ORIGINAL RESEARCH

International Journal of Surgery 11 (2013) 914e918

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International Journal of Surgery

journal homepage: www.journal-surgery.net

Original research

Meta-analysis of randomized controlled trials comparing outcomes

for stapled hemorrhoidopexy versus LigaSure hemorrhoidectomy for
symptomatic hemorrhoids in adults
Ko-Chao Lee a, Hong-Hwa Chen a, Kuan-Chih Chung b, Wan-Hsiang Hu a, Chia-Lo Chang a,
Shung-Eing Lin a, Kai-Lung Tsai a, Chien-Chang Lu a, *
a
Division of Colorectal Surgery, Department of Surgery, Chang Gung Memorial Hospital e Kaohsiung Medical Center, Chang Gung University College of
Medicine, Kaohsiung, Taiwan
b
Department of Anesthesiology, Chang Gung Memorial Hospital e Kaohsiung Medical Center, Chang Gung University College of Medicine, Kaohsiung,
Taiwan

a r t i c l e i n f o

a b s t r a c t

Article history:
Received 22 May 2013
Received in revised form
9 July 2013
Accepted 9 July 2013
Available online 19 July 2013

This purpose of the meta-analysis was to compare treatment outcomes for adult patients with symptomatic hemorrhoids treated by stapled hemorrhoidopexy or LigaSure hemorrhoidectomy.
A search of public medical databases was made to identify randomized controlled trials (RCTs)
comparing stapled hemorrhoidopexy (SH) with LigaSure hemorrhoidectomy (LH) for the treatment of
adult patients with symptomatic grade 3 and grade 4 hemorrhoids. Postoperative pain as measured
using a visual analog scale was the primary outcome, and rate of recurrent prolapse and postoperative
bleeding were secondary outcome measures. Four RCTs were identied that met the inclusion criteria.
Data for the pooled outcomes were analyzed using odds ratio (OR) analysis. None of the studies in the
analysis indicated a signicant difference between SH and LH for the outcomes VAS pain score, recurrence rate, or postoperative bleeding. Pooled analysis revealed a signicant OR in favor of the SH method
for recurrent prolapse (OR 5.529, P 0.016) for up to 2 years after surgery. No signicant differences
between the two methods were identied for VAS pain scores (OR 1.060, P 0.149) or postoperative
bleeding OR 1.188, P 0.871). Pooled analysis of RCT results comparing SH to LH for symptomatic
hemorrhoids revealed a signicantly greater incidence of recurrent prolapse for SH. The two techniques
were associated with similar levels of postoperative pain and postoperative bleeding.
2013 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

Keywords:
Hemorrhoids
Stapled hemorrhoidopexy
LigaSure hemorrhoidectomy
Recurrence
Meta-analysis

1. Introduction
Hemorrhoids are a common health condition characterized by
swelling of the inferior or superior hemorrhoidal plexus and
downward displacement of the anal cushions.1 The condition affects just under 5% of individuals in the United States, with the
highest prevalence in those 45e65 years of age.2 The etiology of
hemorrhoids is not completely understood, but their development
has long been associated with constipation and prolonged straining
that blocks venous return. Hemorrhoids were thought to represent
varicose veins within the anorectal circulation, but evidence has
shown no correlation between hemorrhoids and varices in the
* Corresponding author. Division of Colorectal Surgery, Department of Surgery,
Kaohsiung Chang Gung Memorial Hospital, No. 123, Ta Pei Road, Niao Sung District,
Kaohsiung 833, Taiwan. Tel.: 886 866 7 7317123; fax: 886 866 7 7318762.
E-mail address: cclu999@gmail.com (C.-C. Lu).

