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Cochrane Database of Systematic Reviews

Mesh versus non-mesh for emergency groin hernia repair (Review)

Sæter AH, Fonnes S, Li S, Rosenberg J, Andresen K

Sæter AH, Fonnes S, Li S, Rosenberg J, Andresen K.


Mesh versus non-mesh for emergency groin hernia repair.
Cochrane Database of Systematic Reviews 2023, Issue 11. Art. No.: CD015160.
DOI: 10.1002/14651858.CD015160.pub2.

www.cochranelibrary.com

Mesh versus non-mesh for emergency groin hernia repair (Review)


Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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Informed decisions.
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TABLE OF CONTENTS
ABSTRACT..................................................................................................................................................................................................... 1
PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2
SUMMARY OF FINDINGS.............................................................................................................................................................................. 4
BACKGROUND.............................................................................................................................................................................................. 6
OBJECTIVES.................................................................................................................................................................................................. 7
METHODS..................................................................................................................................................................................................... 7
RESULTS........................................................................................................................................................................................................ 10
Figure 1.................................................................................................................................................................................................. 11
DISCUSSION.................................................................................................................................................................................................. 16
AUTHORS' CONCLUSIONS........................................................................................................................................................................... 19
ACKNOWLEDGEMENTS................................................................................................................................................................................ 20
REFERENCES................................................................................................................................................................................................ 22
CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 26
RISK OF BIAS................................................................................................................................................................................................ 53
DATA AND ANALYSES.................................................................................................................................................................................... 56
Analysis 1.1. Comparison 1: Primary analysis: mesh versus non-mesh, Outcome 1: Surgical site infections (as defined by the 56
included studies) within 30 days of repair..........................................................................................................................................
Analysis 1.2. Comparison 1: Primary analysis: mesh versus non-mesh, Outcome 2: Mortality (defined as all-cause mortality) 57
within 30 days of repair........................................................................................................................................................................
Analysis 1.3. Comparison 1: Primary analysis: mesh versus non-mesh, Outcome 3: Surgical site infections (as defined by the 57
included studies) within 90 days of repair..........................................................................................................................................
Analysis 1.4. Comparison 1: Primary analysis: mesh versus non-mesh, Outcome 4: Clinical recurrence or reoperation for 58
recurrence within 30 days of repair.....................................................................................................................................................
Analysis 1.5. Comparison 1: Primary analysis: mesh versus non-mesh, Outcome 5: Clinical recurrence or reoperation for 58
recurrence within one year of repair...................................................................................................................................................
Analysis 1.6. Comparison 1: Primary analysis: mesh versus non-mesh, Outcome 6: Mesh removal within 30 days of repair......... 59
Analysis 1.7. Comparison 1: Primary analysis: mesh versus non-mesh, Outcome 7: Mesh removal within 90 days of repair......... 59
Analysis 2.1. Comparison 2: Subgroup analysis: hernia type, Outcome 1: Clinical recurrence or reoperation for recurrence within 60
30 days of repair...................................................................................................................................................................................
Analysis 3.1. Comparison 3: Subgroup analysis: contamination degree, Outcome 1: Surgical site infections (as defined by the 61
included studies) within 30 days of repair..........................................................................................................................................
Analysis 3.2. Comparison 3: Subgroup analysis: contamination degree, Outcome 2: Mortality (defined as all-cause mortality) 62
within 30 days of repair........................................................................................................................................................................
Analysis 3.3. Comparison 3: Subgroup analysis: contamination degree, Outcome 3: Mesh removal within 30 days of repair....... 62
Analysis 4.1. Comparison 4: Subgroup analysis: sex, Outcome 1: Clinical recurrence or reoperation for recurrence within 30 days 63
of repair.................................................................................................................................................................................................
Analysis 5.1. Comparison 5: Subgroup analysis: bowel resection, Outcome 1: Mortality (defined as all-cause mortality) within 64
30 days of repair...................................................................................................................................................................................
Analysis 5.2. Comparison 5: Subgroup analysis: bowel resection, Outcome 2: Mesh removal within 30 days of repair................. 65
Analysis 6.1. Comparison 6: Sensitivity analysis, Outcome 1: Clinical recurrence or reoperation for recurrence within one year 66
of repair.................................................................................................................................................................................................
APPENDICES................................................................................................................................................................................................. 66
HISTORY........................................................................................................................................................................................................ 68
CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 68
DECLARATIONS OF INTEREST..................................................................................................................................................................... 68
SOURCES OF SUPPORT............................................................................................................................................................................... 68
DIFFERENCES BETWEEN PROTOCOL AND REVIEW.................................................................................................................................... 68
INDEX TERMS............................................................................................................................................................................................... 69

Mesh versus non-mesh for emergency groin hernia repair (Review) i


Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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[Intervention Review]

Mesh versus non-mesh for emergency groin hernia repair

Ann Hou Sæter1, Siv Fonnes1, Shuqing Li2, Jacob Rosenberg1, Kristoffer Andresen1

1Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, Herlev, Denmark. 2Evidence-based Medicine Research
Center, Jiangxi University of Traditional Chinese Medicine, Nanchang, China

Contact: Ann Hou Sæter, ahsaeter@gmail.com.

Editorial group: Cochrane Colorectal Group.


Publication status and date: New, published in Issue 11, 2023.

Citation: Sæter AH, Fonnes S, Li S, Rosenberg J, Andresen K. Mesh versus non-mesh for emergency groin hernia repair. Cochrane
Database of Systematic Reviews 2023, Issue 11. Art. No.: CD015160. DOI: 10.1002/14651858.CD015160.pub2.

Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT

Background
A groin hernia is a collective name for inguinal and femoral hernias, which can present acutely with incarceration or strangulation of the
hernia sac content, requiring emergency treatment. Timely repair of emergency groin hernias is crucial due to the risk of reduced blood
supply and thus damage to the bowel, but the optimal surgical approach is unclear. While mesh repair is the standard treatment for elective
hernia surgery, using mesh for emergency groin hernia repair remains controversial due to the risk of surgical site infection.

Objectives
To assess the benefits and harms of mesh compared with non-mesh in emergency groin hernia repair in adult patients with an inguinal
or femoral hernia.

Search methods
On 5 August 2022, we searched the following databases: CENTRAL, MEDLINE Ovid, and Embase Ovid, as well as two trial registers for
ongoing and completed trials. Additionally, we performed forward and backward citation searches for the included trials and relevant
review articles. We searched without any language or publication restrictions.

Selection criteria
We included randomised controlled trials (RCTs) comparing mesh with non-mesh repair in emergency groin hernia surgery in adults.
We included any mesh and any non-mesh repairs. All studies fulfilling the study, participant, and intervention criteria were included
irrespective of reported outcomes.

Data collection and analysis


We used standard Cochrane methodology. We presented dichotomous data as risk ratios (RR) with 95% confidence intervals (CI). We based
missing data analysis on best- and worst-case scenarios. For outcomes with sufficiently low heterogeneity, we performed meta-analyses
using the random-effects model. We analysed subgroups when feasible, including the degree of contamination. We used RoB 2 for risk of
bias assessment, and summarised the certainty of evidence using GRADE.

Main results
We included 15 trials randomising 1241 participants undergoing emergency groin hernia surgery with either mesh (626 participants) or
non-mesh hernia repair (615 participants). The studies were conducted in China, the Middle East, and South Asia. Most patients were men,
and most participants had an inguinal hernia (41 participants had femoral hernias). The mean/median age in the mesh group ranged from
35 to 70 years, and from 41 to 69 years in the non-mesh group. All studies were performed in a hospital emergency setting (tertiary care)
and lasted for 11 to 139 months, with a median study duration of 31 months. The majority of the studies only included participants with
clean to clean-contaminated surgical fields.
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For all outcomes, we considered the certainty of the evidence to be very low, mainly downgraded due to high risk of bias (due to deviations
from intended intervention and missing outcome data), indirectness, and imprecision.

Mesh hernia repair may have no effect on or slightly increase the risk of 30-day surgical site infections (RR 1.66, 95% CI 0.96 to 2.88; I2 =
21%; 2 studies, 454 participants) when compared with non-mesh hernia repair, but the evidence is very uncertain. The evidence is also
very uncertain about the effect of mesh hernia repair compared with non-mesh hernia repair on 30-day mortality (RR 1.38, 95% CI 0.58 to
3.28; 1 study, 208 participants). In summary, the results showed 70 more (from 5 fewer to 200 more) surgical site infections and 29 more
(from 32 fewer to 175 more) deaths within 30 days of mesh hernia repair per 1000 participants compared with non-mesh hernia repair.
The evidence is very uncertain about 90-day surgical site infections after mesh versus non-mesh hernia repair (RR 1.00, 95% CI 0.15 to
6.64; 1 study, 60 participants; very low-certainty evidence). No 30-day recurrences were recorded, and mesh hernia repair may not reduce
recurrence within one year (RR 0.19, 95% CI 0.04 to 1.03; I2 = 0%; 2 studies, 104 participants; very low-certainty evidence). Within 30 days
of hernia repair, no meshes were removed from clean to clean-contaminated fields, but 6.7% of meshes (1 study, 208 participants) were
removed from contaminated to dirty surgical fields. Among the four studies reporting 90-day mesh removal, no events occurred.

We were not able to identify any studies reporting complications classified according to the Clavien-Dindo Classification or reoperation
for complications within 30 days of repair.

Authors' conclusions
Our results show that in terms of 30-day surgical site infections, 30-day mortality, and hernia recurrence within one year, the evidence for
the use of mesh hernia repair compared with non-mesh hernia repair in emergency groin hernia surgery is very uncertain. Unfortunately,
firm conclusions cannot be drawn due to very low-certainty evidence and meta-analyses based on small-sized and low-quality studies.
There is a need for future high-quality RCTs or high-quality registry-based studies if RCTs are unfeasible.

PLAIN LANGUAGE SUMMARY

Mesh or no mesh: what works best for groin hernias (swelling or lump in the groin area) requiring emergency surgery?

Key messages

• Overall, we are uncertain about the effect of placing a mesh during emergency surgery in people with groin hernias.

• The poor quality of the studies and the low number of people involved does not allow us to draw any firm conclusions.

What are emergency groin hernias?

A groin hernia is a bulge that protrudes through a weakness in the abdominal wall in the groin region. It is a common surgical condition in
both men and women, but is notably more widespread among males, affecting over one in four men. A rare but dangerous complication
of a hernia occurs if the blood supply to the hernia content gets compromised (strangulation) as a result of the bowel or other content
getting stuck in the hernia opening (incarceration). These conditions are clinically recognised by the sudden onset of a painful lump in the
groin area, sometimes also causing nausea, vomiting, and severe discomfort. People with such groin hernias are in need of urgent surgical
treatment to avoid permanent injury to the bowel, if manual reduction is unsuccessful.

How are emergency groin hernias treated?

There is no agreement on what surgery method is best for treating emergency groin hernias. Firstly, the bulge with tissue (either fatty
tissue or bowel) needs to be returned to the abdominal cavity and the bowel's blood supply needs to be restored so that it does not die.
Secondly, the weakness in the abdominal wall needs to be fixed. In general, this can be done by placing a mesh or using only stitches (non-
mesh). A mesh is a surgical net placed in the abdominal wall where the weakness occurred, intended to strengthen it. The different surgical
methods for groin hernias are referred to as 'hernia repair'. While mesh is the gold standard for planned surgery of groin hernias, its role in
emergency surgery is debated. The theory is that implanting a foreign body (mesh) could increase the risk of infection following emergency
groin hernia surgery, potentially favouring a non-mesh hernia repair, but this theory is yet to be confirmed.

What did we want to find out?

We wanted to find out if mesh hernia repair differed from non-mesh hernia repair in terms of infections related to the surgical wound,
deaths after surgery, the return of the hernia (recurrence), and complications. We also wanted to see how many meshes were later removed
due to complications.

What did we do?

We searched for studies that examined mesh compared with non-mesh hernia repairs in adult people who needed emergency surgery for
their groin hernia.

We compared and summarised the results of the studies. We rated our confidence in the evidence based on factors such as the quality of
the studies and the number of participants.
Mesh versus non-mesh for emergency groin hernia repair (Review) 2
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What did we find?

We found 15 studies involving 1241 people, of which 626 received a mesh repair, and 615 received a non-mesh hernia repair. Most studies
were conducted in China (10 studies), and the remaining studies were conducted in the Middle East and South Asia. The studies lasted
from 11 months to over 11 years.

We found that mesh hernia repair might not affect the risk of wound infections or deaths within 30 days of surgery when compared with
non-mesh hernia repair.

No hernias returned within 30 days. Some hernias returned after one year following the repair, but the analysis could not find any
differences in this risk between mesh and non-mesh hernia repairs.

No meshes were removed within 30 days of repair in the least severe cases of emergency groin hernia but, based on one study, one out
of 15 meshes were removed in the more severe cases.

What are the limitations of the evidence?

There are significant limitations of the evidence, therefore we can not draw strong conclusions. Firstly, we are not certain about the
evidence since the overall quality of the included studies was very low. Also, we could not find data about everything we wanted to find
out, and the few studies that reported the things we were interested in were unfortunately too small to show any potential differences in
the treatment effects.

How up-to-date is this evidence?

This evidence is up-to-date to August 2022.

Mesh versus non-mesh for emergency groin hernia repair (Review) 3


Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Mesh versus non-mesh for emergency groin hernia repair (Review)
SUMMARY OF FINDINGS

Summary of findings 1. Summary of findings table - mesh repair vs. non-mesh repair for adult patients with incarcerated or strangulated groin

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hernia

Patient or population: adult patients with incarcerated or strangulated groin hernia


Setting: emergency groin hernia repair

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Informed decisions.
Trusted evidence.
Intervention: mesh repair
Comparison: non-mesh repair

Outcomes Anticipated absolute effects* Relative effect № of partici- Certainty of Comments


(95% CI) (95% CI) pants the evidence
(studies) (GRADE)
Risk with non- Risk with mesh
mesh repair repair

Surgical site infec- 107 per 1000 177 per 1000 RR 1.66 454 ⊕⊝⊝⊝ Of the 2 RCTs, 1 study only included participants
tions within 30 days (102 to 307) (0.96 to 2.88) (2 RCTs) Very lowa,b,c with clean to clean-contaminated surgical fields,
of repair while the other included participants with contam-
inated to dirty surgical fields.

Mortality within 30 77 per 1000 106 per 1000 RR 1.38 208 ⊕⊝⊝⊝ Four RCTs reported 30-day mortality, but only 1
days of repair (45 to 252) (0.58 to 3.28) (1 RCT) Very lowc,d,e RCT had events. This study comprised 100% of the
weight in the meta-analysis. All 30-day postopera-
tive mortality events were in participants with con-
taminated to dirty surgical fields, and no deaths
occurred in participants with clean to clean-conta-
minated surgical fields.

Complications clas- No data available (0 RCTs) - We could not identify any studies reporting 30-
sified by the Clavien- day postoperative complications classified by the

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Dindo Classification Clavien-Dindo Classification.
within 30 days of re-
pair

Clinical recurrence 0 per 100 0 per 100 Not estimable 200 ⊕⊝⊝⊝ There were no reported recurrences within 30 days
or reoperation for re- (0 to 0) (3 RCTs) Very lowa,c,f of repair in either group, which is why this out-
currence within 30 come could not be compared.
days of repair
4
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Mesh versus non-mesh for emergency groin hernia repair (Review)
Clinical recurrence 137 per 1000 26 per 1000 RR 0.19 104 ⊕⊝⊝⊝ Three RCTs reported clinical recurrence within 1
or reoperation for re- (5 to 141) (0.04 to 1.03) (2 RCTs) Very lowc,g,h year of repair in both arms, but only 2 had events
currence within one and were included in the meta-analysis.

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year of repair

Reoperation due to No data available (0 RCTs) - None of the included studies reported the out-
complications (e.g. come of reoperation due to complications within
infection, seroma, 30 days of repair.
bleeding) within 30

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Trusted evidence.
days of repair

Mesh removal within 0 per 100 0 per 100 Not estimable 402 ⊕⊝⊝⊝ Risk with non-mesh repair: 0 out of 200. Risk with
30 days of repair (0 to 0) (5 RCTs) Very lowc,d,e mesh repair: 7 out of 202. Five studies reported
mesh removal within 30 days of repair, but only
1 RCT had events. All meshes removed within 30
days of repair were in patients with contaminated
to dirty surgical fields. No meshes were removed
from clean to clean-contaminated surgical fields
within 30 days.

*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; RR: risk ratio

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.

See interactive version of this table: https://gdt.gradepro.org/presentations/#/isof/isof_question_revman_web_436004556706560352.

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a Risk of bias was assessed as "high" in three domains and "some concerns" in two, resulting in overall high risk of bias and downgrading the evidence by two levels.
b Downgraded by one level for indirectness due to different inclusion and exclusion criteria in the included RCTs. One RCT only included the most severe cases of emergency groin
hernia with irreversible bowel necrosis, whereas the other RCT excluded femoral hernias and women, potentially only including less severe cases.
c Both sample size and the number of events were low, downgrading the certainty by one level for imprecision.
d The one study comprising 100% of the analysis weight was assessed to have an overall high risk of bias.
e Only the most severe cases of emergency groin hernia were included, downgrading the evidence by one level due to indirectness.
f Downgraded due to indirectness, since none of the RCTs included the most severe cases of emergency groin hernia.
g All included studies had an overall high risk of bias.
h Downgraded due to indirectness, as the 2 RCTs contributing to the meta-analysis either only included male or younger participants (under 64 years).
5
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BACKGROUND • Clean surgical field: no signs of strangulation and no bowel


resection
Description of the condition • Clean-contaminated surgical field: complicated hernia with
Groin hernia is a collective name for inguinal and femoral hernias strangulation, or bowel resection without gross enteric spillage
(Brooks 2021). Around 5% of inguinal hernias and 37% of femoral • Contaminated surgical field: strangulation with bowel necrosis,
hernias present acutely with incarceration or strangulation of the or gross spillage during intestinal resection
hernia sac content and require emergency treatment due to the risk • Dirty surgical field: peritonitis from a bowel perforation
of reduced supply of blood and thus oxygen to the bowel (bowel
ischaemia) (Nilsson 2007; Reinke 2020). In incarcerated hernias, the Implantation of a foreign body, such as a mesh, may increase
sac content cannot be pushed back into its original compartment the risk of postoperative surgical site infection. However, several
(Brooks 2021). Strangulation occurs when an incarcerated hernia studies have reported that synthetic mesh placement is feasible
compromises arterial supply to the content of the hernia sac, in emergency groin hernia repair (Sakamoto 2022; Venara 2014),
resulting in ischaemia and eventually necrosis (Brooks 2021). specifically in clean surgical fields (Lohsiriwat 2007), or in
Emergency groin hernia repair is associated with higher morbidity clean-contaminated surgical fields, even with concurrent bowel
and mortality compared with elective repair (Kjaergaard 2010; resection (Atila 2010; Bessa 2015; Papaziogas 2005; Sakamoto 2022;
Malek 2004; Nilsson 2007; Sæter 2022b). Sawayama 2014; Ueda 2012). Some studies have found mesh hernia
repair to be feasible in contaminated and dirty hernias (Kelly 2002;
Femoral hernias are associated with an increased risk of Pandey 2018), and a recent randomised controlled trial assessing
incarceration or strangulation (Dahlstrand 2009; Hernández- mesh use for contaminated ventral hernias found no mesh-related
Irizarry 2012). A previous study estimated the cumulative reoperations after six months (Rosen 2022). However, the use of
probability of strangulation in femoral hernias to be 22% at one mesh in emergency groin hernia repair in a contaminated surgical
month and 45% at 21 months (Gallegos 1991). In comparison, the field is still controversial due to the potential risk of surgical site
same study estimated the cumulative probability of strangulation infections following mesh implantation. This risk precludes the
in inguinal hernias to be 3% at three months and 5% at 24 months. laparoscopic approach in these circumstances as it always requires
Other risk factors for incarceration and the need for emergency the use of mesh. To date, no comprehensive systematic review
groin hernia repair are advanced age, female sex, hernia-related has been carried out to assess whether the use of mesh is safe or
hospitalisation in the year preceding hernia repair, and recurrent feasible in emergency groin hernia repair in all surgical fields (clean,
hernia (Abi-Haidar 2011; Dahlstrand 2009; Primatesta 1996). clean-contaminated, contaminated, and dirty).

