Choy 2011

Cochrane Database of Systematic Reviews
Stapled versus handsewn methods for ileocolic anastomoses

(Review)
Choy PYG, Bissett IP, Docherty JG, Parry BR, Merrie A, Fitzgerald A
Choy PYG, Bissett IP, Docherty JG, Parry BR, Merrie A, Fitzgerald A.
Stapled versus handsewn methods for ileocolic anastomoses.
Cochrane Database of Systematic Reviews 2011, Issue 9. Art. No.: CD004320.
DOI: 10.1002/14651858.CD004320.pub3.
www.cochranelibrary.com
Stapled versus handsewn methods for ileocolic anastomoses (Review)

Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Figure 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Figure 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Analysis 1.1. Comparison 1 All studies, Outcome 1 Overall anastomotic leak. . . . . . . . . . . . . . . 26
Analysis 1.2. Comparison 1 All studies, Outcome 2 Clinical anastomotic leak. . . . . . . . . . . . . . . 27
Analysis 1.3. Comparison 1 All studies, Outcome 3 Radiological anastomotic leak. . . . . . . . . . . . . 28
Analysis 1.4. Comparison 1 All studies, Outcome 4 Anastomotic stricture. . . . . . . . . . . . . . . . 28
Analysis 1.5. Comparison 1 All studies, Outcome 5 Anastomotic haemorrhage. . . . . . . . . . . . . . 29
Analysis 1.6. Comparison 1 All studies, Outcome 6 Anastomotic time (min). . . . . . . . . . . . . . . 29
Analysis 1.7. Comparison 1 All studies, Outcome 7 Re-operation. . . . . . . . . . . . . . . . . . . 30
Analysis 1.8. Comparison 1 All studies, Outcome 8 Operative mortality. . . . . . . . . . . . . . . . . 31
Analysis 1.9. Comparison 1 All studies, Outcome 9 Intra-abdominal abscess. . . . . . . . . . . . . . . 32
Analysis 1.10. Comparison 1 All studies, Outcome 10 Wound infection. . . . . . . . . . . . . . . . . 33
Analysis 1.11. Comparison 1 All studies, Outcome 11 Length of hospital stay (day). . . . . . . . . . . . . 34
Analysis 2.1. Comparison 2 Cancer, Outcome 1 Overall anastomotic leak. . . . . . . . . . . . . . . . 35
Analysis 2.2. Comparison 2 Cancer, Outcome 2 Clinical anastomotic leak. . . . . . . . . . . . . . . . 36
Analysis 2.3. Comparison 2 Cancer, Outcome 3 Radiological anastomotic leak. . . . . . . . . . . . . . 36
Analysis 2.4. Comparison 2 Cancer, Outcome 4 Anastomotic time. . . . . . . . . . . . . . . . . . 37
Analysis 2.5. Comparison 2 Cancer, Outcome 5 Operative mortality. . . . . . . . . . . . . . . . . . 38
Analysis 2.6. Comparison 2 Cancer, Outcome 6 Intra-abdominal abscess. . . . . . . . . . . . . . . . 38
Analysis 2.7. Comparison 2 Cancer, Outcome 7 Wound infection. . . . . . . . . . . . . . . . . . . 39
Analysis 2.8. Comparison 2 Cancer, Outcome 8 Length of stay. . . . . . . . . . . . . . . . . . . . 40
Analysis 3.1. Comparison 3 Non-Cancer, Outcome 1 Overall anastomotic leak. . . . . . . . . . . . . . 40
Analysis 3.2. Comparison 3 Non-Cancer, Outcome 2 Clinical anastomotic leak. . . . . . . . . . . . . . 41
Analysis 3.3. Comparison 3 Non-Cancer, Outcome 3 Anastomotic stricture. . . . . . . . . . . . . . . 42
Analysis 3.4. Comparison 3 Non-Cancer, Outcome 4 Anastomotic haemorrhage. . . . . . . . . . . . . . 42
Analysis 3.5. Comparison 3 Non-Cancer, Outcome 5 Anastomotic time. . . . . . . . . . . . . . . . 43
Analysis 3.6. Comparison 3 Non-Cancer, Outcome 6 Re-operation. . . . . . . . . . . . . . . . . . 43
Analysis 3.7. Comparison 3 Non-Cancer, Outcome 7 Operative mortality. . . . . . . . . . . . . . . . 44
Analysis 3.8. Comparison 3 Non-Cancer, Outcome 8 Intra-abdominal abscess. . . . . . . . . . . . . . 44
Analysis 3.9. Comparison 3 Non-Cancer, Outcome 9 Wound infection. . . . . . . . . . . . . . . . . 45
Analysis 3.10. Comparison 3 Non-Cancer, Outcome 10 Length of stay. . . . . . . . . . . . . . . . . 46
WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Stapled versus handsewn methods for ileocolic anastomoses (Review) i
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Stapled versus handsewn methods for ileocolic anastomoses (Review) ii

[Intervention Review]
Stapled versus handsewn methods for ileocolic anastomoses
Pui Yee Grace Choy2 , Ian P Bissett1 , James G Docherty3 , Bryan R Parry4 , Arend Merrie5 , Anita Fitzgerald6
1 Dept.of Surgery, Auckland Hospital, Auckland, New Zealand. 2 Surgery, University of Auckland, Auckland, New Zealand. 3 Surgery,
Raigmore Hospital, Inverness, UK. 4 Faculty of Medicine and Health Science, University of Auckland, Auckland, Australia. 5 Department
of General Surgery, Auckland City Hospital, Auckland, New Zealand. 6 New Zealand Guidelines Group, Wellington, New Zealand
Contact address: Ian P Bissett, Dept. of Surgery, Auckland Hospital, Parks Road, Auckland, 1, New Zealand. i.bissett@auckland.ac.nz.
IanB@adhb.govt.nz.
Editorial group: Cochrane Colorectal Cancer Group.

Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 9, 2011.
Review content assessed as up-to-date: 23 April 2011.
Citation: Choy PYG, Bissett IP, Docherty JG, Parry BR, Merrie A, Fitzgerald A. Stapled versus handsewn methods for ileocolic
anastomoses. Cochrane Database of Systematic Reviews 2011, Issue 9. Art. No.: CD004320. DOI: 10.1002/14651858.CD004320.pub3.
ABSTRACT
Background
Ileocolic anastomoses are commonly performed for right-sided colon cancer and Crohn’s disease. The anastomosis may be constructed
using a linear cutter stapler or by suturing. Individual trials comparing stapled versus handsewn ileocolic anastomoses have found little
difference in the complication rate but they have lacked adequate power to detect potential small difference. This is an update of a
Cochrane review first published in 2007.
Objectives
To compare outcomes of ileocolic anastomoses performed using stapling and handsewn techniques. The hypothesis tested was that the
stapling technique is associated with fewer complications.
Search methods
MEDLINE, EMBASE, Cochrane Colorectal Cancer Group specialised register SR-COLOCA, Cochrane Library were searched for
randomised controlled trials comparing use of a linear cuter stapler with any type of suturing technique for ileocolic anastomoses in
adults from 1970 to 2005 and were updated in December 2010. Abstracts presented to the following society meetings between 1970
and 2010 were handsearched: American Society of Colon and Rectal Surgeons, the Association of Coloproctology of Great Britain and
Ireland, European Association of Coloproctology.
Selection criteria
Randomised controlled trials comparing use of linear cutter stapler (isoperistaltic side to side or functional end to end) with any type
of suturing technique in adults.
Data collection and analysis
Eligible studies were selected and their methodological quality assessed. Relevant results were extracted and missing data sought from
the authors. RevMan 5 was used to perform meta-analysis when there were sufficient data. Sub-group analyses for cancer inflammatory
bowel disease as indication for ileocolic anastomoses were performed.
Stapled versus handsewn methods for ileocolic anastomoses (Review) 1
Main results
After obtaining individual data from authors for studies that include other anastomoses, seven trials (including one unpublished) with
1125 ileocolic participants (441 stapled, 684 handsewn) were included. The five largest trials had adequate allocation concealment.
Stapled anastomosis was associated with significantly fewer anastomotic leaks compared with handsewn (S=11/441, HS=42/684, OR
0.48 [0.24, 0.95] p=0.03). One study performed routine radiology to detect asymptomatic leaks. For the sub-group of 825 cancer
patients in four studies, stapled anastomosis led to significantly fewer anastomotic leaks (S=4/300, HS=35/525, OR 0.28 [0.10, 0.75]
p=0.01). In subgroup analysis of non-cancer patients (3 studies, 264 patients) there were no differences for any reported outcomes.
All other outcomes: stricture, anastomotic haemorrhage, anastomotic time, re-operation, mortality, intra-abdominal abscess, wound
infection, length of stay, showed no significant difference.
Authors’ conclusions
Stapled functional end to end ileocolic anastomosis is associated with fewer leaks than handsewn anastomosis.
PLAIN LANGUAGE SUMMARY
A comparison of two methods to join small and large bowel together in surgery
Surgery for right-sided bowel cancer or Crohn’s disease commonly involve removing a segment of bowel and re-joining the small and
large bowel together. The join, or anastomosis, can be made by stapling or sewing.
This systematic review found seven randomised controlled trials with a total of 1125 participants (441 stapled, 684 handsewn) comparing
these two methods. The leak rate from the bowel join for stapled anastomosis was 2.5%, significantly lower than handsewn (6%). For
the sub-group of 825 cancer patients in four studies, stapled join again has fewer leaks compared with handsewn, being 1.3% and
6.7% respectively. For the sub-group of 264 non-cancer patients in three studies, there were no differences for the reported outcomes.
This sub-group included patients with Crohn’s disease. Overall, there was no significant difference in the other outcomes of stricture,
bleeding from the join, time to perform the join, re-operation, mortality, intra-abdominal abscess, wound infection and length of stay,
although these were not consistently reported.
The reason why a handsewn bowel join is more likely to leak is unclear. Possible explanations include less handling of the bowel,
decreased spillage of bowel content during surgery, and uniform closure of all the staples using a stapler. This review did not compare
different sewing materials or methods. The trials included in this review were performed from the early 1980’s to 2009 involving six
countries. The studies in Crohn’s disease were more recent but the combined number of patients was too small to summarise outcomes.
More randomised controlled trials comparing the two surgical techniques in Crohn’s disease are needed.
BACKGROUND Stapling devices have been in use since the late 1970’s. A linear
cutter stapler places two double staggered rows of staples and di-
Ileocolic anastomoses are commonly performed for right-sided
vides the tissue between the two lines of staples at the same time.
colon cancer and Crohn’s disease. Colorectal cancer is the com-
There is however no consensus as to the superiority of stapling
monest gastrointestinal malignancy. It is the second leading cause
over handsewn methods for ileocolic anastomoses. The areas of
of cancer deaths in the developed world. Right sided tumours ac-
contention regarding outcome include leak rate, stricture, speed of
count for around 30 % of colorectal cancer. The most common
anastomosis formation and reoperation due to disease recurrence.
presentation of Crohn’s disease is in the ileum and caecum. Sur-
The major problems associated with anastomoses are anastomotic
gical treatment of these conditions requires right hemicolectomy
leakage, stricture and bleeding (Brennan 1982).
or ileocaecal resection and formation of an ileocolic anastomosis.
Two common methods to construct an anastomosis are the use of Contrast radiography is used in many studies to determine the true
a linear cutter stapler and suturing. rate of leakage as many leaks are not manifested clinically. Stapled
anastomoses are generally thought to have a lower rate of leak- were included. If the trial included other types of gastrointesti-
age, both clinically and radiologically (Moran 1996). Conversely, nal anastomosis, data for ileocolic anastomosis were extracted. If
some reports argued that overall leak rate is similar with handsewn data were unavailable for this group, the authors were contacted
anastomosis (Mann 1996). A higher rate of stricture formation is to provide full details. Trials published after 1970 were included
found with circular stapled anastomosis (MacRae 1998). How- since stapling devices were not available in clinical use prior to this
ever another study demonstrated that wide-lumen stapled anas- time.
tomosis may decrease the incidence of recurrent Crohn’s disease
(Munoz-Juarez 2001).
Types of participants
Proponents of stapling devices cite speed but no study had found
Adults who received stapled and handsewn ileocolic anastomoses,
statistically significant differences in operating time (Brundage
elective or emergency. Subgroup analyses for cancer and inflam-
1999). The operating time with suturing was dependent on the
matory bowel disease.
type of sutures, for example, continuous sutures are quicker to
insert than interrupted sutures.
Stapling devices require familiarity with the instruments and are Types of interventions
associated with a higher rate of technical mishap in the operating Linear cutter stapler forming an ileocolic anastomosis either
room (Moran 1996). Stapled devices are more expensive than su- isoperistaltic side to side or functional end to end, the enterotomy
tures and this cost is not compensated by reduced hospital stay remaining after withdrawal of the stapler may be closed with a
(Scher 1982). stapling instrument or manual suturing; handsewn (any type of
suturing material and technique) ileocolic anastomoses.
Comparison of the different anastomotic techniques is difficult as
ileocolic anastomoses have to date not been analysed separately
from other types of anastomoses or the exact numbers in the groups Types of outcome measures
were not given. Of the studies that have been done sample size has
Primary outcome: overall anastomotic leak - either clinical or ra-
been small giving insufficient power to draw valid conclusions.
diological anastomotic leak
Thus there is uncertainty regarding current evidence. A system-
Secondary outcomes:
atic review to resolve these differences by pooling together and
1. Clinical anastomotic leak: associated with clinical signs and
analysing all the available data was published in 2007 and updated
symptoms
in December 2010. The subject of colorectal anastomosis with
2. Radiological anastomotic leak: anastomotic leak detected on
circular stapler was analysed in a different review and will not be
the control postoperative enema, in a patient with no evidence of
included (Lustosa 2002).
clinical anastomotic leak
3. Anastomotic stricture: narrowing of bowel lumen due to anas-
tomotic healing
OBJECTIVES 4. Anastomotic haemorrhage: postoperative rectal bleeding from
This review compares the use of linear cutter stapler and manual anastomotic site
suturing in the formation of an ileocolic anastomosis. It aims to 5. Anastomotic time: time required to perform the anastomosis
ascertain whether there is any difference in outcome between the 6. Re-operation: surgical intervention for complication or disease
two methods. It will also analyse the outcomes of the two tech- recurrence
niques in subgroups of patients with cancer and inflammatory 7. Operative mortality: within 30 days
bowel disease. The hypothesis to be tested is that stapling tech- 8. Intra-abdominal abscess
nique is associated with decreased level of complications. 9. Wound infection
10. Length of hospital stay: time from operation to discharge from
the hospital
METHODS
Search methods for identification of studies