anorectal circulation.1 Enzymatically mediated deterioration of

connective tissue supporting the anal cushions and increased
microvascularization of the hemorrhoidal plexus are also implicated in the development of hemorrhoids.1
Mild cases of hemorrhoids involving bleeding and/or prolapse
that reduces spontaneously (grades 1 and 2) are well managed
using conservative therapy, which may range from diet and lifestyle
modications to outpatient procedures such as rubber band ligation, sclerotherapy, or infrared coagulation. In selected cases, rubber band ligation may also be effective for prolapsed hemorrhoids
requiring manual reduction (grade 3).1,3 Surgical intervention is
recommended for the treatment of grade 4 hemorrhoids (nonreducible prolapse) and grade 3 cases not managed using rubber
band ligation.3
A number of options are available for the surgical treatment of
hemorrhoids, including conventional hemorrhoidectomy (CH), stapled hemorrhoidopexy (SH, Longo method, Procedure for Prolapsed

1743-9191/$ e see front matter 2013 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.ijsu.2013.07.006

ORIGINAL RESEARCH
K.-C. Lee et al. / International Journal of Surgery 11 (2013) 914e918

Hemorrhoids), Doppler-guided hemorrhoidal artery ligation, and

LigaSure hemorrhoidectomy (LH).1,4 CH, the approach used most
frequently, involves excision of the hemorrhoids using some version of
the open (Milligan-Morgan) or closed (Ferguson) technique. In the
open procedure, hemorrhoidal tissue is excised while preserving skin
bridges to prevent stricture, and the wounds are allowed to heal by
secondary intention. With the closed technique, the hemorrhoidal
plexus is dissected from the internal sphincter, and the wound is
closed with an absorbable suture. Both procedures involve an anodermal wound and are associated with signicant pain, marked
bleeding, and a prolonged period before return to normal activity.5e7
SH and LH methods were introduced to reduce pain and
improve recovery time. SH employs a circular stapler to re-suspend
prolapsed tissue within the anal canal.1,6 The aim of the procedure
is to restore the anal cushions and preserve their function in
maintenance of continence, and to reduce pain by eliminating
anodermal wounds. LH employs a novel electro thermal device to
seal blood vessels through a combination of pressure and radiofrequency ablation.8 This has the effect of limiting the spread of
thermal damage to within 2 mm of the adjacent tissue, and offers a
substantial improvement over conventional diathermy.
Recent meta-analyses and systematic reviews have shown that
SH and LH are effective at reducing postoperative pain and bleeding,
decreasing wound-healing time and time to return to normal activity
and faster wound healing compared to CH.6e11 The objective of this
study was to analyze randomized control trials (RCTs) that directly
compared the outcomes of SH and LH surgery for adult patients with
grade 3 and 4 symptomatic hemorrhoids, with particular emphasis
on VAS pain scores as the primary outcome measure.
2. Methods
2.1. Search strategy
A comprehensive search was performed to identify published results of randomized controlled trials (RCTs) comparing the outcomes for stapled hemorrhoidectomy (SH) versus LigaSure hemorrhoidectomy (LH) techniques for
symptomatic hemorrhoids in adult patients. The following literature databases were
searched through September 30, 2012 using combinations of the search terms
LigaSure, stapled, hemorrhoidectomy, hemorrhoidopexy, procedure for prolapse,
hemorrhoids, haemorrhoids, PPH, mucosectomy, and prolapsectomy: PubMed,
Current Contents, Google Scholar, the Cochrane Library, the Directory of Open Access
Journals, and Biomedical Central. For inclusion in this meta analysis, studies had to
meet the following criteria: (1) designed as prospective, randomized clinical trial;
(2) include adult patients with grade III or IV hemorrhoids, (3) compare the outcomes for SH versus LH, (4) pain score as determined by the patient using a visual
analog scale (VAS, 0e10) as one of the primary outcome measures. Studies reporting
the effects of conventional surgical approaches (excisional hemorrhoidectomy,
Milligan-Morgan technique) were not included.
2.2. Data extraction
The following data were extracted for patients in the SH and LH groups from
each of the studies included in the meta analysis: number of cases per group,
average patient age (range), gender (% males), VAS pain scores (see footnotes to

915

Fig. 1. Flow diagram depicting the process for identifying randomized controlled trials
meeting the inclusion criteria and the rationale for study exclusion.