Description of the intervention How the intervention might work


Surgical repair is the only definitive treatment for emergency Reinforcing the abdominal wall with a prosthetic mesh during groin
groin hernias (Brooks 2021). This procedure must be performed hernia repair reduces the risk of hernia recurrence compared with
immediately after diagnosis due to the risk of strangulation and non-mesh repair (Lockhart 2018). However, mesh placement in
bowel necrosis (Reinke 2020). However, since there is no evidence contaminated surgical fields may be avoided to minimise the risk of
supporting an optimal surgical approach, current guidelines infection. Furthermore, mesh infections can be more complicated
suggest a tailored approach for adult patients presenting with to treat: patients may need another surgical procedure to have
acutely incarcerated or strangulated groin hernias (HerniaSurge the mesh removed and the hernia repaired again, or they may
Group 2018). In general, hernia repair involves the use of mesh need a prolonged course of antimicrobial treatment. Hence, mesh
or the use of sutures only. In mesh repair, the surgeon covers infections are potentially associated with higher costs than simple
the hernia defect with a prosthesis that is typically made from a surgical site infections without mesh, which has been described for
synthetic polymer like polypropylene or polyester (Lockhart 2018). ventral hernia repairs (Plymale 2020).
This procedure can be performed using an open surgical approach
or a minimally invasive laparoscopic approach (McCormack 2003). Why it is important to do this review
In elective groin hernia repair in adults, open or laparoscopic
Emergency groin hernia repair is a common surgical emergency,
mesh repair is recommended to decrease the risk of recurrence
representing over one out of three femoral hernia operations
(HerniaSurge Group 2018). Incarcerated or strangulated groin
(Dahlstrand 2009) and around one out of 11 inguinal hernia
hernias are usually repaired with an open approach, but a
admissions (Primatesta 1996). While mesh repair is the standard
laparoscopic approach may also be feasible in experienced hands
treatment for elective hernia repair (HerniaSurge Group 2018),
(Karatepe 2008).
the optimal surgical approach to treat emergency groin hernias
Surgical site infections are the most common kind of nosocomial remains controversial (HerniaSurge Group 2018). Elective and
infections (hospital-acquired infections) following surgery; they emergency groin hernia repairs are performed under very different
lead to longer hospitalisations, higher mortality, more intensive clinical circumstances, which might not be comparable in research.
care unit transfers, and more readmissions (Kirkland 1999). There are several published Cochrane Reviews on elective groin
Bacteria colonise all surgical wounds, but not all contaminations hernia repairs (Lockhart 2018; Scott 2001; Sun 2017), but none
lead to infection (Birindelli 2017). An expert panel of the World have examined emergency groin hernia repair. In addition, there
Society of Emergency Surgery approved the following classification is no consensus on the use of mesh in acutely contaminated
to define recommendations for emergency repair of abdominal or dirty surgical fields due to the potential risk of infection
wall hernias, which is based on the Centers for Disease Control and (HerniaSurge Group 2018). Even though mesh repair reduces the
Prevention wound classification that stratifies wounds according to risk of recurrence in hernia surgery, it should not be used in
the likelihood and degree of contamination (Birindelli 2017): an emergency setting if it increases the risk of postoperative
complications. Therefore, this Cochrane Review aims to synthesise
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the evidence from all relevant literature to assess whether the use • preperitoneal repair.
of mesh in emergency groin hernia repair is associated with an
increased risk of surgical site infections, postoperative morbidity, Laparoscopic techniques included:
and mortality.
• transabdominal preperitoneal repair (TAPP);
OBJECTIVES • totally extraperitoneal repair (TEP);
• robotic-assisted laparoscopic repair; and
Main objective • single-incision laparoscopic surgery (SILS).
To assess the benefits and harms of mesh compared with non-mesh
in emergency groin hernia repair in adult patients with an inguinal For open non-mesh approaches, any type of sutures could be used
or femoral hernia. (absorbable or non-absorbable). We accepted both tension and
tension-free repair techniques, including:
Secondary objective
• Marcy;
To assess whether the effects of mesh versus non-mesh in • Bassini;
emergency groin hernia repair differ according to the degree of • McVay;
contamination.
• Shouldice; and
METHODS • Desarda.

Criteria for considering studies for this review The non-mesh group was considered the control group for all
outcomes.
Types of studies
Types of outcome measures
The following section is based on the methods presented in the
published protocol for the review (Sæter 2022). Any deviations from All studies fulfilling the study, participant, and intervention criteria
the protocol, including methods not implemented, are outlined were included irrespective of reported outcomes. We focused on
and justified in Differences between protocol and review. short-term outcomes that were relevant to an emergency surgical
setting.
We included all randomised controlled trials (RCTs) and quasi-
RCTs (e.g. randomisation based on personal registration numbers) If the following outcome measures were not reported in the studies,
(Differences between protocol and review) that compared the use we contacted the study authors to request the missing data. If we
of mesh with non-mesh for emergency groin hernia repair. There did not receive a response, we sent at least two follow-up emails
was no limitation on the number of randomised participants in (Differences between protocol and review). The study was included
trials, and we applied no restrictions on publication status or irrespective of response.
language.
Primary outcomes
Types of participants
• Surgical site infections (as defined by the included studies)
• We included all adult patients (aged 18 and over) with an within 30 days of repair
inguinal or femoral hernia undergoing emergency groin hernia • Mortality (defined as all-cause mortality) within 30 days of repair
repair.
• We excluded studies with a paediatric population (aged less Secondary outcomes
than 18 years) if the data on the adult population could not be • Surgical site infections (as defined by the included studies)
extracted separately. within 90 days of repair
Types of interventions • Complications, classified by the Clavien-Dindo Classification
(Dindo 2004) (as classified by the included studies), within 30
We included studies that compared the use of mesh with the use days of repair
of sutures only (non-mesh) in emergency groin hernia repair. We ◦ Clavien-Dindo Classification grade 5 was excluded, as this
considered the procedure 'emergency surgery' when the authors complication was covered in the primary outcome of 30-day
defined it as such or when it was performed within 24 hours. mortality
• Clinical recurrence or reoperation for recurrence within 30 days
As the intervention of interest was mesh use, we chose to pool all
of repair and within one year of repair
mesh-based and non-mesh repairs into two groups.
• Reoperation due to complications (e.g. infection, seroma,
Any technique for surgical repair of a groin hernia with mesh bleeding) within 30 days of repair
implantation was accepted. Any type of mesh could be used (e.g. • Mesh removal within 30 days of repair
absorbable, synthetic, biological). Open techniques included, but • Mesh removal within 90 days of repair
were not limited to:
Search methods for identification of studies
• Lichtenstein repair;
• mesh plug repair; In collaboration with a professional Cochrane-affiliated research
librarian, we developed a search strategy for Ovid MEDLINE, which
• plug and patch;
• bilayer repair; and
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we then adapted to the other databases. There were no restrictions before entering them into Review Manager Web (RevMan Web
on language or publication date. 2020). We used RevMan Web 2020 to perform all data analyses. Any
discrepancies were resolved by discussion within the author group.
Electronic searches
We collected information on study design and setting, patient
We conducted a comprehensive literature search to identify all
characteristics (including race, smoking status, comorbidities,
published and unpublished RCTs.
etc.), the authors' definition of emergency groin hernia repair,
The searches were last run on 5 August 2022 in the following intervention characteristics (including surgical approach and
databases: contamination grade), outcomes assessed, source of funding,
and any conflicts of interest stated by the study authors. We
• Cochrane Central Register of Controlled Trials (CENTRAL 2022, dichotomised the following subgroups prior to data extraction:
Issue 8) in the Cochrane Library (Appendix 1); age into participants ≥ 65 and < 65 years, American Society of
• MEDLINE Ovid (1946 to 5 August 2022) (Appendix 2); Anaesthesiologists’ (ASA) scores into ASA score 1-2 and ASA score
3-4, and body mass index (BMI) into ≥ 30 and < 30 (Differences
• Embase Ovid (1974 to 5 August 2022) (Appendix 3).
between protocol and review). Dichotimisation was done to
Searching other resources facilitate any feasible subgroup analyses to assess heterogeneity.

On 5 August 2022, we searched the World Health Organization If any additional data were required, we contacted the study
International Clinical Trials Registry Platform (ICTRP; apps.who.int/ authors by email, following up with two further emails in case of
trialsearch) and the US National Institutes of Health ongoing trials no response. We addressed missing data with worst-case and best-
register (clinicaltrials.gov) for completed and ongoing studies. The case scenarios (see Dealing with missing data).
search terms used for searching trial registries can be found in
Appendix 4. Assessment of risk of bias in included studies
At least two independent review authors conducted the risk of bias
Other search sources included reference list searching, forward
assessment for RCTs using the Cochrane risk of bias tool (RoB 2;
citation searching, and grey literature. To complete the search for
Sterne 2019). Any discrepancies were resolved by discussion within
relevant studies, we reviewed the reference lists of all included
the author group.
articles (Greenhalgh 2005), and the reference lists of relevant
systematic reviews and guidelines (Bittner 2005; Finch 2019; We applied the risk of bias tool to the following outcomes and time
Hentati 2014; HerniaSurge Group 2018; Li 2012; Lin 2020; Lockhart points.
2018; Reinke 2020). We also performed a forward citation search
of the included articles using Google Scholar (scholar.google.com). • Surgical site infections within 30 days of repair
For each additional record identified from other sources, we • Mortality within 30 days of repair
performed subsequent reference list and forward citation searches.
• Clinical recurrence or reoperation for recurrence within 30 days
The first forward citation search was done on 15 August 2022, and
of repair and within one year of repair
the last forward citation search was completed on 19 August 2022.
• Mesh removal within 30 days and 90 days of repair
If we found unpublished relevant studies in the registries, we
contacted the authors to enquire about unpublished data and For the following outcomes, we performed no risk of bias
results. assessment since we did not identify any studies reporting them:

Data collection and analysis • Complications within 30 days of repair


• Reoperation due to complications (e.g. infection, seroma,
In general, when studies written in a non-English language were bleeding) within 30 days of repair
identified, at least one native speaker of the language assessed
eligibility for inclusion and performed the data extraction and risk Further, if we included studies that did not report a numerical result
of bias assessment. The other author had assistance from a native for an outcome of interest for this review, thus not contributing
speaker if any questions arose (Differences between protocol and to the review, we did not perform a risk of bias assessment
review). (Differences between protocol and review).

Selection of studies We assessed the effect of allocation to the intervention through an


intention-to-treat analysis, meaning that the effect of interest was
Two review authors independently screened the titles and
the effect of assignment. We assessed the risk of bias arising from
abstracts of the included records using Covidence and then
the following domains:
retrieved and assessed the full texts of all records considered
potentially eligible. Any discrepancies were resolved by discussion • The randomisation process
within the review author group.
• Deviations from intended interventions
We searched all eligible studies in the Retraction Watch Database • Missing outcome data
(Differences between protocol and review). • Measurement of outcome
• Selection of the reported results
Data extraction and management
At least two authors independently extracted data into piloted Based on the answers to a series of signalling questions, we made
forms in Covidence. We checked all data for accuracy in Covidence a risk of bias judgement for each domain (low risk of bias, some

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concerns, or high risk of bias). We used the 22 August 2019 version • 75% to 100%: considerable heterogeneity
of the Excel tool provided by riskofbias.info for the assessment.
Assessment of reporting biases
The overall risk of bias for an outcome was the highest individual
If more than 10 studies were identified, we planned to assess
risk of the five domains. This means only considering an outcome
the risk of reporting bias visually using a funnel plot. Funnel
to be at low risk of bias when we judged all five domains to be at
plot asymmetry may indicate substantial publication bias and
low risk. This information is presented in the review and included
overestimation of the intervention effect (Page 2021).
in the analyses and conclusion.
Data synthesis
Measures of treatment effect
We pooled dichotomous outcomes in a meta-analysis if clinical,
We analysed data using RevMan Web 2020.
methodological, and statistical heterogeneity was sufficiently low.
Dichotomous outcomes are expressed as risk ratios (RRs) with
We adopted a random-effects model for data synthesis as we
95% confidence intervals (CIs) (Differences between protocol and
expected some heterogeneity among the populations, study
review). The Clavien-Dindo-classified complications were the only
designs, and definitions of emergency groin hernia repair. All results
categorical outcomes with more than two categories and we
are presented with 95% CIs. We generated forest plots with RevMan
dichotomised these for analyses into grades 1-2 and grades 3-4.
Web 2020. All eligible studies were included in the primary analyses,
None of our outcomes were continuous. regardless of risk of bias. If the I2 value was above 75%, the pooled
estimate is not presented in the forest plots (Burcharth 2015). If a
Unit of analysis issues meta-analysis was not possible, we intended to use non-statistical
methods to synthesise findings across studies, visually displaying
The unit of analysis was the participant (not the hernia).
the results and summarising the effect estimates with the range and
Dealing with missing data distribution of the observed effects (McKenzie 2021).

We dealt with missing data as follows. Subgroup analysis and investigation of heterogeneity

• We contacted the authors to request supplementary data (e.g. If clinical heterogeneity was suspected and there was a sufficient
dropouts, loss to follow-up, or when a study was only published number of participants, we performed subgroup analyses based
as an abstract). on the following characteristics, regardless of the statistical
◦ If any additional data were obtained, we included them in the heterogeneity.
analysis.
• Patient characteristics (sex, age, BMI, ASA score, diabetes,
• If the study did not report means and standard deviations, smoking, and race)
we attempted to calculate these statistics from the available
• Hernia type:
reported data. If data were not reported numerically but
◦ Femoral hernia
graphically, we extracted data from the figures.
◦ Inguinal hernia
• If some participants had missing data, we only included the
available data in the primary analysis. • Contamination according to the World Society of Emergency
Surgery classification (Birindelli 2017):
• We performed sensitivity analyses using a best-case scenario
◦ Clean surgical field: no signs of strangulation and no bowel
(participants with missing data in the intervention arm
resection
developed events for desirable outcomes and participants with
missing data in the control arm did not) and a worst-case ◦ Clean-contaminated surgical field: complicated hernia with
scenario (participants with missing data in the intervention arm strangulation, or bowel resection without gross enteric
developed events for undesirable outcomes and participants spillage
with missing data in the control arm did not). ◦ Contaminated surgical field: strangulation with bowel
• We addressed the potential impact of the missing data in the necrosis, or gross spillage during intestinal resection
discussion section. ◦ Dirty surgical field: peritonitis from a bowel perforation
• Mesh type:
Assessment of heterogeneity ◦ Absorbable mesh, synthetic mesh, and biological mesh
We assessed clinical, methodological, and statistical heterogeneity. • Type of surgery
For clinical heterogeneity, we considered differences in participant ◦ Bowel resection
characteristics (e.g. American Society of Anesthesiology (ASA) ◦ No bowel resection
score, age, sex), intervention, outcome, and length of follow-up. • Use of antibiotics preoperatively at index surgery
For methodological heterogeneity, we considered study design
(e.g. type of follow-up) and risk of bias. We assessed statistical If different contamination degrees were pooled in the original data,
heterogeneity using the I2 statistic (Higgins 2003), interpreting the they were also pooled in the subgroup analysis (e.g. pooling clean
results as follows (Deeks 2022): surgical field and clean-contaminated surgical field) (Differences
between protocol and review).
• 0% to 40%: might not be important
• 30% to 60%: may represent moderate heterogeneity We used the I2 statistic to examine subgroup differences (Higgins
• 50% to 90%: may represent substantial heterogeneity 2003).

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Sensitivity analysis risk of bias, inconsistency, imprecision, indirectness, or publication


bias, according to the GRADE recommendations (Schünemann
We performed sensitivity analysis by excluding studies with low
2021).
methodological quality (overall high risk of bias).
We used the overall RoB 2 judgement to feed into the GRADE
As explained in Dealing with missing data, if some data were
assessment, as risk of bias is one of the five GRADE domains. We
missing from the included studies, we performed sensitivity
summarised risk of bias data before downgrading the certainty of
analyses using a best-case scenario (participants with missing data
the evidence (Schünemann 2021). The three possible categories
in the intervention arm developed events for desirable outcomes
were:
and participants with missing data in the control arm did not)
and a worst-case scenario (participants with missing data in the • low risk of bias (most information for the outcome is generated
intervention arm developed events for undesirable outcomes and from studies at low risk of bias);
participants with missing data in the control arm did not).
• moderate risk of bias (most information is from studies at low
Summary of findings and assessment of the certainty of the risk of bias or studies with some concerns); and
evidence • high risk of bias (the proportion of information from studies
at high risk of bias is sufficient to affect the interpretation of
We used GRADEpro GDT to create a summary of findings table for results).
the following outcomes.
The findings and certainty of evidence are phrased according to the
1. Surgical site infections within 30 days of repair informative statement guidance (Santesso 2020).
2. Mortality within 30 days of repair
3. Complications within 30 days of repair RESULTS
4. Clinical recurrence or reoperation for recurrence within 30 days
Description of studies
of repair and within one year of repair
5. Reoperation due to complications (e.g. infection, seroma, In total, 15 records describing 13 RCTs and two quasi-RCTs were
bleeding) within 30 days of repair included in the Cochrane Review.
6. Mesh removal within 30 days of repair
Results of the search
Two authors independently carried out a certainty of evidence The study selection process is depicted in Figure 1. A total of 3504
assessment for each of the above outcomes using the GRADE records were identified from databases and trial registries, and
approach. Any disagreements were resolved by discussion. 12 records were identified through other sources. After duplicate
Evidence from RCTs was considered high-certainty at the removal, we screened 2731 records, of which we considered 104 in
beginning, but could be downgraded for limitations related to full text for inclusion.

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Figure 1.

2430 records
1074 records 12 records
identified through
identified in trial identified through
database
registries other sources
searching

785 duplicates
removed

2731 records 2627 records


screened excluded

83 full-text records
excluded:

• 26 no non-mesh
control group
• 20 wrong hernia
type (ventral or
incisional hernia)
• 19 elective patient
group
• 18 wrong study
design
104 full-text (non-randomised,
records assessed observational, or
for eligibility retrospective study)

6 records identified as
ongoing or awaiting
classification:

• Awaiting
classification: 5
records (2 studies
and 3 trial
registrations)
• Ongoing: 1 record (1
trial registration)

15 records
included in
qualitative
synthesis:
Mesh versus non-mesh for emergency groin hernia repair (Review) 11
• 15 Wiley
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Figure 1. (Continued)

15 records
included in
qualitative
synthesis:

• 15 published
studies

12 published
studies included in
the quantitative
synthesis
(meta-analysis)

The database and trial registry search yielded the inclusion of included both male and female participants. However, one study
five trials (Duan 2018; Elsebae 2008; Karaca 2016; Memon 2017; did not report the male/female ratio but stated in the methods that
Panda 2012). Furthermore, four registered trials were identified, both males and females were included as trial participants (Panda
of which three are awaiting classification (ChiCTR2100042336; 2012).
NCT02469142; NCT04850131) (Studies awaiting classification) and
one is registered as ongoing (NCT01578538) (Ongoing studies). Age
The mean/median age of the population in the mesh group ranged
Searches in other sources identified 12 additional records. Among
from 35 years (Elsebae 2008) to 70 years (Sun 2010), while the mean/
these, 10 trials were included in this Cochrane Review (Chen 2016;
median age for the non-mesh groups ranged from 41 years (Panda
Darwish 2018; Guo 2015; Li 2010; Ren 2012; Sun 2010; Wang 2014; Ye
2012) to 69 years (Ren 2012). Three studies did not report a mean/
2012; Yin 2013; Zhu 2015), and two trials are awaiting classification
median age for the two groups separately (Duan 2018; Guo 2015;
(He 2006; Nedelcu 2016) (Studies awaiting classification).
Memon 2017), but reported an overall mean/median age of 54 years
A comprehensive description of all 15 included studies is presented (Duan 2018) and 61 years (Guo 2015), or solely reported an age
in the Characteristics of included studies. group ranging from 20 to 60 years (Memon 2017).

Included studies Hernia types

Study characteristics Most of the trials included solely participants with inguinal hernias
(Chen 2016; Darwish 2018; Elsebae 2008; Guo 2015; Karaca 2016;
Fifteen trials randomising a total of 1241 participants met the Li 2010; Memon 2017; Panda 2012; Ren 2012; Ye 2012; Yin 2013).
inclusion criteria for this review (Chen 2016; Darwish 2018; Duan The remaining trials included participants with both inguinal and
2018; Elsebae 2008; Guo 2015; Karaca 2016; Li 2010; Memon 2017; femoral hernias (Duan 2018; Sun 2010; Wang 2014; Zhu 2015),
Panda 2012; Ren 2012; Sun 2010; Wang 2014; Ye 2012; Yin 2013; Zhu comprising 41 participants with a femoral hernia. The trials did not
2015). Among the participants, 626 received a mesh hernia repair, always report the type of inguinal hernia (indirect/direct). However,
and 615 received a non-mesh repair. The number of participants among the trials that did report the type of inguinal hernia, the vast
in each trial ranged from 33 (Ren 2012) to 246 (Karaca 2016). Ten majority of the inguinal hernias were indirect, ranging from 86%
trials were performed in China (Chen 2016; Duan 2018; Guo 2015; (Wang 2014) to 100% (Guo 2015; Ren 2012; Zhu 2015) of all inguinal
Li 2010; Ren 2012; Sun 2010; Wang 2014; Ye 2012; Yin 2013; Zhu hernias.
2015), and the remaining trials were conducted in Egypt (Darwish
2018; Elsebae 2008), India (Panda 2012), Pakistan (Memon 2017), Whether the hernia was primary or recurrent was only reported
and Türkiye (Karaca 2016). All trials were performed in a hospital in six trials (Chen 2016; Darwish 2018; Duan 2018; Elsebae 2008;
emergency setting (tertiary care), and the study duration ranged Memon 2017; Panda 2012), and, among these, four trials only
from 11 (Zhu 2015) to 139 months (Duan 2018). included primary hernias (Darwish 2018; Elsebae 2008; Memon
2017; Panda 2012). Any previous mesh implantation in patients with
Sex recurrent hernias was not reported.
The majority of the participants were males, with a total of 972
males. Five trials only included male participants (Darwish 2018;
Elsebae 2008; Li 2010; Memon 2017; Ren 2012), while the rest
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Description of intervention a dirty surgical field. For details, see Characteristics of included
studies.
All the trials used an open mesh-based tension-free hernia repair
for the interventional mesh repair group, either simply described The remaining studies either did not report perioperative findings
as an "open tension-free hernia repair" (Chen 2016; Guo 2015; to allow the classification of contamination degree (Chen 2016;
Li 2010; Ren 2012; Sun 2010; Wang 2014; Ye 2012; Zhu 2015) or Memon 2017; Zhu 2015) or reported the findings unclearly (Yin
a "Lichtenstein repair" (Darwish 2018; Duan 2018; Elsebae 2008; 2013). For the latter, the participants most likely had clean-
Karaca 2016; Memon 2017; Panda 2012; Yin 2013). contaminated surgical fields due to "strangulated inguinal hernia",
but since it is unclear whether bowel resection or peritonitis was
Two trials did not report the type of mesh used in the intervention
present, it is uncertain whether cases with contaminated and dirty
group (Wang 2014; Yin 2013). All the remaining studies used
surgical fields were included.
synthetic meshes, and no studies reported using absorbable or
biological meshes. The most common mesh was a polypropylene Outcomes reported by the included studies
synthetic mesh (Chen 2016; Darwish 2018; Duan 2018; Elsebae
2008; Guo 2015; Karaca 2016; Li 2010; Panda 2012; Sun 2010; The most common outcomes reported in the included studies
Zhu 2015). Other meshes included Goretex mesh (Ren 2012), were the length of hospitalisation (n = 13, 87%), followed by
polyethylene mesh (Ye 2012), and solely "synthetic mesh" without postoperative local infection (n = 11, 73%), recurrence rate (n
further specification (Memon 2017). = 11, 73%), and operative time (n = 10, 67%). Other reported
outcomes included scrotal haematoma, wound haematoma,
Description of comparison postoperative pain (measured by analgesia rate, visual analogue
scale (VAS) scores, and not reported), intraoperative blood
The Bassini repair was the most common non-mesh hernia repair
loss, time to get out of bed, patient satisfaction, urinary
(Chen 2016; Darwish 2018; Elsebae 2008; Guo 2015; Karaca 2016; Li
retention, dysuria, pneumonia, mesh removal, hospitalisation cost,
2010; Panda 2012; Sun 2010; Wang 2014; Ye 2012; Zhu 2015). Other
subfebrilia, vital intraoperative parameters, seroma, mortality,
non-mesh hernia repairs included "traditional hernia repair" (Ren
systemic complications (pulmonary, cardiac, and renal), and return
2012; Yin 2013), sutured repair (Duan 2018), Darn repair (Memon
to daily activities.
2017), and McVay repair (Wang 2014). Ren 2012 further described
"traditional hernia repair" as either high hernia sac ligation, Detailed descriptions of the outcomes reported in each trial can be
Ferguson repair (on the basis of high hernia sac ligation), or Bassini found in the Characteristics of included studies.
repair.
Most of the reported outcomes were not defined with time points
Other co-interventions for measurement, making the numerical results ineligible for
The reporting of the administration of antibiotics varied in inclusion in the meta-analysis.
the included trials. Five trials reported administering antibiotics
Funding sources
preoperatively (Guo 2015; Sun 2010; Darwish 2018; Memon 2017;
Zhu 2015), and three other trials reported administering antibiotics Funding sources were not reported in most studies (Chen 2016;
postoperatively (Chen 2016; Elsebae 2008; Ye 2012). Some trials Duan 2018; Guo 2015; Karaca 2016; Li 2010; Ren 2012; Sun 2010;
reported the use of perioperative antibiotics, without specifying the Wang 2014; Ye 2012; Yin 2013; Zhu 2015). The remaining studies
time of administration (Duan 2018; Karaca 2016; Panda 2012), and either declared no funding sources (Darwish 2018; Elsebae 2008;
for the remaining four trials, the use of antibiotics was either not Memon 2017), or provided an ambiguous funding source statement
reported (Li 2010; Ren 2012) or unclearly reported (Wang 2014; Yin (Panda 2012).
2013). For details, see Characteristics of included studies.
Excluded studies
Contamination degree
Of all the studies assessed in full text, we excluded 83 records. The
In total, 11 studies enabled the classification of the degree of studies were excluded as they did not meet the inclusion criteria
contamination (Darwish 2018; Duan 2018; Elsebae 2008; Guo 2015; of being a prospective RCT or quasi-RCT, only elective surgery was
Karaca 2016; Li 2010; Panda 2012; Ren 2012; Sun 2010; Wang studied, the hernia type was wrong, or a non-mesh control group
2014; Ye 2012). Among these, all but one study (Duan 2018) was missing. Examples of excluded studies are Huang 2012, Jiang
included participants with clean to clean-contaminated surgical 2016, Jin 2016, and Karatepe 2008, and the reasons for exclusion
fields. One trial only included participants with a clean surgical of these studies can be found under Characteristics of excluded
field (Sun 2010), six trials included participants with clean to clean- studies.
contaminated surgical fields (Darwish 2018; Guo 2015; Karaca 2016;
Panda 2012; Wang 2014; Ye 2012), and three trials only included Key excluded studies are referenced in this review. A full
participants with a clean-contaminated surgical field (Elsebae comprehensive list of the 83 excluded studies assessed in full text
2008; Li 2010; Ren 2012). can be provided by the first author upon request.