Criteria for considering studies for this review We planned to search for published and unpublished randomised
controlled trials performed after 1970 with no restriction on lan-
guage in the following electronic databases: MEDLINE, EM-
Types of studies BASE, Cochrane Colorectal Cancer Group specialised register
All randomised controlled trials comparing the outcomes of lin- SR-COLOCA, Cochrane Central Register of Controlled Trials,
ear cutter stapler and suture techniques for ileocolic anastomosis Cochrane Database of Systematic Reviews, Database of Abstracts

of Reviews of Effectiveness for the years 1970 to 2010. This #6 #5 not (rabbit or dog or rat or pig) 58
search strategy was based on MEDLINE and was adapted for each #5 (sutur* or stapl* or sew or sewn or handsew* or stitch or (suture
database search: techniques) or (surgical staplers)) and (anastom* or anastomosis,
1. Collaborative Review Group search strategy for RCTs sugical) and ((ileocol*) or (large intestin*) or (small intestin*) or
2. anastom$.mp,hw. (large bowel) or (small bowel) or (ileum and colon)) and (random*
3. ileocol$.mp,hw. or (ileum and colon$).mp,hw. or blind* or meta-analysis or placebo*) 65
4. ((small adj2 intestin$) or (small adj2 bowel$)).mp,hw. #4 sutur* or stapl* or sew or sewn or handsew* or stitch or (suture
5. ((large adj2 intestin$) or (large adj2 bowel$)).mp,hw. techniques) or (surgical staplers) 62563
6. 4 or 5 #3 anastom* or anastomosis, sugical 53899
7. (sutur$ or stapl$ or sew or sewn or handsew$ or stitch$).mp,hw. #2 (ileocol*) or (large intestin*) or (small intestin*) or (large bowel)
8. anastomosis, surgical/ or (small bowel) or (ileum and colon) 93009
9. intestine, large/ or colon/ #1 random* or blind* or meta-analysis or placebo* 510192
10. intestine, small/ or ileum/ Where possible principal authors were contacted for further in-
11. 9 or 10 formation relating to the study and any other studies published
12. exp sutures/ and unpublished. All reference lists were checked for further stud-
13. exp suture techniques/ ies. Abstracts presented to the following society meetings between
14. surgical staplers/ 1970 and 2010 were handsearched: American Society of Colon
15. 2 or 8 and Rectal Surgeons, the Association of Coloproctology of Great
16. 3 or 6 or 11 Britain and Ireland, European Association of Coloproctology. Up-
17. 7 or 12 or 13 or 14 date searches run in December 2010 yielded 140 additional refer-
18. 15 and 16 and 17 ences.
Search strategy for this review, performed 16.09.2005 by Karin
Nielsen (CCCG) and updated by Margaret Paterson (New
Zealand Guidelines Group) in December 2010. Data collection and analysis
The titles and abstracts of articles found in the original search
From the Cochrane Library:
were screened by two independent reviewers (IB and PC); updated
#1. (stapler or handsew* or stitch or (suture next techniques) or
searches were carried out by two reviewers (AF and PC). Full text
(surgical next staplers)) 947
of eligible studies were obtained and each reviewer independently
#2. (anastom* or (anastomosis next sugical)) 1293
assessed whether the studies meet the inclusion and exclusion cri-
#3. (ileocol* or ileum or (large next intestin*) or (small next in-
teria. The excluded studies were recorded and the reasons for ex-
testin*) or (large next bowel) or (small next bowel)) 1958
clusion stated. Any difference of opinion was resolved by the third
#4. (#1 and #2 and #3) 31
arbitrator (AM).
(23 hits in The Cochrane Central Register of Controlled Trials
The methodological quality of all studies eligible for the review
(CENTRAL))
were assessed independently. Each included trial was read for the
(5 hits in The Cochrane Database of Systematic Reviews)
following criteria which is presented in a table describing the in-
(1 hit in Database of Abstracts of Reviews of Effects)
cluded studies: concealed randomisation, technique of randomi-
EMBASE (Webspirs, Silver Platter version 2.0) (52 hits): (43 were
sation, time of randomisation (preoperatively, intraoperatively),
saved)
number of randomised patients, number of patients not ran-
#6 #5 not (rabbit or dog or rat) 52
domised and reasons for this, exclusion after randomisation, blind-
#5 (sutur* or stapl* or sew or sewn or handsew* or stitch or (suture
ing of observer, blinding of outcome assessment, similarity be-
techniques) or (surgical staplers)) and (anastom* or anastomosis,
tween treatment and control group at entry, representativeness of
sugical) and ((ileocol*) or (large intestin*) or (small intestin*) or
patients, prospective data collection, dealing with drop outs, fol-
(large bowel) or (small bowel) or (ileum and colon)) and (random*
low-up, standardisation of outcome assessment and whether an
or blind* or meta-analysis or placebo*) 72
intention-to-treat analysis was performed. The presence of a learn-
#4 sutur* or stapl* or sew or sewn or handsew* or stitch or (suture
ing-curve bias was assessed. The previous review utilised a scale
techniques) or (surgical staplers) 33958
assessing quality of randomisation (Jadad 1996). This scale was
#3 anastom* or anastomosis, sugical 40321
no longer used and replaced with ’Risk of bias’ tables.
#2 (ileocol*) or (large intestin*) or (small intestin*) or (large bowel)
Two investigators independently extract the results of each trial on
or (small bowel) or (ileum and colon) 108797
a standardised data sheet and to allow for cross-checking. Where
#1 random* or blind* or meta-analysis or placebo* 436277
possible, missing data were sought from the authors in the form of
MEDLINE (Webspirs, Silver Platter version 2.0) ( 58 hits): (34
individual patient data. The software ’RevMan 5’ provided by the
saved)
Cochrane Collaboration was used for statistical analysis. Where