Table 1), rates of recurrence of hemorrhoids, and rates of postoperative bleeding.

Data were extracted by two independent reviewers, and a third reviewer was
consulted for resolution of disagreements.
2.3. Data analysis
VAS pain score was used as the primary outcome measure to evaluate treatment
efcacy. Means  standard deviations (SD) were calculated and compared between
patients in the SH and LH groups. To analyze studies for which calculation of
mean  SD was not possible, the mean and variance were estimated from the
median, range, and sample size.12 The recurrence rate and incidence of bleeding
were secondary outcomes of the study. Odds ratios (OR) with 95% condence intervals (CI) were calculated for binary outcomes and were compared between patients in each group. A c2 test for homogeneity was performed and the inconsistency
index (I2) statistic was determined. Studies with values of I2 > 50% and I2 > 75% were
considered heterogeneous and highly heterogeneous, respectively, and were
analyzed using a random-effect model. Studies for which I2 values were less than
25% were considered homogeneous and were analyzed using a xed-effect model.
Pooled summary statistics of the difference in the mean for the individual studies
are presented. Pooled differences in means were calculated and two-tailed values of
P < 0.05 were considered statistically signicant. Sensitivity analysis was performed
based on the leave-one-out approach. All analyses were performed using Comprehensive Meta-Analysis statistical software, version 2.0 (Biostat, Englewood, NJ).

3. Results
Fig. 1 depicts the study selection process. Of 127 reports initially
identied in the search, 122 failed to meet the inclusion criteria (see
exclusion details in Fig. 1). Of the remaining ve reports, Sakr and
Moussa13 and Sakr et al.14 detailed results from the same RCT at
different follow-up intervals, and only the rst publication was
included in our analysis. Thus, four studies comparing the outcomes of SH and LH procedures in adult patients with grade III or IV
hemorrhoids were included in the meta-analysis: Arslani et al.,15
Kraemer et al.,16 Sakr and Moussa,13 and Basdanis et al.17

Table 1
Summary of characteristics of the four randomized controlled trials included in meta-analysis.
Ref

First author

Year

Comparison

Cases (n)

Follow up
period

Age

15

Arslani N
Kraemer M
Sakr MF
Basdanis G

2012
2005
2010
2005

SH
SH
SH
SH

46
25
34
50

24 months
6 weeks
12 months
6 months

52
58
44
46

16
13
17

vs
vs
vs
vs

LH
LH
LH
LH

vs
vs
vs
vs

52
25
34
45

vs
vs
vs
vs

50
48
39
44

Sex (male%)

Primary endpoint VAS  SEM or

(range)

Recurrence

Postoperative
bleeding

46
56
62
50

3 (1e5) vs 3 (1e6)a
4.5 (4.1e5.6) vs 4.3 (3.8e5.0)b
5.29  0.91 vs 5.53  1.02c
3 (1e6) vs 6 (3e7)d

11.1% vs 1.9%
e
11.8% vs 2.9%
6.0% vs 0%

6.5% vs 1.9%
0% vs 4.0%
0% vs 0%
6.0% vs 2.2%

vs
vs
vs
vs

44
52
56
56%

SH, Stapled hemorrhoidopexy; LH, LigaSure hemorrhoidectomy.

a
Median VAS pain score over rst 5 postoperative days.
b
Median mean VAS pain score over rst 5 postoperative days, estimated from Fig. 1 of the manuscript.
c
Mean  SEM VAS pain score on postoperative day 1.
d
Maximum VAS pain score 24 h after surgery.