Only one trial assessed mesh repair in contaminated to dirty Risk of bias in included studies
surgical fields (Duan 2018). In this study, they used a modified
The overall risk of bias assessment across the included studies is
three-grade classification system to identify the degree of bowel
presented following the methods given in the Assessment of risk
necrosis. This study grading has been translated to the protocol
of bias in included studies. The risk of bias assessment for each
grading, so grade 1 bowel necrosis corresponds to a contaminated
predefined outcome of relevance in this review for each study is
surgical field, and grade 2 and 3 bowel necrosis corresponds to
presented in the interactive Risk of bias (tables). Each prespecified

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outcome eligible for risk of bias assessment has a table with we assessed none of the included trials at low risk of bias
detailed descriptions of the support for each judgement and the for this domain, and we assessed most trials as having 'some
final score (high, low, or some concerns). Moreover, the risk of concerns' (85%) due to the lack of information. We assessed the
bias assessment is included in the forest plots with traffic lights remaining trials as having 'high risk of bias' (15%). Trials receiving
in all primary analyses for both primary and secondary outcomes. a high risk for selection of the reported results were those that only
The full RoB 2 Excel tool provided by riskofbias.info used for the reported the outcome in one treatment group, or if the reported
assessment is available on reasonable request. outcomes were not in accordance with the analysis intentions
described.
We carried out 27 individual outcome-dependent risk of bias
assessments for the 12 studies presenting a numerical result for Three included studies did not present outcome data of interest
an outcome of interest for this review. In general, the risk of bias with a numerical result. Hence, the risk of bias assessment was not
assessment was very similar for all outcomes in this review, and we completed for these studies as they did not contribute to the review
judged the overall risk of bias in outcomes for all studies to be either (Memon 2017; Sun 2010; Yin 2013).
'some concerns' (n = 5, 18.5%) or 'high' (n = 22, 81.5%).
Effects of interventions
Regarding the randomisation process, we assessed all the included
studies to have 'some concerns' as the only information about the See: Summary of findings 1 Summary of findings table - mesh
randomisation method was that the allocation was randomised repair vs. non-mesh repair for adult patients with incarcerated or
without specifying any further details. However, in general, no strangulated groin hernia
baseline differences were found, suggesting no problems with the
Mesh versus non-mesh repair for emergency groin hernia
randomisation process.
surgery
For the domain regarding deviations from intended interventions, For all outcomes, both primary and secondary, we obtained data
none of the included studies had sufficiently described if or how from published literature. We sought correspondence with the
blinding was carried out. However, since the people delivering study authors, and searched trial registers and web-based data
the intervention were surgeons, the question about whether the repositories, but failed to obtain any additional data.
persons delivering the intervention were aware of the assigned
treatment was responded with 'probably yes' for all studies. Primary outcomes
Surgical site infections (as defined by the included studies) within 30
No trial protocols were found for any of the included studies.
days of repair
Therefore, judging any deviations from the intended intervention
was not possible and hence none of the included trials was Two studies randomising 454 participants reported surgical site
assessed to have low risk of bias for this domain. Most trials were infections within 30 days of repair (Duan 2018; Karaca 2016). In
assessed to have 'high risk of bias' (78%) and the remaining trials total, there were 41/229 events of 30-day surgical site infections
had 'some concerns' (22%). The main difference between studies in the mesh group and 24/225 events in the non-mesh group.
assessed as high risk of bias and some concerns was that for studies The meta-analysis demonstrated little to no effect on surgical site
reporting that all patients were followed up, we assessed there to infections after mesh repair (RR 1.66, 95% CI 0.96 to 2.88; I2 = 21%;
be no potential for a substantial impact (on the result) of the failure Analysis 1.1); thus, there were 70 more (from 5 fewer to 200 more)
to analyse participants in the group since they were all followed up. surgical site infections in the mesh group per 1000 participants.
Using GRADE, we assessed the certainty of the evidence for surgical
Not all included studies reported or discussed missing outcome site infections within 30 days of repair as very low. We downgraded
data, and loss to follow-up was rarely addressed. However, some the certainty of the evidence due to high risk of bias, imprecision,
studies reported no loss to follow-up, and thus had no missing data, and indirectness. The GRADE assessments are outlined in Summary
achieving a low risk of bias for this particular domain (22%). The of findings 1.
remaining studies received a judgement of 'high risk of bias' (78%).
We performed a subgroup analysis for 30-day surgical site
The reporting of outcome measurement was poor. In general, infections regarding the degree of contamination for clean to clean-
the authors did not report how outcome data were measured or contaminated, contaminated, and dirty surgical fields. Overall,
collected, other than stating that the participants were followed only one study was identified per subgroup and the test for
up for a certain amount of time. For the risk of bias assessment, subgroup differences did not suggest any subgroup effect (P =
we considered the outcomes of all-cause mortality and operation 0.20) (Analysis 3.1). However, looking separately at the subgroups,
for mesh removal unlikely to be influenced by the knowledge of little to no difference was found in a clean to clean-contaminated
the intervention received. We therefore assessed these outcomes field (RR 1.09, 95% CI 0.43 to 2.73; 1 study, 246 participants) and
to have low risk of bias regarding the measurement of outcome a contaminated surgical field (RR 1.37, 95% CI 0.55 to 3.40; 1
even when the attempt at outcome assessment blinding was not study, 145 participants), but mesh repair may increase the risk of
described. An equal number of trials received a low (44%) and high surgical site infections in a dirty surgical field (RR 2.69, 95% CI
risk (44%) of bias judgement, and the remaining trials had 'some 1.48 to 4.89; 1 study, 63 participants) (Analysis 3.1). However, the
concerns' (11%). test for subgroup differences suggested no evidence of a difference
between the groups. The subgroups of clean surgical field and
The assessment of risk of bias for the domain selection of
clean-contaminated surgical field were pooled in this subgroup
the reported results was challenged by none of the included
analysis, as they were pooled in the original data (Differences
trials having discussed pre-specified analysis plans, and analysis
between protocol and review). It was not possible to conduct
intentions were not available for any of the included trials. Hence,

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subgroup analyses for hernia type, sex, age, BMI, ASA score, all-cause mortality within 30 days of repair (RR 1.38, 95% CI 0.58 to
diabetes, smoking, race, mesh type, or preoperative antibiotics. 3.28; 1 study, 208 participants; Analysis 1.2).

We did not perform a sensitivity analysis excluding studies with low Secondary outcomes
methodological quality as there were only two studies reporting 30-
Surgical site infections (as defined by the included studies) within 90
day surgical site infection and we assessed both of these studies to days of repair
have high risk of bias. Neither of the two studies reported whether
there were any missing data, so a sensitivity analysis based on best- One study with 60 participants reported surgical site infections
case/worst-case scenarios was not possible. within 90 days of repair (Darwish 2018), reporting 2/30 infections
(6.67%) both for mesh and non-mesh repair (RR 1.00, 95% CI 0.15 to
In summary, mesh hernia repair may have no effect or slightly 6.64; Analysis 1.3). Surgical site infections within 90 days were not
increase the risk of 30-day surgical site infections (RR 1.66, 95% discussed in the remaining 14 studies.
CI 0.96 to 2.88; I2 = 21%; 2 studies, 454 participants; Analysis 1.1)
when compared with non-mesh hernia repair, but the evidence is As only one study reported 90-day surgical site infections, we
very uncertain. However, mesh hernia repair may increase the risk performed no subgroup or sensitivity analyses. Neither loss to
of 30-day surgical site infections in dirty surgical fields (RR 2.69, follow-up nor missing data were reported, so sensitivity analysis
95% CI 1.48 to 4.89; 1 study, 63 participants; Analysis 3.1), but the based on best-case/worst-case scenarios was not possible.
test for subgroup differences suggested no evidence of a difference
between the degrees of contamination. Using GRADE, we assessed the certainty of the evidence for 90-day
surgical site infections as very low. We downgraded the certainty of
Mortality (defined as all-cause mortality) within 30 days of repair the evidence due to high risk of bias, imprecision, and indirectness,
as the trial only included male participants with incarcerated
Four studies randomising 541 participants reported mortality inguinal hernias, excluding the most severe cases of emergency
within 30 days of repair as an outcome (Duan 2018; Elsebae 2008; groin hernia (e.g. female and femoral hernias)
Karaca 2016; Ren 2012). Three trials randomising participants with
clean to clean-contaminated surgical fields had no deaths in either The evidence is very uncertain about the effect of mesh on surgical
group (Elsebae 2008; Karaca 2016; Ren 2012). In total, there were site infections within 90 days of repair.
11/273 events of mortality within 30 days of repair in the mesh
group and 8/268 events in the non-mesh group, resulting in little Complications, classified by the Clavien-Dindo Classification within 30
to no difference in mortality (RR 1.38, 95% CI 0.58 to 3.28; 1 study; days of repair
Analysis 1.2). Thus, there were 29 more (from 32 fewer to 175 more) None of the included studies reported complications classified by
deaths in the mesh group per 1000 participants. We assessed the the Clavien-Dindo Classification within 30 days of repair.
certainty of the evidence for mortality within 30 days of repair as
very low. We downgraded the certainty of the evidence due to most Clinical recurrence or reoperation for recurrence within 30 days of repair
studies having a high risk of bias, imprecision, and indirectness.
Five studies with a total of 254 participants reported 30-day
The details of the GRADE assessments are outlined in Summary of
recurrence as an outcome (Darwish 2018; Elsebae 2008; Panda
findings 1.
2012; Wang 2014; Zhu 2015). Three trials did not report any
Two subgroup analyses could be performed. Firstly, regarding recurrences within 30 days (Darwish 2018; Panda 2012; Zhu 2015)
the degree of contamination, no deaths occurred in a clean to (Analysis 1.4). However, Elsebae 2008 and Wang 2014 reported
clean-contaminated field (3 studies, 333 participants), so an effect recurrences but did not report any time point for recurrence other
measure was not estimable, and little to no difference was found than that the participants were followed up for 22 ± 6 and 30 ±
in a contaminated to dirty surgical field (RR 1.38, 95% CI 0.58 to 6 months, respectively. Both studies observed zero recurrences in
3.28; 1 study, 208 participants; Analysis 3.2). Secondly, regarding the mesh group and 3/27 (11%) and 6/42 (14%) recurrences in
bowel resection, no deaths occurred in participants not undergoing the non-mesh group, respectively. Since a meta-analysis was not
bowel resection (1 study, 54 participants), and little to no difference performed, we also did not perform a sensitivity analysis.
was found for participants undergoing bowel resection (RR 1.38,
Following GRADE assessment, we rated the certainty of the
95% CI 0.58 to 3.28; 1 study, 208 participants; Analysis 5.1). Testing
evidence for 30-day clinical recurrence as very low. We downgraded
for subgroup differences was not possible since both subgroups
the evidence due to an overall high risk of bias, imprecision due
had one group with zero events. It was not possible to conduct
to small studies and zero events, and indirectness, since none of
subgroup analyses for hernia type, sex, age, BMI, ASA score,
the studies included severe cases of emergency groin hernia. The
diabetes, smoking, race, mesh type, or preoperative antibiotics.
GRADE assessment is outlined in Summary of findings 1.
We did not perform sensitivity analysis excluding studies with
Testing for subgroup differences in the following subgroup analyses
low methodological quality, since only one study reported 30-day
for clinical recurrence within 30 days could not be done as
mortality with events. Two of the studies reported no missing data
there were zero events in both groups: inguinal (3 studies,
(Elsebae 2008; Ren 2012), and the remaining two studies did not
180 participants; Analysis 2.1) and femoral hernias (1 study,
report whether there were any missing data. Hence, sensitivity
20 participants; Analysis 2.1), as well as male (2 studies, 125
analyses based on best-case and worst-case scenarios were not
participants; Analysis 4.1) and female sex (1 study, 35 participants;
possible.
Analysis 4.1). It was not possible to conduct the remaining planned
In summary, the evidence is very uncertain about the effect of mesh subgroup analyses.
hernia repair compared with non-mesh hernia repair on the risk of

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Clinical recurrence or reoperation for recurrence within one year of included participants with a clean or clean-contaminated surgical
repair field. We assessed the certainty of the evidence as very low.
Six studies reported recurrence within one year of repair as We downgraded the certainty of the evidence due to risk of
an outcome (Chen 2016; Elsebae 2008; Panda 2012; Ren 2012; bias (assessed as 'some concerns' and 'high'), imprecision, and
Wang 2014; Ye 2012). Three of these studies did not report the indirectness. The GRADE assessment can be found in Summary of
specific time point for measuring recurrence (Chen 2016; Elsebae findings 1.
2008; Wang 2014), excluding these studies from the meta-analysis.
Due to zero events in one or more subgroups, no test of subgroup
However, in these studies, there were no recurrences in the mesh
differences for mesh removal could be estimated for clean to
group, but the recurrence rate in the non-mesh group was reported
clean-contaminated (4 studies, 194 participants; Analysis 3.3) and
to be > 15% (Chen 2016; raw data not reported), 3/27 (11%) (Elsebae
contaminated to dirty surgical fields (1 study, 208 participants;
2008), and 6/42 (14%) (Wang 2014). The remaining three RCTs, with
Analysis 3.3), or for bowel resection (1 study, 208 participants;
a total of 144 participants, reported the recurrence rate in both
Analysis 5.2) and no bowel resection (2 studies, 94 participants;
arms, yielding 1/73 events of recurrence in the mesh group and 7/71
Analysis 5.2). Regarding the subgroup bowel resection, 7/104
events in the non-mesh group. However, Panda 2012 did not report
meshes (6.7%) were removed (Analysis 5.2), corresponding to the
any events, so only two RCTs randomising 104 participants were
subgroup of contaminated to dirty surgical field (Analysis 3.3). No
included in the meta-analysis (Ren 2012; Ye 2012). The statistical
mesh removals were recorded for patients not undergoing bowel
heterogeneity was low I2 = 0%, and the meta-analysis demonstrated
resection (Analysis 5.2).
a very small, but uncertain decrease in the risk of recurrence in the
mesh group within one year of repair (RR 0.19, 95% CI 0.04 to 1.03; Since only one study reported 30-day mesh removal with events,
I2 = 0%; Analysis 1.5). In absolute terms, mesh repair resulted in we did not perform sensitivity analyses. The article did not report
11 fewer recurrences (ranging from 132 fewer to 4 more) per 1000 any loss to follow-up or missing data, so a sensitivity analysis based
participants within one year of repair. The GRADE assessment for on best-case/worst-case scenarios was not possible.
clinical recurrence or reoperation for recurrence within one year of
repair resulted in a very low certainty of evidence. We downgraded We are very uncertain about the effect of mesh hernia repair on the
the certainty of the evidence due to high risk of bias, imprecision, outcome of mesh removal within 30 days of repair.
and indirectness. The results are outlined in Summary of findings 1.
Mesh removal within 90 days of repair
It was not possible to conduct any of the planned subgroup Four studies with 194 participants reported mesh removal within
analyses. 90 days of repair (Guo 2015; Karaca 2016; Li 2010; Panda
Regarding sensitivity analysis, one study reported losing five 2012). All studies only included participants with clean to clean-
patients to follow-up after one year (Ye 2012), with 36/38 contaminated surgical fields, and no meshes were removed
participants in the mesh group and 35/38 participants in the non- (Analysis 1.7). Since no events occurred, we did not perform a meta-
mesh group available for follow-up at one year. We performed a analysis and, consequently, sensitivity analyses were not possible.
sensitivity analysis based on a best-case/worst-case scenario where Furthermore, we also did not perform a GRADE assessment.
the best-case scenario supported the result of the primary analysis, Since no events were reported in either arm regarding mesh
and the worst-case scenario also demonstrated no difference in the removal within 90 days of repair, we performed no subgroup
two treatment groups regarding recurrence (RR 0.45, 95% CI 0.09 to analyses, but we reported the outcome of 90-day mesh removal
2.34; Analysis 6.1). Furthermore, we assessed all studies included separately for the following subgroups: inguinal hernia (4 studies,
in the meta-analysis to have a high risk of bias when assessing the 194 participants), a clean-contaminated surgical field (2 studies,
outcome of clinical recurrence or reoperation for recurrence within 104 participants), male sex (2 studies, 104 participants), ASA 1-2
one year of repair. Hence, we did not perform a sensitivity analysis (3 studies, 154 participants), diabetes (2 studies, 33 participants),
removing studies of low methodological quality. no bowel resection (2 studies, 94 participants), and preoperative
In summary, the evidence suggests that mesh hernia repair may antibiotics (1 study, 50 participants).
reduce clinical recurrence or reoperation for recurrence within one
DISCUSSION
year of repair compared with non-mesh hernia repair, but the
evidence is very uncertain. Summary of main results
Reoperation due to complications (e.g. infection, seroma, bleeding) We included 15 trials randomising 1241 participants in this review.
within 30 days of repair The trials were conducted in China, the Middle East, and South Asia.
None of the included studies reported reoperation rates within 30
days of repair. The effect of mesh on 30-day surgical site infection remains
uncertain and no firm conclusions can be drawn. Two studies with
Mesh removal within 30 days of repair 454 participants suggest that mesh repair may have no effect on or
slightly increase the risk of surgical site infections.
Five studies included 30-day mesh removal as one of their
reported outcomes (Duan 2018; Elsebae 2008; Guo 2015; Li 2010; The effect of mesh hernia repair on 30-day all-cause mortality is also
Panda 2012), comprising a total of 402 participants. Only one uncertain. Most studies did not report any mortality events, but one
study reported events of mesh removal within 30 days of repair study with 208 participants showed a potential increase in deaths
(Duan 2018), removing 7/104 meshes (6.7%), and included only in the mesh group, suggesting that mesh repair may have no effect
participants with a contaminated or dirty surgical field. The on or slightly increase the risk of mortality.
remaining four studies reported zero mesh removals and only
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Limited evidence is available for 90-day surgical site infections, as indirect as they are mainly based on the least severe cases of
and no events were reported for clinical recurrence or reoperation emergency groin hernia, hence they are not generalisable to all
for recurrence within 30 days. However, two studies with patients presenting with an emergency groin hernia (e.g. higher
104 participants suggest that mesh hernia repair may reduce degrees of contamination, elderly patients, female sex, and femoral
recurrence within one year, but the confidence intervals failed to hernias). Furthermore, the studies were conducted in China, Egypt,
exclude the possibility of no difference, and the evidence is very India, Pakistan, and Türkiye, which might make it problematic to
uncertain. extrapolate the findings to more Western healthcare systems in
high-income countries.
Mesh removal within 30 and 90 days was reported in a small number
of cases. Data on complications classified by the Clavien-Dindo To our knowledge, this review is the first to consider the degree
Classification and reoperation for complications within 30 days of of contamination of the surgical fields when assessing the use
repair were not available. of mesh versus non-mesh in emergency groin hernia repair.
Furthermore, it is also the first review regarding emergency groin
Overall, the evidence for all outcomes is very uncertain. The hernia repair to perform a comprehensive literature search in
findings of this review are concisely summarised in Summary of several databases (Appendix 1; Appendix 2; Appendix 3; Appendix
findings 1. 4), which we supplemented with searches in trial registries and
forward and backward citation searching. Citation searching was
Overall completeness and applicability of evidence not only restricted to the included trials but also done for
The benefits and harms of mesh compared with non-mesh in review articles, books, and international guidelines on the topic
emergency groin hernia repair have been assessed. Overall, the for relevant studies. In addition, we imposed no language or
evidence regarding the effects of mesh hernia repair is uncertain for publication restrictions, enabling the identification of several trials
all outcomes. The secondary objective of this review was to assess not previously cited in the emergency groin hernia literature.
whether the effects of mesh compared with non-mesh hernia repair
However, we are not able to draw any strong conclusions from our
differ according to the degree of contamination. Regarding 30-
findings. This is because the analyses in this review are limited to
day surgical site infections, pooling all degrees of contamination
few events or rare outcomes in small study populations, resulting
suggested little to no effect on surgical site infections. However,
in imprecision and, for some of the outcomes, only a single study
looking separately at the different degrees of contamination, mesh
formed the basis of the analysis. For other outcomes, there were
hernia repair may increase the risk of surgical site infections
either no data reported or no events reported as the outcome was
compared with non-mesh hernia repair in a dirty surgical field,
rare or the follow-up time was not long enough for the event to
but testing for subgroup differences based on the degree of
occur, preventing meta-analysis. As a result of this, we have likely
contamination suggested no subgroup effect, which is probably
failed to identify any potential differences between mesh and non-
due to underpowered analyses. In summary, no firm conclusions
mesh hernia repair, as several of the estimated confidence intervals
can be made about the effect of mesh hernia repair on surgical site
could not exclude the possibility of no difference.
infections because the evidence is very uncertain, but it appears
that mesh use is safe in clean to clean-contaminated surgical fields The certainty of the evidence for each outcome was very low,
and we can conclude that the overall 30-day surgical site infection primarily due to studies of low methodological quality with a high
rate in this subgroup of participants is low. risk of bias, and imprecision due to small sample sizes and few
events. Therefore, future high-quality RCTs would most likely have
Four studies reported 30-day mortality (Duan 2018; Elsebae 2008;
a substantial impact on the findings in this review.
Karaca 2016; Ren 2012), but only one study had events of death
(Duan 2018), making it difficult to reach any conclusion regarding
Quality of the evidence
the effect of mesh on postoperative mortality. The single study
reporting events of death was also the only study conducted on Overall, the methodological quality of the included studies was
participants with higher degrees of contamination (contaminated poor. Despite identifying 15 trials with 1241 participants, only a few
to dirty surgical fields) (Duan 2018). On the other hand, since three of these could be included in the meta-analyses due to time points
out of the four RCTs reporting mortality did not have any deaths for outcomes not being specified or reported and studies with zero
within the first 30 days, the overall risk of mortality following events in both arms. The risk of bias was mostly assessed as 'no
emergency groin hernia repair might be lower than the numbers information' as the studies did not specify or clearly state what
presented. However, it is important to note that patients with methods were used, and none of them addressed any potential
higher degrees of contamination were excluded from these studies. biases in their studies.
Furthermore, a total of seven meshes were removed within 30
days of repair, and all of them were removed from participants Using GRADE, we assessed the certainty of the evidence as very
with contaminated or dirty surgical fields (Duan 2018). The single low for all outcomes. The reasons for downgrading the certainty
study with contaminated to dirty surgical fields was also the study of evidence were, in general, similar for all outcomes, resulting in
contributing the most adverse events in this review. downgrading due to risk of bias, indirectness, and imprecision.

