that the PrePex circumcision
conducted; and the WHO has promoted the use of circumcision device used in two trials (Mutabazi 2012; Tshimanga 2016) had
devices as a means to reduce costs (WHO 2013a). There is a been withdrawn (Millard 2019). This may necessitate a potential re-
knowledge gap and a systematic review is needed to assess evaluation of our findings.
resources and costs such as the device itself, delivery methods,
product registration, introduction and staff training. There was variable reporting of pain between studies and it
is likely that there was different intra- and postoperative pain
Quality of the evidence management between intervention groups of trials and between
trials. Furthermore, not all studies evaluated pain at the same time
We graded the certainty of the evidence base using the GRADE
points and time points chosen in the current review evaluating pain
approach. We found that the level of evidence ranged from very low
as a quantitative outcome, allow for comparisons between devices
to moderate. The following reasons for downgrading are provided.
and standard surgical circumcision (WHO 2013a). For circumcision
• Study limitations: selection bias was frequently unclearly devices, we reported pain during device placement and removal,
reported in most studies, raising concern as to whether as well as in situ use, in the narrative additional tables section
participants with genital conditions or poorer baseline values of this review (Table 2). Also, pain protocols varied between the
may have been allocated to the surgical group. Furthermore, studies. Not all studies reported on how pain was managed in the
performance bias was a concern as studies were either unclear perioperative period and on the discharge of participants. These
or did not blind participants and personnel. In particular, factors potentially lead to considerable heterogeneity in these
participants may have been treated differently during the trials. outcomes. Overall, using the GRADE approach, we found that the
Personnel may have provided better pain management during pain evidence was of very low certainty due to imprecision and
and after procedures, or postoperative hygiene care may have study limitations and further trials are likely to provide insight.
been emphasized in one group more than the other. Similarly,
detection bias was a concern because it was unclear whether Agreements and disagreements with other studies or
subjective outcome assessors were blinded. Hence, we judged reviews
the certainty of the evidence to be low or very low for the This systematic review included only RCTs. It applied rigorous
subjective outcomes. Naturally, we acknowledge the difficulty Cochrane methodology with GRADE evaluation to rate the certainty
in blinding personnel conducting the procedures, as well as of the evidence. We compared a wide range of circumcision device
participants and outcome assessors in such trials. types including in situ and disposable devices with standard
• Inconsistency: there was considerable unexplained surgical techniques. The search identified four systematic reviews
heterogeneity prompting us to downgrade the certainty of the and meta-analyses (Cao 2015; Fan 2016; Huang 2017; Huo 2017).
evidence for serious inconsistency. We made an exception for Findings of these reviews can be found in Appendix 3. Of these four
'operative time,' which was not downgraded despite statistical systematic reviews, two included network meta-analysis (Fan 2016;
heterogeneity because there was a consistent reduction in time Huang 2017). Unlike our study, these four reviews did not combine
of at least 10 minutes in the intervention group compared to the all devices when comparing against standard surgical techniques.
standard surgical group. Furthermore, they did not include a certainty of evidence rating
Informed decisions.

but did highlight the methodological limitations of their included Device-based circumcision procedures in comparison to standard
studies. Three systematic reviews assessed adverse events (Cao surgical techniques are consistently reported to be significantly
2015; Huang 2017; Huo 2017), but did not classify them according shorter to conduct, and easier to learn and execute, thus,
to the WHO's Framework for Clinical Evaluation of Devices for Adult minimizing surgical skills and requirements such as injected
Male Circumcision, which provides standardized definitions for anesthesia and suturing. This allows for task-shifting to other
grading adverse events as mild, moderate or severe (WHO 2012; mid-level cadres of staff (nurses and medical officers) and has
WHO 2013a). Three reviews were not in agreement with our results the potential for rapid scale-up of VMMC programs for HIV
and they reported that participants were less likely to have adverse prevention in resource-constrained settings (Barone 2014; Ridzon
events when circumcised with a device compared to standard 2016). However, the use of device-based techniques, does not
surgical techniques. However, Huang 2017 compared disposable eliminate the need for surgical VMMC services as some patients
circumcision suture device (DCSD) and SR devices separately to may not be eligible for a device or would prefer a standard surgical
surgical techniques and reported that participants in the SR group circumcision. Abnormal foreskin anatomy and complications
had higher odds of developing adverse events than those in the related to device use such as slippage or displacement, although
standard surgical technique group. rare, may occur, and require surgical intervention. Thus, healthcare
providers involved in VMMC services should be aware of the
Three systematic reviews reported postoperative pain (Fan 2016; limitations in their skills and expertise and know when to
Huang 2017; Huo 2017). One review did not specify when pain refer to a more qualified clinician should a complication occur
was measured (Fan 2016). The other two reviews measured pain (WHO 2013b). In summary, findings from our systematic review
within 24 hours (Huang 2017; Huo 2017). Two reviews reported that support findings from other reviews related to shorter operative
participants circumcised with devices experienced less pain (Fan time with use of circumcision devices. In comparison to the
2016; Huo 2017). Similar to our findings, they found statistically other reviews described, our review compared a wide range of
significant differences while Huang 2017 reported that participants circumcision devices with standard surgical techniques, used an
experienced pain similarly across the three groups. However, our up-to-date, comprehensive, reproducible search strategy and a
certainty of evidence for pain was low. Participants may have less formal assessment of the certainty of the evidence.
pain from a circumcision device within 24 hours and during the first
seven days there may be little or no difference between the two AUTHORS' CONCLUSIONS
groups.
Implications for practice
Shorter operative time with circumcision devices was a consistent
finding across all reviews and meta-analyses, including ours (Cao We found no differences in serious adverse events when
2015; Fan 2016; Huang 2017; Huo 2017). Notably, reviews by Cao circumcision was performed using a device, and there may be
2015; Huang 2017; and Huo 2017 reported a decrease in SMDs and slightly more moderate adverse effects, compared to standard
MDs of more than 15 minutes. This may be related to standardized surgical techniques. Importantly, circumcision devices probably
procedures making devices such as SR and PrePex easy to use. Four reduce operative time by around 17 minutes. Patients may feel
reviews measured participant satisfaction for penile appearance less postoperative pain within the first 24 hours and may slightly
(Cao 2015; Fan 2016; Huang 2017; Huo 2017). Similarly to our prefer the use of a device rather than standard surgical procedures.
results, these reviews indicated that participants in the device Therefore, circumcision devices are an option for use in clinical
groups were more satisfied than those in the standard surgical practice, and, as they represent a simpler procedure, may enable
groups. task-shifting to different healthcare workers. However, the results
of our systematic review should be considered in conjunction with
Circumcision devices are minimally invasive and do not other contextual factors such as cost; patient preferences and
require cautery or suturing for wound closure compared to values; and access to trained, skilled healthcare workers and health
standard surgical circumcision (Barone 2014). With DCSD, there care in some settings.
is simultaneous mechanical cutting and suturing making the
procedure simple and quick (Huo 2017). Regarding the other Implications for research
outcomes evaluated, differences between our review and the Considering our findings, we have highlighted the following
four reviews (Cao 2015; Fan 2016; Huang 2017; Huo 2017) may research priorities.
be due to heterogeneous study populations, differences in how
devices were categorized in our study (crush versus ligature) as • The certainty of the evidence was low or very low for five
mechanisms of action, need for injectable or topical anesthesia, of the seven outcomes. Thus, there is uncertainty for most
device placement and removal, time in situ and wound closure of our findings. Future trials should be better powered for
techniques may differ between devices within these generic pain outcomes and should describe or improve (or both) their
categories. There were differences in reporting of outcomes such sequence generation and allocation concealment methods.
as follow-up times, pain scores, protocols for pain management, Blinding of participants and personnel may not be feasible
participant satisfaction rating and adverse events or complications in surgical trials, thus performance bias remains an issue to
(Fan 2016). Also, qualifications of staff performing both device- consider. However, future trials need to find ways to blind
based and surgical circumcisions were not the same across studies outcome assessors.
included in the current review (specialist surgeons/urologists • We found that not all trials reported adverse events in
versus general practitioners versus medical officers and nurses). a standardized way as per the World Health Organization
This may influence operative outcomes due to differences in Framework for Clinical Evaluation of Devices for Adult Male
surgical skill and expertise among these types of healthcare Circumcision making it challenging for review authors to classify
providers. these outcomes appropriately (WHO 2012).
Informed decisions.

• There is a need to evaluate outcomes in routine healthcare African Medical Research Council, for travel to Cape Town (22–23
settings, explore other issues related to patient acceptability May 2017) to work on the review.
such as discomfort and odor for in situ devices, period of sexual
abstinence following device placement, and how in situ devices We thank Cochrane Urology, our Contact Editor Philipp Dahm and
affect occupational and daily living activities (WHO 2013a; WHO Managing Editor Robert Lane for the support we received.
2013b).
We acknowledge the support received from those contacted via
• Feasibility and program costs associated with the use of task exchange Nai Ming Lai, Shenxing Du, Xun Li, Ruo-Wen Jiang
circumcision devices need further evaluation. and Yijun Cai and Joy Oliver and Elizabeth Pienaar who assisted us
with developing the search strategy and conducting the searches.
ACKNOWLEDGEMENTS
Tamara Kredo is partly supported by the Research, Evidence and
The authors would like to acknowledge support received from
Development Initiative (READ-It) project. READ-It (Project number
Cochrane South Africa, South African Medical Research Council.
300342-104) is funded by UK aid from the UK government; however,
SE received a travel allowance from Cochrane South Africa, South
the views expressed do not necessarily reflect the UK government's
official policies.
Informed decisions.

REFERENCES

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* Indicates the major publication for the study
November 2015).

Informed decisions.

CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]

Huo 2015
Methods Design: prospective RCT conducted in China. Safety and efficacy of a new male circumcision technique
involving a circular stapler investigated. 180 participants were prospectively enrolled from Department
of Urology, Guangxi Zhuang Autonomous Region People's Hospital.
Ethical approval: The People's Hospital of Guangxi Zhuang Autonomous Region Ethics Committee
Consent: participants provided written informed consent.
Duration of study: enrollment December 2013 to August 2014
Participants Inclusion criteria: adult men with redundant prepuce or phimosis, who had the indication of circumci-
sion (per 2014 Guidelines for the Diagnosis and Treatment of Urological Diseases in China). For the se-
lection criteria, see "Guide to the Diagnosis and Treatment of Urology in China" edited by Na Yanqun.
(那彦群, 叶章群, 孙颖浩, 等主编. 中国泌尿外科疾病诊断治疗指南. 第 1 版. 北京: ⼈⺠卫⽣出版
社, 2014. 406–7).
Exclusion criteria: urinary tract infection or balanoposthitis; severe adhesion between the inner fore-
skin layer and the glans, or short frenum and coagulation disorder; diabetes mellitus or other lying dis-
eases that influenced the effect of surgery.
Baseline characteristics: comparable between groups. No statistically significant difference existed

between age, phimosis and redundant prepuce of 2 groups. Circumcision device group mean age was
30.4 (SD 9.1) years, traditional method mean age was 31.7 (SD 11.7) years
Interventions Providers: experienced urologists.
Intervention group (stapler): 120 participants. The penis was prepared and disinfected using povi-
done-iodine. Local anesthesia performed with 1% lidocaine. Appropriate size of stapler device (Jiangxi
Yuanshenglanghe Medical Equipment Company, China) ascertained by measuring diameter of penis
and procedure conducted according to a defined protocol. Dressing change and evaluation on wound
healing was performed on the 1st, 4th and 7th day after surgery.
Follow-up: pain assessed 24 hours post-procedure. Foreskin oedema assessed on day 7, satisfaction

assessed on day 3 and 30 post-procedure.
Control group (conventional): 60 participants. Dorsal slit circumcision procedure.
Follow-up: pain assessed 24 hours post-procedure. Foreskin oedema assessed on day 7, satisfaction

assessed on day 3 and 30 post-procedure.
Outcomes Primary outcomes:
• operative time (minutes)

• pain score (24 hours after surgery)
• intraoperative blood loss volume (mL)
• incision edema (7 days after surgery): distinguished from other complications and summarized by 3
grades
• postoperative complications/adverse events (infection, hematoma, ecchymosis, reoperation) (24
hours postintervention)
• wound healing time (days)
• cosmetic penile appearance (1 month after surgery)
Funding sources Not stated
Informed decisions.

Huo 2015 (Continued)
Declarations of interest Not stated
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence genera- Low risk Used a random number table.

tion (selection bias)
Allocation concealment Unclear risk No details provided.

(selection bias)
Blinding of participants Unclear risk Not described. Participants were likely aware of interventions received.
and personnel (perfor-
mance bias)
All outcomes
Blinding of outcome as- High risk Not described. Providers were likely aware of interventions; outcome assess-
sessment (detection bias) ment for subjective outcomes may have been affected by lack of blinding; rat-
Subjective outcomes (se- ed at high risk of detection bias.
vere adverse events, mod-
erate adverse events, mi-
nor adverse events, pain,
patient satisfaction)
Blinding of outcome as- Low risk Not described. A lack of blinding is unlikely to have resulted in detection bias
sessment (detection bias) for the outcome 'operation time,' which we considered objective.
Objective outcomes (oper-
ative time)
Incomplete outcome data Low risk No missing data or missing data had limited effect on results.
(attrition bias)
All outcomes
Selective reporting (re- Unclear risk No study protocol; unclear whether there may have been selective outcome
porting bias) reporting.
Other bias Low risk No other biases identified.

Jin 2015
Methods Design: prospective RCT conducted in China. Safety and efficacy of a new male circumcision technique
involving the use of a circular stapler was investigated. 879 participants were prospectively enrolled
from 4 urologic departments: The First Affiliated Hospital, Beilun People's Hospital, Yuyao People's
Hospital, and Xiangshan First People's Hospital.
Ethical approval: the Zhejiang University Ethics Committee
Duration of study: enrollment March 2013 to March 2014
Participants Inclusion criteria: men aged 18–70 years with a redundant prepuce or phimosis.
Informed decisions.