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K.-C. Lee et al. / International Journal of Surgery 11 (2013) 914e918

Table 1 summarizes the results of each study, including the results for the primary (VAS pain score) and secondary (recurrence
rate, postoperative bleeding) outcomes. The studies ranged in size
from 50 to 95 patients and included a total of 311 individuals (53%
males) ranging in age from 17 to 82 years. A total of 155 patients
were treated using the SH technique, and 156 underwent LigaSure
hemorrhoidectomy.

trend associating bleeding with one surgical technique. There were

no instances of postoperative bleeding for patients in either group
in the study by Sakr and Moussa,13 therefore this study was not
included in the OR calculations. Bleeding data from the three
remaining studies showed signicant heterogeneity (Q 4.153,
I2 51.84%, P 0.125), and the data were analyzed using a randomeffects model. The combined OR revealed no signicant difference
in postoperative bleeding between SH and LH groups: OR 1.188
(0.148e9.542), P 0.871 (Fig. 4).

3.2. VAS pain scores

4. Discussion

The primary VAS endpoint in two of the studies assessed pain

24 h after surgery, while pain scores for the other two studies reported pain over the rst ve postoperative days. VAS pain scores
among the four studies ranged from values of 3e6 and were the
highest in the rst 24 h. None of the studies reported a signicant
difference between the VAS pain scores for the two techniques. Odds
ratio analysis indicated that postoperative VAS pain scores for the
four studies were highly heterogeneous (Q 102.152, I2 97.063%,
P < 0.001), therefore the data were analyzed using the randomeffects model (Fig. 2). The pooled mean difference (95% CL)
was 1.060 (2.465 e 0.344) (Fig. 2). No signicant difference was
found in mean postoperative VAS pain scores for patients in the SH
and LH groups (P 0.139).

Stapled hemorrhoidopexy and LigaSure hemorrhoidectomy

have emerged in the last two decades as widely employed alternatives to conventional open or closed hemorrhoidectomy. We
show in this meta-analysis that the OR for recurrent prolapse is
signicantly greater for patients treated by SH than for those
treated by LH. No signicant differences between techniques were
identied with respect to postoperative pain or the incidence of
postoperative bleeding.
We analyzed four RCTs comparing SH vs LH in adult patients
with grade 3 and 4 symptomatic hemorrhoids. SH and LH groups
for each study were of similar size and included equivalent
numbers of patients of each gender. None of the individual studies
reported any signicant differences between SH and LH for VAS
pain scores, recurrence rates, or the incidence of bleeding.
The studies varied in the reporting of VAS pain scores, with two
reporting the median score over the rst ve postoperative days,15,16
one reporting the mean score on day 1,13 and last reporting the
maximum score 24 h after surgery.17 While these differences may
have contributed to differences in pain scores between studies, they
did not impact the comparison between techniques. Recurrence rate
for prolapse was reported in only three of the studies, and each reported recurrence at a different follow-up interval (see Table 1). The
data show a possible trend for recurrence to increase with time
through 12 months post-surgery, but there are insufcient data for a
conclusive assessment.
Other outcomes that were measured in all four RCTs included
urinary retention and postoperative use of analgesics. The incidence
of urinary retention varied from 2.2% to 16% in the four studies, but
none reported a difference between SH and LH. Similarly, all four
studies reported no differences in the postoperative use of analgesics.
In addition to these outcome measures, no differences were found in
the length of hospital stay,13,16,17 time to resumption of normal activities,13,15,17 or incidence of gas or stool incontinence.13,15,16 Other
outcomes assessed in only one or two of the studies include woundhealing time, constipation, anal stenosis, operating time, surgeon
assessment of the procedure, and complications.
Previous meta-analyses have shown that patients treated for
hemorrhoids using SH and LH techniques experience less