The majority of the patients were male, middle-aged, and with an Due to an overall high risk of bias, we downgraded the certainty
inguinal hernia. Furthermore, most studies excluded patients with of the evidence for 30-day mortality by one level due to serious
preoperative peritonitis, local contamination, or the need for bowel risk of bias and for 30- and 90-day surgical site infections,
resection, and we were only able to identify one study randomising one-year clinical recurrence, and 30-day mesh removal by two
participants with contaminated to dirty surgical fields (Duan 2018). levels due to very serious risk of bias. Moreover, inclusion and
Therefore, the results presented in this review may be regarded exclusion criteria varied between the included studies, so we

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regarded the results as indirect. Some trials included only the for each outcome, sensitivity analyses were not always possible to
most severe cases (e.g. irreversible bowel necrosis) and other trials achieve, and it was not possible to create funnel plots to assess
excluded participants with a higher risk of adverse events (e.g. publication bias as fewer than 10 studies were included in the
females, femoral hernias, elderly, higher degree of contamination). analyses for each outcome (Differences between protocol and
Therefore, we downgraded the certainty of the evidence for all review).
outcomes by one level for indirectness. Finally, we downgraded
the certainty of the evidence for all outcomes due to imprecision, Moreover, most studies measured outcomes that were not reported
because the results were all based on small-sized studies and few in a usable format to be incorporated into the meta-analyses. These
events were recorded, potentially failing to identify any benefits or were mainly complication rates without specific time points and
harms related to the use of mesh for emergency groin hernia repair. recurrence rates without specification of the length of follow-up.
We attempted correspondence with all study authors, hoping to
We did not perform a GRADE assessment of the certainty of the retrieve time point-specific outcomes, but unfortunately without
evidence for the outcomes of reoperation due to complications any response. Therefore, these outcomes are not reported in this
(e.g. infection, seroma, bleeding) within 30 days of repair or review, which may introduce bias as adverse outcomes following
complications (classified by the Clavien-Dindo Classification) emergency groin hernia repair are most likely under-reported.
within 30 days of repair as none of the included studies Furthermore, trials reporting zero events for a given outcome over
reported these outcomes. Furthermore, we did not perform GRADE a longer follow-up time could be extracted to fit an outcome with
assessment for the outcomes of clinical recurrence or reoperation a shorter follow-up time relevant to this review (e.g. 30-day, 90-
for recurrence within 30 days of repair and mesh removal within day, or one-year follow-up). In contrast, as an example, we could
90 days of repair as none of the included studies reported any not use articles reporting six recurrences with a mean follow-up
events for these outcomes, preventing an effect measure from of 48 months. Therefore, our review methods, which prespecified
being estimated. time points for outcomes, did not allow the detection of all adverse
outcomes and this is a limitation of this review.
Our GRADE assessment of the certainty of the evidence is outlined
in Summary of findings 1. Lastly, we have expressed dichotomous outcomes as risk ratios
(RRs) using the Mantel-Haenszel method with a random-effects
Potential biases in the review process model according to the methods defined in our protocol (Sæter
2022). However, since most outcome events were rare, a Peto odds
To reduce the risk of potential bias, at least two authors undertook
ratio could have been considered (Deeks 2022).
several stages of the review independently, including literature
screening, data extraction, risk of bias assessment, and GRADE
Agreements and disagreements with other studies or
assessment. Due to the identification of several clinical trials
written in Chinese, we included a native Chinese-speaking author
reviews
(SQL) to assist with the assessment of eligibility for inclusion, data We found one systematic review and meta-analysis assessing mesh
extraction, and risk of bias assessment for the articles written versus non-mesh repair for strangulated inguinal hernias (Hentati
in Chinese. The main author (AHS) extracted data and assessed 2014). This review included both randomised and non-randomised
the risk of bias in the Chinese articles in collaboration with a studies and retained nine studies for analysis, comprising two RCTs
native Chinese speaker (YH) to ensure the robustness of these (Elsebae 2008; Karatepe 2008), three non-randomised prospective
review stages, and all conflicts were resolved by oral discussion. studies, and four retrospective studies. Our review included 15 RCTs
Furthermore, we used a random-effects model for meta-analyses with 1241 participants, which is mainly due to the identification
to take heterogeneity into account, and when zero events were of Chinese literature and the inclusion of non-English reports.
encountered in both arms, preventing meta-analyses, we also Regarding surgical site infections, Hentati 2014 found no difference
presented these results in forest plots to ensure transparency. between mesh and non-mesh groups when pooling all studies (OR
0.46, 95% CI 0.20 to 1.07; 5 studies, 413 participants), but when
However, this Cochrane Review has some limitations, which are outliers were excluded, a difference favouring mesh repair was
discussed as follows. found (OR 0.25, 95% CI 0.08 to 0.72; 4 studies, 282 participants).
Furthermore, in contrast to our review, Hentati 2014 found fewer
Overall, we mainly assessed the risk of bias for the outcomes
recurrences in the mesh repair group (OR 0.20, 95% CI 0.05 to 0.78;
investigated in this review as 'high risk of bias' and none of
3 studies, 260 participants). However, the time point for outcome
the included studies received a 'low risk of bias' judgement
measurement of recurrence was not reported or discussed, and
for any of the outcomes investigated. In addition, the reported
Hentati 2014 did not stratify the results according to degree of
outcomes in the included studies were often missing time points
contamination.
for measurements, which is why we could not include them in
the analyses. We contacted all study authors three times to ask We identified another systematic review and meta-analysis
them to specify the measured outcomes, but unfortunately none assessing the effectiveness and safety of mesh repair for
responded. incarcerated or strangulated hernias (Lin 2020). This study included
different types of hernias, including groin, ventral, paraumbilical,
Despite including 15 trials randomising 1241 participants, the
umbilical, incisional, epigastric, and Spigelian hernias, and
outcomes reported were scarce, and most of our analyses were
presented results based on two RCTs (one of which included
therefore underpowered. Due to limited data, several of the
inguinal hernias; Elsebae 2008) and six prospective studies where
preplanned subgroup analyses could not be performed, and
participants with groin hernias comprised 63% of the total study
the analyses conducted mostly had zero events in both arms.
population. The results indicated that mesh repair lowered the
Furthermore, since few studies were included in the meta-analysis
recurrence rate. If bowel resection was needed, the surgical site
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infection rate was slightly increased when mesh was used, but longer follow-up times, the nature of non-randomised trials, and
these were successfully treated with antibiotics and no mesh an underpowered meta-analysis in our review failing to exclude the
removal was needed, concluding that mesh repair should not be possibility of no difference. On the other hand, in the literature on
contraindicated in emergency hernia repair even if concomitant the topic of elective mesh versus non-mesh repairs of groin hernias,
bowel resection is required. This review did not stratify its results international hernia management guidelines provide a strong
according to degree of contamination. recommendation to use a mesh-based technique in inguinal hernia
repair (HerniaSurge Group 2018), due to the lower recurrence
Surgical site infections (as defined by the included studies) rate following mesh-based techniques and a comparable risk of
within 30 and 90 days of repair postoperative pain. From that perspective, mesh hernia repair
would probably also reduce recurrence following emergency repair
In our review, the included studies reported 41/229 events of 30-day
in selected patients where mesh placement is feasible.
surgical site infections (18%) in the mesh group and 24/225 events
(11%) in the non-mesh group. These numbers are comparable to Mesh removal
previously reported rates, with Ndong 2020 finding a 17% surgical
site infection rate following non-mesh repairs and Ueda 2012 The results from the included studies in this review showed that
finding the rates to be 20% and 18% in the mesh and non-mesh no meshes were removed from 98 participants not receiving bowel
groups, respectively. Furthermore, we could not identify any overall resection, while 7% of meshes in 104 participants undergoing
differences between the mesh and non-mesh group, which is in bowel resection were removed (Duan 2018). Mesh removal rates
line with the results of Hentati 2014, finding no increase in the risk are comparable to those previously reported, with no meshes
of surgical site infections when using mesh. However, it should be removed (Chen 2020; Ueda 2012). However, there are, in general,
noted that the analysis might be underpowered, disabling it from very few studies conducted on participants with contaminated to
excluding the possibility of no difference. dirty surgical fields, so it is difficult to compare the findings from
Duan 2018 with previous literature. Lastly, Bessa 2015 conducted
Mortality (defined as all-cause mortality) within 30 days of a 10-year study, including 234 patients with acutely incarcerated
repair and/or strangulated groin hernias. During the follow-up period,
only one patient (0.5%) developed a mesh infection, occurring after
Among all four studies with 30-day mortality as an outcome,
six months of repair, which necessitated mesh removal. Therefore,
only one reported deaths within 30 days, resulting in an overall
even though the event of mesh removal seems rare, short-term
mortality rate of 3.5%. Previously, the 30-day mortality following
follow-up, such as 30 and 90 days, might not be long enough to
emergency groin hernia repair has been reported to range from
identify all mesh removals. A longer follow-up time is therefore
0% to 12% (Sæter 2022b). The results of this review are, therefore,
necessary.
in line with the estimate, but possibly on the lower end of what
has previously been reported, reflecting that the most severe AUTHORS' CONCLUSIONS
cases of emergency groin hernia repair were excluded from the
clinical trials, which limits the external validity of the results from Implications for practice
this review. Furthermore, the one study included in this review
that reported deaths only included participants undergoing bowel The use of mesh in emergency groin hernia repair has been
resection, which is in accordance with previous findings supporting controversial due to the increased risk of surgical site infections,
that bowel resection increases the risk of mortality substantially mortality, and other harms. Unfortunately, this review has
(Köckerling 2021; Nilsson 2007; Sæter 2022b). These studies also produced results that are most likely underpowered and based on
identified female gender, femoral hernias, and increased age as low-quality studies; strong conclusions therefore cannot be drawn.
risk factors for mortality for patients undergoing emergency groin Overall, in terms of mortality, surgical site infection, and recurrence
hernia repair, but our planned subgroup analyses to investigate rates, the evidence is very uncertain about the effect of mesh
these factors were too limited in data to be performed. compared with non-mesh for hernia repair. The current guideline
for the management of emergency groin hernia repairs suggests
Clinical recurrence a "tailored approach", due to insufficient evidence to support an
optimal approach (HerniaSurge Group 2018). Further, the guideline
Regarding clinical recurrence, we found no events of recurrence suggests using mesh in clean to clean-contaminated surgical fields,
within 30 days and no difference between the two groups within but advises careful consideration if the contamination worsens,
one year of repair. Previous non-randomised studies on emergency with mesh implementation not recommended in contaminated to
groin hernia repair have reported a higher recurrence rate in the dirty surgical fields or worse (HerniaSurge Group 2018).
non-mesh group compared with the mesh group. For instance,
Chen 2020 reported, after 20.5 months of follow-up, a recurrence Implications for research
rate of 21.4% in the non-mesh group compared with 4.3% in the
biological mesh group and 0.0% in the synthetic mesh group. A Since all the clinical trials assessing mesh versus non-mesh
large nationwide register-based study found, in a multivariate Cox emergency groin hernia repairs were of very low quality, future
regression analysis, that mesh reduced the cumulative reoperation high-quality randomised controlled trials (RCTs) are very much
rates for recurrence when compared with non-mesh repairs needed for this important clinical topic. The need for more research
(Sæter 2022c). Lastly, both the systematic reviews and meta- is especially crucial regarding patients with contaminated to dirty
analysis previously mentioned found that mesh reduced the risk surgical fields.
of recurrence following emergency groin hernia repair (Hentati There is a lack of evidence regarding emergency groin hernia repair
2014; Lin 2020). The discrepancy in the results between previous and the existing trials are, unfortunately, of low quality. For many of
systematic reviews and this Cochrane Review can be explained by the outcomes, we could not identify any difference, and additional
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studies would help to detect any potential difference or increase repairing emergency groin hernias in selected patients (Olivero
the robustness of the findings of no difference between mesh and 2022). Future research should investigate its safety and feasibility
non-mesh repairs. However, many studies had zero events in both compared with open mesh repairs (e.g. Lichtenstein) or open non-
arms, probably due to small sample sizes and exclusion criteria that mesh repairs (e.g. Bassini) for incarcerated or strangulated groin
removed the most severe cases of emergency groin hernia from the hernias.
study participants. From this perspective, the feasibility of an RCT
might be questionable as it would probably require multicentre All the included studies in this review used synthetic mesh for the
trials with thousands of participants to detect rare adverse events. mesh-based hernia repair. None reported assessing absorbable or
High-quality registry-based studies could be a better method of biologic meshes; the latter especially have received awareness for
research to detect adverse events on a population basis and would potentially being favourable in emergency hernia surgery when
complement data from RCTs (Bergqvist 2007). Furthermore, it is dealing with potentially contaminated fields (Köckerling 2015).
important to record the degree of contamination in these studies Research on the different mesh types for emergency groin hernia
to facilitate stratified outcome assessment according to disease repair is therefore necessary. We have identified one registered trial
severity, in order to accommodate the inevitable confounding by assessing the effect of an acellular dermal matrix in emergency
indication in observational studies. inguinal hernia repair (NCT02469142).

Assessing the degree of contamination of the surgical field is In conclusion, the existing clinical trials on mesh versus non-mesh
essential when investigating the use of mesh, as its use is for emergency groin hernia repair are of low quality, and more
controversial when contamination is present. None of the included high-quality studies are needed. It is essential to assess the degree
studies used the wound classification system from the Centers of contamination of the surgical fields, particularly for patients
for Disease Control and Prevention (CDC) (Birindelli 2017), and with contaminated to dirty surgical fields. Long-term outcomes
the classification in this review was made by translating the and laparoscopic treatment should be investigated further, and
clinical description provided in the articles to one of the four registry-based studies could complement data from RCTs. Future
contamination degrees. Several studies included participants with RCTs should focus on the blinding of outcome assessors and
more than one degree of contamination, pooling the results participants.
and making it difficult to draw separate conclusions for each
degree. Future studies should report the degree of contamination ACKNOWLEDGEMENTS
according to the CDC wound classification system (Birindelli 2017),
Cochrane Colorectal supported the authors in the development of
to eliminate this barrier to analysis.
this review.
The included studies were of low methodological quality. All
We would like to thank Janne Vendt, the Information Specialist
studies randomised patients into treatment groups, but only a
from Cochrane Anaesthesia, for her contribution to the search
few specified the method of randomisation. This should be done
methods.
better in future studies. Furthermore, the blinding of investigators
and participants was poorly reported. Due to the nature of the We also would like to acknowledge and thank the native Chinese
intervention, it is not possible to blind the surgical team, creating speaker Yurong Hou for assisting the first author in extracting data
a significant source of bias in all surgical clinical trials. However, and assessing the risk of bias in the included studies written in
even though double-blinding is an unrealistic goal to achieve, Chinese.
future studies should focus their efforts on blinding the outcome
assessors and at least blinding the participants to the intervention. Editorial and peer reviewer contributions

We have been challenged by different follow-up times as well as • Sign-off Editor (final editorial decision): Ann Merete Møller,
outcome and complication reporting, which were all sources of Herlev and Gentofte Hospital, University of Copenhagen.
substantial heterogeneity between the trials. Future studies should • Managing Editor (selected peer reviewers, provided comments,
focus on time point-specific outcomes (e.g. reporting how many collated peer reviewer comments, provided editorial guidance
participants had a recurrence after one year instead of a mean to authors, edited the article): Lara Kahale, Cochrane Central
follow-up time) and more uniform outcome reporting, to facilitate Editorial Service.
comparability of studies.
• Editorial Assistant (conducted editorial policy checks and
In this review, we have only included short-term outcomes up to supported editorial team): Lisa Wydrzynski, Cochrane Central
one year, but long-term outcomes, especially long-term recurrence Editorial Service.
rates and chronic pain conditions, should be investigated further • Copy Editor (copy editing and production): Jenny Bellorini,
for this patient group. Since recurrence is an important quality Cochrane Central Production Service.
measure in hernia surgery, and many recurrences may not be • Peer reviewers (provided comments and recommended an
present at 30 days or one year after repair, a longer follow- editorial decision):
up time is necessary and is recognised as a limitation of this ◦ Nuala Livingstone, Evidence Production and Methods
review. Furthermore, laparoscopic treatment has shown benefits in Directorate (methods review);
elective groin hernia repair, and the World Society of Emergency ◦ Brian Duncan (consumer review);
Surgery state in their guidelines for complicated abdominal wall ◦ Jo Platt, Information Specialist, Cochrane GNOC (search
hernias that a laparoscopic approach should be considered, review);
especially in the absence of strangulation and the need for bowel
◦ Takashi Sakamoto, Department of Gastroenterological
resection (Birindelli 2017). Another matched case-control study
Surgery, Gastroenterological Center, Cancer Institute
also showed that laparoscopy is an appropriate alternative for
Mesh versus non-mesh for emergency groin hernia repair (Review) 20
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Cochrane Trusted evidence.
Informed decisions.
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Hospital, Japanese Foundation for Cancer Research (clinical and Translational Research in Metabolism, Maastricht
review); University, Maastricht, The Netherlands (clinical review).
◦ W.A.R. Zwaans, SolviMáx Center of Excellence for Abdominal • The authors Kristoffer Andresen, Siv Fonnes, and Jacob
Wall and Groin Pain, Eindhoven, The Netherlands; Rosenberg are part of the Cochrane Colorectal editorial team but
Department of Surgery, Máxima Medical Center, Veldhoven/ were not involved in the editorial process.
Eindhoven, The Netherlands; NUTRIM School of Nutrition

Mesh versus non-mesh for emergency groin hernia repair (Review) 21


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Library Better health. Cochrane Database of Systematic Reviews

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Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Trusted evidence.
Informed decisions.
Library Better health. Cochrane Database of Systematic Reviews

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* Indicates the major publication for the study

CHARACTERISTICS OF STUDIES

Characteristics of included studies [ordered by study ID]

Chen 2016
Study characteristics

Methods Design: parallel-arm, double-centre randomised controlled trial

Aim: to investigate the clinical effect of a tension-free hernia repair for acutely incarcerated in-
guinal hernia

Setting: tertiary care, Xinxiang City Infectious Disease Hospital and Xinxiang Central Hospital, Xinx-
iang City, Henan Province, China

Study duration: February 2013 to February 2015 (24 months)

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Chen 2016 (Continued)


Other: acutely incarcerated inguinal hernia was defined as the "irreducibility of hernia contents in-
to the abdominal cavity causing abdominal pain and acute infarction"

Participants Number of randomised participants: 70

Inclusion criteria: patients with acutely incarcerated inguinal hernia admitted to Xinxiang City In-
fectious Disease Hospital and Xinxiang Central Hospital

Exclusion criteria: none reported

Baseline characteristics:

• Intervention group (tension-free repair group): 20 males and 15 females, aged 40 to 72 years old,
with an average age of 61.2 ± 6.5 years
• Comparison group (Bassini repair group): 16 males and 19 females, aged 42 to 77 years, with an
average age of 59.5 ± 6.0 years
• There were no significant differences in baseline data, such as age and gender, between the two
groups (P > 0.05)
• Recurrence: 16 out of the 70 (23%) included patients had recurrent hernias

Contamination degree: not reported

Interventions Intervention:

• Participants: 35
• Mesh repair: open tension-free hernia repair
• Mesh type: synthetic, polypropylene mesh. "The imported patch SMPL01 from the United States
was used"

Comparison:

• Participants: 35
• Non-mesh repair: open Bassini repair

Co-interventions:

• Postoperative antibiotics in both groups. Further specification on doses and types of antibiotics
was not reported.