Jin 2015 (Continued)
Exclusion criteria: acute infection of the genitalia (acute posthitis or balanitis), thickened prepuce sec-
ondary to chronic inflammation, severe foreskin adhesion, or other contraindications to male circumci-
sion such as a concealed penis or a sexually transmitted disease.
Baseline characteristics: comparable between groups. However, an increased number of participants

in the conventional group had phimosis, which was statistically significant between the 2 groups. Cir-
cumcision device group mean age was 26.9 (SD 9.1) years, conventional group mean age was 25.3 (SD
7.1) years.
Interventions Providers: trained urologists.
Intervention group (stapler): 441 participants. Appropriate size of stapler device ascertained by mea-
suring penis just below glans. The penis was disinfected using povidone-iodine. Dorsal penile nerve
block and circumferential block performed with 1% lidocaine, and procedure conducted according to a
defined protocol.
Follow-up: 56 participants in stapler group were followed up for 1 year.
Control group (conventional): 438 participants. Male circumcision performed using dorsal slit tech-
nique with an electric scalpel (Sanli Medical Equipment Company, China) in accordance with WHO
guidance manual.
Participants in both groups were counselled to avoid sexual intercourse and masturbation for about 4
weeks after the procedure.
Follow-up: 1 day; 1, 2 and 3 weeks; and 1 and 3 months after surgery;

• pain score (intraoperative and 1 hour after surgery)
• blood loss volume (mL)
• postoperative complications (bleeding, wound dehiscence, severe edema, infection)
• healing time (days)
• satisfaction
• treatment costs (US dollars)
Definitions for each were clearly outlined in the paper.
Funding sources Qianjiang Talent Program of Science and Technology Agency of Zhejiang Province (#2013R10045)
Declarations of interest None stated
Notes
Risk of bias
Random sequence genera- Unclear risk No information provided to determine how a random sequence was generat-
tion (selection bias) ed. The only evidence to suggest randomization was in the title of the paper.
Allocation concealment High risk No information provided about allocation concealment. There was a differ-
(selection bias) ence in baseline characteristics where the standard surgical care group had
more participants with phimosis (11.2% surgical care group vs 6.8% in stapler
group; P < 0.05), which could account for poorer outcomes in this group com-
pared to the stapler group.
Informed decisions.

Jin 2015 (Continued)
Blinding of participants Unclear risk Blinding of participants and personnel was not possible with this surgical in-
and personnel (perfor- tervention; unclear whether this may have impacted the performance of either
mance bias) group.
All outcomes
Blinding of outcome as- High risk Blinding not mentioned in the trial report and was assumed unlikely. Despite
sessment (detection bias) the insufficient information on blinding and its potential impact, outcome as-
Subjective outcomes (se- sessment for subjective outcomes may have been affected by lack of blinding;
vere adverse events, mod- high risk of detection bias.
Blinding of outcome as- Low risk A lack of blinding is unlikely to have resulted in detection bias for the outcome
sessment (detection bias) 'time measurement,' which we considered objective.
ative time)
Incomplete outcome data Low risk All 441 participants randomized to the device group and 438 to the conven-
(attrition bias) tional group were reported. The reported attrition was < 10% and equal in
All outcomes both groups; low risk of attrition bias.
Selective reporting (re- Unclear risk No study protocol and, therefore, unclear whether there may have been selec-
porting bias) tive outcome reporting. There was no clinical trials registration number in the
published report.

Kanyago 2013
Methods Design: effectiveness RCT conducted in southwestern Uganda. Compared SR with FG male circumci-
sion. 138 adult male students (≥ 15 years) attending a local university and undergoing male circumci-
sion recruited from the surgical outpatient department.
Ethical approval: Institutional Review Board Committee at Mbarara University of Science and Technol-
ogy. Study registered with ClinicalTrials.gov (NCT01757938)
Consent: participants provided written informed consent. Those who presented for circumcision but
who did not consent to participate in the trial were offered standard FG adult male circumcision.
Duration of study: January–May 2011
Participants Inclusion criteria: adult male students attending Mbarara University (aged ≥ 15 years) who consented
to participate in the trial.
Exclusion criteria: self-reported HIV infection, chronic paraphimosis, genital ulcers, penile carcinoma,
filariasis, xerotica obliterans, balanitis, glans-prepuce adhesions, frenula scar tissue, or any urethral
anatomical abnormality such as hypospadias or epispadias.
Baseline characteristics: median age of participants: 22 (interquartile range 21–23) years.
Interventions Providers: single study surgeon performed all procedures; however, he had no prior experience with
the SR procedure.
Informed decisions.

Kanyago 2013 (Continued)
Intervention group (SR): 73 participants. Appropriate size of SR ascertained. Penis disinfected using
povidone-iodine solution. Dorsal penile nerve block and circumferential block performed with 1% lido-
caine.
Follow-up: assessed 1 hour after procedure, and on the 3rd, 7th, 14th and 21st postoperative days
Control group (FG): 65 participants. Male circumcision performed using a standard technique.
Follow-up: not reported for control group
• procedure time
• pain scores
• time to resumption of normal activity
• minor and major complications
• patient satisfaction
• time to complete healing
Funding sources 1 author, Mark J Siedner, received salary support from the Fogarty International Clinical Research
Scholars and Fellows Program at Vanderbilt University (R24 TW007988), and the NIH (T32 AI007433).
Declarations of interest SR devices supplied by an independent third-party with no affiliation to Wuhu Santa Medical Devices
Technology Co Ltd, China, who was not involved in the design, interpretation or writing of study.
Notes
Risk of bias
Random sequence genera- Unclear risk Process for generating the randomization sequence not described; unclear risk
tion (selection bias) of bias.
Allocation concealment Low risk Allocation concealment adequately reported; low risk of bias.
(selection bias)
Quote: "Consenting participants selected an opaque envelope from a box for
randomisation to SR or FG groups."
mance bias) group.
All outcomes
Blinding of outcome as- High risk No blinding of outcome assessment was done or was possible for the out-
sessment (detection bias) comes that were considered subjective. The presence of the non-surgical in-
Subjective outcomes (se- tervention, an SR, until removal would increase the potential risk of bias in
vere adverse events, mod- these subjective outcomes assessments.
Blinding of outcome as- Low risk The lack of blinding was unlikely to have resulted in a detection bias for this
sessment (detection bias) objective outcome.
ative time)
Informed decisions.

Kanyago 2013 (Continued)
Incomplete outcome data High risk There was differential attrition in the 2 groups: 25% attrition in surgical group
(attrition bias) and 0% attrition in device group. Investigators suggested that the loss to fol-
All outcomes low-up in the surgical group likely means that there were no adverse events to
report (participants with adverse outcomes are likely to present to the clinic).
However, the differential loss to follow-up without clear reporting on the rea-
sons for losses may have introduced a risk of bias. High risk of bias.
Selective reporting (re- Low risk Study protocol available on ClinicalTrials.gov (NCT01757938). All study's pre-
porting bias) specified outcomes were reported.

Lagarde 2009
Methods Design: RCT conducted in South Africa. Compared the TK device with FG male circumcision. 69 partici-
pants of the control group of a male circumcision RCT conducted in South Africa were recruited.
Ethical approval: University of the Witwatersrand Human Research Ethics Committee (Medical). Ad-
verse events forms were transmitted to a Data Safety Monitoring Board.
Consent: participants provided informed consent.
Duration of study: September–November 2004
Participants Inclusion criteria: uncircumcised males from the control group of a male circumcision RCT with no
contraindication to circumcision, of good general health with normal physical and genital condition
and consenting to participate in trial. They had to agree to avoid sexual contacts (except with condom
protection) during the 6 weeks following circumcision, consent to a medical visit 6 weeks after circum-
cision and consent to reporting of any adverse events.
Exclusion criteria: contraindications to circumcision, abnormal physical and genital conditions and
not consenting to participate in the trial.
Baseline characteristics: groups comparable with no statistically significant differences between

them for the listed characteristics. Circumcision device group mean age was 21.5 , interquartile range
(IQR) 20 - 23.25 years , traditional method mean age was 22, IQR (21 - 24) years.
Interventions Providers: 3 GPs who had extensive experience with FG circumcision method conducted both proce-
dures.
Intervention group (TK): 35 participants. Appropriate size TK ascertained. Penis disinfected using
povidone-iodine solution. Dorsal penile nerve block and circumferential block performed with 1% lido-
caine. Foreskin pulled slightly forward over rim of an inner tube and positioned inside an outer ring. 2
plastic arms locked into place to force 2 surfaces (inner tube and outer clamping ring) into tight contact
with foreskin trapped between them. If foreskin was tight, a dorsal slit was required to gain access for
ring to be applied over glans. Then foreskin trapped forward of clamping device was cut away. Device
was intended to remain on the penis for 7–10 days until removal or it fell off with the necrotized fore-
skin.
Control group (FG): 34 participants. Foreskin was pulled outwards in front of the glans, and forceps
clamped across it, parallel to the corona of the glans and immediately in front of the glans. The scalpel
was run across the face of the foreskin, and absorbable sutures used to close the cut edges. Excess
bleeding controlled with ligature, direct pressure or cautery. Sutured area was covered with sterile
paraffin tulle gras, sterile gauze and paper tape; dressing was removed 24–48 hours after surgery by the
GP who performed it.
Informed decisions.

Lagarde 2009 (Continued)
Follow-up: For all groups, 3 days after surgery and participants advised to return to center 6 weeks af-
ter surgery for a genital exam and completion of a short questionnaire. Adverse events recorded using
a standardized form.
• number and nature of adverse events

• penile infection
• delay in wound healing
• excessive or insufficient skin removed
• erectile dysfunction
• pain score
• bleeding within 2 weeks following the procedure
• lesions to the penis, swelling or hematoma within 2 weeks following the procedure, any problem when
urinating
• satisfaction with penis appearance
Funding sources Agence Nationale de Recherche sur le Sida et le Hépatites, Institut Nationale de la Santé et de la
Recherche Médicale (Paris) and National Institute for Communicable Diseases (NICD) (Johannesburg).
Quote: "INSERM and the NICD signed collaboration and licensing agreements with a private South
African company for providing all sterilised instruments and consumables for performing a single male
circumcision according to the FG method."
Declarations of interest Funders had no role in study design, data collection and analysis, decision to publish or manuscript
preparation.
Notes All participants who attended the center for their last visit of the male circumcision RCT follow-up re-
ceived a ZAR 150 (EUR 20) payment whether or not they participated in the study. Participants were
asked to return to the center 6 weeks after surgery for a genital exam and completion of a short ques-
tionnaire. Participants who attended this postcircumcision visit were paid ZAR 40.
Risk of bias
Random sequence genera- Unclear risk Process for development of the random sequence not described; unclear risk
tion (selection bias) of bias.
Allocation concealment Unclear risk Some information about allocation concealment was provided.
(selection bias)
Quote: "For randomisation, each participant chose an envelope containing the
group name from a basket of 10 envelopes. After each choice, a new envelope
taken sequentially from a set of envelopes prepared in such a way that each
set of 10 envelopes contained the same number of Usual and TK tokens, was
added to the basket."
Comment: certain details that would inform whether the allocation could be
tampered with were not provided. For example it was not reported whether
envelopes were sealed or opaque; unclear risk of bias.
mance bias) group.
All outcomes
Quote: "Neither GPs, participants nor investigators were blinded to the ran-
domisation group. At interview, the nurse was not aware of the method used
but on examination could conclude which technique was used."
Informed decisions.

Lagarde 2009 (Continued)
Blinding of outcome as- Unclear risk Outcome assessment was not blinded.
sessment (detection bias)
Subjective outcomes (se- Quote: "…nurse who performed the interview and the clinical examination
vere adverse events, mod- was blinded to the intervention group, but was obviously able to identify the
erate adverse events, mi- group from seeing the scar."
As many of the outcomes were subjective, this may have introduced a high risk
of detection bias.
Incomplete outcome data High risk There was greater attrition in the TK group (20% with TK vs 10% with surgery).
(attrition bias) 4 participants crossed over to the standard surgical group. 19/35 participants
All outcomes randomized to the TK group were analyzed for all the outcomes; 7 partici-
pants did not visit the GP after circumcision and were excluded from the analy-
ses. 29/34 participants randomized to the FG group were analyzed for all out-
comes; 6 did not visit the GP in the FG group and were excluded from further
analyses. High risk of attrition bias.
Selective reporting (re- Unclear risk No study protocol and, therefore, it was unclear whether there may have been
porting bias) selective outcome reporting. No mention of clinical trials database registra-
tion.
Other bias High risk There was potential for bias due to early stopping of the trial and the trial
not meeting its planned sample size for the primary outcome (power). The
planned number of participants of 400 in each group was not achieved be-
cause of trial interruption owing to a high number of adverse events in the TK
group.
Quote: "The protocol was designed to randomize participants to three groups,

including men circumcised with a single-use sterile surgery kit, but because of
delay in its availability, the study started with only two (the TK vs. FG method
with re-usable instruments). The postcircumcision visit was originally planned
exactly 6 weeks after surgery, but only 3 participants made the visit 1–3 days
before 6 weeks. Median and mean intervals between circumcision and vis-
it were more than 6 weeks. The trial investigators informed the DSMB and
stopped the trial."
Comment: the TK supplier attributed the high number of adverse events to the
inexperience of GPs using the device and an experienced practitioner was sent
to provide additional training to the GPs.

Li 2010
Methods Design: prospective RCT conducted in China. The safety and efficacy of SR circumcision compared to
conventional surgical procedures was investigated. 724 participants prospectively enrolled from the
Department of Urology in Shaanxi Second People's Hospital.
Ethical approval: not described
Duration of study: enrollment March 2008 to August 2009
Participants Inclusion criteria: males who wished to undergo circumcision.
Exclusion criteria: not described.
Informed decisions.

Li 2010 (Continued)
Baseline characteristics: participant characteristics comparable between groups. Circumcision de-
vice group, there were 282 participants in the 16 - 35 years age group, 98 participants in the 36 - 55 age
group, 22 in the 56 - 69 age group. For the traditional methods group, there were 219 participants in the
16 - 35 years age group, 87 participants in the 36 - 55 age group, 16 in the 56 - 69 age group.
Interventions Providers: not described in detail.
Intervention group (SR): 402 participants (single or double date of visit). Appropriate size of SR was
ascertained. Penis was disinfected using povidone-iodine solution. Dorsal penile nerve block and cir-
cumferential block performed with 1% lidocaine.
Follow up: Pain assessed at 24 hours post-procedure
Control group (conventional): 322 participants. A circumcision laser incision was used.
Follow up: Pain assessed at 24 hours post-procedure
Outcomes Postoperative observation items:
• operation time (minutes)

• postoperative pain scores (24 hours after surgery) using VAS
• postoperative complications (bleeding, wound dehiscence, edema, infection, healing time)
• postoperative appearance satisfaction
• postoperative sexual function
• cost
Funding sources Unclear
Declarations of interest Unclear
Notes
Risk of bias
Random sequence genera- High risk Participants were randomized according to day/date of clinic visit.
Allocation concealment Unclear risk Not described.

(selection bias)
Blinding of participants Unclear risk Not described. Participants were likely aware of interventions they had re-
and personnel (perfor- ceived.
mance bias)
All outcomes
sessment (detection bias) ment for subjective outcomes may have been affected by lack of blinding; high
Subjective outcomes (se- risk of detection bias.
Blinding of outcome as- Low risk Not described. A lack of blinding was unlikely to have resulted in detection
sessment (detection bias) bias for the outcome 'operation time,' which we considered objective.
ative time)
Informed decisions.

Li 2010 (Continued)
(attrition bias)
All outcomes
Selective reporting (re- Unclear risk No study protocol available and, therefore, it was unclear whether there may
porting bias) have been selective outcome reporting.

