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. 2002 Sep 2;120(5):132–136. doi: 10.1590/S1516-31802002000500002

Stapled versus handsewn methods for colorectal anastomosis surgery: a systematic review of randomized controlled trials

Suzana Angélica da Silva Lustosa, Delcio Matos ✉, Álvaro Nagib Atallah, Aldemar Araujo Castro
PMCID: PMC11152340  PMID: 12436148

ABSTRACT

CONTEXT:

The interest in the results from comparisons between handsewing and stapling in colorectal anastomoses has been reflected in the progressive increase in the number of clinical trials. These studies, however, do not permit conclusions to be drawn, given the lack of statistical power of the samples analyzed.

OBJECTIVE:

To compare stapling and handsewing in colorectal anastomosis, testing the hypothesis that in colorectal anastomosis the technique of stapling is superior to that of handsewing.

DESIGN:

A systematic review of randomized controlled trials.

SURVEY STRATEGY:

Systematic revision of the literature and meta-analysis were used, without restrictions on language, dates or other considerations. The sources of information used were Embase, Lilacs, Medline, Cochrane Controlled Clinical Trials Database, and letters to authors and industrial producers of staples and thread.

SELECTION CRITERIA:

Studies were included in accordance with randomization criteria. The external validity of the studies was investigated via the characteristics of the participants, the interventions and the variables analyzed. An independent selection of clinical studies focusing on analysis of adult patients attended to on an elective basis was made by two reviewers.

DATA COLLECTION AND ANALYSIS:

The methodological quality of the studies was assessed by the same reviewers. In addition to the randomization criteria, the masking, treatment intention, losses and exclusions were also analyzed. The meta-analysis was performed using risk difference and weighted average difference, with their respective 95% confidence intervals. The variables studied were mortality, clinical and radiological anastomotic dehiscence, anastomotic stricture, hemorrhage, reoperation, wound infection, time taken to perform the anastomosis and hospital stay.

RESULTS:

Nine clinical trials were selected. After verifying that it was possible to perform one of the two techniques being compared, 1,233 patients were included, of whom 622 underwent stapling and 611 the handsewing technique. No statistical difference was found between the variables, except for stenosis, which was more frequent in stapling (p < 0.05), and the time taken to perform the anastomosis, which was greater in handsewing (p < 0.05).

CONCLUSION:

The evidence found was insufficient to demonstrate superiority of the stapling method over handsewing, independent of the level of colorectal anastomosis.

KEY WORDS: Surgical anastomosis, Systematic review, Meta-analysis, Colorectal surgery

INTRODUCTION

The interest in the results from comparisons between handsewing and stapling has been progressively growing. However, the majority of the results come from studies of inadequate methodological quality. Looking only at the conclusions from randomized studies, it can be seen that the results are not uniform.1–9 In considering whether the level of the anastomosis is supra or infra-peritoneal, the controversy is further widened.1,10–12

A systematic review and meta-analysis of 17 studies comparing handsewing and stapling in ileocolonic, colocolonic and colorectal anastomoses was done by MacRae & McLeod13 in 1998. They concluded that although intraoperative technical problems were more common in those that were stapled, no evidence of differences between the two groups was found in the other variables, and they considered the two techniques to be effective. Systematic reviews that exclusively included comparisons of colorectal anastomosis have not been found.

The accomplishment of a systematic review is the best manner for describing the state of our knowledge, and hence becomes the best way of obtaining quality scientific evidence. Consequently, this systematic review and meta-analysis was proposed, so as to analyze the results from clinical trials that compared only colorectal anastomoses done using stapling or handsewing.

METHODS

The method of systematic review with meta-analysis of randomized clinical trials was used, making comparisons between stapling and handsewing in elective colorectal anastomoses in adult patients. The mechanical suturing was always performed using a circular stapler and there was no restriction as to the anastomosis technique or material used in manual suturing. The studies were located via electronic databases: registers of randomized clinical trials of the colorectal cancer group of the Cochrane Collaboration, Medline, Embase, Lilacs and contact with authors and industrial producers of staples and threads. An evaluation of the methodology of the clinical trials was performed, with the objective of accessing the applicability of the findings, validity of the individual studies and the characteristics of the research model.

The inclusion or non-inclusion of a study depended on the evaluation of the randomization. The most important criterion for the classification was the secrecy of the allocation, which should be maintained until the time of the intervention.14 The data were collected using software from the Cochrane Collaboration: Review Manager, Version 4.0 for Windows, Oxford (UK).

The variables analyzed were: mortality, anastomotic dehiscence, stenosis, hemorrhage, reoperation, infection of the operative wound, time taken to perform the anastomosis and length of hospitalization. Anastomotic dehiscence was regarded as the most important variable to be taken into consideration.