there were sufficient data, a summary statistic for each outcome Risk of bias in included studies
was calculated. Where appropriate, formal meta-analysis and in-
The methodological details are shown in the ’Characteristics of
vestigation of heterogeneity among trials were conducted.
included studies’ table. All seven studies were prospective ran-
There were sub-group analyses for malignant disease and Crohn’s
domised in design. Randomisation time was during the operation
disease as the indication for ileocolic anastomoses using the same
after the resection when either technique was deemed to be fea-
outcome measurements.
sible and equally appropriate. In four trials, randomisation tech-
nique was sealed envelopes or concealment in sequential forms
(Docherty 1995; Docherty 1991; Ikeuchi 2000; Kracht 1993) and
one study used a phone-in randomisation method, which kept al-
RESULTS location concealed (McLeod 2009). These methods were consid-
ered adequate. The technique was not described for two studies,
thus the allocation concealment was rated as unclear (Didolkar
1986; Izbicki 1998). The largest study (Kracht 1993) contributed
Description of studies 39% of patients .
See: Characteristics of included studies; Characteristics of excluded All studies had clearly defined inclusion & exclusion criteria. As-
studies. sessment of randomisation success was done in all studies by show-
Electronic search on MEDLINE, EMBASE and the Cochrane Li- ing that there was no significant difference between most of the
brary yielded 250 hits. Only 29 studies matched the inclusion cri- baseline patient characteristics. Three studies had excluded partic-
teria. The same data set was published in three articles on two occa- ipants post randomisation for a variety of reasons including proto-
sions (Akyol 1991; Docherty 1995; West 1991; Yamamoto 1999a; col violation and the palliative nature of surgery (Docherty 1995;
Yamamoto 1999; Yamamoto 1999b), and in two articles on two Kracht 1993; McLeod 2009). Patients excluded post randomisa-
occasions (Ikeuchi 2000; Kracht 1990; Kracht 1993; Kusunoki tion for palliative nature of surgery were included in the individual
1998). Eighteen studies were excluded mainly due to a lack of patient data meta-analysis (Docherty 1995).
randomisation. One unpublished study (Docherty 1991) was ob- Follow-up duration ranged from 30 days post discharge (Kracht
tained from the author of one of the included studies (Docherty 1993) to a median of 87 months (Ikeuchi 2000). In one study
1995) through personal correspondence. It was unpublished due (Docherty 1995), it was left to the discretion of surgeon, and in
to problems with follow-up. This leaves six distinct trials for inclu- another (Didolkar 1986), standardised protocols for malignancy
sion. Search of the SR-COLOCA by Trials Search Co-coordinator follow-up were used. Four studies mentioned lost to follow-up
at CCCG and hand searching of the above mentioned meeting ab- (Docherty 1995; Ikeuchi 2000; Izbicki 1998; McLeod 2009).
stracts have not yielded other studies that were considered eligible Intention to treat analysis was reported in one study (Docherty
for assessment. Searches were re-run in December 2010, resulting 1995).
in the inclusion of one additional article (McLeod 2009) and two Sample size was calculated in two studies (Docherty 1995; Kracht
excluded studies. 1993). Two articles commented that the study situation reflected
Only one series of patients looked at ileocolic anastomosis cases daily surgical practice (Docherty 1995; Kracht 1993). Learning
exclusively (Kracht 1993). For the remainder, ileocolic anastomo- curve was taken into account in four studies in the selection of
sis was one of the different types of anastomoses studied. The surgeons (Didolkar 1986; Docherty 1995; Kracht 1993; McLeod
total number of ileocolic participants were 1125 of which 441 2009). Only one study had blinded assessment of outcome by
(39%) were stapled and 684 (61%) were handsewn. This unequal radiologist (Kracht 1993), while another was stated to be double-
distribution was due to the major study in this review having 4 blind but the blinding was not explained (Ikeuchi 2000).
different groups of handsewn anastomosis (Kracht 1993). More
patients (100 patients) were included in the stapled group so that
this group could be compared with the 4 sutured groups taken as
a whole or individually (80 patients).
Effects of interventions
Two studies examined anastomosis in Crohn’s disease patients The main results from analysis of seven trials with a total of 1125
only (Ikeuchi 2000; McLeod 2009) while another study excluded ileocolic anastomosis patients (Stapled=441, Handsewn=684) are
Crohn’s disease (Izbicki 1998). Three studies focused on patients shown here, see ’Data and analyses’ for further details. Individual
with cancer (Didolkar 1986; Docherty 1991; Kracht 1993). The patient data were used for Docherty 1991, Docherty 1995 &
remaining study had no restriction on type of disease. Two studies Ikeuchi 2000.
excluded emergency operations (Izbicki 1998; Kracht 1993). Sub- (1) Overall anastomotic leak (7 studies, 1125 patients): stapled
group analysis excluded the study by Izbicki 1998 as individual anastomosis (11/441, 2.5%) was associated with significantly
patient data for cancer were not available. The new study included fewer leaks compared with handsewn (42/684, 6%) with odds ra-
patients who had laparoscopic resections (McLeod 2009). tio of 0.48 [95% confidence interval 0.24, 0.95; p=0.03] (Figure

1).
Figure 1. Forest plot of comparison: 1 All studies, outcome: 1.1 Overall anastomotic leak.
(2) Clinical anastomotic leak (7 studies, 1125 patients): stapled

anastomosis (10/441, 2.3%) appeared to have fewer leaks com-
pared with handsewn (29/684, 4.2%) with OR 0.55 [0.27, 1.15,
p=0.11] however the difference between groups was not signifi-
cant (Figure 2).
Figure 2. Forest plot of comparison: 1 All studies, outcome: 1.2 Clinical anastomotic leak.
(3) Radiological anastomotic leak (1 study, 440 patients) rate for

stapled anastomosis was 0.9% (1/106) and handsewn was 3.9% (5) Anastomotic haemorrhage (2 studies, 65 patients): no occur-
(13/334), OR 0.24 [0.03, 1.82, p=0.17]. rences in the studies
(4) Anastomotic stricture (2 studies, 65 patients): stapled anas- (6) Anastomotic time (1 study, 255 patients): though only one
tomosis (1/26) & handsewn (6/39), occurrence too low to allow study, stapled anastomosis took an average of 8.72 min (standard
meta-analysis. deviation 5.12) to construct & handsewn 22.36 min (S.D. 11.54).

(7) Re-operation (2 studies, 199 patients): there were no differ- (9) Intra-abdominal abscess (5 studies, 932 patients): There were
ences in re-operation rates between stapled anastomosis (7/95, no differences between stapled (4/356, 1.1%) and handsewn (19/
7.3%) and handsewn (12/104, 11.5%) with and OR of 0.61 [0.25, 576, 3.3%) groups with OR 0.41 [0.14, 1.25, p=0.12]
1.18, p=0.43]. (10) Wound infection (5 studies, 932 patients): There were no
(8) Operative mortality (6 studies, 1087 patients): minor variation differences between stapled (33/356, 9.3%) and handsewn (53/
in length of follow up but all included death within 30 days. 576, 9.2%) groups, OR 1.05 [0.66, 1.70, p=0.83]
For Docherty 1995, 2 out of 6 deaths in handsewn group had (11) Length of hospital stay (3 studies, 424 patients): no difference
anastomotic leak. For Docherty 1991, all 3 deaths in handsewn between stapled & handsewn anastomoses, OR 0.19 [-1.50, 1.87,
group had anastomotic leak. None of the deaths in stapled group p=0.8]
had anastomotic leak. In Kracht 1993, 4 of the 14 deaths had In subgroup analysis of cancer patients (4 studies, 825 patients):
intra-abdominal sepsis, and were all in the handsewn group. Three (a) Overall anastomotic leak rate was significantly lower in stapled
studies reported no operative mortality in either group. (Ikeuchi group (4/300, 1.3%) than handsewn group (35/525, 6.7%) with
2000; Izbicki 1998; McLeod 2009) OR 0.28 [0.10, 0.75, p=0.01] (Figure 3).
Figure 3. Forest plot of comparison: 2 Cancer, outcome: 2.1 Overall anastomotic leak.
(b) Clinical anastomotic leak: Stapled anastomosis (3/300, 1%)

was associated with significantly fewer leaks compared with hand-
sewn (22/525, 4.2%) with OR 0.30 [0.10, 0.95, p=0.04] (Figure
4).
Figure 4. Forest plot of comparison: 2 Cancer, outcome: 2.2 Clinical anastomotic leak.

(c) Radiological anastomotic leak: the study that considered radi-
ological leak only included cancer patients and is reported above.
(d) Except for anastomotic time being shorter in stapled group
(see above), operative mortality, intra-abdominal abscess, wound
infection & length of stay showed no difference.
In subgroup analysis of non-cancer patients (3 studies, 264 pa-
tients) there were no differences between groups for overall anas-
tomotic leak (Figure 5), clinical anastomotic leak, re-operation,
operative mortality, intra-abdominal abscess or wound infection.
Other outcomes were not estimable as the number of participants
was too small.
Figure 5. Forest plot of comparison: 3 Non-Cancer, outcome: 3.1 Overall anastomotic leak.
(0.92, 0.69-1.12). Another meta-analysis (Simillis 2007) investi-