Li 2014
Methods Design: prospective RCT conducted in China. The safety and efficacy of a new male circumcision tech-
nique involving the use of a circular stapler was investigated. 249 participants prospectively enrolled
from Department of Urology, Second Affiliated Hospital of Wenzhou Medical University.
Ethical approval: not stated
Duration of study: May 2013 to December 2013
Participants Inclusion criteria: men with redundant prepuce or phimosis, who intended to have circumcision.
Exclusion criteria: acute urinary tract infection, occult penis, severe foreskin penis head adhesion, too
short foreskin and long foreskin, history of neurologic or psychiatric disorders, leukemia, bleeding dis-
orders and uncontrolled diabetes.
Baseline characteristics: participant characteristics comparable between groups in age, phimosis and
redundant prepuce. Mean age of both groups combined was 26.94 (SD 6.25) years.
Interventions Providers: not described in detail.
Intervention group (stapler): 129 participants. Appropriate size of stapler device (Jiangxi Yuan-
shenglanghe Medical Equipment Company, China) ascertained and procedure performed according to
defined protocol.
Follow up: pain assessed at 24 hours, 3rd and 30th day post-procedure.
Follow up: pain assessed at 24 hours, 3rd and 30th day post-procedure.

• pain score using VAS (intraoperative and 24 hours after surgery)
• postoperative complications (infection, edema, bleeding, wound dehiscence)
• wound healing time (days)
• penile appearance satisfaction (3 days and 1 month after surgery)
• total treatment cost (Chinese Yuan)
Informed decisions.

Li 2014 (Continued)
Notes
Risk of bias
Random sequence genera- Unclear risk No details given.

Allocation concealment Unclear risk No details given.

(selection bias)
Blinding of participants Unclear risk Not described. Participants were likely aware of interventions.
and personnel (perfor-
mance bias)
All outcomes
ative time)
(attrition bias)
All outcomes
Selective reporting (re- Unclear risk No study protocol and, therefore, unclear whether there may have been selec-
porting bias) tive outcome reporting.

Lv 2014
Methods Design: prospective RCT conducted at 5 different hospitals in China. Compared conventional circumci-
sion vs SR vs DCSD. 942 participants from 5 hospitals.
Ethical approval: ethics committee (number: 2012-Research-52)
Duration of study: October 2012 to May 2013
Participants Inclusion criteria: men requiring circumcision for a redundant prepuce or phimosis.
Exclusion criteria: ages < 18 years, dense adhesions between glans and foreskin and obese men with
partly buried penis.
Informed decisions.

Lv 2014 (Continued)
Baseline characteristics: mean age across groups: 31.5 (SD 5.4; range 18–58) years. No significant age
differences between groups (P > 0.05). No other comments were made regarding other characteristics
evaluated across groups. Mean age of both groups combined was 31.5 (SD 5.4) years, age ranging be-
tween 18 - 58 years.
Interventions Providers: 1 experienced surgeon who had performed conventional and SR circumcisions and was
trained to use the devices before the study began was chosen from each of the 5 hospitals.
Intervention group 1 (DCSD): 314 participants. 5% lidocaine cream was used for anesthesia. The de-
vice had bell-shaped glans pedestal, suture staple, ring-shaped blade, handle and shell. The glans was
covered by the U-shaped glans rest with the edge of the U-shape at the level of the coronary sulcus. Af-
ter the foreskin was wrapped around the rod, the rod was inserted into the center hole of the circumci-
sion device. The application knob was tightened, the safe buckle was removed and the rod was pushed
down to trigger the circumcision device. After triggering the application knob when the ring-shaped
blade hidden in the shell was pushed out with the staples. The blade cut the foreskin instantly, while si-
multaneously placing staples, by tightening the application knob at the bottom for 3–5 seconds and re-
leasing it.
Intervention group 2 (SR): 314 participants. 2% lidocaine injection (10 mL) for dorsal penile nerve
block and a suitable sized device used.
Control group (conventional): 314 participants. 2% lidocaine injection (10 mL) for dorsal penile nerve
block and a traditional electrosurgical knife and absorbable suture used.
Follow-up: 1 and 2 weeks, and 1 month after for all groups
• postoperative complications (hematoma, edema, disruption of incision, incision infection)

• healing time
• intraoperative and postoperative pain
• intraoperative blood loss
• operation time
Funding sources Jiangxi Yuansheng Lang He Medical Instrument Co., Ltd. for the equipment and technique provided.
Declarations of interest Authors declared no competing interests.
Notes
Risk of bias
Random sequence genera- Low risk Random number table used to develop random sequence.
Allocation concealment Unclear risk No information about the process for ensuring allocation concealment.
(selection bias)
mance bias) group.
All outcomes
No information provided regarding blinding of participants and personnel.
Informed decisions.

Lv 2014 (Continued)
Blinding of outcome as- High risk Outcome assessment was unblinded and would most likely result in detection
sessment (detection bias) bias for the subjective outcomes.
Subjective outcomes (se-
vere adverse events, mod- The researchers attempted to standardize outcome assessment for adverse ef-
erate adverse events, mi- fects, as it stated in the paper.
Quote: "we defined assessment standards for incision healing: the incision is
closed and covered by skin, no rupture under moderate exercise; with time,
the healed incision can withstand certain stretching force and pressure, the
pigmentation is relieved and is close to the color of normal skin; return to the
intact normal skin function."
Comment: despite this, as outcome detection still had an element of subjectiv-

ity; high risk of detection bias.
Blinding of outcome as- Low risk Lack of blinding was unlikely to affect the outcomes assessment of operative
sessment (detection bias) time, which we considered an objective outcome.
ative time)
Incomplete outcome data Low risk All participants randomized were included in the analysis of all outcomes.
(attrition bias)
All outcomes
Selective reporting (re- Unclear risk No study protocol. Therefore, unclear whether there may have been selective
porting bias) outcome reporting. No mention of clinical trials database registration.

Miao 2015
Methods Design: prospective RCT conducted in China. Clinical effects of circumcision stapler, circumcision cer-
clage and traditional circumcision in the treatment of phimosis and redundant prepuce. 276 partici-
pants prospectively enrolled from Department of Urology, Zhangjiagang First People's Hospital.
Ethical approval: First Hospital of Zhangjiagang Affiliated to Suzhou University Ethics Committee
Duration of study: January 2012 to January 2014
Participants Inclusion criteria: Males with redundant prepuce or phimosis.
Exclusion criteria: people with acute inflammation, edema or deformity in the surgical site.
redundant prepuce. Mean age 22.5 (SD 5.7) years, ranging from nine to 56 years.
Interventions Providers: not clearly described.
Intervention group 1 (stapler): 92 participants. Appropriate size of stapler device (Jiangxi Yuan-
shenglanghe Medical Equipment Company, China) ascertained by measuring diameter of penis using a
specialized measurement card. Dorsal penile nerve block with 1% lidocaine (5–10 mL) and procedure
performed according to a defined protocol.
Intervention group 2 (cerclage): 92 participants. Disposable circumcision ring pack produced by

Guangzhou Nanfeng Biotech Company. Hemostatic forceps used to clamp the inner and outer plates
Informed decisions.

Miao 2015 (Continued)
of both sides of foreskin and side bands of foreskin, double-stretch elastic ligature used to evenly ligate
the foreskin in groove of collar, excess foreskin removed and wound disinfected.
Follow up: 3 months for both intervention groups
Follow up: 3 months

• pain score using VAS (intraoperative and 24 hours after surgery)
• postoperative complications (edema, hematoma, deformity and infection)
Notes Information on the proportion of the total number of participants younger than 10 years was not avail-
able
Risk of bias


(selection bias)
mance bias)
All outcomes
ative time)
(attrition bias)
All outcomes
Selective reporting (re- Unclear risk No study protocol; therefore, it was unclear whether there may have been se-
porting bias) lective outcome reporting.
Informed decisions.


Millard 2013
Methods Design: single-center non-blinded RCT conducted in Mozambique. Compared open surgical circumci-
sion with suturing and Gomco instrument plus tissue adhesive. 200 participants recruited via a poster
at the medical school in Beira, Mozambique.
Ethical approval: University of Pittsburgh Institutional Review Board and the National Committee of
Bioethics of the Mozambique Ministry of Health
Duration of study: 30 October 2012 to 2 March 2013
Participants Inclusion criteria: healthy uncircumcised men ages > 18 years, including men with a scarred frenulum.
Exclusion criteria: concurrent illness, history of bleeding disorder, previous reaction to local anesthet-
ic, infection, penile abnormality and phimosis.

them for the listed characteristics. Circumcision device group, there were 49 participants in the 18 - 20
years age group, 27 participants in the 21 - 24 age group, 24 in the > 25 age group. For the traditional
methods group, there were 43 participants in the 18 - 20 years age group, 26 participants in the 21 - 24
age group, 31 in the > 25 age group.
Participants received HIV prevention counseling. HIV testing offered, but was not a study prerequisite.
Participants advised to abstain from sexual intercourse until wound was completely healed and for ≥ 4
weeks after circumcision.
Interventions Providers: 2 doctors performed each circumcision: a faculty member – highly experienced in circumci-
sion – and a recent medical graduate with basic surgical skills. As junior team members became more
skilled, they performed more of the procedure with assistance from the senior doctor.
Intervention group (Gomco circumcision clamp with cyanoacrylate skin adhesive): 100 partici-
pants. Local anesthesia (2% lidocaine as a subcutaneous ring block at base of penis) provided as per
the WHO Manual for Male Circumcision under Local Anaesthesia. Gomco circumcision clamp with cyano-
acrylate skin adhesive. Gomco clamp is a metal, sterilizable instrument, available in sizes from infant
to adult. 4 diameters were available: 2.6 cm, 2.9 cm, 3.2 cm and 3.5 cm. Clamp was applied to penis and
after 5 minutes the foreskin was excised with a surgical scalpel. Instrument was then removed and the
apposed skin–mucosal edges sealed with high viscosity 2-octyl cyanoacrylate skin adhesive. Wound
was covered with an adherent tape or absorbent gauze.
Control group (open surgical technique): 100 participants. Local anesthesia (2% lidocaine as a sub-
cutaneous ring block at the base of penis) given and dorsal slit technique used as described in the WHO
Manual for Male Circumcision under Local Anaesthesia. After suturing, wound was covered with an ab-
sorbent gauze dressing.
Follow-up: 2 and 7 days, 2 and 4 weeks. Those who were not completely healed by 4 weeks had an ad-
ditional 6-week follow-up visit for all groups.
Outcomes Primary outcome:
• intraoperative time
Secondary outcomes:
• doctor-described ease in performing the technique

• operative and postoperative complications (anesthetic complications, bleeding, hematoma, infec-
tion, wound disruption, problems with urination, subsequent procedures conducted to correct com-
plications and occupational exposure to blood and body fluids)
• postoperative pain
Informed decisions.

Millard 2013 (Continued)
• time to healing
• cosmetic result
• cost of expendable materials
Outcome definitions were provided in the paper
Funding sources Funded by the Catholic University of Mozambique and by a Fogarty International Center, National Insti-
tutes of Health grant (no. 3 D43 TW01038) to the University of Pittsburgh. No funding bodies played any
role in the design, writing or decision to publish the manuscript.
Declarations of interest None stated
Notes
Risk of bias
Random sequence genera- Low risk Randomization using a random number table in blocks of 10 to ensure bal-
tion (selection bias) anced numbers in each arm.
Allocation concealment Unclear risk Although methods of concealment of allocation groups were described, such
(selection bias) as using sealed opaque envelopes, the block randomization method increases
predictability of allocation groups in a non-blinded trial; unclear risk of bias.
mance bias) group.
All outcomes
Blinding of outcome as- High risk This study was not blinded. The subjective outcomes were self-reported and
sessment (detection bias) could have been influenced by the lack of blinding; high risk of detection bias.
Blinding of outcome as- Low risk Low risk of bias as more objective outcomes are unlikely to be influenced by
sessment (detection bias) lack of blinding.
ative time)
Incomplete outcome data Low risk Low attrition (< 5%) in each group; low risk of attrition bias.
(attrition bias)
All outcomes
Selective reporting (re- Unclear risk No study protocol and it was, therefore, unclear whether there may have been
porting bias) be selective outcome reporting. There was no mention of clinical trials data-
base registration.

Informed decisions.

Millard 2014
Methods Design: single-center non-blinded RCT conducted in South Africa. Compared open surgical circumci-
sion with suturing and the Unicirc disposable instrument plus tissue adhesive. 150 participants recruit-
ed via posters at 2 affiliated primary healthcare clinics in Cape Town, South Africa.
Ethical approval: South African Medical Association's Ethics Committee (SAMAREC). ClinicalTrials.gov
identifier: NCT01877408
Duration of study: 21 June to 8 August 2013
Participants Inclusion criteria: healthy uncircumcised men ages > 18 years, including men with partial phimosis
without adhesions and with scarring of the frenulum.
Exclusion criteria: concurrent illness, history of bleeding disorder, past reaction to local anesthetic, in-
fection, penile abnormality and phimosis.

them for the listed characteristics. Circumcision device group, there were 21 participants in the 18 -
25 years age group, 49 participants in the 26 - 35 age group, 30 in the > 36 age group. For the tradition-
al methods group, there were 12 participants in the 18 - 25 years age group, 21 participants in the 26 -
35 age group, 17 in the > 36 age group
Participants received HIV prevention counseling. HIV testing offered, but was not a study prerequisite.
Participants advised to abstain from sexual intercourse until wound was completely healed and for ≥ 4
weeks after circumcision.
Interventions Providers: 4 generalist doctors, assisted by registered nurses.
Intervention group (Unicirc disposable instrument plus tissue adhesive): 100 participants. 2% lido-
caine with marcaine local anesthetic used as subcutaneous ring block at base of penis as per the WHO
Manual for Male Circumcision under Local Anaesthesia. Unicirc with cyanoacrylate skin adhesive. Unicirc
is a plastic and metal single-use disposable instrument. The instruments were gas sterilized in sealed
packages. Applied the Unicirc to foreskin, and waited 5 minutes before excising the foreskin with a sur-
gical scalpel. Then removed the instrument and sealed the apposed skin–mucosal edges with cyano-
acrylate skin adhesive. Used 4 different Unicirc sizes: 2.6 cm, 2.9 cm, 3.2 cm and 3.5 cm. Covered wound
with an adherent tape (Hypafix) and absorbent gauze.
Control group (open surgical technique): 50 participants. 2% lidocaine with marcaine local anesthe-
sia used as a subcutaneous ring block at the base of the penis as per the WHO Manual for Male Circum-
cision under Local Anaesthesia. Dorsal slit technique, sleeve technique or FG technique performed ac-
cording to doctor preference as described in the WHO M anual for Male Circumcision under Local Anaes-
thesia. After suturing, the wound was covered with an absorbent gauze dressing.
Follow-up: For all group, 2nd and 7th day, 2nd and 4th week. Those who were not completely healed
by 4 weeks had an additional 6-week follow-up visit.
• intraoperative time
Secondary outcomes:
• doctor-described ease in performing the technique

• operative and postoperative complications (anesthetic complications, bleeding, hematoma, infec-
tion, wound disruption, problems with urination, subsequent procedures conducted to correct com-
plications and occupational exposure to blood and body fluids)
• postoperative pain
• time to healing
Informed decisions.