Outcomes Outcomes of interest in this review:

• Clinical recurrence within 1 year of repair (but no time point-specific outcome measure for both
groups, hence excluded from meta-analysis)

Outcomes reported in the trial:

The study did not define any primary or secondary outcome, but the following outcomes were re-
ported:

• Operation time
• Intraoperative blood loss
• Hospitalisation time
• Time to get out of bed

Notes Funding: not reported

Declaration of interest: not reported

Ethics: whether ethical approval or informed consent was received before conducting the study
was not registered.

Authors' conclusion:

Mesh versus non-mesh for emergency groin hernia repair (Review) 27


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Chen 2016 (Continued)


In summary, the authors conclude that tension-free hernia repair for an acutely incarcerated in-
guinal hernia can achieve significant therapeutic effects and shorten the treatment time, which is
worthy of clinical promotion.

Darwish 2018
Study characteristics

Methods Design: parallel-arm, single-centre, quasi-randomised trial (randomised on the patients' registra-
tion number)

Aim: to assess and compare ‘tension‑free’ mesh repair (Lichtenstein technique) with the
Bassini technique for treating incarcerated inguinal hernia

Setting: tertiary care, General Surgery Department, Menoufia University, Menoufia, Egypt

Study duration: May 2015 to May 2016 (12 months)

Other: the study was controlled, so that mesh repair was not attempted in patients needing bowel
resection

Participants Number of randomised participants: 60

Inclusion criteria: male patients above 18 years of age with an incarcerated inguinal hernia

Exclusion criteria: recurrent hernias, strangulated hernia with subsequent resection and anasto-
mosis of the intestine or generalised peritonitis, or patients with ascites

Baseline characteristics

• Intervention group: age 24 to 80 years. Smoking was found in 25 participants (83%).


• Comparison group: age 20 to 84 years. Smoking was found in 24 participants (80%).
• No significant baseline differences in terms of age, ASA score and smoking status

Contamination degree: clean surgical field to clean-contaminated surgical field

Interventions Intervention:

• Participants: 30
• Mesh repair: open tension-free anterior repair according to Lichtenstein ‘tension-free’ technique
• Mesh type: synthetic, monofilament polypropylene mesh

Comparison:

• Participants: 30
• Non-mesh repair: open Bassini technique

Co-interventions:

• Preoperative antibiotics: "Before the incision, a bolus dose of 1 g of third-generation


cephalosporin injection was administered." "Postoperatively, analgesia was administrated, and
all patients received a third-generation cephalosporin parenteral injection twice daily and
metronidazole infusion three times daily for 2 days."
• Dose of metronidazole was not reported.

Outcomes Outcome of interest to this review:

• Surgical site infections (as defined by the included studies) within 90 days of repair
• Clinical recurrence or reoperation for recurrence within 30 days of repair

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Darwish 2018 (Continued)


Outcomes reported in the trial:

"The primary concern was to compare the postoperative rate of local wound infection between the
two techniques."

Other reported outcomes included:

• Operative time
• Hospital stay
• Postoperative morbidity (haematoma, pain, swelling, wound infection)
• Recurrence of hernia

Notes Funding: the authors declare no funding sources.

Declaration of interest: the authors declare no possible conflicts of interest.

Ethics: a study protocol received ethical approval from the ethical committee of Menoufia Univer-
sity, and written consent was obtained from each participant.

Authors' conclusion:

The authors concluded that mesh repair is applicable in patients with incarcerated inguinal hernias
with an overall low morbidity rate. "Significantly higher rates for mean length of hospital stay and
mean length of operation and a higher rate for postoperative chronic pain were found in incarcer-
ated inguinal hernia patients who underwent Bassini repair."

Duan 2018
Study characteristics

Methods Design: parallel-arm, single-centre randomised controlled trial

Aim: to investigate the use of prosthetic repair in the emergency management of acutely strangu-
lated groin hernias in patients with different grades of bowel necrosis

Setting: tertiary care, Department of General Surgery, The Third People’s Hospital of Jinan, China

Study duration: January 2005 to August 2016 (139 months)

Other: emergency groin hernia defined as "unilateral strangulated groin hernia with irreversible
bowel necrosis". The study utilised a modified 3-grade classification system of bowel necrosis. For
details, see below.

Participants Number of participants: 208

Inclusion criteria: participants with unilateral strangulated groin hernia with irreversible bowel
necrosis undergoing emergency hernia repair with simultaneous bowel resection

Exclusion criteria: not reported

Baseline characteristics:

208 participants, including 184 men and 24 women whose average age was 54 years (range: 26 to
83 years), of whom 44 had comorbid diseases. The majority had a strangulated inguinal hernia (n =
192, 92%), and the rest had femoral hernias (n = 16, 8%).

• Intervention group: mostly males (n = 91, 88%), and most participants were under 65 years of age
(n = 81, 78%). Regarding hernia type, 91% and 9% had inguinal and femoral hernias, respectively.
Most hernias were primary (n = 96, 92%).

Mesh versus non-mesh for emergency groin hernia repair (Review) 29


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Duan 2018 (Continued)


• Comparison group: mostly males (n = 93, 89%), and most participants were under 65 years of age
(n = 78, 75%). Regarding hernia type, 93% and 7% had inguinal and femoral hernias, respectively.
Most hernias were primary (n = 99, 95%).
• No differences were found in baseline patient characteristics between the 2 treatment groups (all
P > 0.05).
• Recurrence: 13 out of the 206 (6%) included patients had recurrent hernias.

Contamination degree: contaminated to dirty surgical field

This study used a modified 3-grade classification system of bowel necrosis:

• Grade I: "The bowel was purplish-black but shows normal morphology with no perforation. Patho-
logic observation showed partial or full-thickness muscular necrosis. The hernia sac was complete
without congestion and inflammation. The exudates within the hernia sac were yellow or dark red
in color, but tested negative for bacteria."
• Grade II: "The bowel lost its normal form and collapsed or cracked. Pathologic assessment showed
loss of full-thickness cellular structures. The hernia sac remained complete, but the sac wall ex-
hibited congestion and swelling. The content was mixed liquids of intestinal juice and necrotic
tissues, and there was evidence of bacterial growth."
• Grade III: "The bowel was completely cracked without form, and the hernia sac was filled with pu-
rulent liquid. Pathologic observation showed red-stained unstructured substance with neutrophil
infiltration. The hernia sac wall was also festered and cracked or perforated. There was evidence
of cellulitis."

According to the protocol grading, we have translated this 3-grade classification system to:

• Grade I corresponds to the protocol grading "contaminated surgical field"


• Grade II and III both correspond to the protocol grading "dirty surgical field"

Interventions Intervention:

• Participants: 104
• Mesh repair: Lichtenstein method, open repair
• Mesh type: Onlay Prolene lightweight and large porous mesh repair

Comparison:

• Participants: 104
• Non-mesh repair: primary suture repair

Co-interventions:

It is reported that "All wounds were primarily closed, and systemic antibiotic therapy was uniform-
ly used routinely in all cases." Note: it is not reported whether antibiotics were administered pre- or
postoperatively.

Outcomes Outcomes of interest in this review:

• Surgical site infections (as defined by the included studies) within 30 days of repair
• Mortality (defined as all-cause mortality) within 30 days of repair
• Mesh removal within 30 days of repair

Outcomes reported in the trial:

Primary and secondary outcomes were not defined, however the following outcomes were report-
ed:

• "Wound-related morbidity included wound infection, seroma, and hematoma. Wound infection
was defined as “infection that occurs within 30 days after operation, involves only skin or subcu-
taneous tissue of the incision,” including superficial surgical site infection (SSI) and deep SSI."
• "Mortality was determined by the number of deaths within 30 days of surgery."

Mesh versus non-mesh for emergency groin hernia repair (Review) 30


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Duan 2018 (Continued)

Notes Funding: not reported

Declaration of interest: not reported

Ethics: "The study protocol was approved by the Institutional Review Board. All patients voluntary
participated in this study and provided written informed consent."

Authors’ conclusion:

The authors conclude that "(...) this study demonstrates that greater levels of bowel necrosis
are associated with higher incidences of wound infections. The use of prosthetic mesh repair in
Grade II and III patients can significantly increase wound-related morbidity. But for patients with
Grade I necrosis, there is no difference in wound infection rate between mesh repair and suture re-
pair. Therefore, the use of prosthetic mesh in the emergency repair of acutely strangulated her-
nias seems to be as safe as suture repair in patients with noninfected strangulated bowel (Grade I
necrosis). The use of prosthetic mesh repair is a rational choice according to the degree of bowel
necrosis in the emergency management of acutely strangulated hernias."

Elsebae 2008
Study characteristics

Methods Design: parallel-arm, single-centre, quasi-randomised trial (randomisation depending on the pa-
tient's registration number)

Aim: to compare “tension-free” mesh repair by the Lichtenstein technique with the Bassini tech-
nique used to treat strangulated inguinal hernias

Setting: tertiary care, Department of General Surgery, Theodore Bilharz Research Institute, Imba-
ba, Giza 12411, Egypt

Study duration: May 2004 and December 2006 (31 months)

Other: the mean follow-up time was 22 ± 6 months and the study was controlled, so mesh was not
used for those in need of bowel resection. The authors defined emergency surgery for inguinal her-
nias as a "strangulated inguinal hernia presented to the clinic after 6-12 hours of strangulation."

Participants Number of participants: 54

Inclusion criteria: patients who were 18 years of age or older, submitted to emergency operation
between May 2004 to December 2006 due to strangulated inguinal hernia, and where consent was
obtained

Exclusion criteria: recurrent hernia, preoperative peritonitis, inflammatory hernia and/or associ-
ated other hernias or intra-abdominal masses, ascites, or bowel resection

Baseline characteristics:

• Intervention: all male, all ASA score 1-2, mean age (range): 34.6 (21 to 63), diabetes (n = 11, 41%)
• Comparison: all male, all, ASA score 1-2, mean age (range): 43.2 (36 to 68), diabetes (n = 8, 30%)

Contamination degree: clean-contaminated surgical field

Interventions Intervention:

• Participants: 27
• Mesh repair: open repair: Lichtenstein "tension-free" technique
• Mesh type: synthetic mesh, monofilament polypropylene mesh

Comparison:

Mesh versus non-mesh for emergency groin hernia repair (Review) 31


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Elsebae 2008 (Continued)


• Participants: 27
• Non-mesh repair: open Bassini technique

Co-interventions:

• Postoperatively administered antibiotics: a prophylactic daily dose of 500 mg ciprofloxacin was


given for 5 days after the operation in all patients
• Low molecular weight heparin to prevent deep venous thrombosis was given in all high-risk pa-
tients (e.g. obese patients)
• Mobilisation after about 6 hours of surgery
• Closed suction drainages removed on the day of discharge if used

Outcomes Outcomes of interest in this review:

• Mortality (defined as all-cause mortality) within 30 days of repair


• Clinical recurrence or reoperation for recurrence within 30 days of repair
• Clinical recurrence or reoperation for recurrence within 1 year of repair
• Mesh removal within 30 days of repair

Outcomes reported in the trial:

The primary outcome was to assess surgical complications and the length of hospital stay.

Secondary outcomes included recurrence of hernia, but operative time and postoperative mortali-
ty are also discussed in the report.

Notes Funding: the authors declare no study funding sources.

Declaration of interest: the authors declare no possible conflicts of interest.

Ethics: ethical approval was received from the local ethical committee at the Theodore Bilharz Re-
search Institute, and informed consent was obtained from the included participants.

Authors’ conclusion:

“The presence of a strangulated inguinal hernia cannot be considered a contraindication for the
use of a prosthetic mesh. The use of Lichtenstein ”tension-free” technique in emergency treatment
of strangulated inguinal hernia is safe, effective with an acceptably low rate of postoperative com-
plications and without recurrence”

Guo 2015
Study characteristics

Methods Design: parallel-arm, single-centre randomised controlled trial

Aim: to compare the efficacy and safety of tension-free hernia repair with the traditional Bassini
method in treating acute incarcerated inguinal hernia

Setting: tertiary care, Department of General Surgery, Shiba Hospital of Boluo county, Huizhou
City, Guangdong Province, 516153 China

Study duration: June 2012 to June 2014 (24 months)

Other: all patients followed up for 6 to 24 months

Participants Number of participants: 50

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Guo 2015 (Continued)


Inclusion criteria: patients with an acutely incarcerated inguinal hernia who were diagnosed
and treated at the Department of General Surgery, Shiba Hospital of Boluo county, Huizhou City,
Guangdong Province, 516153 China

Exclusion criteria: peritonitis, bowel necrosis, bilateral hernia, and mental disorders

Baseline characteristics: not reported separately for the treatment groups

Overall, there were 47 males and 3 females aged 41 to 77 years, averaging 61.4 ± 10.2 years. The in-
carceration time ranged from 2 to 15 hours, with an average of 5.3 ± 2.2 hours. All participants had
a unilateral indirect hernia, and the contents of incarcerated hernia included the small intestine in
42 cases and the greater omentum in 8 patients. 32 participants were classified in ASA class 1 and
18 in ASA class 2. There were no significant differences in clinical data such as gender, age, incar-
ceration time, incarcerated contents, and ASA grade between the 2 groups (P > 0.05).

Contamination degree: clean to clean-contaminated surgical fields

Interventions Intervention:

• Participants: 26
• Mesh repair: open tension-free repair
• Mesh type: synthetic, "mesh plug polypropylene mesh"

Comparison:

• Participants: 24
• Non-mesh repair: open Bassini operation "according to the standard method"

Co-interventions:

Preoperative antibiotics: the patients received preoperative preparations such as antibiotics and
fluid infusion after hospitalisation. Antibiotics were continued for 2 to 4 days after the operation.
Further specifications were not reported.

Outcomes Outcomes of interest in this review:

• Mesh removal within 30 days of repair


• Mesh removal within 90 days of repair

Outcomes reported in the trial:

The study did not define any primary or secondary outcome. However, the following outcomes
were reported:

• Perioperative indicators:
◦ Operative time
◦ Postoperative hospitalisation days
• Postoperative complications:
◦ Haematoma
◦ Scrotal effusion
◦ Surgical site infection
◦ Pneumonia
◦ Dysuria
◦ Recurrence (follow-up for 6 to 24 months)
◦ Mesh removal

Notes Funding: not reported

Declaration of interest: not reported

Mesh versus non-mesh for emergency groin hernia repair (Review) 33


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Guo 2015 (Continued)


Ethics: whether ethical approval or informed consent was obtained prior to conducting the study
is not reported.

Authors’ conclusion:

The authors conclude that tension-free repair for acutely incarcerated inguinal hernia has advan-
tages of short operation time, fast postoperative recovery, and no increase in complications such
as postoperative infection, so it is safe and feasible. However, the vitality of the bowel should be
correctly judged during the operation, and tension-free hernia repair should not be performed for
patients with severe local contamination or severe infection. Studies on the long-term recurrence
rate of acute incarcerated inguinal hernia are required.

Karaca 2016
Study characteristics

Methods Design: parallel-arm, single-centre randomised controlled trial

Aim: to investigate the effect of graft use on morbidity and mortality in adult patients who under-
went an emergency operation for incarcerated inguinal hernia

Setting: tertiary care, Department of General Surgery, Bartin State Hospital, Bartın, Türkiye

Study duration: January 2007 and January 2012 (60 months)

Other: irreduction of external hernias was defined as “incarceration”, and signs of intraoperative
ischaemia and necrosis in addition to irreduced hernia were defined as “strangulation”

Participants Number of participants: 246

Inclusion criteria: participants admitted to the Department of General Surgery, Bartin State Hospi-
tal, Bartın, Türkiye with an incarcerated inguinal hernia

Exclusion criteria: not reported

Baseline characteristics:

• Intervention: male (n = 102, 82%), age 47.6 ± 13.7, all inguinal hernia
• Comparison: male (n = 92, 76%), age 48.4 ± 13.0, all inguinal hernia

Contamination degree: clean to clean-contaminated surgical fields.

Interventions Intervention:

• Participants: 125
• Mesh repair: open Lichtenstein repair
• Mesh type: synthetic, polypropylene mesh

Comparison:

• Participants: 121
• Non-mesh repair: Bassini repair

Co-interventions:

Possibly antibiotics: "Antibiotic treatment was planned according to the risk of infection associat-
ed with the operation and in line with the Institutional Infection Committee’s guidelines". Time of
administration not reported.

Outcomes Outcomes of interest in this review:

Mesh versus non-mesh for emergency groin hernia repair (Review) 34


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Karaca 2016 (Continued)


• Surgical site infections (as defined by the included studies) within 30 days of repair
• Mortality (defined as all-cause mortality) within 30 days of repair
• Mesh removal within 90 days of repair

Outcomes reported in the trial:

Primary and secondary outcomes were not defined. However, the study reported postoperative
complications subdivided into:

• Systemic complications: pulmonary, cardiac, and renal postoperative complications


• Local complications: surgical site infection, haematoma, wound disintegration, and seroma

Notes Funding: not reported

Declaration of interest: the authors declare no competing interests.

Ethics: ethical approval was received from the institutional ethics committee, and informed con-
sent was obtained from each participant.

Authors’ conclusion:

The authors concluded that "polypropylene mesh can safely be used in strangulated hernias that
require emergency operation as its use is associated with low rates of postoperative complica-
tions."

Li 2010
Study characteristics

Methods Design: a parallel-arm, single-centre randomised controlled trial

Aim: to investigate the feasibility of applying tension-free hernia repair in treating strangulated in-
guinal hernia in the elderly

Setting: tertiary care, the Second Hospital of Jilin University, Changchun, Jilin Province, 130041,
China

Study duration: January 2005 to December 2008 (35 months)

Other: the follow-up period ranged from 6 months to 3 years, with an average of (2.5 ± 1.7) years

Participants Number of participants: 50

Inclusion criteria: patients with strangulated inguinal hernias, male, > 60 years, and ASA class 1-2

Exclusion criteria: preoperative peritonitis, bowel necrosis, ASA class 3-4, female, and patients <
60 years

Baseline characteristics:

The participants were all males, aged 60 to 83 years, and all patients were preoperatively graded 1
to 2 by the American Society of Anesthesiology (ASA) classification. The average time from the on-
set of symptoms to the start of surgery was 8.4 ± 2.3 hours. All hernias were inguinal hernias, and
most of them were indirect, with 23 (92%) and 22 (88%) in the mesh and non-mesh groups, respec-
tively. The two groups had no significant differences in age, hernia type, and physical condition.

• Intervention: age 65.3 ± 3.2, all male, all ASA 1-2, diabetes (n = 8, 32%)
• Comparison: age 66.7 ± 4.1, all male, all ASA 1-2, diabetes (n = 6, 24%)

Contamination degree: clean-contaminated surgical field

Mesh versus non-mesh for emergency groin hernia repair (Review) 35


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Li 2010 (Continued)

Interventions Intervention:

• Participants: 25
• Mesh repair: open tension-free hernia repair
• Mesh type: synthetic, polypropylene mesh

Comparison:

• Participants: 25
• Non-mesh repair: open Bassini repair

Co-interventions:

Other interventions, including the use of antibiotics, were not reported.

Outcomes Outcomes of interest in this review:

• Mesh removal within 30 days of repair


• Mesh removal within 90 days of repair

Outcomes reported in the trial:

Neither primary nor secondary outcomes were defined. However, the following outcomes were re-
ported:

• Operative time
• Length of hospitalisation
• Postoperative complications such as haematoma, superficial and deep surgical site infection
• Mesh removal
• Recurrence

Notes Funding: not reported

Declaration of interest: not reported

Ethics: whether ethical approval or informed consent was obtained prior to conducting the study
was not reported.

Authors’ conclusion:

In summary, the incidence of postoperative complications did not differ significantly between the
2 groups. The haematoma and incision infection in the tension-free hernia repair group recovered
well after proper treatment, and there was no need for mesh removal. Tension-free hernia repair
with mesh implantation was not found to increase the complication rate in this study. Therefore,
tension-free hernia repair with a mesh should not be considered a contraindication in elderly pa-
tients with strangulated inguinal hernias.

Memon 2017
Study characteristics

Methods Design: parallel-arm, singel-centre randomised trial

Aim: to compare the complications in Lichtenstein repair with tension-free Darn repair for both
elective and emergency inguinal hernia repair

Setting: tertiary care, both emergency and elective surgery at the Surgical Unit-I, Peoples Universi-
ty of Medical & Health Sciences, Nawabshah, Sindh, Pakistan

Mesh versus non-mesh for emergency groin hernia repair (Review) 36


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Memon 2017 (Continued)


Study duration: January 2014 to December 2015 (23 months)

Other: mixed elective/emergency population. Among the 92 included participants, 26 were admit-
ted for an emergency inguinal hernia repair.