gated the outcomes of different anastomotic types after resection
DISCUSSION for Crohn’s disease. It found reduced ileocolonic anastomotic leaks
in other anastomotic configurations compared with end-to-end
This is the largest systematic review that specifically investigates anastomosis (OR3.8, p=0.05). However the investigators noted
the relative results of handsewn and stapled ileocolic anastomoses. potential for bias due to the retrospective nature of most of the
Ileocolic anastomosis needs to be analysed separately from other included studies.
colonic anastomosis, as the involved bowel ends are different with
regard to diameter, wall structure, location in the abdomen and In this systematic review, stapled ileocolic anastomosis was associ-
bacterial characteristics (Kracht 1993). The stapled technique for ated with fewer anastomotic leaks compared with handsewn over-
ileocolic anastomosis differs from distal anastomoses and anasto- all and in the subgroup of cancer patients. None of the seven stud-
motic leak rate, and is higher with left-sided anastomosis (Lipska ies individually found a significant difference in leak rate between
2006). Except for two studies (Kracht 1993; McLeod 2009), all the two groups. The overall leak rate was 2.5% for stapled and 6%
studies included other colonic, small bowel, and/or upper gas- for handsewn anastomoses. Although high it includes radiological
trointestinal anastomoses. To enable direct comparison of out- leaks. The clinical leak rate was 2.3% for stapled and 4.2% for
come measures, individual patient data regarding ileocolic anas- handsewn. The reported leak rate falls between the published rates
tomoses were used. of 0.5%-7.0% (Alves 2002; Brennan 1982; Chassin 1978; Isbister
2001; Leslie 2003; Lipska 2006; Scher 1982; Simillis 2007).
The aim of this review is to compare ileocolic anastomosis only,
thus most other studies have the results affected by other types It was imperative that each of the included studies used vigorous
of anastomoses. A previous meta-analysis (MacRae 1998) which methodology. All studies were prospectively randomised after re-
included other colon & rectal anastomoses showed no significant section when either technique was deemed appropriate. Allocation
difference between handsewn and stapled methods in terms of leak concealment for Docherty 1991; Docherty 1995; Ikeuchi 2000;
rate. It stated overall leak rate of 9% for both handsewn and stapled Kracht 1993 and McLeod 2009 were adequate as the randomi-
anastomoses, with odds ratio favoured slightly stapled anastomosis sation technique was sealed envelopes or concealment in sequen-
tial forms or computer generated with a phone-in service. Kracht Many papers specify only the materials used and not the method
1993 was the largest and it looked at four different methods of of constructing the anastomosis. There are still controversies re-
suturing. It was constructed such that more patients were included garding which is the preferred handsewn technique. The study by
in the stapled group so that this group could be compared with the Kracht 1993 attempted to address the influence of suture tech-
4 sutured groups taken as a whole or individually. The leak rate nique on outcome. Each of these handsewn techniques had a trend
of stapled anastomosis (2.8%) was less than handsewn varieties to increased leak rate compared with stapled, although only the
(8.4%) overall with an a posterior gamma risk of less than 5%. leak rate for end to end continuous suture reached statistical sig-
The other six trials had similar number of participants in the two nificance alone.
groups. No significant differences in baseline characteristics were
The reason why handsewn ileocolic anastomoses have an increased
found by authors of Docherty 1995; Ikeuchi 2000; Izbicki 1998
leak rate is unclear. Possible reason is that the increased rate of
and McLeod 2009.
local spillage with handsewn is a contributory factor. The uniform
The five comparison groups in Kracht 1993 had comparable pre- closure of all the staples may also be important, as well as reduction
operative criteria except there were significantly more women (n= in tissue manipulations and less inflammation (Simillis 2007).
72) compared with men (n=34) in stapled group (p<0.02). There
Anastomotic time theoretically should be shorter with stapled. But
were however more women (n=261) then men (n=179) in the en-
only one study examined and confirmed this finding (Docherty
tire study. Allocation concealment was adequate using appropri-
1995). Both Didolkar 1986 & Izbicki 1998 included anastomotic
ately generated sequence of randomisation. The discrepancy may
time with other anastomoses and both found stapled anastomoses
be due to individual group size rather than failure of randomisa-
slightly faster to perform. However it does not always translate
tion as 2 of the sutured groups also had more women than men.
into shorter operation time (Izbicki 1998; Scher 1982). However,
Some studies (Lipska 2006; Walker 2004) have shown that women
McLeod 2009 found both the anastomotic time and duration
have a lower incidence of anastomotic leak compared with men
of operation to be significantly faster with stapled anastomosis.
but the authors did not comment on the contribution of gender
Only one study (Izbicki 1998) examined cost and they found
distribution to the anastomotic leak rates.
stapled anastomoses were more expensive. Whether this expense
Kracht 1993 did speculate however that a significantly lower rate can be offset by savings in theatre time & staff pay is dependent
of intra-operative septic spillage in the stapled group (p<0.02) was on systemic issues in the hospital. An in depth analysis of costs
a theoretical advantage of the functional end to end stapling tech- between the two methods has not been performed.
nique. Stapled anastomosis led to less tissue trauma and decreased
This systematic review included studies performed from the early
chances of peritoneal contamination (Tewari 2005; Simillis 2007).
1980’s to 2009 from six countries, one being a multi-centre
Intra-operative septic conditions have been shown to be a risk
study spanning Canadian, American and British centres (McLeod
factor for clinically significant anastomotic leak (Alves 2002). In
2009). The majority of excluded papers did not randomise be-
this systematic review, intra-abdominal abscess also appeared more
tween stapled and handsewn groups. Though statistically sig-
common in handsewn anastomosis. There was a non significant
nificant results were found for the primary outcome of anasto-
trend to more intra-abdominal abscess in the sutured group.
motic leak, too few of the other outcomes were reported to al-
Only one study performed routine post-operative gastrografin en- low meaningful meta-analysis. There were more recent investiga-
ema which picked up asymptomatic radiological leaks (Kracht tions (McLeod 2009;Simillis 2007) in patients with Crohn’s dis-
1993). For the other two large studies (Docherty 1991; Docherty ease, there was a relative paucity of randomised controlled trials
1995), radiology was used to confirm clinical suspicion of anas- in Crohn’s disease with too few anastomotic leaks to draw any
tomotic leak. The asymptomatic leaks detected by radiology may conclusions.
however have clinical sequelae from a finding that even localised This systematic review provides evidence on whether to use a linear
anastomotic leak is associated with diminished overall and cancer-
cutter stapler or suturing to construct an ileocolic anastomosis. It
specific survival (Ho 2010; Walker 2004).
affirms that the stapling technique has the advantage of a lower
When individual patient data in the sub-group of 825 patients anastomotic leak rate.
with cancer in 4 studies were analysed together, overall anasto-
motic leak rate for stapled anastomoses was 1.3% and again was
significantly lower than handsewn (6.7%). Moreover, stapled anas- AUTHORS’ CONCLUSIONS
tomosis (3/300, 1%) was associated with significantly fewer clini- Implications for practice
cal leaks compared with handsewn (22/525, 4.2%) with OR 0.30
Stapled functional end to end ileocolic anastomosis is associated
[0.10, 0.95, p=0.04].
with fewer anastomotic leaks than handsewn anastomosis, and
The main shortcoming of this systematic review is that it was not should be considered the standard against which all other tech-
able to compare between specific types of handsewn anastomosis. niques should be compared.

Implications for research
There is no clear evidence in Crohn’s disease. More randomised
controlled trials on stapled versus handsewn ileocolic anastomosis
in Crohn’s disease are needed.
ACKNOWLEDGEMENTS
Sue Foggin, Information Services Librarian, Philson Library, Uni-
versity of Auckland, Auckland, New Zealand, for assisting with
search strategy.
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Didolkar MS, Reed WP, Elias EG, Schnaper LA, Brown disease after ileocolic resection is not affected by anastomotic
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902–909. ∗
Indicates the major publication for the study

CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]
Didolkar 1986
Methods 1) Study location: Baltimore, Maryland

2) Study duration: not mentioned
3) Follow-up duration: not mentioned (long-term follow-up for their malignancies, often
following standardised protocols, no reference given)
4) Randomisation technique: not mentioned
5) Randomisation time: in the OR after examination of the abdomen
6) Blinding: none
Participants 1) Source population: all patients in the Surgical Oncology Service requiring a large or
small bowel anastomosis, under the care of 3 surgeons
2) Type of disease: any cancer
3) Type of anastomosis: small bowel-small bowel, colon-small bowel, colon-colon
4) Inclusion criteria: histologically proven cancer, one or more adverse factors for healing
(advanced stage, carcinomatosis, prior radiation or chemotherapy, bowel obstruction,
adhesions, infection, or steroid therapy)
5) Exclusion criteria: use of EEA stapler for low rectal anastomosis, gastric or oesophageal
anastomoses
6) Number of participants: ileocolic n=38 (total in study, n=88)
7) Excluded post randomisation: not mentioned
8) Lost to follow-up: not mentioned
Interventions 1) Group S: functional end-to-end with GIA and TA55 stapling instruments, ileocolic
n=22
2) Group HS: a through-and-through layer of 3-0 chromic catgut and outer seromuscular
layer of 3-0 silk suture, ileocolic n=16
Outcomes 1) Overall anastomotic leak: 0

2) Clinical anastomotic leak: 0
3) Intra-abdominal abscess: 0
4) Wound infection: 0
Notes 1) Randomisation success: preoperative laboratory values as a group comparable (except

alkaline phosphatase higher in stapled, p=0.0543), other patient characteristics com-
parable except more female in stapled group, the incidence of patients with advanced
cancer and abdominal carcinomatosis was higher in the stapled group (p=0.02), number
of patients who underwent emergency operation was comparable
2) Representativity: not mentioned
3) Sample size: not calculated
4) Intention to treat: not done as no loss to follow-up is mentioned
5) Learning curve: all surgeons had three years of experience in stapling techniques
6) Others: stratification for prior radiation therapy, presence of bowel obstruction, in-
fection, and the site of bowel anastomosis
7) individual data for ileocolic group not available as author (MS Didolkar) no longer
keeps the files

Didolkar 1986 (Continued)
Risk of bias
Bias Authors’ judgement Support for judgement
Blinding (performance bias and detection Low risk No blinding, but the review authors judge
bias) that the outcome and the outcome mea-
Subjective outcomes surement are not likely to be influenced by
lack of blinding
Incomplete outcome data (attrition bias) Low risk Reasons for missing outcome data unlikely
All outcomes to be related to true outcome
Selective reporting (reporting bias) Low risk Reported all pre-specified outcomes
Docherty 1991
Methods 1) Study location: Scotland

2) Study duration: August 1991 to mid 1997.
3) Follow-up duration: planned to be 2 years
4) Randomisation technique: batch of sealed envelopes
5) Randomisation time: during operation when either technique would be equally fea-
sible
6) Blinding: not described
Participants 1) Source population: all patients under care of participating consultants with diagnosis
of colorectal cancer, elective or emergency
2) Type of disease: colorectal cancer
3) Type of anastomosis: stapled or handsewn colonic & rectal anastomoses
4) Inclusion criteria: providing either stapled or handsewn techniques are feasible
5) Exclusion criteria: if one technique is not feasible then no randomisation but remain
in study
6) Number of participants: n=157
8) Lost to follow-up: not mentioned
Interventions 1) Group S: Ethicon functional end-to-end staplers, n=70

2) Group HS: Ethicon sutures, n=87
Outcomes 1) Overall anastomotic leak: S=0, HS=4

2) Clinical anastomotic leak: S=0, HS=4
3) Operative mortality: S=2, HS=3
4) Length of stay: S=11.36 days (5-41, median 10); HS=12.34 days (5-88, median 10)
Notes 1) unpublished study; individual patient data obtained from author (JG Docherty), all
patients included were randomised
Risk of bias