Millard 2014 (Continued)
• cosmetic result
• cost of expendable materials
Outcome definitions are provided in the paper
Funding sources None stated
Declarations of interest Supported by Simunye Primary Health Care. No funding bodies played any role in the design, writing or
decision to publish the manuscript
Notes
Risk of bias
Random sequence genera- Low risk Randomization sequence generated using a random number table and an in-
tion (selection bias) vestigator who was not involved in the surgeries allocated participants in a 2:1
ratio in blocks of 15 using a random number table.
Allocation concealment Low risk Methods were used to conceal allocation groups as stated.
(selection bias)
Quote: "Slips of paper with the group assignment were folded and placed
in sealed, opaque envelopes. Each envelope was opened only at the time of
surgery."
Comment: 1 disadvantage of block randomization is that the allocation of par-

ticipants may be predictable in an unblinded trial; however, we rated alloca-
tion concealment at low risk of bias as baseline characteristics were similar
between groups and did not reveal selection bias in group allocation.
and personnel (perfor- tervention and it was, therefore, unclear whether this may have impacted the
mance bias) performance of either group.
All outcomes
Blinding of outcome as- High risk Lack of blinding was judged to confer a high risk of performance bias for these
sessment (detection bias) subjective outcomes.
Blinding of outcome as- Low risk No mention of blinded outcome assessors. The lack of blinding was unlikely to
sessment (detection bias) affect the assessment of the objectively defined outcomes, such as operative
Objective outcomes (oper- time, which was the primary outcome.
ative time)
Incomplete outcome data Low risk There was a very low attrition rate, and no difference between groups; low risk
(attrition bias) of attrition bias.
All outcomes
Selective reporting (re- Low risk The study outline was found on ClinicalTrials.gov (NCT01877408) and all out-
porting bias) comes were reported; low risk of selective reporting bias.
Informed decisions.


Mutabazi 2012
Methods Design: single-center unblinded RCT conducted in Rwanda. Compared PrePex device to surgical cir-
cumcision (dorsal-slit technique). 226 men randomized and allocated according to WHO allocation rec-
ommendations (2:1) = (PrePex circumcision: surgical circumcision).
Ethical approval: Rwanda National Ethics Committee on 13 January 2011, approval number N0 001/
RNEC/2011
Duration of study: 17 February 2011 to 8 April 2011
Participants Inclusion criteria: men ages 21–54 years who were willing to undergo both surgical and PrePex device
circumcisions.
Exclusion criteria: any contraindication to surgical circumcision (anatomical abnormalities, genital ul-
cer disease, previous circumcision etc.), HIV or unwilling to consent to an HIV test, and mental illness
with unreliable follow-up.
Baseline characteristics: no difference in baseline characteristics. Mean age: 26 years. All were HIV
negative. Circumcision device group mean age was 26 (SD 5.17) years, traditional method mean age
was 24 (SD 4.10) years
Interventions Providers: all surgical circumcisions conducted by surgeons experienced in circumcision. All non-sur-
gical circumcision procedures were performed by surgeons who participated in prior safety and effica-
cy studies using PrePex in Rwanda.
Intervention group (PrePex circumcision device): 150 participants. Clean skin preparation, anesthet-
ic cream (lidocaine and prilocaine) followed by application of the PrePex device, dry gauze dressing ap-
plied and the device removed 7 days later.
Follow-up: assessed 16 hour after procedure, and on the 3rd, 9th, 14th, 21st, 28th, 35th, 42nd, 49th,
56th, 63rd postoperative days
Control group (conventional [dorsal slit] surgical circumcision): 76 participants. Sterile skin prepa-
ration, injection base penile ring block, dorsal-slit technique followed by absorbable skin closure and
dry dressings.
Follow-up: 7th postoperative day
• total male circumcision time (skin to skin)
Secondary outcomes:
• procedure preparation time

• clinical adverse event rates
• surgical procedure-related and device-related incident rates
• expected adverse effects
• pain at key time points and during erection on days 3 and 9
• loss of productivity
• time to complete healing
Funding sources Government of Rwanda. PrePex devices were provided by Circ MedTech Limited (Tortola, British Virgin
Islands).
Informed decisions.

Mutabazi 2012 (Continued)
Declarations of interest Disclosed no conflicts of interest.
Notes
Risk of bias
Random sequence genera- Low risk The process for randomization was clearly described.
Quote: "A randomized number table was created by the study PI using the
RAND algorithm in Excel (Microsoft Corp, Redmond, WA) in which each ran-
domized number was distributed between 1.00000 and 0.00000. To achieve an
allocation ratio of 2:1, each random number below 0.33333 was assigned to
the surgical arm and each number higher than 0.333334 was assigned to the
PrePex arm."
Comment: low risk of selection bias.
Allocation concealment Low risk The process for allocation concealment was clearly described.
(selection bias)
Quote: "Study numbers, randomised numbers and their respective treatment
arms were then placed in envelopes that were validated to be non-transpar-
ent. This was done by the principal study investigator who was not involved
in the enrolment and treatment allocation. It was also done before the enrol-
ment process."
Comment: low risk of selection bias.
All outcomes
Blinding of outcome as- High risk There were no independent outcome assessors. The lack of blinding was
sessment (detection bias) judged to potentially affect the assessment of these subjective outcomes. In
Subjective outcomes (se- addition, the trial design allowed for differential follow-up schedules for the
vere adverse events, mod- intervention group (PrePex) within the first visit at 3 days compared to the sur-
erate adverse events, mi- gical group who had follow-up at 7 days. This may introduce some bias as the
nor adverse events, pain, adverse effects related to wound healing may be expected to be different. High
patient satisfaction) risk of detection bias.
Blinding of outcome as- Low risk As the operative time was considered an objective outcome, the lack of blind-
sessment (detection bias) ing was not considered a risk of detection bias. In addition, the trial put in
Objective outcomes (oper- place additional measures to minimize biased reporting.
ative time)
Quote: "Time intervals were measured using a stopwatch; as a backup, a video
of each procedure was recorded."
Incomplete outcome data Low risk Attrition for the main outcomes was very low and considered a low risk of at-
(attrition bias) trition bias. It should be noted that there was high attrition (35%) for the out-
All outcomes come 'participant satisfaction' which required a questionnaire to be complet-
ed.
Selective reporting (re- Low risk Study registered at ClinicalTrials.gov (NCT01284088) and the prespecified out-
porting bias) comes align with those reported in the published trial.
Informed decisions.


Pang 2015
Methods Design: prospective RCT conducted in China. The safety and efficacy of a circular stapler compared
with conventional surgery. 56 participants prospectively enrolled from the Department of Urology at
Huainan Chaoyang Hospital.
Duration of study: not stated
Participants Inclusion criteria: men with redundant prepuce or phimosis.
Exclusion criteria: other diseases such as urinary tract infection, leukemia and bleeding disease.

redundant prepuce. Mean age 21.3 (SD 2.5) years, ranging from 12 to 61 years.
Intervention group (stapler): 28 participants. Penis prepared and disinfected using povidone-iodine
and procedure performed according to a defined protocol.
Follow-up: Not reported
Control group (conventional surgical): 60 participants. Sterile skin preparation, injection base penile
ring block, dorsal slit circumcision procedure performed.
Follow-up: Not reported

• pain score (24 hours after surgery)
• postoperative complications (edema, infection, deformity)
• satisfaction
• treatment costs
Notes
Risk of bias


(selection bias)
Informed decisions.

Pang 2015 (Continued)
mance bias)
All outcomes
ative time)
(attrition bias)
All outcomes
Selective reporting (re- High risk No study protocol and, therefore, it was unclear whether there may have been
porting bias) selective outcome reporting. In addition, the pain outcome was not reported.

Ren 2014
Methods Design: prospective RCT conducted in China. The safety and efficacy of a circular stapler compared
with conventional surgery. 220 participants prospectively enrolled from Department of Urology,
Xuecheng People's Hospital, Zaozhuang City, Shandong Province.
Consent: not stated
Duration of study: from January 2013 to March 2014
Participants Inclusion criteria: Males with redundant prepuce or phimosis.
Exclusion criteria: other diseases such as urinary tract infection, leukemia and bleeding disease.
Baseline characteristics: not stated. 84 cases in the control group, including 18 cases of phimosis and
66 cases of redundant foreskin. Intervention group (device group) included 136 cases, including 27 cas-
es of phimosis and 109 cases of redundant foreskin. Mean age 24 years, ranging from seven to 56 years.
Intervention group (stapler): 136 participants. Penis prepared and disinfected using povidone-iodine.
Dorsal penile nerve block with 1% lidocaine and procedure performed according to a defined protocol.
Follow up: satisfaction assessed day 30 post-procedure
Control group (conventional surgery): 84 participants. Sterile skin preparation, injection base penile
ring block, dorsal slit circumcision procedure was performed.
Informed decisions.

Ren 2014 (Continued)
Follow up: satisfaction assessed day 30 post-procedure

• pain score (intraoperative and 24 hours after surgery)
• postoperative complications (hemorrhage, hematoma, wound disruption, edema, infection)
• satisfaction (30 days after surgery)
Definitions for each are clearly outlined in the paper
Notes Information on the proportion of the total number of participants younger than 10 years was not avail-
able
Risk of bias


(selection bias)
mance bias)
All outcomes
sessment (detection bias) ment for subjective outcomes may have been be affected by lack of blinding;
Subjective outcomes (se- high risk of detection bias.
ative time)
(attrition bias)
All outcomes
Selective reporting (re- High risk No study protocol and, therefore, it was unclear whether there may have been
porting bias) selective outcome reporting. In addition, the pain outcome was not reported.
Informed decisions.


Shenje 2016
Methods Design: single-center non-blinded, parallel RCT conducted in South Africa. Compared Unicerc devise vs
surgery. 75 men randomized in 2:1 (Unicirc device: surgical circumcision) allocation ratio in balanced
blocks of 15.
Ethical approval: South African Medical Association's Ethics Committee (SAMAREC)
Duration of study: 15 July to 7 August 2015
Participants Inclusion criteria: healthy uncircumcised men ages ≥ 16 years (age of consent in South Africa).
Exclusion criteria: current illness, bleeding disorder, reaction to local anesthetic, infection or penile
abnormality potentially complicating the circumcision.
Baseline characteristics: there were no differences in baseline characteristics between groups. Medi-
an age was 37.5 years for the Unicirc group and 34 years for the surgical group. Most were married or
in a relationship. Most were of Christian faith. Most cited reasons for seeking circumcision as being im-
proved hygiene and to reduce HIV infection. Although HIV testing was performed as per hospital policy,
it was NOT an exclusion criterion for the trial. Investigators were unaware of the HIV status.
Interventions Providers: same 2 doctors for both open surgical and device circumcisions.
Intervention group (Unicirc with cyanoacrylate tissue adhesive): 50 participants. Skin preparation
with povidone iodine, topical anesthetic cream (lidocaine and prilocaine) application, device size selec-
tion by means of a sizing plate. The device was then applied for 5 minutes, followed by excision with a
scalpel. The skin–mucosa edges were then sealed with cyanoacrylate glue (Dema-Flex QS). Dressings
were dry sterile gauze with Hypafix adhesive tape.
Control group (open surgical technique): 25 participants. Standard FG circumcision technique under
local anesthesia (as above).
Follow-up: assessed at day 7, and week 4 and 6 for all groups.
• intraoperative duration
Secondary outcome:
• pain (intraoperative and postoperative using VAS)

• adverse events (intraoperative and postoperative – classified according to the WHO Framework)
• wound disruption
• healing at 4 weeks
• patient satisfaction (5-point Likert scale)
Funding sources Simunye Primary Health Care. The funder had no role in study design, data collection or analysis, deci-
sion to publish or preparation of the manuscript.
Declarations of interest Declared as no competing or conflicts of interest.
Notes
Risk of bias
Informed decisions.

Shenje 2016 (Continued)
Random sequence genera- Low risk The sequence was generated using a random number table; low risk of selec-
tion (selection bias) tion bias.
Quote: "An investigator who was not involved in the surgeries allocated par-
ticipants in a 2:1 ratio using a random number table; block randomisation (in
blocks of 15) was used to ensure exact 2:1 allocation."
Allocation concealment Low risk Allocation concealed using opaque sealed envelopes. A disadvantage of block
(selection bias) randomization used in this trial was that the allocation of participants may be
predictable in an unblinded trial; however, we rated allocation concealment
at low risk of bias as baseline characteristics were relatively similar between
groups and did not indicate selection bias in group allocation.
All outcomes
Blinding of outcome as- High risk This study was not blinded. Despite attempts to provide specific descriptions
sessment (detection bias) of the outcomes for assessment, there was a risk of detection bias for the sub-
Subjective outcomes (se- jective outcomes such as adverse effects. High risk for detection bias.
Blinding of outcome as- Low risk As the operative time was considered an objective outcome, the lack of blind-
sessment (detection bias) ing was not considered a risk of detection bias.
ative time)
Incomplete outcome data Low risk Overall, attrition was low and follow-up good; low risk of attrition bias.
(attrition bias)
All outcomes
Selective reporting (re- Low risk Study protocol in ClinicalTrials.gov (NCT02443792). The prespecified out-
porting bias) comes were reported; low risk of selective outcome reporting.

Sokal 2014
Methods Design: parallel-group open-label RCT with 1-to-1 allocations conducted in 2 sites in Kenya. Designed
as a superiority trial to prove superiority of Shang Ring over conventional circumcision. 400 men ran-
domized.
Ethical approval: FHI 360, the Kenya Medical Research Institute, and the University of Zambia. The
Zambia Ministry of Health also granted permission to conduct the study
Duration of study: March–June 2011
Participants Inclusion criteria: healthy uncircumcised, HIV-negative men ages 18–54 years.
Informed decisions.