3.1. Study characteristics

3.3. Recurrence rates

Recurrence rates for prolapsed hemorrhoids after SH and LH were
not reported by Kraemer et al.16 Overall recurrence rates in the three
included studies were low, ranging from 0% to 11.8%. Recurrence
tended to be higher among patients in the SH group, but no signicant differences in recurrence rates for patients in the SH and LH
groups were reported. It should be noted that the recurrence was
dened differently in the three publications. Basdanis et al.17 indicated recurrent prolapse in three SH patients at the 6-month followup. Sakr and Moussa13 reported recurrent prolapse 12 months after
surgery for one LH patient and four SH patients. None required
further surgical intervention, and all were managed successfully with
conservative treatment. Arslani et al.15 reported recurring symptoms
or new prolapse at the 24-month assessment. Odds ratio analysis
indicated that recurrence data were homogenous (Q 0.067,
I2 0.000%, P 0.967). Analysis using a xed-effect model revealed a
statistically signicant greater rate of recurrence associated with the
SH technique (Fig. 3): OR 5.529 (1.383e22.189), P 0.016.
3.4. Postoperative bleeding
The incidence of postoperative bleeding in each of the studies
was low, ranging from 0% to 6.5% of patients, and there was no clear

Fig. 2. Forest plot for VAS pain score. The data were found to be highly heterogeneous (I2 97.063%), therefore a random-effects model was applied. No statistically signicant
difference in VAS pain scores was identied for the SH and LH groups.

ORIGINAL RESEARCH
K.-C. Lee et al. / International Journal of Surgery 11 (2013) 914e918

917

Fig. 3. Forest plot for recurrence rate. Analysis showed the data to be homogeneous (I2 0.000%), and a xed-effect model was applied. The overall analysis showed a statistically
greater rate of recurrence with the SH technique (P 0.016).

Fig. 4. Forest plot for bleeding. The data were found to be highly heterogeneous (I2 51.84%). Application of the appropriate random-effects model indicated no difference between
the SH ad LH methods regarding the incidence of postoperative bleeding.

postoperative pain and bleeding than those treated with conventional hemorrhoidectomy.6e8,11 LH has also been reported to have a
lower rate of recurrent prolapse compared to conventional hemorrhoidectomy.8,18 Recurrence rates for LH of 2.4% and 3.1% at 1year and 2-year intervals, respectively, have been reported previously.5,18 The studies assessed in our analysis indicated similar low
rates of recurrence, 0%e2.9%, for the LH technique. The rate of
recurrent prolapse for the SH technique, however, in known to be
signicantly higher than for CH. A recurrence rate of 13% was reported in two studies at follow-up assessments at 32 and 34
months,19,20 and a previous study reported a long-term recurrence
rate of 8%.10 This trend was also evident in the RCTs examined in
this analysis, for which recurrent prolapse for the SH technique
ranged between 6% and 11.8%. Importantly, the higher incidence of
recurrence was borne out in our combined analysis of the data,
showing signicantly greater odd for recurrence in the SH group
(OR 5.539, P 0.016).
The main limitation of this meta-analysis is that only four RCTs
could be found comparing SH to LH in adult patients with symptomatic grade 3 and 4 hemorrhoids are included in the meta-analysis.
A more comprehensive analysis may be possible in the future.
Although there were variations in the assessment of VAS pain scores
and the times at which recurrence was assessed, these were unlikely
to have affected the overall comparisons of the SH and LH techniques.
In conclusion, this meta-analysis of RCTs comparing outcomes
with SH and LH for grade 3 to 4 symptomatic hemorrhoids revealed
no signicant differences in the VAS pain score or incidence of
postoperative bleeding. In contrast, the SH method had a signicantly higher recurrence rate compared with LH technique. More

clinical trials are needed to compare the short-term and long-term

outcomes between SH and LH.
Author contribution
Ko-Chao Lee: guarantor of integrity of the entire study; study
concepts; study design; denition of intellectual content; manuscript preparation; manuscript editing.
Hong-Hwa Chen: clinical studies; data analysis; statistical
analysis; manuscript preparation.
Kuan-Chih Chung: clinical studies; data analysis; manuscript
editing.
Wan-Hsiang Hu: literature research; experimental studies.
Chia-Lo Chang: literature research; experimental studies.
Shung-Eing Lin: data acquisition.
Kai-Lung Tsai: data acquisition.
Chien-Chang Lu: guarantor of integrity of the entire study; study
concepts; study design; denition of intellectual content; statistical
analysis; manuscript review.
Conict of interest
None declared.
Acknowledgments
None.
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