Docherty 1991 (Continued)
Random sequence generation (selection Low risk Batch of sealed envelopes

bias)
Allocation concealment (selection bias) Low risk
Blinding (performance bias and detection Low risk Outcome measurements are not likely to
bias) be influenced by lack of blinding
Subjective outcomes
Docherty 1995
Methods 1) Study location: five surgical units in Scotland

2) Study duration: April 1985 to April 1989
3) Follow-up duration: at the discretion of surgeon
4) Randomisation technique: stratified randomisation - equal number of sealed envelopes
indicating sutures or staples for each surgeon
5) Randomisation time: after resection when surgeon satisfied either technique feasible
and equally appropriate
Participants 1) Source population: not described

2) Type of disease: no restriction
3) Type of anastomosis: oesophageal, upper gastrointestinal, colonic (ileocolic, colocolic,
colostomy closures), colorectal
4) Inclusion criteria: all patients under the care of a participating surgeon undergoing
elective or emergency surgery which was likely to results in a gastrointestinal anastomosis.
5) Exclusion criteria: in patients for whom one or another technique was considered to
offer a particular advantage, randomisation did not take place. They were observed for
follow-up in an identical way but analysed separately (ileocolic n=17) (p.178)
6) Number of participants: total n=1169, total randomised n=1004, ileocolic n=272,
ileocolic randomised n=255 (cancer ileocolic n=190)
7) Excluded post randomisation: those who had palliative resection (n=97 altogether;
ileocolic n=70) in the published study but they are included in individual patient data
8) Lost to follow-up: for cancer group incomplete follow-up n=15 altogether & not in
final study group (p.179)
Interventions 1) Group S: combinations of GIA, TA and EEA, ileocolic n=133 (cancer n=102)
2) Group HS: either single layer interrupted 2/0 polyamide or in two layers with inner
continuous 2/0 polyglycolic and outer 2/0 polyamide, ileocolic n=122 (cancer n=88)
Outcomes 1) Overall anastomotic leak: S=1 (0.8%), HS=4 (3.3%)

2) Clinical anastomotic leak: S=1 (0.8%), HS =4 (3.3%)
3) Anastomotic time: S=8.72 min (2-30, median 7); HS=22.36 min (8-90, median 20)
4) Operative mortality: S=6 (4.5%), HS=6 (4.9% )
5) Intra-abdominal abscess: S=1 (0.8%), HS=4 (3.3%)
6) Wound infection: S=14 (10.5%), HS=9 (7.4%)
Docherty 1995 (Continued)
7) Length of stay: S=13.63 days (2-30, median 7); HS=13.25 days (8-90, median 20)
Notes 1) Randomisation success: the patients in sutured group versus stapled group is matched
in terms of baseline characteristics
2) Representativity: situation was thought to reflect average surgical practice in UK
3) Sample size: 1000 randomised patients gives adequate statistical power to detect a
difference between true leak rates of 5% and 10% at a 5% significance level
4) Intention to treat: yes
5) Learning curve: consultants had preliminary experience with surgical stapling, only
one consultant is a regular stapler user, junior staff contributed, none of the surgeons has
specific GI interest
6) In 10% random sample of study patients the key study variables were checked against
original case notes as data recording audit.
7) Includes data published in West 1991, Akyol 1991 and individual data obtained from
author (JG Docherty)
Risk of bias
Random sequence generation (selection Low risk Stratified randomisation

bias)
Allocation concealment (selection bias) Low risk Sealed envelopes
Subjective outcomes
Incomplete outcome data (attrition bias) Low risk No missing outcome data
All outcomes
Other bias Low risk
Ikeuchi 2000
Methods 1) 1) Study location: Hyogo, Japan

2) Study duration: July 1987 to August 1996
3) Follow-up duration: median 87 (range 36-140) months for all groups
4) Randomisation technique: sealed envelopes (random fashion)
5) Randomisation time: during the operation after resection
6) Blinding: mentioned to be double-blind but not explained
Participants 1) Source population: patients with Crohn’s disease who underwent intestinal resection
at the institution
2) Type of disease: Crohn’s disease

Ikeuchi 2000 (Continued)
3) Type of anastomosis: ileoileal, ileocolic, colocolic, ileorectal

4) Inclusion criteria: 68 patients with Crohn’s disease who underwent intestinal resection
5) Exclusion criteria: not described
6) Number of participants: ileocolic n=29 (30 anastomoses) (total in study, n=68)
7) Excluded post randomisation: none
8) Lost to follow-up: n=5 for whole study (p.494 geographical distance, death)
9) Age: 26.4 (15-44, median 25)
10) Sex: M=20, F=9
Interventions 1) Group S: functional end-to-end - linear stapling instrument (RL60), and linear anas-
tomotic instrument (PLC50 or PLC75) (ileocolic n=11)
2) Group HS: layer-to-layer with inner running 3-0 Monocryl and outer interrupted 4-
0 Vicryl (ileocolic n=18) (1 patient had ileocaecal resection then right hemicolectomy
as reoperation, only ileocaecal resection included for outcomes)
Outcomes 1) Overall anastomotic leak: 0

2) Clinical anastomotic leak: 0
3) Anastomotic stricture: S=1, HS=6
4) Anastomotic haemorrhage: 0
5) Anastomotic time: individual patient data unavailable
6) Re-operation: S=1, HS=6
7) Operative mortality: 0
8) Intra-abdominal abscess: 0
9) Wound infection: S=0, HS=5
10) Length of stay: Stapled: 30 days (21-51, median 30); Handsewn: 23.7 days (16-50,
median 21.5)
Notes 1) Randomisation success: no significant difference between the two groups in patient
characteristics
3) Sample size: not calculated
4) Intention to treat: not mentioned
5) Learning curve: not assessed
6) Others: patients on elemental diet for at least 2 months post surgery
7) Individual data not available in publication were obtained from correspondence with
author (H Ikeuchi)
8) Includes data published in Kusunoki 1998
Risk of bias
Random sequence generation (selection Low risk Random sequence generation

bias)
Allocation concealment (selection bias) Low risk Sealed envelopes

Ikeuchi 2000 (Continued)
Blinding (performance bias and detection Low risk ’double-blind’

bias)
Subjective outcomes
All outcomes
Other bias Low risk
Izbicki 1998
Methods 1) Study location: Hamburg

2) Study duration: 1 April 1993 to 31 December 1995
3) Follow-up duration: patients contacted by telephone at 3 months. Patients with
complaints were invited for a personal visit. Data available up to 5 months.
4) Randomisation technique: not described
5) Randomisation time: after the resection if both handsewn and stapled anastomosis
could be done

2) Type of disease: carcinoma, non-cancer
3) Type of anastomosis: gastrectomy, gastric resection (Billroth II), Whipple’s procedure,
segmental colonic resection, right hemicolectomy, left hemicolectomy, sigmoid- or an-
terior rectal resections, total colectomy with pouch-anal anastomosis
4) Inclusion criteria: patients with elective resection of the gastrointestinal tract; only
included if both handsewn and stapled anastomosis could be done
5) Exclusion criteria: Crohn’s disease
6) Number of participants: right hemicolectomy n=36, total n=200
8) Lost to follow-up: n=9 (4.5%)
Interventions 1) Group S: functional end-to-end with linear stapler (side-to-side ileo-transversostomy)

(ileocolic n=15)
2) Group HS: single layer continuous (ileocolic n=21)
Outcomes 1) Overall anastomotic leak: S=1, HS=0

2) Clinical anastomotic leak: S=1, HS=0
3) Anastomotic stricture: 0
4) Anastomotic haemorrhage: 0
5) Operative mortality: 0
Notes 1) Randomisation success: difference in age between 2 groups not statistically significant,
no other baseline characteristics considered
3) Sample size: not mentioned

Izbicki 1998 (Continued)
4) Intention to treat: not mentioned

5) Learning curve: not mentioned
6) Others: original paper in German
7) Authors were contacted for further information but it has not yet been provided
Risk of bias
Subjective outcomes
Incomplete outcome data (attrition bias) Low risk Reasons for missing outcome data unlikely
All outcomes to be related to true outcome
Selective reporting (reporting bias) Low risk Reported all pre-specified outcomes[
Kracht 1993
Methods 1) Study location: 29 centres in France (at least 10 patients operated on in each centre,
at least 4 enrolled per year per centre)
2) Study duration: 1981 through 1990
3) Follow-up duration: 30 days following discharge
4) Randomisation technique: unfolding the previously folded and stapled, opaque right
corner of structured forms, bound together sequentially, under which the type of anas-
tomosis to be performed was concealed. Allocation order was established by computer-
generated randomisation. Random assignment was balanced within each centre and ad-
justed for each 5-10 patients.
5) Randomisation time: during operation once the colon had been resected and the
surgeon was sure that all techniques were feasible and appropriate
6) Blinding: of outcome assessment (radiologist)

2) Type of disease: right colonic adenocarcinoma 3) Type of anastomosis: ileocolic
4) Inclusion criteria: 457 consecutive patients undergoing right hemicolectomy for right
colonic adenocarcinoma, whether with curative or palliative intent, no limits on age,
general health, degree of tumour growth or extension, patients with contained pericolic
abscess or infected tumour were included
5) Exclusion criteria: non-resection of the right colon, right hemicolectomy performed
for inflammatory or non-malignant lesions, as well as emergency resections for which
preoperative colonic preparation was impossible, presence of overt local sepsis
7) Excluded post randomisation: n=17 (protocol violation: use of technique other than
the one randomly assigned, definitive pathology examination showing a non-malignant
lesion, or emergency resection), equally distributed between five groups, no statistically
significant difference in assessment criteria among the withdrawn patients.
8) Lost to follow-up: none mentioned

Kracht 1993 (Continued)
9) Age: mean 70.2 years +/- 12.3 years (range 27 to 92 years)

10) Sex: F=261, M=179
Interventions 1) Group S: side-to-side, using GIA and TA-90 stapling devices, n=106
2) Group HS: n=334, all done with one extramucosal layer with polyglycolic acid or
polygalactin 3/0 (1) end-to-end with interrupted sutures (EEI) n=84; (2) end-to-end
with continuous sutures (EEC) n=77; (3) end-to-side with interrupted sutures (ESI) n=
82; (4) end-to-side with continuous sutures (ESC) colonic stump closed either manual
or staples according to surgeon preference, n=91
Outcomes 1) Overall anastomotic leakage: S=3 (2.8%), HS=28 (8.4%)