When appropriate, the studies were placed in subgroups for performing the meta-analysis according to the anastomotic level (supra or infra-peritoneal). For dichotomous variables, the meta-analysis was effected in accordance with the method of risk difference for a random model and number needed for treatment. For the continuous variables, the weighted average difference was used. The respective confidence interval for all these was 95%.15 The date of the last search for clinical trials for this systematic review was December 2001.

RESULTS

Nine randomized controlled clinical trials comparing stapling with handsewing anastomosis were found in the literature search. Thus, 1233 patients were studied after verifying that the use of both techniques would have been possible: 622 underwent the stapling and 611 the handsewing anastomotic technique. The clinical trials included in the systematic review, the sample sizes and the levels of the colorectal anastomoses are shown in Table 1.

Table 1. Clinical trials included in the systematic review and meta-analysis.

Authors Sample Stapled Handsewn Anastomosis Levels
Beart et al., 19811 70 35 35 supra-peritoneal
Elhadad et al., 19906 272 139 133 not specified
Fingerhut et al., 199411 113 54 59 supra-peritoneal
Fingerhut et al., 199512 159 85 74 supra-peritoneal
Gonzalez et al., 19895 113 55 58 not specified
Kracht et al., 19918 268 137 131 not specified
McGinn et al., 19853 118 58 60 infra-peritoneal
Sarker et al., 19949 60 30 30 supra-peritoneal
Thiede et al., 19842 60 29 31 not specified
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The mortality results were based on 7 studies that included 901 patients, in which 2.4% (11/453) of the handsewn group and 3.6% (16/448) of the stapled group died. No significant statistical difference was shown, with a 95% confidence interval of −2.8 to 1.6% and a risk difference of −0.6%.

Overall anastomotic dehiscence that included clinical and radiological anastomotic breakdown was analyzed in 9 studies that included 1,233 patients: 81 out of 622 (13.0%) and 82 out of 611 (13.4%) patients in the handsewn and stapled groups respectively showed this complication. No significant statistical difference was found, with a risk difference of 0.2% and a 95% confidence interval of −5.0 to 5.3%.

Clinical anastomotic dehiscence results were based on 9 studies that included 1,233 patients, among whom 39 (626) were in the handsewn group (6.33%) and 44 (617) in the stapled group (7.1%); no significant statistical difference was found, with a risk difference of −1.4% and a 95% confidence interval of −5.2 to 2.3%.

Radiological anastomotic dehiscence was analyzed in 6 studies that included 825 patients: 33 out of 421 (7.8%) and 30 out of 414 (7.2%) in the handsewn and stapled groups respectively showed this finding. No significant statistical difference was found, with a risk difference of 1.2% and a 95% confidence interval of −4.8 to 7.3%.

Anastomotic stricture results were based on 7 studies that included 1042 patients, of whom 8% (40/500) were in the handsewn group and 2% (10/496) in the stapled group. A significant statistical difference was found (p = 0.00001), favoring the handsewn technique, with a risk difference of 4.6% and a 95% confidence interval of 12 to 31%.

Hemorrhage from the anastomotic site was analyzed in 4 studies that included 662 patients: 5.4% (18/336) and 3.1% (10/326) in the handsewn and stapled groups respectively showed this complication. No significant statistical difference was found, with a risk difference of 2.7% and a 95% confidence interval of −0.1 to 5.5%.

Reoperation of the patients after anastomotic complications was analyzed in 3 studies that included 544 patients: 7.6% (21/278) and 4.1% (11/266) of the handsewn and stapled groups respectively. No significant statistical difference was found, with a risk difference of 3.9% and a 95% confidence interval of 0.3 to 7.4%.

Wound infection was analyzed in 6 studies that included 567 patients: 5.9% (17/286) and 4.3% (12/282) of the handsewn and stapled groups respectively. No significant statistical difference was found, with a risk difference of 1.0% and a 95% confidence interval of −2.2 to 4.3%.

Anastomosis duration, or the time taken to perform the anastomosis, was analyzed as a continuous outcome in just 1 study that included 159 patients. The weighted mean difference value was −7.6 minutes, with a 95% confidence interval of −12.9 to −2.2. This result showed a significant statistical difference (p = 0.005), favoring the stapling technique.

The length of hospital stay was also analyzed as a continuous variable, in 1 study that included 159 patients. The average value found was 2.0 days, and no significant statistical difference was found, with a 95% confidence interval of −3.2 to 7.2.

A summary of the meta-analysis results for each variable is presented in Table 2, with the number of studies included, the number of participants, and the results from the heterogeneity and overall effect tests.

Table 2. Summary of the meta-analysis results.