Sokal 2014 (Continued)
Exclusion criteria: active genital infection, previous circumcision, an anatomic abnormality or anoth-
er condition that contraindicated elective surgery under local anesthesia (e.g. bleeding diathesis, lido-
caine allergy).
Baseline characteristics: in both the Kenyan and Zambian groups, there were no differences in base-
line characteristics between groups. The median age was 19 years in Kenya and 22.5 years in Zambia.
Interventions Providers: 2 physicians and 2 nurses (experienced in conventional circumcisions and trained on SR)
performed the procedures.
Intervention group (SR): 200 participants. Local anesthetic (dorsal penile nerve and ring blocks in-
jected with 1% lidocaine) and application of SR as per previous description in the literature. No specific
mention of skin preparation techniques.
Control group (conventional circumcision): 200 participants. Local anesthetic technique as above
and conventional circumcision as per previous description in the literature. FG technique in Kenya and
dorsal-slit method in Zambia.
Follow-up: assessed on the 2nd, 7th, 14th, 21st, 28th, 35th, 42nd, 60th postoperative days for all
groups.
• safety assessed using the Public Services International/WHO Adverse Event Action Guide to classify
adverse events as mild, moderate and severe
• moderate wound dehiscence: mucocutaneous gap of > 1 cm between wound edges
• pain and acceptability outcomes were assessed using a VAS
• ease of use and provider preferences
• measured duration of procedure (minutes)
• surgical difficulties encountered
Funding sources Bill and Melinda Gates Foundation to FHI 360 (Grant OPPGH5166)
Declarations of interest No conflicts of interest to disclose.
Notes
Risk of bias
Random sequence genera- Low risk Random sequences generated using permuted blocks with randomly chosen
tion (selection bias) block size; low risk of selection bias.
Allocation concealment Low risk Allocation concealment was done using sequentially numbered, opaque,
(selection bias) sealed, tamper-evident envelopes. The unblinded nature of the trial coupled
with block randomization could make allocations predictable; however, this
was mitigated by use of random block size. Low risk of selection bias.
All outcomes
Blinding of outcome as- High risk The outcome assessment was unblinded and would result in a possibility of
sessment (detection bias) detection bias for the subjective outcomes such as adverse effects.
Informed decisions.

Sokal 2014 (Continued)
Blinding of outcome as- Low risk As the operative time was an objective outcome, the lack of blinding was not
sessment (detection bias) considered a risk of detection bias.
ative time)
Incomplete outcome data Low risk Attrition was clearly described in the published trial and was low for both
(attrition bias) groups.
All outcomes
Selective reporting (re- Low risk Study protocol available in ClinicalTrials.gov (NCT01300910) and the planned
porting bias) outcomes matched those reported in the trial; low risk of selective outcome
reporting.

Tshimanga 2016
Methods Design: randomized, open-label RCT conducted in Zimbabwe and Malawi. Compared the performance
of the PrePex device to FG surgical circumcision. 240 men randomized.
Ethical approval: Medical Research Council of Zimbabwe's (MRCZ) and Battelle's Institutional Review
Board approved this study (MRCZ: approval 5 September 2011, MRCZ/A/1628; Battelle: approval Octo-
ber 2011, IRB000284). All interviewers and nurses attended study protocol training sessions, as well as
a good clinical practice (GCP) courses offered jointly by the Research Support Centre, College of Medi-
cine of Malawi and MRCZ
Consent: participants provided written formal consent and confirmed their understanding of their par-
ticipation.
Duration of study: 21 November 2011 to 18 January 2012
Participants Inclusion criteria: males aged ≥ 18 years, uncircumcised and agreement to be circumcised, HIV-neg-
ative, ability to understand study procedures and requirements, and freely give informed consent
for participation in this study, agreement to abstain from sexual intercourse and directly rubbing cir-
cumcised area (up to 70 days after procedure) and until the end of the follow-up, and to return to the
healthcare facility for follow-up visits (or as instructed).
Exclusion criteria: active genital infection, anatomic abnormality, or other condition, which in the
opinion of the investigator prevented the participant from undergoing a circumcision. Men who had
phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospa-
dias, epispadias, known bleeding/coagulation abnormality, uncontrolled diabetes, did not agree to
anonymous video and photographs of the procedure and follow-up visits, HIV-positive, refusal to take
HIV test and ages < 18 years.
Baseline characteristics: no differences in baseline characteristics between groups. Mean age: 29.1
(SD 9.0) years for the PrePex group and 27.6 (SD 7.6) years for surgical group (difference not statistically
significant). 49.2% were single and 73% were employed.
Interventions Providers: doctors and nurses trained by PrePex Masters from Rwanda.
Intervention group (PrePex): 160 participants. Clean and non-sterile preparation followed by dermal
anesthetic cream (5% lidocaine). The device was then applied.
Informed decisions.

Tshimanga 2016 (Continued)
Follow-up: 7 days for device removal, 2 days later for dressing removal and weekly thereafter for 6
weeks.
Control group (surgical circumcision): 80 participants. Surgical circumcisions were done under local
anesthesia using the FG method consistent with the national guidelines adapted from the WHO Manual
for Male Circumcision under Local Anesthesia.
Follow-up: assessed on the 3rd, 7th, 14th, 21st, 42nd postoperative days
• procedure operative time
Secondary outcomes:
• pain using VAS

• safety – adverse events (bleeding; hematoma, edema, infection, device-related adverse events)
• satisfaction (participant and partner filled out questionnaire using a 5-point scale)
• time to complete healing based on treating physician's objective wound assessment using specified
parameters
• difficulty during procedure based on reports
• cost of procedure
Funding sources United Nations Population Fund
Declarations of interest The authors declared that they had no competing interests.
Notes
Risk of bias
Random sequence genera- Low risk Randomization sequence generated using Excel; low risk of selection bias.
Allocation concealment Unclear risk Allocation concealment in the trial used numbered marbles picked out of a
(selection bias) box. Participants picked 1 numbered marble from the box, which was then
set aside. The participant was assigned that number. The nurse verified which
study arm the participant was assigned to according to the randomization list.
If a participant opted out of the assigned arm, he was excluded from the study.
His marble was put back in the box. It is possible that this approach could re-
sult in changes to allocation. Unclear risk of selection bias.
All outcomes
Blinding of outcome as- High risk There was no mention of independent outcome assessment. The lack of blind-
sessment (detection bias) ing of subjective outcome assessment could confer a high risk of detection
Subjective outcomes (se- bias. In addition, each arm received different follow-up visit days which could
vere adverse events, mod- also result in differential assessment of the outcomes. High potential risk of
erate adverse events, mi- detection bias.
Blinding of outcome as- Low risk As the operative time was an objective outcome, the lack of blinding was not
sessment (detection bias) considered a risk of detection bias.
Informed decisions.

Tshimanga 2016 (Continued)
ative time)
Incomplete outcome data Low risk Overall there was low attrition between groups with no differences in numbers
(attrition bias) lost to follow-up; low risk of attrition bias.
All outcomes
Selective reporting (re- High risk Study outline in ClinicalTrials.gov (NCT01956370). The primary outcome was
porting bias) unchanged; however, reporting on pain was not explicitly mentioned in the
registry record. Therefore, indicated a potential reporting bias.

Wang 2014
Methods Design: randomized, multicenter pilot RCT conducted in China with non-inferiority design. Compared
a novel disposable device to conventional dissection technique (control group). 120 men randomized.
Ethical approval: Medical Ethics Committee of the Jiangxi Province People's Hospital (approval No.
2011-clinical inspection 20) with the authorization of the Medical Ethics Committee of the Jiangxi Uni-
versity of Traditional Chinese Medicine
Consent: participants provided informed signed consent.
Duration of study: 20 October 2011 to 12 February 2012
Participants Inclusion criteria: males ages > 16 years; redundant prepuce (glans penis covered completely or par-
tially by prepuce under the relaxed condition, and a glans penis that was uncovered with the coronary
sulcus exposed by force) or phimosis; and willing to sign informed consent for study participation.
Exclusion criteria: penis size or shape incompatible with the tested device; malformations of the glans
penis or prepuce, including wide-range adhesion between glans penis and prepuce; infection and ede-
ma of the glans penis or prepuce; suspected penis carcinoma; systemic diseases, such as bleeding ten-
dency, hypoproteinemia, or serious cardiovascular disease; other surgical contraindications; participa-
tion in another clinical trial of medical devices or drugs within the past 30 days; and refusal to comply
with study protocols.
years ranging from 17 - 67 years with similar number of penile conditions in both groups.
Interventions Providers: specialist urologists for both groups.
Intervention group (novel circumcision device): 60 participants. Lidocaine 1% injection. No mention

of skin preparation techniques. Device applied and method executed according to specifications. Fore-
skin removed. Staples mostly fell off spontaneously by 2 weeks. Dry gauze dressings applied.
Control group (surgical circumcision): 60 participants. Standard sleeve dissection technique with
blade or scissors.
Follow-up: assessed on the 1st, 3rd, 7th, and 14th postoperative days for all groups
• surgical success rate (not defined in article, but inferred to be completion of an acceptable circumci-
sion until wound healing)
Secondary outcomes:
Informed decisions.

Wang 2014 (Continued)
• intraoperative bleeding
• surgery duration
• pain
• healing
• satisfaction
Funding sources Stated as "Departmental sources"
Declarations of interest Authors declared no competing interests existed.
Notes
Risk of bias
Random sequence genera- Low risk Sequence generated using a random table method generated by computer;
tion (selection bias) low risk of selection bias.
Allocation concealment Unclear risk Process for treatment allocation concealment not reported; unclear risk of
(selection bias) bias.
All outcomes
Blinding of outcome as- High risk No independent outcome assessors and this could have resulted in a high risk
sessment (detection bias) of detection bias for the subjective outcomes.
Blinding of outcome as- Low risk Although unblinded, low risk for detection bias for objective outcomes such as
sessment (detection bias) operative time.
ative time)
Incomplete outcome data Low risk Very low attrition in both groups and no expected attrition bias.
(attrition bias)
All outcomes
porting bias) selective outcome reporting. No mention of study registration on a clinical tri-
als database.

Wang 2017
Informed decisions.

Methods Design: randomized, open-label RCT conducted in China. Compared the performance of the DCSD
(produced by Jiangxi Langhe Medical Instrument Co., Ltd., Jiangxi, China) to FG surgical circumcision.
102 men randomized.
Ethical approval: Ethics Committee of Shandong Provincial Hospital
Consent: participants provided signed written informed consent
Duration of study: June 2013 to December 2014
Participants Inclusion criteria: men with typical phimosis or redundant prepuce who needed operative treatment;
normal development of penis; signed informed consent.
Exclusion criteria: penis dysplasia and genital tract malformation; premature ejaculation caused by
spermatocystitis, urethritis and prostatitis; without re-examination and follow-up visit according to
study requirement.
(SD 7.69) in device group and 29.35 (SD 8.18) in surgical group. Similar number of penile conditions in
both groups (38 cases of redundant prepuce in device group and 35 cases in surgical group. 13 cases of
phimosis in device group and 16 cases in surgical group).
Interventions Providers: Department of Plastic and Aesthetic Surgery. Authors did not mention the qualifications of
staff who provided the procedures.
Intervention group (DCSD device): 51 participants. DCSD instrument applied. The 2nd, 6th and 10th
migration spots of inner and outer plates of prepuce were raised by hemostatic forceps. 30-degree an-
gle towards the dorsal part between penis axis and the bar axis of campaniform glans penis base was
kept. Ribbon or silk thread used for fixation on rod and to take safety catch out. Application knob was
pressed for 10 seconds, to lightly spin and quit the campaniform glans penis base to stop the bleeding.
Pressure released after 20 seconds to check the suture situation, with pressure dressing to the incision.
Control group (surgical circumcision): 51 participants. Traditional method. Hemostatic forceps

clamped the middle frenum of the prepuce flank area, and were pulled for cutting the bilateral prepuce
tissue along the parallel site (with a parallel distance of 5 mm) of coronary sulcus. The prepuce frenum
tissue was kept at approximately 10 mm. Electrocoagulation applied to stop the bleeding and the inci-
sion sutured after detection of active hemorrhage.
Follow-up: assessed at 6 months for all groups
• operation time
• intraoperative bleeding volume
• incision healing time
• incision infection
• incision edema
• pain using VAS
• incision aesthetic satisfaction
• sexual function and psychologic states
Funding sources Not reported
Declarations of interest Not reported
Notes
Risk of bias
Informed decisions.

Random sequence genera- Low risk Randomization sequence generated using computer software; low risk of se-
tion (selection bias) lection bias.
Allocation concealment Unclear risk Allocation concealment was not reported and, therefore, it was unclear
(selection bias) whether there was any possible bias introduced. There were no systematic dif-
ferences in baseline characteristics.
All outcomes
Blinding of outcome as- High risk Given that many of the outcomes were subjective, the lack of blinding may
sessment (detection bias) have resulted in a high risk of detection bias.
Blinding of outcome as- Low risk Although unblinded, there was low risk for detection bias for objective out-
sessment (detection bias) comes such as operative time.
ative time)
Incomplete outcome data Low risk No attrition; low risk of attrition bias.
(attrition bias)
All outcomes
porting bias) selective outcome reporting. There was no mention of study registration on a
clinical trials database.
DCSD: disposable circumcision suture device; FG: forceps guided; GP: general practitioner; RCT: randomized controlled trial; SD: standard
deviation; SR: Shang Ring; TK: Tara KLamp; VAS: visual analog scale; WHO: World Health Organization.

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion
Awori 2016 Ineligible study design.
Cheng 2012 Comparison between 2 application methods of 1 device.
Decastro 2010 Comparison between 2 surgical methods of circumcision.
Feldblum 2014 Ineligible study design.
Feldblum 2016 Comparison between 2 application methods of 1 device.
Lei 2015 Ineligible study design.
Liang 2012 Ineligible study design.
Informed decisions.

Study Reason for exclusion
Yu 2014 Ineligible study design.
Yue 2012 Article retracted, was published elsewhere the year before.

Characteristics of ongoing studies [ordered by study ID]

ChiCTR-TRC-13003428
Study name New circumcision standardized application and reproductive health effects, a large multi-center
clinical trial
Methods Randomized parallel-group trial
Participants Inclusion criteria: males ages 18–60 years with redundant prepuce or phimosis with no abnormal-
ities on blood, coagulation or urine routine exam. They should be willing to participate in study and
follow study procedures, understand the research and sign an informed consent.
Exclusion criteria: foreskin/glans infection, edema, hypospadias, priapism, epispadias, penile tor-
sion, concealed penis, webbed penis, small penis, urethra hypoplasia, hermaphroditism, suspect-
ed penile cancer; systemic disease (bleeding tendency, severe cardiovascular disease, diabetes);
skin or connective tissue diseases that may affect wound healing.
Interventions Intervention group: circumcision using the disposable circumcision stapler
Control group: traditional surgical circumcision
• operation time
• amount of bleeding
• postoperative pain scores
• wound healing time
• incidence of complications
• appearance satisfaction rate
• evaluation of sexual satisfaction
Secondary outcomes:
• reproductive health indicators (HIV, human papillomavirus, herpes simplex virus, syphilis)
Starting date 1 January 2014
Contact information dch0313@163.com; brianzg86@163.com
Notes Primary sponsor: The First Affiliated Hospital of Sun Yat-Sen University
Awaiting a response from authors to obtain data. Contact made using the email addresses provid-
ed in the Chinese Clinical Trial Registry.

DATA AND ANALYSES

Informed decisions.