2) Clinical anastomotic leak: S=2 (1.9%), HS=15 (4.5%)
3) Radiological anastomotic leak (at eighth to tenth postoperative day): S=1 (0.9%),
HS=13 (3.9%)
4) Mortality: S=2 (1.9%), HS=12 (3.6%)
5) Intra-abdominal abscess or peritonitis: S=2 (1.9%), HS= 14 (4.2%)
6) Wound abscess: S=10 (9.4%), HS=31 (9.3%)
Notes 1) In total, Dukes: A=68; B=176; C=112 (all incomplete)

2) Randomisation success: preoperative criteria were comparable, except there were sig-
nificantly more women in stapled group. Comparable in pre-operative, intra-operative
& pathological criteria except intra-operative septic spillage was significantly lower in
stapled group; no difference between centres concerning patient demographics, colonic
preparation, or outcome; comparable regarding curative (78%) or palliative (22%) na-
ture of operation, tumour spread (Dukes); no statistically significant difference in num-
ber of stumps closed by hand or staples in end-to-side technique
3) Representativity: protocol constructed to correspond to the practical aspects of every-
day surgery, 457 consecutive patients
4) Sample size: designed as a pragmatic trial as defined by Schwartz. The hypothesis that
a 5% reduction of anastomotic leakage (10-5%) could be obtained by a specific type of
anastomosis, with an expected gamma error of 5%. The gamma error accounts for the
risk in assuming that one treatment is better than another, even though it may be worse.
Accordingly, the number of patients necessary for this study was calculated to be 420.
More patients (100 patients) were included in the stapled group so that this group could
be compared with the 4 sutured groups taken as a whole or individually (80 patients).
5) Intention to treat: not mentioned, not done as no lost to follow-up was mentioned
6) Learning curve: all surgeons performing anastomosis or preceptors assisting residents
in these anastomoses had at least four years experience with both techniques
7) Schwartz D, Flamant R, Lellouch J (1980). Clinical trials. Academic Press Inc, Lon-
don.
8) Same data also published in Kracht 1990
Risk of bias
Random sequence generation (selection Low risk Computer generated randomisation

bias)

Kracht 1993 (Continued)
Allocation concealment (selection bias) Low risk Sequential sealed forms
Blinding (performance bias and detection Low risk Radiologist who assessed radiological anas-
bias) tomotic leak
Subjective outcomes
All outcomes
Other bias Low risk
McLeod 2009
Methods 1) Study location: 10 Canadian, 6 American, 1 British centres

2) Study duration: Jan 2001 to Jul 2004
3) Follow-up duration: 12 months
4) Randomisation technique: centralised computer generated block randomisation
within each strata stratified by centre
5) Randomisation time: intraoperatively when either type of anastomosis could be per-
formed safely
6) Blinding: patient, gastroenterologist who performed the colonoscopy to assess disease
recurrence
Participants 1) Source population: patients were accrued from ten Canadian, six American, and one
British centre
2) Type of disease: Crohn’s disease
3) Type of anastomosis: ileocolic. Surgery was performed open or laparoscopic depending
on patient factors and surgeon preference
4) Inclusion criteria: patients with Crohn’s disease limited to the distal ileum and right
colon who were scheduled for an elective ileocolic resection, patients with an internal
fistula who required resection of an otherwise normal segment of bowel, patients with
minimal perianal disease that did not require treatment
5) Exclusion criteria: previous resection, requirement for a defunctioning ileostomy, on
medications for Crohn’s disease that could not be discontinued postoperatively
7) Excluded post randomisation: n=1 (had terminal ileal resection rather than ileocolic
resection)
8) Lost to follow-up: total n=31: Lost to follow-up n=9 (S=6, HS=3), n=22 (S=12, HS=
10) refused follow-up investigations despite being followed for a mean of 11.2 +/- 1.
9 months. The follow-up investigation was a colonoscopy to check for recurrence.) If
symptomatic recurrence within the 12 months follow up period, the participation in the
study was terminated as they were considered to have reached an end point
9) Age: mean age S=40.3 years, HS=38.2 years
10) Sex: male to female ratio of 30:54 for stapled group and 32:54 for handsewn group
11) Notes: change of study protocol. Initially used 5-ASA maintenance therapy, then no
maintenance therapy as 5-ASA was not approved. After 72 patients were entered into

McLeod 2009 (Continued)
the trial, due to problems with accrual an investigators’ meeting was held in November
2002. It was decided to include individuals who fit the inclusion criteria but were advised
to take postoperative azathioprine. The decision regarding the need for maintenance
therapy had to be made pre-operatively, and patients were stratified to an azathioprine
stratum or no maintenance therapy stratum before they were randomised to the two
treatment groups
Interventions 1) Group S: stapled side-to-side anastomosis (STSA), either side-to-side with stapler
passing through enterotomies, or functional end-to-end, both using a TLC 100 mm
stapler or a transverse stapler, n=84
2) Group HS: end-to-end anastomosis (ETEA), either a single-layer or two-layer anas-
tomosis with 2-0 PDS, n=86
Outcomes 1) Clinical anastomotic leak: S=6 (7%), HS=6 (7%), p=0.86

2) Anastomotic time (range not reported): S=15 minutes, HS=31 minutes (p<0.0001)
3) Re-operation: S=6 (7%), HS=6 (7%), p=0.86
4) Operative mortality: S=0, HS=0
5) Intra-abdominal abscess: S=1 (1%), HS=1 (1%)
6) Wound infection: S=9 (11%), HS=8 (9%)
7) Length of hospital stay (range not reported): S=8.3 days, HS=6.8 days (p<0.05)
Notes 1) Randomisation success: baseline characteristics were similar. However there were more
females compared with males in the whole trial
3) Sample size: The main outcome of the study was endoscopic recurrence. The statistical
power of the study was 70 percent to detect a significant absolute risk difference of 20
percent, or 80 percent power to detect an absolute risk difference of 23 percent
4) Intention to treat: no. Although none of the patients lost to follow-up or those who
refused follow-up colonoscopy had symptoms suggestive of recurrent disease, they were
not included in the analysis of disease recurrence
5) Learning curve: all surgery was performed by colorectal surgeons experienced in the
surgical treatment of Crohn’s disease
Risk of bias
Random sequence generation (selection Low risk The study used computer generated block
bias) randomisation stratified by centre
Allocation concealment (selection bias) Low risk The study used a central phone-in ran-
domisation service, which presumably kept
the allocation concealed
Blinding (performance bias and detection Low risk To minimize observer bias, where pos-
bias) sible, a gastroenterologist performed the
Subjective outcomes colonoscopy

McLeod 2009 (Continued)
Incomplete outcome data (attrition bias) Low risk Patients who were lost to follow up (6/84
All outcomes in stapled group, 3/86 in handsewn group)
or who refused follow up investigation (12/
84 in stapled group, 10/86 in handsewn
group) were explained
Selective reporting (reporting bias) Low risk It is clear that the published report included
pre-specified and expected outcomes
Other bias Low risk
Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Alessandroni 2009 not randomised
Anwar 2004 not randomised
Brennan 1982 circular stapler
Brundage 1999 not randomised
Bubrick 1991 not randomised between stapled and handsewn anastomosis
Cajozzo 1990 EEA not function end-to-end
Chassin 1978 non-randomised retrospective comparison
Corman 1989 not randomised between stapled and handsewn anastomosis
Demetriades 2002 not randomised
Dyess 1990 not randomised between stapled and handsewn anastomosis
Hashemi 1998 longitudinal study, not randomised
Munoz-Juarez 2001 not RCT, is case-control
Reiling 1980 not functional end to end
Resegotti 2005 techniques chosen by surgeon’s preference. The randomised proportion is not analysed separately
Scarpa 2004 not randomised

(Continued)
Scarpa 2007 not randomised
Scher 1982 not randomised
Tersigni 2003 not randomised
Wolmark 1986 not randomised
Yamamoto 1999 retrospective non-randomised comparison

DATA AND ANALYSES
Comparison 1. All studies
No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size
1 Overall anastomotic leak 7 1125 Odds Ratio (M-H, Fixed, 95% CI) 0.48 [0.24, 0.95]
2 Clinical anastomotic leak 7 1125 Odds Ratio (M-H, Fixed, 95% CI) 0.55 [0.27, 1.15]
3 Radiological anastomotic leak 1 440 Odds Ratio (M-H, Fixed, 95% CI) 0.24 [0.03, 1.82]
4 Anastomotic stricture 2 65 Odds Ratio (M-H, Fixed, 95% CI) 0.2 [0.02, 1.95]
5 Anastomotic haemorrhage 2 65 Odds Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
6 Anastomotic time (min) 1 255 Mean Difference (IV, Fixed, 95% CI) -13.64 [-15.86, -11.
42]
7 Re-operation 2 199 Odds Ratio (M-H, Fixed, 95% CI) 0.67 [0.25, 1.81]
8 Operative mortality 6 1087 Odds Ratio (M-H, Fixed, 95% CI) 0.74 [0.33, 1.65]
9 Intra-abdominal abscess 5 932 Odds Ratio (M-H, Fixed, 95% CI) 0.41 [0.14, 1.25]
10 Wound infection 5 932 Odds Ratio (M-H, Fixed, 95% CI) 1.05 [0.66, 1.70]
11 Length of hospital stay (day) 3 424 Mean Difference (IV, Fixed, 95% CI) 0.19 [-1.50, 1.87]
Comparison 2. Cancer
No. of No. of
3 Radiological anastomotic leak 1 440 Odds Ratio (M-H, Fixed, 95% CI) 0.24 [0.03, 1.82]
4 Anastomotic time 1 190 Mean Difference (IV, Fixed, 95% CI) -13.64 [-16.26, -11.
02]
8 Length of stay 2 334 Mean Difference (IV, Fixed, 95% CI) -0.42 [-2.30, 1.45]
Comparison 3. Non-Cancer
No. of No. of
3 Anastomotic stricture 1 29 Odds Ratio (M-H, Fixed, 95% CI) 0.2 [0.02, 1.95]
4 Anastomotic haemorrhage 1 29 Odds Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
5 Anastomotic time 1 65 Mean Difference (IV, Fixed, 95% CI) -14.27 [-18.54, -8.
00]
6 Re-operation 2 199 Odds Ratio (M-H, Fixed, 95% CI) 0.67 [0.25, 1.81]
10 Length of stay 2 90 Mean Difference (IV, Fixed, 95% CI) 3.12 [-0.78, 7.03]
Analysis 1.1. Comparison 1 All studies, Outcome 1 Overall anastomotic leak.
Review: Stapled versus handsewn methods for ileocolic anastomoses
Comparison: 1 All studies
Outcome: 1 Overall anastomotic leak
Study or subgroup Stapled Handsewn Odds Ratio Weight Odds Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Didolkar 1986 0/22 0/16 Not estimable
Docherty 1991 0/70 4/87 14.7 % 0.13 [ 0.01, 2.49 ]
Docherty 1995 1/133 4/122 15.3 % 0.22 [ 0.02, 2.03 ]
Ikeuchi 2000 0/11 0/18 Not estimable
Izbicki 1998 1/15 0/21 1.4 % 4.45 [ 0.17, 116.94 ]
Kracht 1993 3/106 28/334 48.3 % 0.32 [ 0.09, 1.07 ]
McLeod 2009 6/84 6/86 20.3 % 1.03 [ 0.32, 3.32 ]
Total (95% CI) 441 684 100.0 % 0.48 [ 0.24, 0.95 ]