Participants Number of participants: 92 participants, of which 26 were admitted for an emergency inguinal
hernia repair

Inclusion criteria: male patients between 20 to 60 years with direct or indirect inguinal hernia, ad-
mitted for either emergency or elective repair

Exclusion criteria: ASA class IV or above, malignancy or gangrenous bowls as content of sac, recur-
rent inguinal hernia or ascites

Baseline characteristics:

Limited information, as baseline characteristics were pooled together for both the elective and
emergency groups in the report

• Intervention: all male, all primary inguinal hernias


• Comparison: all male, all primary inguinal hernias

Contamination degree: perioperative findings not reported disabling contamination degree clas-
sification

Interventions Intervention:

• Participants: 12
• Mesh repair: hernioplasty/Lichtenstein tension-free mesh repair (open)
• Mesh type: synthetic mesh, without further specification

Comparison:

• Participants: 14
• Non-mesh repair: Darn repair (open)

Co-interventions:

• Preoperative antibiotics: "Prophylactic antibiotic (cefotaxime) 1 g administered half hour before


surgery followed by two further doses 12 hourly after surgery in all the study patients"

Outcomes Outcomes of interest in this review:

None

Outcomes reported in the trial:

Primary outcome: complications

Secondary outcome: surgical site infections (including deep and superficial surgical site infections),
length of hospital stay, time taken to return to normal routine and recurrence of the hernia. The
outcomes were classified as:

• Immediate postoperative (within 14 days)


• Early postoperative (within 6 weeks)
• Late postoperative (within 1 year)

Notes Funding: the authors report no funding sources.

Declaration of interest: not reported

Ethics: ethical approval was not reported, but the authors report that informed consent was ob-
tained from every participant.

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Memon 2017 (Continued)


Authors’ conclusion:

The authors concluded that Lichtenstein's repair for inguinal hernia is more promising in compar-
ison to Darn repair. However, hospital stay and surgical site infections were higher in this group of
patients.

Panda 2012
Study characteristics

Methods Design: parallel-arm, single-centre randomised trial

Aim: to compare the outcomes following pure tissue repair and mesh repair in obstructed inguinal
hernia

Setting: tertiary care, City Teaching Hospital in India. City and state of the hospital not specified.

Study duration: January 2009 to June 2010 (17 months)

Other: —

Participants Number of participants: 40

Inclusion criteria: male and female participants, aged 20 to 65 years with obstructed inguinal her-
nia

Exclusion criteria: preoperative peritonitis, perforation of the gut or the need for resection/anas-
tomosis, and severe comorbidities

Baseline characteristics:

The mean age of the patients was 42.63 ± 11.22 (mean ± SD) with a median of 41.5 and a range of 26
to 64 years. About 15% of the participants presented with features of strangulation.

• Intervention: age 44.55 ± 12.23


• Comparison: 40.7 ± 10.04

Contamination degree: clean to clean-contaminated surgical field

Interventions Intervention:

• Participants: 20
• Mesh repair: open tension-free repair (Lichtenstein repair)
• Mesh type: synthetic, monofilament polypropylene mesh

Comparison:

• Participants: 20
• Non-mesh repair: "(...) modified Bassini tissue repair (...)" and "(...) tissue repair with number 1/0
polypropylene sutures"

Co-interventions:

• Antibiotics: "(...) ceftriaxone 1 g twice daily) for three doses (further antibiotic if required were con-
tinued with the same till culture and sensitivity results available)." Time of administration (pre-
or postoperatively) was not reported.

Outcomes Outcomes of interest in this review:

• Clinical recurrence or reoperation for recurrence within 30 days of repair

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Panda 2012 (Continued)


• Clinical recurrence or reoperation for recurrence within 1 year of repair
• Mesh removal within 30 days of repair
• Mesh removal within 90 days of repair

Outcomes reported in the trial:

Primary and secondary outcomes were not defined, however the following outcomes were report-
ed:

1. Operating time
2. Postoperative morbidity - pain, swelling, haematoma, and wound infection
3. Hospital stay
4. Recurrence - 2-year period

Notes Funding: An ambiguous funding source statement was reported: "The source(s) of support in the
form of grants, equipment, drugs, etc.".

Declaration of interest: The authors declare no conflicts of interest.

Ethics: The authors report that ethical approval was received and that informed consent was ob-
tained before study inclusion.

Authors’ conclusion:

In conclusion, the authors summarize that "Tension-free hernioplasty using polypropylene mesh in
adults with an obstructed inguinal hernia has advantages in terms of average operating time, sero-
ma formation, and hospital stay compared with the conventional hernia repair (pure tissue repair),
especially without resection anastomosis or gut perforation. The comparison is limited to the an-
alyzed patients because of the small number in both groups and the short (2-year) follow-up. This
study encourages larger study with longer follow-up."

Ren 2012
Study characteristics

Methods Design: parallel-arm, single-centre randomised trial

Aim: to investigate the efficacy of tension-free hernia repair with mesh in treating strangulated in-
guinal hernia

Setting: tertiary care, Department of Surgery, Boai Hospital, Xiangyang City, Hubei Province, China

Study duration: March 2008 to March 2011 (36 months)

Other: unclear whether all patients underwent bowel resection or not

Participants Number of participants: 33

Inclusion criteria: males with unilateral indirect inguinal hernia confirmed by operation as incar-
cerated inguinal hernia with strangulation and necrosis of hernia contents

Exclusion criteria: the exclusion criteria were any obvious local infection

Baseline characteristics:

• Intervention: all male, age (mean ± SD) 69.4 ± 5, diabetes (n = 1, 6%)


• Comparison: all male, age (mean ± SD) 68.5 ± 6, diabetes (n = 2, 12%)
• All patients had indirect inguinal hernia. There were no significant differences in age, preoperative
comorbid diseases, incarceration time and necrosis of hernia contents between the 2 groups (P
> 0.05).
Mesh versus non-mesh for emergency groin hernia repair (Review) 39
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Ren 2012 (Continued)


Contamination degree: clean-contaminated surgical field; "strangulated hernia with necrotic her-
nia contents without obvious local infection"

Interventions Intervention:

• Participants: 17
• Mesh repair: open tension-free repair
• Mesh type: synthetic mesh, Goretex mesh

Comparison:

• Participants: 16
• Non-mesh repair: open non-mesh repair; in the non-mesh group, 10 patients underwent high her-
nia sac ligation, 2 patients underwent Ferguson hernia repair on the basis of high hernia sac liga-
tion, and 1 patient underwent traditional Bassini hernia repair

Co-interventions:

Antibacterial treatment was given postoperatively. Further specifications on doses or types of an-
tibiotics were not reported.

Outcomes Outcomes of interest in this review:

• Mortality (defined as all-cause mortality) within 30 days of repair


• Clinical recurrence or reoperation for recurrence within 1 year of repair

Outcomes reported in the trial:

The study did not report any primary or secondary outcomes. However, the following outcomes
were reported:

• Operative time
• Length of hospital stay
• The postoperative local infection rate
• 12-month postoperative recurrence

Notes Funding: not reported

Declaration of interest: not reported

Ethics: neither ethical approval nor informed consent were reported

Authors’ conclusion:

To sum up, the authors concluded that on the basis of strict and standardised surgical treatment,
one-stage tension-free hernia repair is a safe and effective method for the treatment of strangulat-
ed inguinal hernia in the elderly. It also avoids secondary surgery and reduces the financial burden
on patients. However, the use of mesh should only be considered when there is no obvious local in-
fection during the operation.

Sun 2010
Study characteristics

Methods Design: parallel-arm, single-centre randomised trial

Aim: to assess whether the tension-free repair was suitable for treating inguinal incarcerated her-
nia without strangulation

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Setting: tertiary care, Department of Surgery, General Hospital of Beijing Jingmei Group, Beijing,
102300, China

Study duration: February 2002 to December 2009

Other: the study only reported and compared perioperative data with no follow-up after patients
were discharged from the hospital.

Participants Number of participants: 44

Inclusion criteria: patients with incarcerated inguinal hernia without strangulation

Exclusion criteria: strangulated inguinal hernias, patients with bowel necrosis, wound contamina-
tion, and the need for bowel resection

Baseline characteristics:

• Intervention: average age was 69.96, femoral hernia (n = 2, 8%), all male
• Comparison: average age was 63.11, femoral hernia (n = 0, 0%), female (n = 1, 5%)
• The majority of the inguinal hernias were indirect, with 18 (94.7%) and 40 (95.2%) in the mesh and
non-mesh groups, respectively.

Contamination degree: clean surgical field

Interventions Intervention:

• Participants: 25
• Mesh repair: open tension-free repair
• Mesh type: synthetic, polypropylene mesh. "Mesh-Plug products from Bard Company in the
United States and Prolite-UltraTM from the parent company of iResearch, both of which are
polypropylene"

Comparison:

• Participants: 19
• Non-mesh repair: open Bassini repair

Co-interventions:

Preoperative antibiotics. All patients were given a broad-spectrum antibiotic (second-generation


cephalosporin) 0.5 hours before surgery, and antibiotics were given for 2 to 7 days after surgery.

Outcomes Outcomes of interest in this review:

None. The study only reported and compared perioperative data with no follow-up after patients
were discharged from the hospital.

Outcomes reported in the trial:

The study did not define any primary or secondary outcomes. However, the following outcomes
were reported:

• Postoperative complications, including both local complications (scrotal oedema, urinary reten-
tion, and incision liquefaction) and systemic complications (pulmonary infection, urinary tract in-
fection, delirium, abdominal infection and ARDS)
• Postoperative pain
• Length of hospital stay
• Time until gastrointestinal function

Notes Funding: not reported

Declaration of interest: not reported

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Ethics: both ethical approval and informed consent were not reported

Authors’ conclusion:

In summary, the authors concluded that the postoperative recovery of patients with incarcerated
inguinal hernia without strangulation is not determined by the surgical method, indicating that the
implantation of a mesh does not affect the prognosis and tension-free mesh repair is therefore fea-
sible in this patient group. Moreover, the higher comfort after tension-free repair suggests that ten-
sion-free hernia repair should be the first choice.

Wang 2014
Study characteristics

Methods Design: parallel-arm, single-centre, randomised trial

Aim: to compare the efficacy of tension-free hernia repair and traditional hernia repair in treating
incarcerated inguinal hernia

Setting: tertiary care, Department of Surgery, the Traditional Chinese Medicine Hospital of Luqiao
District, Taizhou City, Zhejiang Province, China

Study duration: June 2008 to June 2013 (60 months)

Other: —

Participants Number of participants: 84

Inclusion criteria: (1) meeting the diagnostic criteria for incarcerated inguinal hernia, (2) incarcer-
ation time less than 12 hours, and (3) failed manual reduction

Exclusion criteria: reducible hernias and obvious symptoms/signs of intestinal necrosis and peri-
tonitis

Baseline characteristics:

• Intervention: mean age was 61.8 ± 5.7, with 25 males and 17 females, femoral hernia (n = 2, 4.8%)
• Comparison: mean age was 62.1 ± 6.2, with 23 males and 19 females, femoral hernia (n = 1, 2.4%)
• The remaining participants had inguinal hernias. Most inguinal hernias were indirect hernias; n =
34, 81.0% and n = 36, 85.7% in the mesh and non-mesh group, respectively

Contamination degree: clean to clean-contaminated surgical fields

Interventions Intervention:

• Participants: 42
• Mesh repair: open tension-free hernia repair
• Mesh type: not reported

Comparison:

• Participants: 42
• Non-mesh repair: open traditional non-mesh repair, including Bassini (n = 27), McVay repair (n =
8), or not reported (n = 7)

Co-interventions:

Local compression was performed for 6 to 8 hours postoperatively for the tension-free repair
group.

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Wang 2014 (Continued)


The use of antibiotics is unclearly reported. It is stated that antibiotics were given to prevent infec-
tion for 5 to 6 days, but further specifications on doses and types of antibiotics were not reported,
and it is unclear if antibiotics were given in the non-mesh group.

Outcomes Outcomes of interest in this review:

• Clinical recurrence or reoperation for recurrence within 30 days of repair


• Clinical recurrence or reoperation for recurrence within 1 year of repair

Outcomes reported in the trial:

The study did not report any primary or secondary outcomes. However, the following outcomes
were reported:

• Operative time
• Intraoperative blood loss
• Time to get out of bed
• Postoperative analgesia rate
• Length of hospitalisation
• Intraoperative and postoperative complications
• Recurrence rate

Notes Funding: not reported

Declaration of interest: not reported

Ethics: the hospital ethics committee approved a study protocol, and all patients signed informed
consent before inclusion in the study

Authors’ conclusion:

The study authors conclude that tension-free hernia repair is effective in treating incarcerated in-
guinal hernia, with the advantages of the short operation time, early postoperative ambulation
time, low postoperative analgesia rate, short postoperative hospital stay, fewer postoperative com-
plications, and low recurrence rate. With these advantages, it can gradually replace traditional her-
nia repair as the first choice for treating incarcerated inguinal hernia without intestinal necrosis.

Ye 2012
Study characteristics

Methods Design: parallel-arm, single-centre randomised trial

Aim: to compare the clinical efficacy and postoperative recurrence of tension-free repair and Bassi-
ni method for incarcerated inguinal hernia

Setting: tertiary care, Department of Surgery, Dexing People's Hospital, Dexing, Jiangxi Province,
China

Study duration: October 2006 to October 2008 (24 months)

Other: the participants were followed up for 3 years for recurrence rate.

Participants Number of participants: 67

Inclusion criteria: acutely incarcerated inguinal hernias

Exclusion criteria: clinical signs of intestinal necrosis and peritonitis

Baseline characteristics:
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Ye 2012 (Continued)
• Intervention: 31 males and 8 females aged 35 to 59 years with an average age of 46.2 ± 11.3 years
• Comparison: 34 males and 4 females ranging from 34 to 64 years of age, with an average age of
47.5 ± 13.2 years
• Only inguinal hernias

Contamination degree: clean to clean-contaminated surgical fields

Interventions Intervention:

• Participants: 38
• Mesh repair: open tension-free inguinal hernia repair
• Mesh type: synthetic, polyethylene mesh

Comparison:

• Participants: 38
• Non-mesh repair: open Bassini hernia repair

Co-interventions:

Both groups received necessary preparations to balance water-electrolyte and acid-base distur-
bances and both groups were given postoperative antibiotic therapy. No further specifications on
type or doses were reported.

Outcomes Outcomes of interest in this review:

• Clinical recurrence or reoperation for recurrence within 1 year of repair

Outcomes reported in the trial:

The study did not define any primary or secondary outcomes, however the following outcomes
were reported:

• Operative time
• Postoperative hospital stay
• Postoperative complications such as urinary retention, scrotal haematoma, and wound infection

Moreover, patients were followed for 3 years for recurrence. However, only the recurrence rate
within 1 year of repair is reported.

Notes Funding: not reported

Declaration of interest: not reported

Ethics: not reported

Authors’ conclusion:

To sum up, the authors concluded that the tension-free repair, compared with the traditional
Bassini repair, is effective in treating incarcerated inguinal hernia, with less damage, faster recov-
ery, and lower postoperative recurrence rate, and can be used as the first choice in clinical practice.

Yin 2013
Study characteristics

Methods Design: parallel-arm, single-centre randomised controlled trial

Aim: to analyze the clinical effect of tension-free hernia repair in treating strangulated inguinal her-
nia in the elderly
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Setting: tertiary care, Xuzhou City Hospital of Traditional Medicine, Xuzhou City, Jiangsu Province,
221000, China

Study duration: October 2008 to August 2013

Other: —

Participants Number of participants: 100

Inclusion criteria: elderly patients (age not specified) with strangulated inguinal hernias

Exclusion criteria: contraindications to surgery, anaesthesia, severe drug allergies, mental dis-
eases, and severe cardiovascular and cerebrovascular diseases

Baseline characteristics:

• Intervention: all inguinal hernias, 41 males and 9 females ranging from 61 to 77 years, with an
average age of 62.5 ± 4.0 years
• Comparison: all inguinal hernias, 2 males and 8 females ranging from 60 to 76 years, with an av-
erage age of 63.5 ± 4.5 years
• There was no significant difference in age, course of disease and gender ratio between the 2
groups (P > 0.05).

Contamination degree:

Most likely clean-contaminated due to "strangulated inguinal hernia". Unclear whether bowel re-
section or peritonitis was present, so it is uncertain whether cases with contaminated and dirty sur-
gical fields were included.

Interventions Intervention:

• Participants: 50
• Mesh repair: open tension-free repair, "Lichtenstein"
• Mesh type: not reported

Comparison:

• Participants: 50
• Non-mesh repair: "traditional hernia repair". The method of repair is not further specified but
Bassini and McVay repair are stated as examples of traditional hernia repair in the discussion sec-
tion.

Co-interventions:

It is stated in the discussion that broad-spectrum antibiotics should be used in the perioperative
period. Unclear if antibiotics were used in this study.

Outcomes Outcomes of interest in this review:

None

Outcomes reported in the trial:

The study does not define any primary or secondary outcomes, however the following outcomes
were reported:

• Length of hospitalisation
• Patient satisfaction
• Recurrence rate

Notes Funding: not reported

Declaration of interest: not reported


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Yin 2013 (Continued)


Ethics: ethical approval not reported, but all participants in the 2 groups underwent surgical treat-
ment with informed consent from both the patients and their families

Authors’ conclusion:

In summary, the authors conclude that tension-free hernia repair for elderly patients with a stran-
gulated inguinal hernia can effectively reduce the postoperative recurrence rate, significantly im-
prove postoperative satisfaction, shorten postoperative hospitalisation time, and significantly pro-
mote postoperative recovery of patients without serious adverse effects.

Zhu 2015
Study characteristics

Methods Design: parallel-arm, single-centre, randomised trial

Aim: to observe the clinical efficacy of tension-free repair and conventional repair in treating incar-
cerated inguinal hernia

Setting: tertiary care, Department of General Surgery, the People's Hospital of Luhe County, Shan-
wei, Guangdong Province, 516700 China

Study duration: April 2013 and March 2014 (11 months)

Other: —

Participants Number of participants: 100

Inclusion criteria: patients with incarcerated inguinal hernia diagnosed according to the Chinese
Society of Hernia and Abdominal Wall Science criteria through relevant clinical features, imaging
studies, and laboratory tests

Exclusion criteria: severe contamination or intestinal necrosis

Baseline characteristics:

In total, there were 64 males and 36 females, ranging in age from 20 to 72 years old, with an aver-
age age of 56.5 ± 8.3 years. There were 20 cases of unilateral femoral hernia, 30 cases of bilateral in-
carcerated indirect inguinal hernia, and 50 cases of unilateral incarcerated indirect inguinal hernia.
Incarceration time ranged from 4 to 35 hours, averaging at 6.5 ± 0.3 hours.

• Intervention: male (n = 33, 66%), mean age 56.5 ± 8.2 years, ranging from 20 to 72 years, femoral
hernia (n = 10, 20%), average incarceration time of 6.5 ± 0.2 hours, ranging from 4 to 35 hours.
• Comparison: male (n = 32, 64%), mean age 56.4 ± 8.1 years, ranging from 20 to 72 years, femoral
hernia (n = 10, 20%), average incarceration time of 6.4 ± 0.4 hours, ranging from 4 to 35 hours.
• There was no significant difference in the type of disease, incarceration time, age, and gender
between the 2 groups of patients.

Contamination degree: did not report sufficient perioperative findings to enable classification of
contamination degree

Interventions Intervention:

• Participants: 50
• Mesh repair: open tension-free hernia repair
• Mesh type: synthetic polypropylene mesh

Comparison:

• Participants: 50

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Zhu 2015 (Continued)


• Non-mesh repair: open Bassini repair

Co-interventions:

Preoperative antibiotics: other interventions included preoperative preparations such as antibi-


otics and fluid replacement, which were performed in both groups. Further specifications on doses
and types of antibiotics were not reported.

Outcomes Outcomes of interest in this review:

• Clinical recurrence or reoperation for recurrence within 30 days of repair

Outcomes reported in the trial:

This study did not define any primary or secondary outcomes. However, the following outcomes
were reported:

• The time until getting out of bed


• Perioperative blood loss
• Operation time
• Hospitalisation cost
• Hospitalisation time
• Intraoperative vital parameters such as respiratory rate, systolic and diastolic blood pressure
• Visual analogue pain scores
• Postoperative complications such as urinary retention, scrotal oedema, incision infection, and
subfebrilia
• Recurrence within 6 months after surgery

Notes Funding: not reported

Declaration of interest: not reported

Ethics: not reported (both ethical approval or informed consent)

Authors’ conclusion:

The study authors conclude that tension-free hernia repair for incarcerated inguinal hernia is easy
to operate, has fewer postoperative complications, quicker recovery, and has definite clinical ef-
fects, which is worthy of promotion. However, the clinical recurrence of tension-free hernia repair
needs further research.

ARDS: acute respiratory distress syndrome


ASA: American Society of Anesthesiology

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Huang 2012 The study randomised 64 participants with incarcerated inguinal hernia into an observation group
and a control group. There were 32 patients in the mesh group, ranging from 7 to 65 years of age,
and 32 patients in the non-mesh group, ranging from 9 to 68 years of age. Data from the adult pop-
ulation could not be extracted separately from the published report, and the contact information
for the study authors was irretrievable, which is why this study was not assessed as eligible for in-
clusion.

Jiang 2016 This study randomised a total of 100 patients with an incarcerated inguinal hernia between Jan-
uary 2006 to June 2016 into a mesh group and a control non-mesh group, with 50 cases in each
group. The patients in the control group underwent traditional hernia repair, and the surgical and
postoperative conditions of the 2 groups were observed and compared.
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Study Reason for exclusion


The control group included patients down to 3 years of age, and data could not be extracted solely
for the non-paediatric population. The study authors' contact information was sought but found ir-
retrievable, which is why this study is excluded due to the mixed adult and paediatric population.

Jin 2016 This study randomised 27 participants with incarcerated inguinal hernia into 2 groups: 14 partici-
pants in an experimental group that got EasyProstheses partially absorbable mesh and 13 partici-
pants in an observational group that got polypropylene mesh. The study was not eligible for inclu-
sion since there was no non-mesh control group.