Comparison 1. Circumcision devices versus standard surgical techniques
Outcome or subgroup title No. of studies No. of partici- Statistical method Effect size
pants
1.1 Serious adverse events 11 3472 Risk Ratio (M-H, Random, 95% CI) Not estimable
1.1.1 Crush devices 9 3006 Risk Ratio (M-H, Random, 95% CI) Not estimable
1.1.2 Ligature devices 2 466 Risk Ratio (M-H, Random, 95% CI) Not estimable
1.2 Moderate adverse 10 3370 Risk Ratio (M-H, Random, 95% CI) 1.31 [0.55, 3.10]
events
1.2.1 Crush devices 8 2904 Risk Ratio (M-H, Random, 95% CI) 1.60 [0.67, 3.80]
1.2.2 Ligature devices 2 466 Risk Ratio (M-H, Random, 95% CI) 0.17 [0.02, 1.60]
1.3 Mild adverse events 10 3370 Risk Ratio (M-H, Random, 95% CI) 1.09 [0.44, 2.72]
1.4 Operative time (min- 14 4812 Mean Difference (IV, Random, 95% -17.26 [-19.96, -14.57]
utes) CI)
1.4.1 Crush devices 12 4346 Mean Difference (IV, Random, 95% -18.31 [-21.05, -15.57]
CI)
1.4.2 Ligature devices 2 466 Mean Difference (IV, Random, 95% -11.07 [-13.52, -8.62]
CI)
1.5 Pain during the first 24 9 3022 Mean Difference (IV, Random, 95% -1.30 [-2.37, -0.22]
hours (VAS means) CI)
1.5.1 Crush devices 8 2796 Mean Difference (IV, Random, 95% -1.38 [-2.56, -0.20]
CI)
1.5.2 Ligature devices 1 226 Mean Difference (IV, Random, 95% -0.60 [-0.96, -0.24]
CI)
1.6 Pain during the first 7 4 1430 Mean Difference (IV, Random, 95% 0.11 [-0.89, 1.11]
days (VAS means) CI)
1.7 Pain during erection 2 626 Mean Difference (IV, Random, 95% -0.74 [-4.57, 3.08]
(VAS means) CI)
1.8 Participant satisfaction 15 4501 Risk Ratio (M-H, Random, 95% CI) 1.19 [1.04, 1.37]

Informed decisions.

Analysis 1.1. Comparison 1: Circumcision devices versus

standard surgical techniques, Outcome 1: Serious adverse events
Circumcision devices Surgical technique Risk Ratio Risk Ratio

Study or Subgroup Events Total Events Total Weight M-H, Random, 95% CI M-H, Random, 95% CI
1.1.1 Crush devices

Jin 2015 0 441 0 438 Not estimable
Kanyago 2013 0 73 0 65 Not estimable
Lv 2014 0 628 0 314 Not estimable
Millard 2013 0 100 0 100 Not estimable
Millard 2014 0 100 0 50 Not estimable
Shenje 2016 0 50 0 25 Not estimable
Sokal 2014 0 200 0 200 Not estimable
Wang 2014 0 60 0 60 Not estimable
Subtotal (95% CI) 1703 1303 Not estimable
Total events: 0 0
Test for overall effect: Not applicable

Mutabazi 2012 0 150 0 76 Not estimable
Tshimanga 2016 0 160 0 80 Not estimable
Subtotal (95% CI) 310 156 Not estimable
Total events: 0 0
Test for overall effect: Not applicable
Total (95% CI) 2013 1459 Not estimable

Total events: 0 0
Heterogeneity: Not applicable 0.1 0.2 0.5 1 2 5 10
Test for overall effect: Not applicable Favors devices Favors surgery
Test for subgroup differences: Not applicable

Informed decisions.

Analysis 1.2. Comparison 1: Circumcision devices versus standard

surgical techniques, Outcome 2: Moderate adverse events

1.2.1 Crush devices

Jin 2015 7 441 16 438 18.4% 0.43 [0.18 , 1.05]
Kanyago 2013 23 73 5 65 18.2% 4.10 [1.65 , 10.15]
Lv 2014 10 628 0 314 6.6% 10.52 [0.62 , 178.89]
Millard 2013 13 100 4 100 16.7% 3.25 [1.10 , 9.63]
Millard 2014 20 100 8 50 19.4% 1.25 [0.59 , 2.64]
Shenje 2016 1 50 0 25 5.6% 1.53 [0.06 , 36.25]
Sokal 2014 0 200 2 200 6.0% 0.20 [0.01 , 4.14]
Subtotal (95% CI) 1652 1252 91.0% 1.60 [0.67 , 3.80]
Total events: 74 35

Mutabazi 2012 1 150 3 76 9.0% 0.17 [0.02 , 1.60]
Tshimanga 2016 0 160 0 80 Not estimable
Subtotal (95% CI) 310 156 9.0% 0.17 [0.02 , 1.60]
Total events: 1 3
Total (95% CI) 1962 1408 100.0% 1.31 [0.55 , 3.10]

Total events: 75 38
Heterogeneity: Tau² = 0.86; Chi² = 21.60, df = 7 (P = 0.003); I² = 68% 0.001 0.1 1 10 1000
Test for subgroup differences: Chi² = 3.34, df = 1 (P = 0.07), I² = 70.1%

Informed decisions.


standard surgical techniques, Outcome 3: Mild adverse events

1.3.1 Crush devices

Jin 2015 5 441 18 438 12.4% 0.28 [0.10 , 0.74]
Kanyago 2013 19 73 7 65 13.0% 2.42 [1.09 , 5.38]
Lv 2014 103 628 105 314 14.3% 0.49 [0.39 , 0.62]
Millard 2013 69 100 14 100 13.9% 4.93 [2.98 , 8.15]
Millard 2014 27 100 5 50 12.7% 2.70 [1.11 , 6.59]
Shenje 2016 0 50 1 25 5.3% 0.17 [0.01 , 4.03]
Sokal 2014 8 200 5 200 12.0% 1.60 [0.53 , 4.81]
Subtotal (95% CI) 1652 1252 83.6% 1.21 [0.43 , 3.37]

Mutabazi 2012 3 150 5 76 10.8% 0.30 [0.07 , 1.24]
Tshimanga 2016 2 160 0 80 5.6% 2.52 [0.12 , 51.78]
Subtotal (95% CI) 310 156 16.4% 0.57 [0.08 , 3.87]
Total events: 5 5
Total (95% CI) 1962 1408 100.0% 1.09 [0.44 , 2.72]


Informed decisions.


surgical techniques, Outcome 4: Operative time (minutes)
Circumcision devices Surgical technique Mean Difference Mean Difference

Study or Subgroup Mean SD Total Mean SD Total Weight IV, Random, 95% CI IV, Random, 95% CI
1.4.1 Crush devices

Huo 2015 7.1 1.4 120 22.6 4.6 60 7.1% -15.50 [-16.69 , -14.31]
Jin 2015 6.8 3.1 441 24.2 3.2 438 7.2% -17.40 [-17.82 , -16.98]
Kanyago 2013 8.7 6.9 73 23.2 5.5 65 6.9% -14.50 [-16.57 , -12.43]
Li 2010 4.7 1.3 402 25.6 8.3 322 7.2% -20.90 [-21.82 , -19.98]
Li 2014 4.02 0.69 129 30.8 4.05 120 7.2% -26.78 [-27.51 , -26.05]
Lv 2014 6.75 3.66 628 21.4 5.8 314 7.2% -14.65 [-15.35 , -13.95]
Miao 2015 6.88 2.19 184 28.36 4.22 92 7.2% -21.48 [-22.40 , -20.56]
Millard 2013 12.8 2.7 83 22.5 6.6 81 7.1% -9.70 [-11.25 , -8.15]
Pang 2015 3.9 0.8 28 31.2 3.9 28 7.1% -27.30 [-28.77 , -25.83]
Ren 2014 8.2 1.6 136 30.4 4.7 84 7.2% -22.20 [-23.24 , -21.16]
Sokal 2014 7.2 2 197 20.3 4.8 201 7.2% -13.10 [-13.82 , -12.38]
Wang 2014 7.6 4.5 60 23.6 4.4 60 7.1% -16.00 [-17.59 , -14.41]
Subtotal (95% CI) 2481 1865 85.6% -18.31 [-21.05 , -15.57]

Mutabazi 2012 3.1 1.1 150 15.4 3.1 76 7.2% -12.30 [-13.02 , -11.58]
Tshimanga 2016 4.8 1.2 160 14.6 4.2 80 7.2% -9.80 [-10.74 , -8.86]
Subtotal (95% CI) 310 156 14.4% -11.07 [-13.52 , -8.62]
Total (95% CI) 2791 2021 100.0% -17.26 [-19.96 , -14.57]

Test for overall effect: Z = 12.55 (P < 0.00001) -20 -10 0 10 20

surgical techniques, Outcome 5: Pain during the first 24 hours (VAS means)

1.5.1 Crush devices

Huo 2015 1.9 1.3 120 5.2 1.7 60 11.1% -3.30 [-3.79 , -2.81]
Jin 2015 4 0.9 441 5.8 1 438 11.4% -1.80 [-1.93 , -1.67]
Kanyago 2013 2 2.5 73 3 2.2 65 10.7% -1.00 [-1.78 , -0.22]
Li 2010 1.83 0.86 402 5.27 1.74 322 11.3% -3.44 [-3.65 , -3.23]
Li 2014 1.84 1.02 129 4.99 1.36 120 11.3% -3.15 [-3.45 , -2.85]
Miao 2015 2.52 0.98 184 1.82 0.75 92 11.3% 0.70 [0.49 , 0.91]
Millard 2013 3.3 2.7 100 3.3 2.4 100 10.9% 0.00 [-0.71 , 0.71]
Millard 2014 4.2 2.7 100 3.1 2.4 50 10.6% 1.10 [0.25 , 1.95]
Subtotal (95% CI) 1549 1247 88.7% -1.38 [-2.56 , -0.20]

Mutabazi 2012 0.3 0.8 150 0.9 1.5 76 11.3% -0.60 [-0.96 , -0.24]
Subtotal (95% CI) 150 76 11.3% -0.60 [-0.96 , -0.24]
Total (95% CI) 1699 1323 100.0% -1.30 [-2.37 , -0.22]

Informed decisions.


surgical techniques, Outcome 6: Pain during the first 7 days (VAS means)

Kanyago 2013 0.7 1.6 73 0.6 1.2 65 26.7% 0.10 [-0.37 , 0.57]
Lv 2014 4.55 2.41 628 3.3 0.8 314 28.0% 1.25 [1.04 , 1.46]
Millard 2013 1.8 6 100 2.5 1.9 100 19.8% -0.70 [-1.93 , 0.53]
Millard 2014 0.7 1.6 100 1.2 2 50 25.4% -0.50 [-1.14 , 0.14]
Total (95% CI) 901 529 100.0% 0.11 [-0.89 , 1.11]

Test for subgroup differences: Not applicable Favors devices Favors surgery

surgical techniques, Outcome 7: Pain during erection (VAS means)

Mutabazi 2012 2.5 1.8 150 5.2 2.2 76 49.8% -2.70 [-3.27 , -2.13]
Sokal 2014 3.5 1.9 200 2.3 1.7 200 50.2% 1.20 [0.85 , 1.55]
Total (95% CI) 350 276 100.0% -0.74 [-4.57 , 3.08]

Test for subgroup differences: Not applicable Favors devices Favors surgery

Informed decisions.


standard surgical techniques, Outcome 8: Participant satisfaction

1.8.1 Crush devices

Huo 2015 114 120 51 60 7.0% 1.12 [1.00 , 1.25]
Jin 2015 402 441 395 438 7.2% 1.01 [0.97 , 1.05]
Kanyago 2013 54 73 39 65 6.0% 1.23 [0.97 , 1.57]
Li 2010 400 402 224 322 7.2% 1.43 [1.33 , 1.54]
Li 2014 127 129 109 120 7.2% 1.08 [1.02 , 1.15]
Lv 2014 484 628 66 314 6.2% 3.67 [2.95 , 4.56]
Millard 2013 95 100 99 100 7.2% 0.96 [0.91 , 1.01]
Millard 2014 93 100 48 50 7.1% 0.97 [0.90 , 1.05]
Pang 2015 27 28 20 28 6.0% 1.35 [1.06 , 1.72]
Ren 2014 133 136 74 84 7.1% 1.11 [1.02 , 1.21]
Shenje 2016 44 50 23 25 6.7% 0.96 [0.82 , 1.12]
Wang 2014 58 60 60 60 7.2% 0.97 [0.91 , 1.02]
Wang 2017 50 51 39 51 6.7% 1.28 [1.10 , 1.50]
Subtotal (95% CI) 2318 1717 88.8% 1.20 [1.03 , 1.40]

Mutabazi 2012 91 150 55 76 6.4% 0.84 [0.69 , 1.01]
Tshimanga 2016 74 160 23 80 4.7% 1.61 [1.10 , 2.36]
Subtotal (95% CI) 310 156 11.2% 1.14 [0.57 , 2.28]
Total (95% CI) 2628 1873 100.0% 1.19 [1.04 , 1.37]

Test for overall effect: Z = 2.44 (P = 0.01) Favors surgery Favors devices
ADDITIONAL TABLES
Table 1. Adverse events
Study ID Device Group n Incision edema, n Hematoma,Ecchy- Infection, n Reoper- Defor- Wound Bleed- De-
Library
Cochrane
type (%) n (%) mosis, n (%) ation, n mity, n dehis- ing, n vice-re-
(%) (%) (%) cence, n (%) lateda, n
(%) (%)
Huo Crush DCSD 120 Mild: 80 (66.7%) 2 (1.7%) 25 3 (2.5%) — — — — —

2015 (20.8%)
Better health.
Informed decisions.
Trusted evidence.
Moderate: 34
(28.3%)
Severe: 6 (5.0%)
Surgical 60 Mild: 25 (41.7%) 4 (3.3%) 5 (8.3%) 3 (5.0%) 3 (5.0%) — — — —
Moderate: 27
(45.0%)
Severe: 8 (13.3%)
P = 0.04 P = 0.186 P < 0.01 P = 0.660 P = 0.064 — — — —
Lagarde Crush Tara 35 3 (8.6%) — — 5 (14.2%) — — — 1 (2.9%) 7

2009 KLamp (20.0%)
Surgical 34 0 (0%) — — 0 (0%) — — — 0 (0%) N/A
Li 2010 Crush Shang 402 85 (21.1%) — — 3 (0.78%) — — 7 (1.7%) 2 (0.5%) —

Ring
Surgical 322 115 (35.7) — — 39 (12.1%) — — 5 (1.6%) 40 —

(12.4%)

Li 2014 Crushb DCSD 129 10 (7.8%) — — 1 (0.8%) — — 4 (3.1%) 6 (4.7%) 4 (3.1%)
Surgical 120 5 (4.2%) — — 1 (0.8%) — — 1 (0.8%) 1 (0.8%) 2 (1.7%)
Miao Crush/ DCSD 92 2 (2.2%) 2 (2.2%) — 2 (2.2%) — — — — —

2015 ligaturec
Foreskin 92 9 (9.8%) 1 (1.1%) — 3 (3.3%) — — — — —
cerclage
Surgical 92 2 (2.2%) 1 (1.1%) — 3 (3.3%) — — — — —

69

Table 1. Adverse events (Continued)
Pang Crushd DCSD 28 1 (3.6%) — — — — — — — —
2015
Library
Cochrane
Surgical 28 6 (21.4%) — — 2 (7.1%) — 3 — — —
(10.7%)
Ren Crush DCSD 136 Overall complications reported, i.e. bleeding, hematoma, infection, wound dehiscence, wound edema: 9.6% (13/136) in
2014 DCSD group and 17.9% (15/84) in the surgical group; P < 0.05.
Surgical 84
Better health.
Informed decisions.
Trusted evidence.
DCSD: disposable circumcision disposable device; n: number of participants; N/A: not applicable.
aPoor lacing, suture incarceration, device remained in tissue for too long, etc.
bThe incidence of complications was higher in the DCSD group versus the foreskin cerclage group (P = 0.24).
cThe incidence of complications was significantly lower in the DCSD group versus the foreskin cerclage group (P < 0.05).
dThe incidence of complications in the stapler group was significantly lower than the surgical group (P < 0.05).