Total events: 11 (Stapled), 42 (Handsewn)
Heterogeneity: Chi2 = 5.04, df = 4 (P = 0.28); I2 =21%
Test for overall effect: Z = 2.12 (P = 0.034)
Test for subgroup differences: Not applicable
0.1 0.2 0.5 1 2 5 10

Favours stapled Favours handsewn

Analysis 1.2. Comparison 1 All studies, Outcome 2 Clinical anastomotic leak.
Outcome: 2 Clinical anastomotic leak

Docherty 1991 0/70 4/87 18.9 % 0.13 [ 0.01, 2.49 ]
Docherty 1995 1/133 4/122 19.6 % 0.22 [ 0.02, 2.03 ]
Izbicki 1998 1/15 0/21 1.8 % 4.45 [ 0.17, 116.94 ]
Kracht 1993 2/106 15/334 33.6 % 0.41 [ 0.09, 1.82 ]
McLeod 2009 6/84 6/86 26.1 % 1.03 [ 0.32, 3.32 ]
Total (95% CI) 441 684 100.0 % 0.55 [ 0.27, 1.15 ]

0.1 0.2 0.5 1 2 5 10


Analysis 1.3. Comparison 1 All studies, Outcome 3 Radiological anastomotic leak.
Outcome: 3 Radiological anastomotic leak

Kracht 1993 1/106 13/334 100.0 % 0.24 [ 0.03, 1.82 ]
Total (95% CI) 106 334 100.0 % 0.24 [ 0.03, 1.82 ]

Heterogeneity: not applicable
0.1 0.2 0.5 1 2 5 10

Favour stapled Favours handsewn
Analysis 1.4. Comparison 1 All studies, Outcome 4 Anastomotic stricture.
Outcome: 4 Anastomotic stricture

Ikeuchi 2000 1/11 6/18 100.0 % 0.20 [ 0.02, 1.95 ]
Izbicki 1998 0/15 0/21 Not estimable
Total (95% CI) 26 39 100.0 % 0.20 [ 0.02, 1.95 ]

0.1 0.2 0.5 1 2 5 10


Analysis 1.5. Comparison 1 All studies, Outcome 5 Anastomotic haemorrhage.
Outcome: 5 Anastomotic haemorrhage

Total (95% CI) 26 39 Not estimable

Test for overall effect: not applicable
0.1 0.2 0.5 1 2 5 10

Analysis 1.6. Comparison 1 All studies, Outcome 6 Anastomotic time (min).
Outcome: 6 Anastomotic time (min)
Mean Mean
Study or subgroup Stapled Handsewn Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI
Docherty 1995 133 8.72 (5.12) 122 22.36 (11.54) 100.0 % -13.64 [ -15.86, -11.42 ]
Total (95% CI) 133 122 100.0 % -13.64 [ -15.86, -11.42 ]

Test for overall effect: Z = 12.02 (P < 0.00001)
-10 -5 0 5 10

Analysis 1.7. Comparison 1 All studies, Outcome 7 Re-operation.
Outcome: 7 Re-operation

Ikeuchi 2000 1/11 6/18 42.9 % 0.20 [ 0.02, 1.95 ]
McLeod 2009 6/84 6/86 57.1 % 1.03 [ 0.32, 3.32 ]
Total (95% CI) 95 104 100.0 % 0.67 [ 0.25, 1.81 ]

0.1 0.2 0.5 1 2 5 10


Analysis 1.8. Comparison 1 All studies, Outcome 8 Operative mortality.
Outcome: 8 Operative mortality

Docherty 1991 2/70 3/87 18.2 % 0.82 [ 0.13, 5.07 ]
Docherty 1995 6/133 6/122 41.9 % 0.91 [ 0.29, 2.91 ]
Kracht 1993 2/106 12/334 39.8 % 0.52 [ 0.11, 2.34 ]
McLeod 2009 0/84 0/86 Not estimable
Total (95% CI) 419 668 100.0 % 0.74 [ 0.33, 1.65 ]

Heterogeneity: Chi2 = 0.36, df = 2 (P = 0.84); I2 =0.0%
0.1 0.2 0.5 1 2 5 10


Analysis 1.9. Comparison 1 All studies, Outcome 9 Intra-abdominal abscess.
Outcome: 9 Intra-abdominal abscess

Docherty 1995 1/133 4/122 35.3 % 0.22 [ 0.02, 2.03 ]
Kracht 1993 2/106 14/334 56.4 % 0.44 [ 0.10, 1.97 ]
McLeod 2009 1/84 1/86 8.3 % 1.02 [ 0.06, 16.64 ]
Total (95% CI) 356 576 100.0 % 0.41 [ 0.14, 1.25 ]

0.1 0.2 0.5 1 2 5 10


Analysis 1.10. Comparison 1 All studies, Outcome 10 Wound infection.
Outcome: 10 Wound infection

Docherty 1995 14/133 9/122 25.4 % 1.48 [ 0.62, 3.55 ]
Ikeuchi 2000 0/11 5/18 12.3 % 0.11 [ 0.01, 2.14 ]
Kracht 1993 10/106 31/334 40.9 % 1.02 [ 0.48, 2.15 ]
McLeod 2009 9/84 8/86 21.3 % 1.17 [ 0.43, 3.19 ]
Total (95% CI) 356 576 100.0 % 1.05 [ 0.66, 1.70 ]

0.1 0.2 0.5 1 2 5 10


Analysis 1.11. Comparison 1 All studies, Outcome 11 Length of hospital stay (day).
Outcome: 11 Length of hospital stay (day)
Mean Mean
Docherty 1991 68 11.36 (5.87) 84 12.34 (9.46) 47.0 % -0.98 [ -3.44, 1.48 ]
Docherty 1995 127 13.63 (10.93) 116 13.25 (8.89) 45.5 % 0.38 [ -2.12, 2.88 ]
Ikeuchi 2000 11 30 (8.44) 18 23.7 (7.76) 7.5 % 6.30 [ 0.16, 12.44 ]
Total (95% CI) 206 218 100.0 % 0.19 [ -1.50, 1.87 ]

-10 -5 0 5 10

Analysis 2.1. Comparison 2 Cancer, Outcome 1 Overall anastomotic leak.
Comparison: 2 Cancer

Docherty 1991 0/70 4/87 19.7 % 0.13 [ 0.01, 2.49 ]
Docherty 1995 1/102 3/88 15.7 % 0.28 [ 0.03, 2.75 ]
Kracht 1993 3/106 28/334 64.6 % 0.32 [ 0.09, 1.07 ]
Total (95% CI) 300 525 100.0 % 0.28 [ 0.10, 0.75 ]

0.1 0.2 0.5 1 2 5 10


Analysis 2.2. Comparison 2 Cancer, Outcome 2 Clinical anastomotic leak.

Docherty 1991 0/70 4/87 28.0 % 0.13 [ 0.01, 2.49 ]
Docherty 1995 1/102 3/88 22.3 % 0.28 [ 0.03, 2.75 ]
Kracht 1993 2/106 15/334 49.7 % 0.41 [ 0.09, 1.82 ]
Total (95% CI) 300 525 100.0 % 0.30 [ 0.10, 0.95 ]

0.1 0.2 0.5 1 2 5 10

Analysis 2.3. Comparison 2 Cancer, Outcome 3 Radiological anastomotic leak.
Outcome: 3 Radiological anastomotic leak

Kracht 1993 1/106 13/334 100.0 % 0.24 [ 0.03, 1.82 ]
Total (95% CI) 106 334 100.0 % 0.24 [ 0.03, 1.82 ]

0.1 0.2 0.5 1 2 5 10


Analysis 2.4. Comparison 2 Cancer, Outcome 4 Anastomotic time.
Outcome: 4 Anastomotic time
Mean Mean
Docherty 1995 102 8.7 (5.13) 88 22.34 (11.59) 100.0 % -13.64 [ -16.26, -11.02 ]
Total (95% CI) 102 88 100.0 % -13.64 [ -16.26, -11.02 ]

-10 -5 0 5 10

Analysis 2.5. Comparison 2 Cancer, Outcome 5 Operative mortality.

Docherty 1991 2/70 3/87 19.3 % 0.82 [ 0.13, 5.07 ]
Docherty 1995 3/102 5/88 38.6 % 0.50 [ 0.12, 2.17 ]
Izbicki 1998 2/106 12/334 42.1 % 0.52 [ 0.11, 2.34 ]
Total (95% CI) 278 509 100.0 % 0.57 [ 0.23, 1.41 ]

0.1 0.2 0.5 1 2 5 10

Analysis 2.6. Comparison 2 Cancer, Outcome 6 Intra-abdominal abscess.

Docherty 1995 1/102 3/88 32.5 % 0.28 [ 0.03, 2.75 ]
Kracht 1993 2/106 14/334 67.5 % 0.44 [ 0.10, 1.97 ]
Total (95% CI) 230 438 100.0 % 0.39 [ 0.11, 1.37 ]

0.1 0.2 0.5 1 2 5 10


Analysis 2.7. Comparison 2 Cancer, Outcome 7 Wound infection.