Karatepe 2008 The study randomised 40 participants with a strangulated inguinal hernia to undergo either a
preperitoneal repair or a Lichtenstein repair. Both methods were mesh-based repairs, and there
was no non-mesh control group. Hence, this study was not assessed as eligible for inclusion.

Characteristics of studies awaiting classification [ordered by study ID]

ChiCTR2100042336
Methods The study aims to compare a laparoscopic approach to an open approach for incarcerated inguinal
hernia. It is unclear whether there is a non-mesh control group, so this study is listed as "awaiting
classification".

"Objective to investigate the effect of laparoscopic approach on the clinical prognosis of incarcer-
ated inguinal hernia. Then the operation methods of incarcerated hernia patients under different
conditions were formulated accordingly, in order to reduce the adverse prognosis of patients due
to improper surgical methods"

The start date was 1 April 2021, and the study is planned to end on 1 April 2024, with a planned
sample size of 80 participants with 40 participants in both intervention and control group. The par-
ticipants will be randomly allocated to a treatment group using a computer software-generated
random number into group 1 and group 2.

Participants The study includes adults and both sexes admitted to Yibin Second People's Hospital, West China
Hospital of Sichuan University Yibin Hospital, Sichuan, China between April 2021 and April 2024.

Inclusion criteria

1. Patients with incarcerated inguinal hernia


2. Aged 18 to 80 years
3. First onset

Exclusion criteria:

1. Before admission, patient had treatment history in other medical institutions


2. Systemic infection related to incarcerated hernia had occurred
3. ASA score above grade III
4. Accompanied by other acute system diseases
5. Congenital or acquired immune deficiency
6. Total peritonitis
7. The patient/patient's family members did not agree to join the study
8. Patients and their families are not willing to bear the necessary treatment expenses during hos-
pitalisation

Interventions Group 1: "total laparoscopic approach"

Group 2: "Open approach"

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ChiCTR2100042336 (Continued)
Other interventions in the study are not reported.

Outcomes Primary outcome was defined as anastomotic leakage and operation time, while the study's sec-
ondary outcomes included incision infection, intraperitoneal infection, postoperative bleeding,
and recurrence of the hernia.

Notes Unclear whether there was a non-mesh control group. Authors have been contacted.

Recruiting status: recruiting

He 2006
Methods This study aimed to compare the postoperative complications and recurrence rate between mesh
plug hernia repair (tension-free group) and traditional hernia repair (traditional group) and to
analyse whether mesh plug hernia repair is suitable for incarcerated inguinal hernia. Participants
with incarcerated inguinal hernia without intestinal perforation or infectious ascites were ran-
domised according to their economic status and preferences into 2 treatment arms: a tension-free
repair group and a non-mesh repair group.

Inclusion criteria: incarcerated inguinal hernia

113 of the 114 cases in the study were followed up by telephone, resulting in a follow-up rate of
99%. The follow-up time ranged from 2 to 36 months, with an average of 28 months.

Participants 114 patients admitted to the Department of Surgery, Shunde First People's Hospital Affiliated Xing-
tan Hospital, Shunde, China, between January 2001 and January 2006 were included. A total of 69
patients were in the tension-free repair group, and 45 were in the non-mesh group, with a mean
age of 66 and 64, respectively. The majority were male patients, with 91% and 89% in the ten-
sion-free and non-mesh repair groups, respectively.

The contamination grade of the included participants ranged from clean surgical field to contami-
nated surgical field, since patients with intestinal perforation were excluded (dirty surgical field).

Interventions Intervention group: in the tension-free hernia repair group, 69 participants underwent mesh repair
using mesh plugs and meshes produced by the American Bard Company. The mesh used was syn-
thetic.

Control group: the non-mesh group underwent either Bassini (38 participants) or McVay repair (7
participants)

Other interventions in the study:

Preoperative prophylactic antibiotics are described in the intervention group. Unclear whether this
was used in the comparison group.

Outcomes Primary and secondary outcomes were not defined. However, the following outcomes were report-
ed:

• Operative time
• Postoperative pain
• Time to return to daily activities
• Recurrence
• Wound infection
• Hospital stay
• Urinary retention
• Scrotal oedema
• Pneumonia

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He 2006 (Continued)
• Foreign body sensation

Notes —

NCT02469142
Methods In this registered clinical trial, the investigators try to address the role of acellular dermal matrix
(ADM) in treating patients with an incarcerated inguinal hernia by randomising 100 participants to
undergo either ADM tension hernia repair or "just repair incarcerated inguinal hernia by nothing in
tension".

Participants Inclusion criteria:

• Clinical diagnosis of incarcerated hernia


• 16 to 85 years
• Both sexes
• Randomisation agreed by patients and family members

Exclusion criteria:

• Severe organ dysfunction


• Contraindications for anaesthesia or surgery
• Long term glucocorticoid-use
• Severe intraperitoneal adhesion
• "Spirit disease patients"
• "Automatically exit"

Interventions The intervention group will undergo ADM tension hernia repair and the control group will "just re-
pair incarcerated inguinal hernia by nothing in tension".

Outcomes The primary outcome is the recurrence rate after the operation with a follow-up of 10 years.

1. Complications
2. Postoperative hospital stay
3. Hospitalisation costs
4. Self-evaluation of gastro-oesophageal reflux symptoms
5. Quality of life (QOL) at 6 months, and then yearly until 5 years after the operation

Notes Unclear whether mesh is used in the control group, so this study is awaiting classification. Study
authors have been contacted, but with no response.

NCT04850131
Methods "A total of 82 patients with inguinal hernias were selected randomly to participate in this study.
They were subjected to either Lichtenstein hernioplasty or Desarda herniorrhaphy. A follow-up was
conducted to analyze the hospital stay, return to work, recurrence rate, chronic pain, postoperative
complications, and cost-effectiveness."

Participants 82 participants were included between 1 May 2019 and 30 March 2020, with 41 in each group. The
study was conducted at Benazir Bhutto Hospital, Rawalpindi, Pakistan.

"Patients aged between 20 and 70 years (...) with inguinal hernias were randomly selected to par-
ticipate in this study. Consented to participate in the research."

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NCT04850131 (Continued)
Inclusion criteria:

• Patients aged between 20 and 70 years


• Primary inguinal hernia
• Consented to participate in the research

Exclusion criteria:

• Aged below 20
• Recurrent and pantaloon hernia
• Patients who did not give informed consent
• Patients "who lose the follow-up"

Interventions One group was assigned to receive Lichtenstein repair, and the other was assigned to undergo De-
sarda repair.

"Desarda is a new tissue-based technique developed from applying the externally oblique mus-
cle aponeurosis in the form of an undetached strip making the posterior wall in the inguinal canal
stiffer."

Outcomes Primary outcome:

Postoperative pain (VAS) at 24 hours and 3 months and recurrence at 1 year postoperatively

Secondary outcomes:

Wound complications at 30 days postoperatively ("seroma, hematoma formation and surgical site
infection")

Notes It is unclear whether this was elective or emergency groin hernia repair, which is why this study is
awaiting classification. Authors have been contacted.

The protocol on clinicaltrials.gov was retrospectively registered. The study is registered as com-
pleted. Further correspondence is necessary to determine the elective/emergency setting and
study results.

Nedelcu 2016
Methods This randomised, single-blinded, multicentre, prospective study aimed to compare the surgical
treatment of inguinal or abdominal incisional hernia using biological meshes compared with no
mesh in a potentially contaminated setting.

The study was conducted in 20 French hospitals from January 2009 to October 2010. Randomisa-
tion was stratified by the centre using the Medical Information Department of CHU Montpellier,
CLINSIGHT software.

Participants The participants were a mix of patients with inguinal hernia and incisional hernia. Among the 134
randomised participants, 52 had inguinal hernias with 25 participants in group A (non-mesh) and
27 in group B (biological mesh).

Baseline characteristics were pooled for inguinal and incisional hernia, and therefore not present-
ed here. However, no differences in baseline characteristics were found, making the groups compa-
rable.

Interventions For the treatment of inguinal hernias:

Group A: Shouldice or McVay repair (non-mesh procedures) (n = 25)

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Nedelcu 2016 (Continued)


Group B: tension-free repair (Lichtenstein repair) with a biological mesh (Tutomesh TUTOGEN bio-
logical prothesis) (n = 27)

Other interventions included:

"Antibiotic therapy was administered according to the clinical condition of the patient in the peri-
operative phase"

Outcomes Primary outcome:

• 30-day postoperative complications

Secondary outcomes:

• Survival of the herniorrhaphy after 1 year (recurrence?)


• Quality of life assessment using the SF-12 questionnaire at 1, 6, and 12 months after intervention
• Assessment of pain (VAS) at 1 and 12 months
• Socioeconomic impact at 1 and 12 months

Outcome data were collected at follow-up appointments or through phone-calls at 6 and 12


months.

Notes Outcomes reported are pooled for inguinal and abdominal hernias, so results and conclusions are
not presented here.

It is unclear whether all inguinal hernias were repaired in an emergency setting, so this study is
awaiting classification regarding inclusion/exclusion.

Authors have been contacted for clarification and the possibility of extracted raw data solely for
the inguinal hernias. No answer has been received yet (11 October 2022).

ADM: acellular dermal matrix


ASA: American Society of Anesthesiology
VAS: visual analogue scale

Characteristics of ongoing studies [ordered by study ID]

NCT01578538
Study name Safety of mesh used repairs in emergency abdominal wall hernias. Prospective randomized multi-
center trial (hernia)

Methods Methods of randomisation are not specified other than that the participants will be randomly allo-
cated to either undergo "mesh used hernia repair" or "non-mesh hernia repair techniques".

Participants Men and women age 16 years and older admitted to SB Istanbul Education and Research Hospital,
Istanbul, Türkiye

Sample size is 200 randomised participants

Inclusion criteria:

• Older than 16 years old


• Strangulated inguinal hernia
• No contraindications to operation

Exclusion criteria:

• Younger than 16 years old


• Non-strangulated inguinal hernia

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NCT01578538 (Continued)
• Contraindications to operation

Interventions Intervention group will undergo mesh hernia repair and the control group will undergo non-mesh
hernia repair.

Other interventions in the study are not reported.

Outcomes The study's primary outcome is wound infection.

Other outcomes are not reported.

Starting date February 2012

Contact information Erhan Aysan, Prof. Dr., SB Istanbul Education and Research Hospital Contact: adnan yuksel, prof
904531700 ayuksel@bezmialem.edu.tr

Notes Limited study protocol available on clinicaltrials.gov. The protocol was retrospectively registered.

Study registered with an estimated completion date in June 2016. No published article has been
found, and we have tried contacting the study authors without any reply.

RISK OF BIAS

Legend: Low risk of bias High risk of bias Some concerns

Risk of bias for analysis 1.1 Surgical site infections (as defined by the included studies) within 30 days of repair

Bias

Study Randomisation Deviations Missing Measurement Selection of Overall


process from intended outcome data of the outcome the reported
interventions results

Duan 2018

Karaca 2016

Risk of bias for analysis 1.2 Mortality (defined as all-cause mortality) within 30 days of repair

Bias

Study Randomisation Deviations Missing Measurement Selection of Overall


process from intended outcome data of the outcome the reported
interventions results

Duan 2018

Elsebae 2008

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Bias

Study Randomisation Deviations Missing Measurement Selection of Overall


process from intended outcome data of the outcome the reported
interventions results

Karaca 2016

Ren 2012

Risk of bias for analysis 1.3 Surgical site infections (as defined by the included studies) within 90 days of repair

Bias

Study Randomisation Deviations Missing Measurement Selection of Overall


process from intended outcome data of the outcome the reported
interventions results

Darwish 2018

Risk of bias for analysis 1.4 Clinical recurrence or reoperation for recurrence within 30 days of repair

Bias

Study Randomisation Deviations Missing Measurement Selection of Overall


process from intended outcome data of the outcome the reported
interventions results

Darwish 2018

Panda 2012

Zhu 2015

Risk of bias for analysis 1.5 Clinical recurrence or reoperation for recurrence within one year of repair

Bias

Study Randomisation Deviations Missing Measurement Selection of Overall


process from intended outcome data of the outcome the reported
interventions results

Panda 2012

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Bias

Study Randomisation Deviations Missing Measurement Selection of Overall


process from intended outcome data of the outcome the reported
interventions results

Ren 2012

Ye 2012

Risk of bias for analysis 1.6 Mesh removal within 30 days of repair

Bias

Study Randomisation Deviations Missing Measurement Selection of Overall


process from intended outcome data of the outcome the reported
interventions results

Duan 2018

Elsebae 2008

Guo 2015

Li 2010

Panda 2012

Risk of bias for analysis 1.7 Mesh removal within 90 days of repair

Bias

Study Randomisation Deviations Missing Measurement Selection of Overall


process from intended outcome data of the outcome the reported
interventions results

Elsebae 2008

Guo 2015

Li 2010

Panda 2012

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DATA AND ANALYSES

Comparison 1. Primary analysis: mesh versus non-mesh

Outcome or subgroup title No. of studies No. of partici- Statistical method Effect size
pants

1.1 Surgical site infections (as defined by the 2 454 Risk Ratio (M-H, Ran- 1.66 [0.96, 2.88]
included studies) within 30 days of repair dom, 95% CI)

1.2 Mortality (defined as all-cause mortality) 4 541 Risk Ratio (M-H, Ran- 1.38 [0.58, 3.28]
within 30 days of repair dom, 95% CI)

1.3 Surgical site infections (as defined by the 1 60 Risk Ratio (M-H, Ran- 1.00 [0.15, 6.64]
included studies) within 90 days of repair dom, 95% CI)

1.4 Clinical recurrence or reoperation for re- 3 200 Risk Ratio (M-H, Ran- Not estimable
currence within 30 days of repair dom, 95% CI)

1.5 Clinical recurrence or reoperation for re- 3 144 Risk Ratio (M-H, Ran- 0.19 [0.04, 1.03]
currence within one year of repair dom, 95% CI)

1.6 Mesh removal within 30 days of repair 5 Risk Ratio (M-H, Ran- Subtotals only
dom, 95% CI)

1.7 Mesh removal within 90 days of repair 4 Risk Ratio (M-H, Ran- Subtotals only
dom, 95% CI)

Analysis 1.1. Comparison 1: Primary analysis: mesh versus non-mesh, Outcome 1:


Surgical site infections (as defined by the included studies) within 30 days of repair

Mesh Non-mesh 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

Duan 2018 32 104 16 104 69.6% 2.00 [1.17 , 3.42] ? − − − ? −


Karaca 2016 9 125 8 121 30.4% 1.09 [0.43 , 2.73] ? − − − ? −

Total (95% CI) 229 225 100.0% 1.66 [0.96 , 2.88]


Total events: 41 24
Heterogeneity: Tau² = 0.04; Chi² = 1.26, df = 1 (P = 0.26); I² = 21% 0.01 0.1 1 10 100
Test for overall effect: Z = 1.82 (P = 0.07) Favours mesh Favours non-mesh
Test for subgroup differences: Not applicable

Risk of bias legend


(A) Bias arising from the randomization process
(B) Bias due to deviations from intended interventions
(C) Bias due to missing outcome data
(D) Bias in measurement of the outcome
(E) Bias in selection of the reported result
(F) Overall bias

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Analysis 1.2. Comparison 1: Primary analysis: mesh versus non-mesh,


Outcome 2: Mortality (defined as all-cause mortality) within 30 days of repair

Mesh Non-mesh 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

Duan 2018 11 104 8 104 100.0% 1.38 [0.58 , 3.28] ? − − + ? −


Elsebae 2008 0 27 0 27 Not estimable ? − − + ? −
Karaca 2016 0 125 0 121 Not estimable ? − − + ? −
Ren 2012 0 17 0 16 Not estimable ? ? + + ? ?

Total (95% CI) 273 268 100.0% 1.38 [0.58 , 3.28]


Total events: 11 8
Heterogeneity: Not applicable 0.01 0.1 1 10 100
Test for overall effect: Z = 0.72 (P = 0.47) Favours mesh Favours non-mesh
Test for subgroup differences: Not applicable

Risk of bias legend


(A) Bias arising from the randomization process
(B) Bias due to deviations from intended interventions
(C) Bias due to missing outcome data
(D) Bias in measurement of the outcome
(E) Bias in selection of the reported result
(F) Overall bias

Analysis 1.3. Comparison 1: Primary analysis: mesh versus non-mesh, Outcome 3:


Surgical site infections (as defined by the included studies) within 90 days of repair

Mesh Non-mesh 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

Darwish 2018 2 30 2 30 100.0% 1.00 [0.15 , 6.64] ? − − − ? −

Total (95% CI) 30 30 100.0% 1.00 [0.15 , 6.64]


Total events: 2 2
Heterogeneity: Not applicable 0.01 0.1 1 10 100
Test for overall effect: Z = 0.00 (P = 1.00) Favours mesh Favours non-mesh
Test for subgroup differences: Not applicable

Risk of bias legend


(A) Bias arising from the randomization process
(B) Bias due to deviations from intended interventions
(C) Bias due to missing outcome data
(D) Bias in measurement of the outcome
(E) Bias in selection of the reported result
(F) Overall bias

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Analysis 1.4. Comparison 1: Primary analysis: mesh versus non-mesh, Outcome


4: Clinical recurrence or reoperation for recurrence within 30 days of repair

Mesh Non-mesh 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

Darwish 2018 0 30 0 30 Not estimable ? − − − ? −


Panda 2012 0 20 0 20 Not estimable ? − − ? ? −
Zhu 2015 0 50 0 50 Not estimable ? − − − ? −

Total (95% CI) 100 100 Not estimable


Total events: 0 0
Heterogeneity: Not applicable 0.01 0.1 1 10 100
Test for overall effect: Not applicable Favours mesh Favours non-mesh
Test for subgroup differences: Not applicable

Risk of bias legend


(A) Bias arising from the randomization process
(B) Bias due to deviations from intended interventions
(C) Bias due to missing outcome data
(D) Bias in measurement of the outcome
(E) Bias in selection of the reported result
(F) Overall bias

Analysis 1.5. Comparison 1: Primary analysis: mesh versus non-mesh, Outcome


5: Clinical recurrence or reoperation for recurrence within one year of repair

Mesh Non-mesh 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

Panda 2012 0 20 0 20 Not estimable ? − − ? ? −


Ren 2012 1 17 5 16 68.5% 0.19 [0.02 , 1.44] ? ? + − ? −
Ye 2012 (1) 0 36 2 35 31.5% 0.19 [0.01 , 3.91] ? − − − − −

Total (95% CI) 73 71 100.0% 0.19 [0.04 , 1.03]


Total events: 1 7
Heterogeneity: Tau² = 0.00; Chi² = 0.00, df = 1 (P = 0.99); I² = 0% 0.01 0.1 1 10 100
Test for overall effect: Z = 1.93 (P = 0.05) Favours mesh Favours non-mesh
Test for subgroup differences: Not applicable

Footnotes
(1) Ye 2012: After 1 year of follow-up, 36/38 patients in group A and 35/38 patients in group B were available for follow-up

Risk of bias legend


(A) Bias arising from the randomization process
(B) Bias due to deviations from intended interventions
(C) Bias due to missing outcome data
(D) Bias in measurement of the outcome
(E) Bias in selection of the reported result
(F) Overall bias

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Analysis 1.6. Comparison 1: Primary analysis: mesh versus


non-mesh, Outcome 6: Mesh removal within 30 days of repair

Mesh Non-mesh Risk Ratio Risk Ratio Risk of Bias


Study or Subgroup Events Total Events Total M-H, Random, 95% CI M-H, Random, 95% CI A B C D E F

Duan 2018 7 104 0 104 15.00 [0.87 , 259.29] ? − − ? ? −


Elsebae 2008 0 27 0 27 Not estimable ? − − + ? −
Guo 2015 0 26 0 24 Not estimable ? ? + + ? ?
Li 2010 0 25 0 25 Not estimable ? ? + + ? ?
Panda 2012 0 20 0 20 Not estimable ? − − + ? −

0.01 0.1 1 10 100


Risk of bias legend Favours mesh Favours non-mesh
(A) Bias arising from the randomization process
(B) Bias due to deviations from intended interventions
(C) Bias due to missing outcome data
(D) Bias in measurement of the outcome
(E) Bias in selection of the reported result
(F) Overall bias

Analysis 1.7. Comparison 1: Primary analysis: mesh versus


non-mesh, Outcome 7: Mesh removal within 90 days of repair

Mesh Non-mesh Risk Ratio Risk Ratio Risk of Bias


Study or Subgroup Events Total Events Total M-H, Random, 95% CI M-H, Random, 95% CI A B C D E F

Elsebae 2008 0 27 0 27 Not estimable ? − − + ? −


Guo 2015 0 26 0 24 Not estimable ? ? + + ? ?
Li 2010 0 25 0 25 Not estimable ? ? + + ? ?
Panda 2012 0 20 0 20 Not estimable ? − − + ? −

0.01 0.1 1 10 100


Risk of bias legend Favours mesh Favours non-mesh
(A) Bias arising from the randomization process
(B) Bias due to deviations from intended interventions
(C) Bias due to missing outcome data
(D) Bias in measurement of the outcome
(E) Bias in selection of the reported result
(F) Overall bias

Comparison 2. Subgroup analysis: hernia type

Outcome or subgroup title No. of studies No. of partici- Statistical method Effect size
pants

2.1 Clinical recurrence or reoperation 3 200 Risk Ratio (M-H, Random, Not estimable
for recurrence within 30 days of repair 95% CI)

2.1.1 Inguinal hernia 3 180 Risk Ratio (M-H, Random, Not estimable
95% CI)

2.1.2 Femoral hernia 1 20 Risk Ratio (M-H, Random, Not estimable


95% CI)

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Analysis 2.1. Comparison 2: Subgroup analysis: hernia type, Outcome 1:


Clinical recurrence or reoperation for recurrence within 30 days of repair

Mesh Non-mesh Risk Ratio Risk Ratio


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

2.1.1 Inguinal hernia


Darwish 2018 0 30 0 30 Not estimable
Panda 2012 0 20 0 20 Not estimable
Zhu 2015 0 40 0 40 Not estimable
Subtotal (95% CI) 90 90 Not estimable
Total events: 0 0
Heterogeneity: Not applicable
Test for overall effect: Not applicable