70

Informed decisions.


Table 2. Pain as reported in individual trials
Study ID Device Pain out- Pain during first 24 hours Pain during Pain on Pain dur-
type come para- the first 7 device re- ing erec-
meter days moval tion
Huo 2015 Crush VAS (mean, Mean score: 1.9 (SD 1.3) with device vs 5.2 Not reported Not applic- Not report-
SD) (SD 1.7) with surgery; P < 0.01 able ed
Jin 2015 Crush VAS (mean, Mean intraoperative pain score: 0.8 Not reported Not applic- Not report-
SD) (SD 0.5) with device vs 2.4 (SD 0.8) with able ed
surgery; P < 0.001
Mean 1-hour postoperative pain scores:

4.0 (SD 0.9) with device vs 5.8 (SD 1.0)
with surgery; P < 0.001
Kanyago Crush VAS (medi- Median pain score: 1/10 (IQR 0–4) with Pain-free at 3 Not report- Not report-
2013 an, IQR) device vs 3/10 (IQR 2–5) with surgery; P = days: 69.9% ed ed
0.01 with device
vs 62.7%
with surgery;
RR 1.11, 95%
CI 0.87 to
1.43; P = 0.5.
All partici-
pants in both
groups were
pain free at 7
days
Lagarde Crush VAS (mean Not reported As-treated Not applic- Not report-
2009 pain score analyses re- able ed
[0–10]) sults: mean
pain score
at postoper-
ative day 3:
9.5 with TK
vs 6.1 with
FG; P = 0.003
Li 2010 Crush VAS (mean, Mean intraoperative pain score: 0.21 Not reported Not applic- Not report-
SD) (SD 0.65) with SR vs 3.72 (SD 1.45) with able ed
surgery
Mean pain score at 24 hours: 1.83 (SD

0.86) with SR vs 5.27 (SD 1.74) with
surgery
Li 2014 Crush VAS (mean, Mean intraoperative pain score: 0.81 (SD Not reported Not applic- Not report-
SD) 0.81) with for DCSD vs 2.42 (SD 1.15) with able ed
surgery; P < 0.05

1.02) with DCSD vs 4.99 (SD 1.36) with
surgery; P < 0.05
Lv 2014 Crush VAS (mean, Mean intraoperative pain score: 1.9 (SD Pain scores Not report- Not report-
SD) 1.3) with DCSD vs 5.8 (SD 2.1) with SR vs at 1 week: ed for SR. ed
6.2 (2.2) with surgery. Pain scores using 2.7 (SD 0.9) Not applic-
with DCSD vs
Informed decisions.

Table 2. Pain as reported in individual trials (Continued)

DCSD was significantly lower than both 6.4 (SD 2.0) able for
SR and surgical circumcision; P < 0.001 with SR vs DCSD
3.3 (SD 0.8)
with surgery;
P < 0.001
Miao 2015 Crush VAS (mean, Mean intraoperative pain score: 1.37 (SD Not reported Not applic- Not report-
SD) 0.68) with DCSD vs 1.20 (SD 0.79) with able ed
foreskin cerclage vs 3.06 (SD 0.75) with
surgery. Pain scores using foreskin cer-
clage were significantly lower than surgi-
cal circumcision; P < 0.05

0.63) with DCSD vs 3.18 (SD 0.82) with
foreskin cerclage vs 1.82 (SD 0.75) with
surgery
Millard Crush VAS (mean, Mean pain score: 3.3 (SD 2.7) with device Mean score Not applic- Not report-
2013 SD) vs 3.3 (SD 2.4) with conventional surgery; at 48 hours: able ed
P = 0.91 1.8 (SD 1.6)
with device
vs 2.5 (SD
1.9) with
conventional
surgery; P =
0.008
Millard Crush VAS (mean, Mean pain score: 4.2 (SD 2.7) with device Mean score Not applic- Not report-
2014 SD) vs 3.1 (SD 2.4) with conventional surgery; reported at able ed
P = 0.01 48 hours: 0.7
(SD 1.6) with
device vs 1.2
(SD 2) with
conventional
surgery; P =
0.04
Mutabazi Ligature VAS (mean, During placement: mean pain levels: 0.8 Not reported Mean pain Mean pain
2012 SD) (SD 1.2) with device vs 2.4 (SD 0.9) with levels were levels dur-
surgery 4.7 (SD 1.9) ing erec-
during de- tion at day
Mean pain score at 1 hour: 5.6 (SD 1.8) vice re- 3: 2.5 (SD
with device vs 3.8 (SD 2.1) with surgery moval vs 1.8) with
1.4 (SD 1.6) device vs
Mean pain score at 2 hours: 4.1 (SD 1.9)
1 hour im- 5.2 (SD 2.2)
with device vs 2.3 (SD 1.6) with surgery
mediate- with surgi-
Mean pain score at 3 hours: 2.8 (SD 1.8) ly after re- cal meth-
with device vs 1.4 (SD 1.5) with surgery moval. ods.
Mean pain score at 4 hours: 1.9 (SD 1.5) Statistical Mean pain
with device vs 0.9 (SD 1.3) with surgery significance score dur-
not reporting erec-
Mean pain score at 8 hours: 1.1 (SD 1.6) ed tion at day
with device vs 0.7 (SD 1.2) with surgery 9: 1.9 (SD
1.5) with
Mean pain score at 16 hours: 0.3 (SD 0.8) device.
with device vs 0.9 (SD 1.5) with surgery
The pain
Statistical difference between groups scores dur-
were not reported ing erection
Informed decisions.


for the sur-
gical group
was signif-
icant high-
er com-
pared with
the PrePex
group
(P<0.0001).
Pang 2015 Crush Not report- Not reported Not reported Not applic- Not report-
ed able ed
Ren 2014 Crush Not report- Not reported Not reported Not applic- Not report-
ed able ed
Shenje Crush VAS (Medi- Median intraoperative pain score: 1 (IQR Not reported Not applic- Not report-
2016 an, IQR) 0.5–2) with device vs 1 (IQR 0 to 2) with able ed
surgery
Median immediate postoperative pain

score: 1 (IQR 0.5–2) with device vs 1 (IQR
0–5) with surgery
Sokal 2014 Crush VAS (mean, Immediately after procedure and 1 hour: At 2 days: Not report- SR had
SD) and Kenya: pain scores: 0.2 with device vs 1.2 similar pain ed worse pain
VAS (medi- with surgery (P < 0.001), but was the same scores in during
an, IQR) 1 hour after surgery (combined mean 3.8 both groups erections:
[SD 1.8]). Zambia: pain scores: 0.6 with with median 3.5 (SD 1.9)
device vs 0.2 with surgery (P = 0.046), but VAS scores of with SR
were similar 1 hour after surgery (com- 1.0 vs 2.3 (SD
bined mean 3.4 [SD 1.9]) 1.7) with
surgery (P <
0.001). This
required
early re-
moval in 2
cases
Tshimanga Ligature VAS (cate- Periprocedurally: all participants in de- 111/160 Transient Pain dur-
2016 gories 0, 2, vice groups had VAS score of 0, while over (69%) partic- pain (VAS ing erec-
4, 6, 8) with 90% in surgical group had a VAS score ipants expe- 2–6) report- tion (VAS 2–
percent- 4–6. After procedure: device group had rienced pain ed in 93.6% 4): 81/160
ages of par- VAS score of 0 up to 3 hours while surgi- (VAS 0–2) at of device (51%) par-
ticipants cal group had VAS score 0–2. No statisti- end of the group. Pain ticipants
experienc- cal differences were reported first week after re- with de-
ing pain at with the de- moval re- vice vs
these levels vice vs 14/80 ported in 57/80 (71%)
(17.5%) par- 66% partici-
ticipants pants with
with surgery surgery
Wang 2014 Crush Categori- 53 minor pain, 4 moderate pain and 1 se- Day 3 — —
cally: minor vere pain with devices vs 54 minor pain, 6
(no/slight moderate pain and 0 severe pain
pain), mod-
erate (toler-
able pain)
and severe
(intolerable
Informed decisions.


pain requir-
ing medica-
tion or in-
tervention
with aceta-
minophen)
on days 1,
3, 7 and 14;
with num-
bers per
category
Wang 2017 Crush VAS (the Pain scores: 6 hours after operation: 5.13 Not reported Not applic- Not report-
units of (SD 1.14) with disposable stitching device able ed
measure- vs 7.16 (SD 1.23) with surgery; P < 0.0001
ment, i.e.
mean/me- 12 hours after operation: 3.16 (SD 1.13)
dian, were with disposable stitching device vs 5.33
not speci- (SD 1.25) with surgery; P < 0.0001
fied)
24 hours after operation: 1.85 (SD 1.14)
with disposable stitching device vs 3.58
(SD 1.26) with surgery; P < 0.0001
Postoperative VAS score improvements in

the device group were significantly high-
er than those of the surgery group at the
time points specified
CI: confidence interval; DCSD: disposable circumcision disposable device; FG: forceps guided; IQR: interquartile range; n: number; RR: risk
ratio; SD: standard deviation; SR: Shang Ring; TK: Tara KLamp; VAS: visual analog scale

Table 3. Participant satisfaction (cosmesis)
Study ID Country Comparison Device type Number of Findings
participants
Huo 2015 China DCSD vs dor- Crush DCSD: 120; Satisfied with the cosmetic penile appear-
sal slit circum- dorsal slit 0 ance: 77.5% (93/120) participants with DCSD
cision vs 51.7% (31/60) with dorsal slit
Moderately satisfied with the cosmetic pe-

nile appearance: 17.5% (21/120) with DCSD
vs 33.3% (20/60) with dorsal slit; P = 0.01
Not satisfied with the cosmetic penile ap-

pearance: 5.0% (6/120) with DCSD vs 15.0%
(9/60) with dorsal slit
Jin 2015 China Circular sta- Crush Total: 879; Satisfied with the cosmesis and results of
pler vs dorsal stapler: 441; procedure: 91.2% (402/441) with stapler vs
slit circumci- dorsal slit: 438 90.2% (395/438) with dorsal slit; P = 0.619
sion with elec-
tric scalpel
Kanyago Uganda SR vs FG cir- Crush Total: 138; SR: High patient satisfaction: 74.0% (54/73) with
2013 cumcision 73; FG: 65 SR vs 60.0% (39/65) with FG; RR 1.38, 95% CI
0.94 to 2.02; P = 0.10
Informed decisions.

Table 3. Participant satisfaction (cosmesis) (Continued)

Lagarde 2009 South Africa TK vs conven- Crush As-treated Satisfied with penile appearance: 84.2%
tional FG cir- analyses, to- (16/19) with TK vs 100% (19/19) with FG; P =
cumcision tal: 29; TK: 19; 0.056
FG: 19
Li 2010 China SR vs dorsal Crush SR: 402; dor- Satisfied with cosmetic penile appearance:
slit circumci- sal slit: 322 99.5% (400/402) with SR vs 69.6% (224/322)
sion with dorsal slit
Li 2014 China DCSD vs con- Crush DCSD: 129; Satisfied with cosmetic penile appear-
ventional cir- conventional: ance: 98.4% (127/129) with DCSD vs 90.8%
cumcision 120 (109/120) with conventional; P = 0.01
Lv 2014 China DCSD vs SR vs Crush Total: 942; Extremely satisfied overall: 30.9% (97/314)
electrosurgi- DCSD: 314; SR: with DCSD vs 18.5% (58/314) with SR vs
cal knife and 314; electro- 14.3% (45/314) with electrosurgical knife
suture circum- surgical knife and suture; P < 0.005
cision and suture:
214 Extremely satisfied with penile appearance:
29.3% (92/314) with DCSD vs 24.8% (78/314)
with SR vs 10.5% (33/314) with electrosurgi-
cal knife and suture; P < 0.05
Miao 2015 China DCSD vs fore- Crush DCSD: 92; Not reported
skin cerclage foreskin cer-
vs conven- clage: 92; con-
tional circum- ventional: 92
cision
Millard 2013 Mozambique Gomco/tissue Crush Total: 200: Very satisfied with cosmetic results after
adhesive vs Gomco/tissue procedure: 58.9% (56/95) with Gomco/ad-
dorsal slit cir- adhesive: 100; hesive vs 70.7% (70/99) with dorsal slit; P =
cumcision dorsal slit: 100 0.09
Satisfied with cosmetic results after proce-

dure: 41.1% (39/95) with Gomco/adhesive vs
29.3% (29/99) with dorsal slit; P = 0.09
Millard 2014 South Africa Unicirc and Crush Total: 150; Very satisfied with cosmetic results after
tissue adhe- Unicirc/adhe- procedure: 79.6% (78/98) with Unicirc/adhe-
sive vs dorsal sive: 100; dor- sive vs 80.0% (40/50) with dorsal slit
slit circumci- sal slit: 50
sion Satisfied with cosmetic results after proce-
dure: 15.3% (15/98) with Unicirc/adhesive vs
16.0% (8/50) with dorsal slit
Not satisfied with cosmetic results after pro-

cedure: 5.1% (5/98) with Unicirc/adhesive vs
4% (2/50) with dorsal slit; P = 0.9
Mutabazi Rwanda PrePex vs dor- Ligature Total: 226; Satisfied with cosmetic results after proce-
2012 sal slit circum- PrePex: 150; dure: 99.0% (91/92) with PrePex vs 100%
cision dorsal slit: 76 (55/55) with dorsal slit; no significant differ-
ence
Pang 2015 China DCSD vs dor- Crush DCSD: 28; dor- Satisfied with the cosmetic penile appear-
sal slit circum- sal slit: 28 ance: 96.4% (27/28) with DCSD vs 71.4%
cision (20/28) with dorsal slit
Informed decisions.