Docherty 1995 12/102 7/88 32.9 % 1.54 [ 0.58, 4.11 ]
Kracht 1993 10/106 31/334 67.1 % 1.02 [ 0.48, 2.15 ]
Total (95% CI) 230 438 100.0 % 1.19 [ 0.66, 2.14 ]

0.1 0.2 0.5 1 2 5 10


Analysis 2.8. Comparison 2 Cancer, Outcome 8 Length of stay.
Outcome: 8 Length of stay
Mean Mean
Docherty 1991 68 11.36 (5.87) 84 12.34 (9.46) 57.9 % -0.98 [ -3.44, 1.48 ]
Docherty 1995 99 13.63 (10.93) 83 13.29 (8.92) 42.1 % 0.34 [ -2.54, 3.22 ]
Total (95% CI) 167 167 100.0 % -0.42 [ -2.30, 1.45 ]

-10 -5 0 5 10
Analysis 3.1. Comparison 3 Non-Cancer, Outcome 1 Overall anastomotic leak.
Comparison: 3 Non-Cancer

Docherty 1995 0/31 1/34 20.4 % 0.35 [ 0.01, 9.03 ]
McLeod 2009 6/84 6/86 79.6 % 1.03 [ 0.32, 3.32 ]
Total (95% CI) 126 138 100.0 % 0.89 [ 0.30, 2.64 ]

0.1 0.2 0.5 1 2 5 10


Analysis 3.2. Comparison 3 Non-Cancer, Outcome 2 Clinical anastomotic leak.

Docherty 1995 0/31 1/34 20.4 % 0.35 [ 0.01, 9.03 ]
McLeod 2009 6/84 6/86 79.6 % 1.03 [ 0.32, 3.32 ]
Total (95% CI) 126 138 100.0 % 0.89 [ 0.30, 2.64 ]

0.1 0.2 0.5 1 2 5 10


Analysis 3.3. Comparison 3 Non-Cancer, Outcome 3 Anastomotic stricture.
Outcome: 3 Anastomotic stricture

Ikeuchi 2000 1/11 6/18 100.0 % 0.20 [ 0.02, 1.95 ]
Total (95% CI) 11 18 100.0 % 0.20 [ 0.02, 1.95 ]

0.1 0.2 0.5 1 2 5 10

Analysis 3.4. Comparison 3 Non-Cancer, Outcome 4 Anastomotic haemorrhage.
Outcome: 4 Anastomotic haemorrhage

Total (95% CI) 11 18 Not estimable

Test for overall effect: not applicable
0.1 0.2 0.5 1 2 5 10


Analysis 3.5. Comparison 3 Non-Cancer, Outcome 5 Anastomotic time.
Outcome: 5 Anastomotic time
Mean Mean
Docherty 1995 31 8.46 (4.76) 34 22.73 (11.7) 100.0 % -14.27 [ -18.54, -10.00 ]
Total (95% CI) 31 34 100.0 % -14.27 [ -18.54, -10.00 ]

-10 -5 0 5 10
Analysis 3.6. Comparison 3 Non-Cancer, Outcome 6 Re-operation.
Outcome: 6 Re-operation

Ikeuchi 2000 1/11 6/18 42.9 % 0.20 [ 0.02, 1.95 ]
McLeod 2009 6/84 6/86 57.1 % 1.03 [ 0.32, 3.32 ]
Total (95% CI) 95 104 100.0 % 0.67 [ 0.25, 1.81 ]

0.1 0.2 0.5 1 2 5 10


Analysis 3.7. Comparison 3 Non-Cancer, Outcome 7 Operative mortality.

Docherty 1995 3/31 1/34 100.0 % 3.54 [ 0.35, 35.93 ]
McLeod 2009 0/84 0/86 Not estimable
Total (95% CI) 126 138 100.0 % 3.54 [ 0.35, 35.93 ]

0.1 0.2 0.5 1 2 5 10

Analysis 3.8. Comparison 3 Non-Cancer, Outcome 8 Intra-abdominal abscess.

Docherty 1995 0/31 1/34 59.1 % 0.35 [ 0.01, 9.03 ]
McLeod 2009 1/84 1/86 40.9 % 1.02 [ 0.06, 16.64 ]
Total (95% CI) 126 138 100.0 % 0.63 [ 0.08, 4.86 ]

0.1 0.2 0.5 1 2 5 10


Analysis 3.9. Comparison 3 Non-Cancer, Outcome 9 Wound infection.

Docherty 1995 2/31 2/34 13.8 % 1.10 [ 0.15, 8.35 ]
Ikeuchi 2000 0/11 5/18 31.6 % 0.11 [ 0.01, 2.14 ]
McLeod 2009 9/84 8/86 54.6 % 1.17 [ 0.43, 3.19 ]
Total (95% CI) 126 138 100.0 % 0.83 [ 0.37, 1.86 ]

0.1 0.2 0.5 1 2 5 10


Analysis 3.10. Comparison 3 Non-Cancer, Outcome 10 Length of stay.
Outcome: 10 Length of stay
Mean Mean
Docherty 1995 28 13.84 (11.21) 33 12.87 (8.45) 59.6 % 0.97 [ -4.08, 6.02 ]
Ikeuchi 2000 11 30 (8.44) 18 23.7 (7.76) 40.4 % 6.30 [ 0.16, 12.44 ]
Total (95% CI) 39 51 100.0 % 3.12 [ -0.78, 7.03 ]

-10 -5 0 5 10
WHAT’S NEW
Last assessed as up-to-date: 23 April 2011.
Date Event Description
24 April 2011 New citation required but conclusions have not changed added a new author & one included study, updated RoB
tables & text
24 April 2011 New search has been performed 1st update
HISTORY
Protocol first published: Issue 3, 2003
Review first published: Issue 3, 2007

Date Event Description
1 December 2010 New search has been performed Seach for new studies
5 August 2008 Amended Converted to new review format.
1 March 2007 New citation required and conclusions have changed Substantive amendment
CONTRIBUTIONS OF AUTHORS
None mentioned
DECLARATIONS OF INTEREST
JG Docherty: Research had been funded by both Ethicon and by Autosuture (now Tyco). Both had helped with attending and presenting
at scientific and educational meetings.
SOURCES OF SUPPORT
Internal sources
• Auckland Medical Research Foundation Summer Studentship, New Zealand.
External sources
• No sources of support supplied
INDEX TERMS
Medical Subject Headings (MeSH)

∗ Surgical Stapling [adverse effects]; ∗ Suture Techniques [adverse effects]; Anastomosis, Surgical [adverse effects; methods]; Colon
[∗ surgery]; Colorectal Neoplasms [surgery]; Crohn Disease [surgery]; Ileum [∗ surgery]; Randomized Controlled Trials as Topic; Surgical
Wound Dehiscence [etiology]

MeSH check words
Adult; Humans


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Cochrane Database of Systematic Reviews

Stapled versus handsewn methods for ileocolic anastomoses

Stapled versus handsewn methods for ileocolic anastomoses (Review)

Stapled versus handsewn methods for ileocolic anastomoses (Review) ii

Stapled versus handsewn methods for ileocolic anastomoses

Editorial group: Cochrane Colorectal Cancer Group.

Data collection and analysis

PLAIN LANGUAGE SUMMARY

Search methods for identification of studies

Stapled versus handsewn methods for ileocolic anastomoses (Review) 3

Stapled versus handsewn methods for ileocolic anastomoses (Review) 4

Stapled versus handsewn methods for ileocolic anastomoses (Review) 5

(2) Clinical anastomotic leak (7 studies, 1125 patients): stapled

(3) Radiological anastomotic leak (1 study, 440 patients) rate for

Stapled versus handsewn methods for ileocolic anastomoses (Review) 6

(b) Clinical anastomotic leak: Stapled anastomosis (3/300, 1%)

Stapled versus handsewn methods for ileocolic anastomoses (Review) 7

(0.92, 0.69-1.12). Another meta-analysis (Simillis 2007) investi-

Stapled versus handsewn methods for ileocolic anastomoses (Review) 9

Stapled versus handsewn methods for ileocolic anastomoses (Review) 11

Stapled versus handsewn methods for ileocolic anastomoses (Review) 12

Characteristics of included studies [ordered by study ID]

Methods 1) Study location: Baltimore, Maryland

Outcomes 1) Overall anastomotic leak: 0

Notes 1) Randomisation success: preoperative laboratory values as a group comparable (except

Stapled versus handsewn methods for ileocolic anastomoses (Review) 13

Bias Authors’ judgement Support for judgement

Methods 1) Study location: Scotland

Interventions 1) Group S: Ethicon functional end-to-end staplers, n=70

Outcomes 1) Overall anastomotic leak: S=0, HS=4

Stapled versus handsewn methods for ileocolic anastomoses (Review) 14

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Batch of sealed envelopes

Allocation concealment (selection bias) Low risk

Methods 1) Study location: five surgical units in Scotland

Participants 1) Source population: not described

Outcomes 1) Overall anastomotic leak: S=1 (0.8%), HS=4 (3.3%)

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Stratified randomisation

Allocation concealment (selection bias) Low risk Sealed envelopes

Other bias Low risk

Methods 1) 1) Study location: Hyogo, Japan

Stapled versus handsewn methods for ileocolic anastomoses (Review) 16

3) Type of anastomosis: ileoileal, ileocolic, colocolic, ileorectal

Outcomes 1) Overall anastomotic leak: 0

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Random sequence generation

Allocation concealment (selection bias) Low risk Sealed envelopes

Stapled versus handsewn methods for ileocolic anastomoses (Review) 17

Blinding (performance bias and detection Low risk ’double-blind’

Other bias Low risk

Methods 1) Study location: Hamburg

Participants 1) Source population: not described

Interventions 1) Group S: functional end-to-end with linear stapler (side-to-side ileo-transversostomy)

Outcomes 1) Overall anastomotic leak: S=1, HS=0

Stapled versus handsewn methods for ileocolic anastomoses (Review) 18

4) Intention to treat: not mentioned

Bias Authors’ judgement Support for judgement

Participants 1) Source population: not described

Stapled versus handsewn methods for ileocolic anastomoses (Review) 19

9) Age: mean 70.2 years +/- 12.3 years (range 27 to 92 years)

Outcomes 1) Overall anastomotic leakage: S=3 (2.8%), HS=28 (8.4%)

Notes 1) In total, Dukes: A=68; B=176; C=112 (all incomplete)