2.1.2 Femoral hernia


Zhu 2015 0 10 0 10 Not estimable
Subtotal (95% CI) 10 10 Not estimable
Total events: 0 0
Heterogeneity: Not applicable
Test for overall effect: Not applicable

Total (95% CI) 100 100 Not estimable


Total events: 0 0
Heterogeneity: Not applicable 0.01 0.1 1 10 100
Test for overall effect: Not applicable Favours mesh Favours non-mesh
Test for subgroup differences: Not applicable

Comparison 3. Subgroup analysis: contamination degree

Outcome or subgroup title No. of studies No. of partici- Statistical method Effect size
pants

3.1 Surgical site infections (as defined by 2 454 Risk Ratio (M-H, Random, 1.74 [0.97, 3.13]
the included studies) within 30 days of 95% CI)
repair

3.1.1 Clean to clean-contaminated surgi- 1 246 Risk Ratio (M-H, Random, 1.09 [0.43, 2.73]
cal field 95% CI)

3.1.2 Contaminated surgical field 1 145 Risk Ratio (M-H, Random, 1.37 [0.55, 3.40]
95% CI)

3.1.3 Dirty surgical field 1 63 Risk Ratio (M-H, Random, 2.69 [1.48, 4.89]
95% CI)

3.2 Mortality (defined as all-cause mor- 4 541 Risk Ratio (M-H, Random, 1.38 [0.58, 3.28]
tality) within 30 days of repair 95% CI)

3.2.1 Clean to clean-contaminated surgi- 3 333 Risk Ratio (M-H, Random, Not estimable
cal field 95% CI)

3.2.2 Contaminated to dirty surgical 1 208 Risk Ratio (M-H, Random, 1.38 [0.58, 3.28]
field 95% CI)

3.3 Mesh removal within 30 days of re- 5 402 Risk Ratio (M-H, Random, 15.00 [0.87,
pair 95% CI) 259.29]

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Outcome or subgroup title No. of studies No. of partici- Statistical method Effect size
pants

3.3.1 Clean to clean-contaminated surgi- 4 194 Risk Ratio (M-H, Random, Not estimable
cal field 95% CI)

3.3.2 Contaminated to dirty surgical 1 208 Risk Ratio (M-H, Random, 15.00 [0.87,
field 95% CI) 259.29]

Analysis 3.1. Comparison 3: Subgroup analysis: contamination degree, Outcome 1:


Surgical site infections (as defined by the included studies) within 30 days of repair

Mesh Non-mesh Risk Ratio Risk Ratio


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

3.1.1 Clean to clean-contaminated surgical field


Karaca 2016 9 125 8 121 27.4% 1.09 [0.43 , 2.73]
Subtotal (95% CI) 125 121 27.4% 1.09 [0.43 , 2.73]
Total events: 9 8
Heterogeneity: Not applicable
Test for overall effect: Z = 0.18 (P = 0.86)

3.1.2 Contaminated surgical field


Duan 2018 10 74 7 71 27.8% 1.37 [0.55 , 3.40]
Subtotal (95% CI) 74 71 27.8% 1.37 [0.55 , 3.40]
Total events: 10 7
Heterogeneity: Not applicable
Test for overall effect: Z = 0.68 (P = 0.50)

3.1.3 Dirty surgical field


Duan 2018 22 30 9 33 44.8% 2.69 [1.48 , 4.89]
Subtotal (95% CI) 30 33 44.8% 2.69 [1.48 , 4.89]
Total events: 22 9
Heterogeneity: Not applicable
Test for overall effect: Z = 3.24 (P = 0.001)

Total (95% CI) 229 225 100.0% 1.74 [0.97 , 3.13]


Total events: 41 24
Heterogeneity: Tau² = 0.11; Chi² = 3.29, df = 2 (P = 0.19); I² = 39% 0.01 0.1 1 10 100
Test for overall effect: Z = 1.85 (P = 0.06) Favours mesh Favours non-mesh
Test for subgroup differences: Chi² = 3.20, df = 2 (P = 0.20), I² = 37.5%

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Analysis 3.2. Comparison 3: Subgroup analysis: contamination degree,


Outcome 2: Mortality (defined as all-cause mortality) within 30 days of repair

Mesh Non-mesh Risk Ratio Risk Ratio


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

3.2.1 Clean to clean-contaminated surgical field


Elsebae 2008 0 27 0 27 Not estimable
Karaca 2016 0 125 0 121 Not estimable
Ren 2012 0 17 0 16 Not estimable
Subtotal (95% CI) 169 164 Not estimable
Total events: 0 0
Heterogeneity: Not applicable
Test for overall effect: Not applicable

3.2.2 Contaminated to dirty surgical field


Duan 2018 11 104 8 104 100.0% 1.38 [0.58 , 3.28]
Subtotal (95% CI) 104 104 100.0% 1.38 [0.58 , 3.28]
Total events: 11 8
Heterogeneity: Not applicable
Test for overall effect: Z = 0.72 (P = 0.47)

Total (95% CI) 273 268 100.0% 1.38 [0.58 , 3.28]


Total events: 11 8
Heterogeneity: Not applicable 0.01 0.1 1 10 100
Test for overall effect: Z = 0.72 (P = 0.47) Favours mesh Favours non-mesh
Test for subgroup differences: Not applicable

Analysis 3.3. Comparison 3: Subgroup analysis: contamination


degree, Outcome 3: Mesh removal within 30 days of repair

Mesh Non-mesh Risk Ratio Risk Ratio


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

3.3.1 Clean to clean-contaminated surgical field


Elsebae 2008 0 27 0 27 Not estimable
Guo 2015 0 26 0 24 Not estimable
Li 2010 0 25 0 25 Not estimable
Panda 2012 0 20 0 20 Not estimable
Subtotal (95% CI) 98 96 Not estimable
Total events: 0 0
Heterogeneity: Not applicable
Test for overall effect: Not applicable

3.3.2 Contaminated to dirty surgical field


Duan 2018 7 104 0 104 100.0% 15.00 [0.87 , 259.29]
Subtotal (95% CI) 104 104 100.0% 15.00 [0.87 , 259.29]
Total events: 7 0
Heterogeneity: Not applicable
Test for overall effect: Z = 1.86 (P = 0.06)

Total (95% CI) 202 200 100.0% 15.00 [0.87 , 259.29]


Total events: 7 0
Heterogeneity: Not applicable 0.01 0.1 1 10 100
Test for overall effect: Z = 1.86 (P = 0.06) Favours mesh Favours non-mesh
Test for subgroup differences: Not applicable

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Comparison 4. Subgroup analysis: sex

Outcome or subgroup title No. of studies No. of partici- Statistical method Effect size
pants

4.1 Clinical recurrence or reoperation 2 160 Risk Ratio (M-H, Random, 95% Not estimable
for recurrence within 30 days of re- CI)
pair

4.1.1 Male sex 2 125 Risk Ratio (M-H, Random, 95% Not estimable
CI)

4.1.2 Female sex 1 35 Risk Ratio (M-H, Random, 95% Not estimable
CI)

Analysis 4.1. Comparison 4: Subgroup analysis: sex, Outcome 1: Clinical


recurrence or reoperation for recurrence within 30 days of repair

Mesh Non-mesh Risk Ratio Risk Ratio


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

4.1.1 Male sex


Darwish 2018 0 30 0 30 Not estimable
Zhu 2015 0 33 0 32 Not estimable
Subtotal (95% CI) 63 62 Not estimable
Total events: 0 0
Heterogeneity: Not applicable
Test for overall effect: Not applicable

4.1.2 Female sex


Zhu 2015 0 17 0 18 Not estimable
Subtotal (95% CI) 17 18 Not estimable
Total events: 0 0
Heterogeneity: Not applicable
Test for overall effect: Not applicable

Total (95% CI) 80 80 Not estimable


Total events: 0 0
Heterogeneity: Not applicable 0.01 0.1 1 10 100
Test for overall effect: Not applicable Favours mesh Favours non-mesh
Test for subgroup differences: Not applicable

Comparison 5. Subgroup analysis: bowel resection

Outcome or subgroup title No. of studies No. of partici- Statistical method Effect size
pants

5.1 Mortality (defined as all-cause 2 262 Risk Ratio (M-H, Random, 95% 1.38 [0.58, 3.28]
mortality) within 30 days of repair CI)

5.1.1 Bowel resection 1 208 Risk Ratio (M-H, Random, 95% 1.38 [0.58, 3.28]
CI)

5.1.2 No bowel resection 1 54 Risk Ratio (M-H, Random, 95% Not estimable
CI)

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Outcome or subgroup title No. of studies No. of partici- Statistical method Effect size
pants

5.2 Mesh removal within 30 days of 3 302 Risk Ratio (M-H, Random, 95% 15.00 [0.87,
repair CI) 259.29]

5.2.1 Bowel resection 1 208 Risk Ratio (M-H, Random, 95% 15.00 [0.87,
CI) 259.29]

5.2.2 No bowel resection 2 94 Risk Ratio (M-H, Random, 95% Not estimable
CI)

Analysis 5.1. Comparison 5: Subgroup analysis: bowel resection, Outcome


1: Mortality (defined as all-cause mortality) within 30 days of repair

Mesh Non-mesh Risk Ratio Risk Ratio


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

5.1.1 Bowel resection


Duan 2018 11 104 8 104 100.0% 1.38 [0.58 , 3.28]
Subtotal (95% CI) 104 104 100.0% 1.38 [0.58 , 3.28]
Total events: 11 8
Heterogeneity: Not applicable
Test for overall effect: Z = 0.72 (P = 0.47)

5.1.2 No bowel resection


Elsebae 2008 0 27 0 27 Not estimable
Subtotal (95% CI) 27 27 Not estimable
Total events: 0 0
Heterogeneity: Not applicable
Test for overall effect: Not applicable

Total (95% CI) 131 131 100.0% 1.38 [0.58 , 3.28]


Total events: 11 8
Heterogeneity: Not applicable 0.01 0.1 1 10 100
Test for overall effect: Z = 0.72 (P = 0.47) Favours mesh Favours non-mesh
Test for subgroup differences: Not applicable

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Analysis 5.2. Comparison 5: Subgroup analysis: bowel resection, Outcome 2: Mesh removal within 30 days of repair

Mesh Non-mesh Risk Ratio Risk Ratio


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

5.2.1 Bowel resection


Duan 2018 7 104 0 104 100.0% 15.00 [0.87 , 259.29]
Subtotal (95% CI) 104 104 100.0% 15.00 [0.87 , 259.29]
Total events: 7 0
Heterogeneity: Not applicable
Test for overall effect: Z = 1.86 (P = 0.06)

5.2.2 No bowel resection


Elsebae 2008 0 27 0 27 Not estimable
Panda 2012 0 20 0 20 Not estimable
Subtotal (95% CI) 47 47 Not estimable
Total events: 0 0
Heterogeneity: Not applicable
Test for overall effect: Not applicable

Total (95% CI) 151 151 100.0% 15.00 [0.87 , 259.29]


Total events: 7 0
Heterogeneity: Not applicable 0.01 0.1 1 10 100
Test for overall effect: Z = 1.86 (P = 0.06) Favours mesh Favours non-mesh
Test for subgroup differences: Not applicable

Comparison 6. Sensitivity analysis

Outcome or subgroup title No. of studies No. of partici- Statistical method Effect size
pants

6.1 Clinical recurrence or reoperation 3 Risk Ratio (M-H, Random, Subtotals only
for recurrence within one year of repair 95% CI)

6.1.1 Best-case scenario 3 149 Risk Ratio (M-H, Random, 0.19 [0.04, 1.03]
95% CI)

6.1.2 Worst-case scenario 3 149 Risk Ratio (M-H, Random, 0.45 [0.09, 2.34]
95% CI)

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Analysis 6.1. Comparison 6: Sensitivity analysis, Outcome 1: Clinical


recurrence or reoperation for recurrence within one year of repair

Mesh Non-mesh Risk Ratio Risk Ratio


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

6.1.1 Best-case scenario


Panda 2012 0 20 0 20 Not estimable
Ren 2012 1 17 5 16 68.5% 0.19 [0.02 , 1.44]
Ye 2012 (1) 0 38 2 38 31.5% 0.20 [0.01 , 4.03]
Subtotal (95% CI) 75 74 100.0% 0.19 [0.04 , 1.03]
Total events: 1 7
Heterogeneity: Tau² = 0.00; Chi² = 0.00, df = 1 (P = 0.97); I² = 0%
Test for overall effect: Z = 1.92 (P = 0.05)

6.1.2 Worst-case scenario


Panda 2012 0 20 0 20 Not estimable
Ren 2012 1 17 5 16 47.7% 0.19 [0.02 , 1.44]
Ye 2012 (2) 2 38 2 38 52.3% 1.00 [0.15 , 6.74]
Subtotal (95% CI) 75 74 100.0% 0.45 [0.09 , 2.34]
Total events: 3 7
Heterogeneity: Tau² = 0.40; Chi² = 1.40, df = 1 (P = 0.24); I² = 28%
Test for overall effect: Z = 0.95 (P = 0.34)

0.01 0.1 1 10 100


Footnotes Favours mesh Favours non-mesh
(1) Participants with missing data in the intervention arm developed events for desirable outcomes and participants with missing data in the control arm did not.
(2) Participants with missing data in the intervention arm developed events for undesirable outcomes and participants with missing data in the control arm did not.

APPENDICES

Appendix 1. CENTRAL search strategy


#1 MeSH descriptor: [Hernia, Inguinal] explode all trees

#2 MeSH descriptor: [Hernia, Femoral] explode all trees

#3 (herni*):ti,ab,kw

#4 (inguina* or femoral or groin* or pantaloon or medial or lateral or indirect or direct or internal):ti,ab,kw

#5 (#3 and #4)

#6 (#1 or #2 or #5)

#7 MeSH descriptor: [Acute Disease] explode all trees

#8 MeSH descriptor: [Emergencies] explode all trees

#9 (acute or emergen* or urgent* or strangu* or incarc* or obstru*):ti,ab,kw

#10 (#7 or #8 or #9)

#11 (#6 and #10)

Appendix 2. Ovid MEDLINE search strategy


Ovid MEDLINE(R) ALL

1. exp Hernia, Inguinal/

2. exp Hernia, Femoral/

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3. ((Inguina* or femoral or groin* or pantaloon or direct or indirect or medial or lateral or internal) and herni*).mp.

4. 1 or 2 or 3

5. exp Acute Disease/

6. exp Emergencies/

7. (acute or emergen* or urgent* or strangu* or incarc* or obstru*).mp

8. 5 or 6 or 7

9. randomized controlled trial.pt.

10. controlled clinical trial.pt.

11. randomi?ed.ab.

12. placebo.ab.

13. drug therapy.fs.

14. randomly.ab.

15. trial.ab.

16. groups.ab.

17. 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16

18. exp animals/ not humans.sh.

19. 17 not 18

20. 4 and 8 and 19

Appendix 3. Ovid EMBASE search strategy


1. exp inguinal hernia/

2. exp femoral hernia/

3. ((Inguina* or femoral or groin* or pantaloon or direct or indirect or medial or lateral or internal) and herni*).mp.

4. 1 or 2 or 3

5. exp acute disease/

6. exp emergency/

7. (acute or emergen* or urgent* or strangu* or incarc* or obstru*).mp.

8. 5 or 6 or 7

9. (randomized controlled trial/ or controlled clinical study/ or random$.ti,ab. or randomization/ or intermethod comparison/ or
placebo.ti,ab. or (compare or compared or comparison).ti. or ((evaluated or evaluate or evaluating or assessed or assess) and (compare
or compared or comparing or comparison)).ab. or (open adj label).ti,ab. or ((double or single or doubly or singly) adj (blind or blinded or
blindly)).ti,ab. or double blind procedure/ or parallel group$1.ti,ab. or (crossover or cross over).ti,ab. or ((assign$ or match or matched or
allocation) adj5 (alternate or group$1 or intervention$1 or patient$1 or subject$1 or participant$1)).ti,ab. or (assigned or allocated).ti,ab.
or (controlled adj7 (study or design or trial)).ti,ab. or (volunteer or volunteers).ti,ab. or human experiment/ or trial.ti.) not (((random$ adj
sampl$ adj7 (cross section$ or questionnaire$1 or survey$ or database$1)).ti,ab. not (comparative study/ or controlled study/ or randomi?
ed controlled.ti,ab. or randomly assigned.ti,ab.)) or (cross-sectional study/ not (randomized controlled trial/ or controlled clinical study/
or controlled study/ or randomi?ed controlled.ti,ab. or control group$1.ti,ab.)) or (((case adj control$) and random$) not randomi?ed
controlled).ti,ab. or (Systematic review not (trial or study)).ti. or (nonrandom$ not random$).ti,ab. or Random field$.ti,ab. or (random
cluster adj3 sampl$).ti,ab. or ((review.ab. and review.pt.) not trial.ti.) or (we searched.ab. and (review.ti. or review.pt.)) or update review.ab.
or (databases adj4 searched).ab. or ((rat or rats or mouse or mice or swine or porcine or murine or sheep or lambs or pigs or piglets or rabbit
or rabbits or cat or cats or dog or dogs or cattle or bovine or monkey or monkeys or trout or marmoset$1).ti. and animal experiment/) or
(Animal experiment/ not (human experiment/ or human/)))
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10. 4 and 8 and 9

Appendix 4. Search terms in trial registries


emergency AND hernia

incarcerated AND hernia

strangulated AND hernia

mesh AND hernia

HISTORY
Protocol first published: Issue 6, 2022

CONTRIBUTIONS OF AUTHORS
• Ann Hou Sæter: corresponding author and guarantor of this review, search strategy development, search and selection of studies for
inclusion, data extraction and risk of bias assessment for all included studies, entering of data into RevMan Web, analysis of data,
certainty of evidence assessment, interpretation of the data, drafting the final review, and final approval of the manuscript.
• Siv Fonnes: search and selection of studies for inclusion, data extraction and risk of bias assessment for included studies written
in English, certainty of evidence assessment, interpretation of the data, critical revisions of the review, and final approval of the
manuscript.
• Shuqing Li: data extraction and risk of bias assessment for included studies written in Chinese, critical revisions of the review, and final
approval of the manuscript.
• Jacob Rosenberg: conception/design of the work, interpretation of the data, critical revisions of the review, and final approval of the
manuscript.
• Kristoffer Andresen: conception/design of the work, interpretation of the data, critical revisions of the review, and final approval of the
manuscript.

All authors agreed to be accountable for all the aspects of this review, ensuring that any questions regarding the accuracy or integrity of
the work were appropriately investigated and resolved.

DECLARATIONS OF INTEREST
The authors Kristoffer Andresen, Siv Fonnes, and Jacob Rosenberg are part of the Cochrane Colorectal editorial team but were not involved
in the editorial process for this review.

The authors Ann Hou Sæter and Shuqing Li have no conflicts of interest.

SOURCES OF SUPPORT

Internal sources
• No internal sources of support, Other

No internal sources of support

External sources
• No external sources of support, Other

No external sources of support

DIFFERENCES BETWEEN PROTOCOL AND REVIEW


Background

In the background section of the protocol, we wrongly classified the participants in Elsebae 2008 as having clean surgical fields. In the final
review, this reference has been changed to Lohsiriwat 2007.

We have included quasi-RCTs (e.g. randomised on personal registration numbers). The handling of quasi-randomised trials was not
specified in the initial protocol.

Searching other resources

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We have specified that 'other sources' included reference list searching, a forward citation search, and searching of grey literature.

Study selection

All eligible studies were searched in the Retraction Watch Database.

Types of outcome measures

We contacted all study authors at least three times, not only twice as stated in the protocol.

Data extraction and management

We dichotomised the following subgroups prior to data extraction: age into participants ≥ 65 years and < 65 years, ASA scores into ASA
score 1-2 and ASA score 3-4, and BMI into ≥ 30 and < 30.

Secondary outcomes

We only included the secondary outcome 'Complications, classified by The Clavien-Dindo Classification (Dindo 2004), within 30 days of
repair' if the complications were already classified in the included studies.

Assessment of risk of bias in included studies

In the methods section, it is now specified that if we included a study that did not report a numerical result for a prespecified outcome of
interest for this review, we would not perform a risk of bias assessment for the given study as it did not contribute to the review.

Subgroup analysis and investigation of heterogeneity

If different degrees of contamination were pooled in the original data, they were also pooled in the subgroup analysis (e.g. pooling clean
surgical field and clean-contaminated surgical field).

We only included subgroup analyses with two or more subgroups. In the interest of transparency, we also reported the subgroup analyses,
even when one or more subgroups had zero events, which prevented testing for subgroup differences.

Identification of non-English articles

When studies written in a non-English language were identified, at least one native speaker of the language assessed eligibility for inclusion
and performed the data extraction and risk of bias assessment. The other author had assistance from a native speaker if any questions
arose.

Methods not implemented

Dichotomous outcomes are only expressed as risk ratios (RRs) and not risk differences (RDs).

Since none of the included studies reported Clavien-Dindo-classified complications, these were not dichotomised for analyses into grades
1 to 2 and grades 3 to 4.

We did not identify any multi-arm studies and hence did not implement the methods for handling the different arms. If we had included
any multi-arm studies, we would have combined the different arms into one group if they could be regarded as subtypes of the same
intervention. If the arms could not be combined in this way, we would have treated the specific arms as separate studies and split the
shared participants (either the intervention or the control group) between the specific arms to avoid double counting (Higgins 2022).

We did not identify more than 10 studies reporting on the same outcome, which is why a funnel plot assessing the risk of reporting bias
was not performed as described in Assessment of reporting biases.

INDEX TERMS

Medical Subject Headings (MeSH)


Groin [surgery]; *Hernia, Femoral [surgery]; *Hernia, Inguinal [surgery]; Herniorrhaphy [adverse effects] [methods]; Surgical Mesh
[adverse effects]; Surgical Wound Infection

MeSH check words


Adult; Aged; Female; Humans; Male; Middle Aged

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