Table 3. Participant satisfaction (cosmesis) (Continued)

Ren 2014 China DCSD vs dor- Crush DCSD: 136; Satisfied with cosmetic penile appearance:
sal slit circum- dorsal slit: 84 97.8% (133/136) with DCSD vs 88.1% (74/84)
cision with dorsal slit
Shenje 2016 South Africa Unicirc vs FG/ Crush Total: 75; Uni- Very satisfied with result: 97.7% (43/44) with
dorsal slit cir- circ: 50; FG/ Unicirc vs 95.7% (22/23) with FG/dorsal slit
cumcision dorsal slit: 25
Satisfied with result: 2.3% (1/44) with Uni-
circ vs 4.3% (1/23) with FG/dorsal slit
No significant difference in satisfaction
Sokal 2014 Kenya and SR vs FG/dor- Crush Total: 400; SR: Very satisfied with cosmetic appearance at
Zambia sal slit circum- 200; FG/dorsal 60 days in Kenya: 95.7% with SR vs 85.9%
cision slit: 200 with FG/dorsal slit; P = 0.02
Very satisfied with cosmetic appearance at

60 days in Zambia: 96.8% with SR vs 71.3%
with FG/dorsal slit; P < 0.01
Tshimanga Zimbabwe PrePex vs FG Ligature Total 240; 'Very' or 'extremely' satisfied with proce-
2016 circumcision PrePex: 160; dure and cosmetic results at 2-week post-
FG: 80 procedure interview: 71.2% (74/104) with
PrePex vs 76.7% (23/30) with FG; P > 0.05
'Very' or 'extremely' satisfied with proce-

dure and cosmetic results at 90-day post-
procedure interview: 88.0% (97/110) with
PrePex vs 94.1% (48/51) with FG; P > 0.05
Satisfied with procedure and cosmetic re-

sults at 90-day postprocedure interview:
99.1% (109/110) with PrePex vs 98.0%
(50/51) with FG; P > 0.05
Wang 2014 China DCSD vs stan- Crush Total: 120; Full satisfaction with penile appearance:
dard surgical DCSD: 60; 96.6% (56/58) with DCSD vs 95% (57/60) with
sleeve dissec- standard standard sleeve; P > 0.05
tion sleeve: 60
Moderately satisfied with penile appear-
ance: 3.4% (2/58) with DCSD vs 5.0% (3/60)
with standard sleeve; P > 0.05
Wang 2017 China DCSD vs tradi- Crush Total: 102; Satisfaction with the incision aesthetic:
tional surgical DCSD: 51; 98.0% (50/51) with DCSD vs 76.5% (39/51)
circumcision traditional with traditional surgery; P < 0.0001
surgery: 51
CI: confidence interval; DCSD: disposable circumcision disposable device; FG: forceps guided; SR: Shang Ring; TK: Tara KLamp; RR: risk
ratio.

APPENDICES
Appendix 1. Definitions and timing of outcome measurement

Informed decisions.


Outcome Definition Timing
Serious adverse events Requirement of transfusion, hospitalization or resultant per- Within intraoperative and early postop-
manent damage, e.g. penile injury erative period (30 days)
Moderate adverse Requirement of active treatment, e.g. suturing, antibiotics, Within intraoperative and early postop-
events surgical hemostasis erative period (30 days)
Mild adverse events Requirement of little or no intervention, e.g. slight wound dis- Within intraoperative and early postop-
ruption, minor bleeding erative period (30 days)
Operative time Time from first clamp on foreskin until dressing placed mea- Intraoperative
sured in minutes
Pain assessment Visual analog scale (0–10) Within intraoperative and early postop-
erative period (30 days)
Participant satisfaction Defined as satisfactory or unsatisfactory to participant Early postoperative period (30 days)
(cosmesis)
Inadequate removal of Assess for clearly uncovered glans with an adequately cov- Within intraoperative and early postop-
foreskin ered penile shaft and a healed paracoronal wound (Al-Rah- erative period (30 days)
man 1999)

Appendix 2. Electronic search strategies

The Cochrane Library
#1 circumcis* OR [mh "Circumcision, male"]
#2 Device* OR [mh "Surgical Instruments"] OR Clamp*
#3 Gomco
#4 Mogen
#5 Plastibell*
#6 Accucirc
#7 Alisklamp
#8 Ali’s clamp
#9 Ali’s Klamp
#10 Ismail Clamp
#11 PrePex
#12 Shang ring
#13 Tara Klamp
#14 Unicirc
#15 Smartclamp
Informed decisions.

(Continued)
#16 Smartklamp
#17 infant* OR neonat* OR [mh "infant, newborn"]
#18 #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16
#19 #1 AND #2
#20 #1 AND #18
#21 (#19 OR #20) NOT #17
MEDLINE (PubMed)
#1 "Circumcision, male" [Mesh Terms] OR circumcis*
#2 Device* OR "Surgical Instruments" [Mesh terms] OR Clamp*
#3 Gomco
#4 Mogen
#5 Plastibell*
#6 Accucirc
#7 Alisklamp
#8 Ali’s clamp
#9 Ali’s Klamp
#10 Ismail Clamp
#11 PrePex
#12 Shang ring
#13 Tara Klamp
#14 Unicirc
#15 Smartclamp
#16 Smartklamp
#17 Neonat* OR "infant, newborn"[Mesh Terms] OR infant*
#19 #1 AND #2
#20 #1 AND #18
#21 (#19 OR #20) NOT #17
Embase
#1 'circumcision'/exp OR circumcis*:ti,ab
#2 Device*:ti,ab OR 'clamp'/exp OR Clamp*:ti,ab
#3 Gomco:ab,ti
#4 Mogen:ab,ti
Informed decisions.

(Continued)
#5 'plastibell'/exp
#6 Accucirc:ab,ti
#7 Alisklamp:ab,ti
#8 (Ali* next/1 clamp):ab,ti
#9 (Ali* next/1 Klamp):ab,ti
#10 (Ismail next/1 Clamp):ab,ti
#11 PrePex:ab,ti
#12 (Shang next/1 ring):ab,ti
#13 (Tara next/1 Klamp):ab,ti
#14 Unicirc:ab,ti
#15 Smartclamp:ab,ti
#16 Smartklamp:ab,ti
#18 'circumcision device'/exp
#19 'newborn period'/exp OR Neonat* OR 'infancy'/exp OR infant*
#20 #1 AND #2
#21 #1 AND #17
#22 (#18 OR #20 OR #21) NOT #19
Web of Science Core Collection
#1 ALL=(male circumcision ) OR TI=(circumci*) OR ALL=(circumci*)
Indexes=SCI-EXPANDED, SSCI, A&HCI, ESCI Timespan=All years
#2 ALL=(gomco OR mogen OR plastibell OR accucirc OR alisklamp OR (ali's klamp) OR (ali's clamp) OR (ismail clamp) OR prepex OR
(shang ring) OR shangring OR (tara klamp) OR unicirc OR smartclamp OR (smart clamp) OR (smart klamp) OR quill)
#3 ALL=((surgical instruments) OR (surgical instrument*) OR clamp* OR device*)
#4 #2 AND #1
#5 #3 AND #1
#6 #5 OR #4
#7 (All=((randomized controlled trial) OR (controlled clinical trial)) OR TI=randomized OR TI=placebo OR ALL=(drug therapy) OR
TI=randomly OR TI=trial OR TI=groups )

Informed decisions.

(Continued)
#8 #7 AND #6
ClinicalTrials.gov
gomco OR mogen OR plastibell OR accucircOR alisklamp OR ali'sklamp OR ali'sclamp OR ismail clamp OR prepex OR shang ring OR
shangring OR tara klamp OR unicirc OR smartclamp OR smart clamp OR smart klamp OR quill OR device | Interventional Studies | cir-
cumcision | Studies with Male Participants
World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP)
Search for "circumcisions"

Appendix 3. Systematic reviews of circumcision devices

Author Number Devices Outcomes reported (compared to surgical circumcision technique)
of includ- used
ed RCTs Adverse Operative time Postoperative time pain Postoperative
(number events during first 24 hours appearance or
of partici- satisfaction
pants)
Cao 2015 8 (3314) SR RR 0.54, 95% MD –17.44, 95% Intraoperative pain score: RR 1.29, 95% CI
CI 0.39 to 0.74; CI –21.61 to – MD –3.13, 95% CI 3.79 to 1.07 to 1.56; P =
vs P < 0.001 13.27; P < 0.001 2.47; P < 0.001 0.007
standard
surgical cir-
cumcision
Fan 2016 10 (4649) CDD such as CDD: RR 1.00, CDD: SMD –4.33, CDD: SMD –1.38, 97.5% CI – CDD: RR 1.12,
DCSD and 97.5% CI 0.30 97.5% CI –6.43 to 2.28 to –0.48 97.5% CI 0.96 to
(pair-wise Unicirc to 3.39 –2.23 1.30
and net- ISD: SMD –0.95, 97.5% CI –
work meta- vs ISD: RR 0.77, ISD: SMD –5.72, 3.09 to 1.19 ISD: RR 1.17,
analysis 97.5% CI 0.47 97.5% CI –7.11 to 97.5% CI 1.02 to
conducted) ISD, e.g. SR to 1.26 –4.33 (no specific time point men- 1.35
and PrePex tioned for measuring post-
operative pain)
vs
surgical cir-
cumcision
technique
Huang 18 (6179) DCSD DCSD: OR DCSD: SMD – DCSD: SMD –2.01, 95% CrI – DCSD: OR 11.42,
2017 0.37, 95% CrI 20.60, 95% CrI – 4.57 to 0.60 95% CrI 3.60 to
(pair-wise vs 0.19 to 0.71 23.38 to –17.83 37.68
and net- SR: SMD –1.64, 95% CrI –
work meta- SR SR: OR 1.27, SR: SMD –19.14, 3.77 to 0.54 SR: OR 3.85, 95%
analyses 95% CrI 0.71 95% CrI –21.86 to CrI 1.29 to 12.79
vs
conducted) to 2.31 –16.50
surgical cir-
cumcision
technique
Informed decisions.

(Continued)
Huo 2017 9 (1898) DCSD DCSD: OR DCSD: SMD – DCSD: SMD –2.36, 95% CI – DCSD: OR 8.77,
0.60, 95% CI 21.44, 95% CI – 2.50 to –2.22; P < 0.00001 95% CI 5.90
vs 0.41 to 0.87; P 25.08 to –17.79; P to 13.02; P <
= 0.008 < 0.00001 0.00001
surgical cir-
cumcision
technique
CDD: circular disposable devices; CI: confidence interval; CrI: credible interval; DCSD: disposable circumcision suture device; ISD: in
situ device; MD: mean difference; OR: odds ratio; RCT: randomized controlled trial; RR: risk ratio; SMD: standardized mean difference;
SR: Shang Ring.

HISTORY
Protocol first published: Issue 6, 2016
Review first published: Issue 3, 2021
CONTRIBUTIONS OF AUTHORS
AH: screened titles and abstracts, assessed full-text eligibility, performed data extraction, analyzed results and wrote the final manuscript.
SE: wrote the protocol, developed the search strategy, screened titles and abstracts, assessed full-text eligibility, performed data extraction,
analyzed results and drafted the manuscript.
MZS: conceptualized the project, wrote the protocol, developed the search strategy, screened titles and abstracts, assessed full-text
eligibility, performed data extraction and drafted the manuscript.
TK: reviewed and approved the protocol and manuscript drafts.
DECLARATIONS OF INTEREST
AH: none.
MZS: none.
SE: none.
TK: none.
SOURCES OF SUPPORT
Internal sources
• N/A, South Africa
N/A
External sources
• Department for International Development, UK
Project number 300342-104
DIFFERENCES BETWEEN PROTOCOL AND REVIEW
This review is based on a published protocol (Shaik 2016), with differences as described here.
We did not search CINAHL as we considered it an irrelevant database for this review.
Embase access not possible in 2020 as the license was not renewed.
Informed decisions.

NOTES
We based parts of the Methods section and Appendix 1 of this Cochrane review on a standard template developed by the Cochrane
Metabolic and Endocrine Disorders Group, which the Cochrane Urology Group modified and adapted for use.

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Hohlfeld A, Ebrahim S, Shaik MZ, Kredo T

Hohlfeld A, Ebrahim S, Shaik MZ, Kredo T.

Circumcision devices versus standard surgical techniques in adolescent

Ameer Hohlfeld1, Sumayyah Ebrahim2, Muhammed Zaki Shaik2, Tamara Kredo1

Contact address: Ameer Hohlfeld, ameer.hohlfeld@mrc.ac.za, hhlste001@gmail.com.

Editorial group: Cochrane Urology Group.

Data collection and analysis

Patient or population: adolescent and adult male circumcisions

Cochrane Database of Systematic Reviews

GRADE Working Group grades of evidence

Cochrane Database of Systematic Reviews

BACKGROUND techniques are the traditional forceps-guided technique, the dorsal

Method and timing of outcome measurement Searching other resources

Figure 1. Study flow diagram.

0% 25% 50% 75% 100%

Low risk of bias Unclear risk of bias High risk of bias

Random sequence generation (selection bias)

Random sequence generation (selection bias)

Allocation concealment (selection bias)

Selective reporting (reporting bias)

• Serious adverse events. Unit of analysis issues

Assessment of heterogeneity • Restricting the analysis to very long or extensive studies to

We expected the following characteristic to introduce clinical Results of the search

Sensitivity analysis Included studies

1.2.1 Crush devices

1.2.2 Ligature devices

Total (95% CI) 1962 1408 100.0% 1.31 [0.55 , 3.10]

Risk of bias legend

1.3.1 Crush devices

1.3.2 Ligature devices

Total (95% CI) 1962 1408 100.0% 1.09 [0.44 , 2.72]

Risk of bias legend

1.4.1 Crush devices

1.4.2 Ligature devices

Total (95% CI) 2791 2021 100.0% -17.26 [-19.96 , -14.57]

Risk of bias legend

1.5.1 Crush devices

1.5.2 Ligature devices

Total (95% CI) 1699 1323 100.0% -1.30 [-2.37 , -0.22]

Risk of bias legend

1.8.1 Crush devices

1.8.2 Ligature devices

Total (95% CI) 2628 1873 100.0% 1.19 [1.04 , 1.37]

Risk of bias legend

Gray 2007 Krieger 2005

Guyatt 2011 Liberati 2009

Higgins 2011a Morris 2016

prevalence of male circumcision. Population Health Metrics WHO/UNAIDS 2011

Characteristics of included studies [ordered by study ID]

Consent: participants provided written informed consent.

Duration of study: enrollment December 2013 to August 2014

Baseline characteristics: comparable between groups. No statistically significant difference existed

Interventions Providers: experienced urologists.

Follow-up: pain assessed 24 hours post-procedure. Foreskin oedema assessed on day 7, satisfaction

Control group (conventional): 60 participants. Dorsal slit circumcision procedure.

Follow-up: pain assessed 24 hours post-procedure. Foreskin oedema assessed on day 7, satisfaction

Outcomes Primary outcomes:

• operative time (minutes)

Funding sources Not stated

Bias Authors' judgement Support for judgement

Random sequence genera- Low risk Used a random number table.

Allocation concealment Unclear risk No details provided.

Other bias Low risk No other biases identified.