Clinical outcome Number of studies Number of participants Statistical Methods Effect sixe Test for heterogeneity Test for overall effect
Mortality 7 901 Peto OR
(95% Cl)		 0.69
(0.32 to 1.49)		 Chi-squared
7.10
df = 6
P = 0.31		 Z = −0.94
P = 0.3
Overall dehiscence 9 1,233 Peto OR
(95% Cl)		 0.99
(0.71 to 1.40)		 Chi-squared
15.84
df = 8
P = 0.045		 Z = −0.03
P = 1
Clinical dehiscence 10 1,233 Peto OR
(95% Cl)		 0.80
(0.51 to 1.24)		 Chi-squared
973
df = 7
P = 0.2		 Z = −0.99
P = 0.3
Radiological dehiscence 6 835 Peto OR
(95% Cl)		 1.10
(0.66 to 1.85)		 Chi-squared
13.89
df = 5
P = 0.016		 Z = 0.37
P = 0.7
Stricture 7 996 Peto OR
(95% Cl)		 3.59
(2.02 to 6.35)		 Chi-squared
4.80
df = 5
P = 0.44		 Z = 4.38
P = 0.00001
Hemorrhage 4 662 Peto OR
(95% Cl)		 1.78
(0.84 to 3.81)		 Chi-squared
4.65
df = 3
P = 0.2		 Z = 1.49
P = 0.14
Reoperation 3 544 Peto OR
(95% Cl)		 1.94
(0.95 to 3.98)		 Chi-squared
1.73
df = 2
P = 0.42		 Z = 1.81
P = 0.07
Wound infection 6 568 Peto OR
(95% Cl)		 1.43
(0.67 to 3.04)		 Chi-squared
4.12
df = 5
P = 0.53		 Z = 0.93
P = 0.4
Anastomotic duration 1 159 WMD [Fixed]
(95% Cl)		 -7.60
(-12.92 to-2.28)		 Chi-squared
0.0
df = 0		 Z = 2.80
P = 0.005
Hospital stay 1 159 WMD [Fixed]
(95% Cl)		 2.00
(-3.27 to 7.27)		 Chi-squared
0.0
df = 0		 Z = 0.74
P = 0.5
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CI = confidence interval; OR = odds ratio; WMD = weight mean difference; df = degrees of freedom; p = p-value.

The results from the meta-analysis of the anastomotic clinical dehiscence, regarded as the main variable of this study, are shown in Figure 1.

Figure 1. Anastomotic clinical dehiscence — Meta-analysis.

Figure 1

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DISCUSSION

The basic premise of this systematic review was that by grouping studies without statistical power but with methodological quality, a sample large enough to show up any possible significant differences could be obtained. This was not observed, given that the majority (7/9) of the variables analyzed were not significantly different. Perhaps this fact can be explained by insufficient sample sizes for demonstrating the magnitude of the difference formulated, which highlights the necessity for periodic updating of this review.

The data relating to mortality show that clinical dehiscence was responsible for four deaths in the group sutured by stapling, and for two deaths in the handsewn group. The anastomotic dehiscence, evaluated clinically and radiologically, did not show a significantly different incidence between the techniques of stapling and handsewing. Infra-peritoneal colorectal anastomoses are considered to be higher in risk, accepting that more distal anastomoses are frequent hosts for this complication.17,18

The classification criteria for colorectal anastomoses in relation to this were not uniform in the literature surveyed in this review. Thus, some authors refer to endoscopic measurements for classifying anastomoses,1,3,11,12 while others classify anastomoses as high or low without referring to the criteria adopted.8

In several non-randomized studies, a greater incidence of stenosis is attributed to the technique of stapling.21–24 In the present systematic review it was observed that the length of follow-up for the stenosis parameter varied a lot between the different studies, which made comparison excessively difficult and may have made the overall result imprecise.

In this systematic review, it was also noted that stenosis occurred to a significant extent in patients submitted to colorectal anastomosis using stapling, especially in infra-perito-neal anastomoses. This scientific evidence may be considered relevant in this survey. However, the majority of the studies (7/9) considered this complication to be irrelevant from a clinical point of view, given the favorable evolution with conservative treatment in the great majority of the cases. A statistically significant difference in the results, favoring the handsewing technique, was thus expressed, albeit without there having been any relevant clinical difference between the two techniques. One explanation for the mismatch between the statistical and clinical differences is the possible lack of methodological adequacy in the studies.

The time taken to perform the anastomosis was significantly shorter in colorectal anastomoses done with the stapler than when handsewing was done. A limitation to the analysis of this variable was that only one study12 provided data (average and standard deviation) that could be introduced into the program for later statistical analysis. The time taken to perform the anastomosis has a relative value when analyzed in isolation, i.e. when not associated with the total length of the operative procedures or hospitalization of the patient. The other variables analyzed did not demonstrate any advantage of one technique over the other.

Comparing anastomoses performed by handsewing with others that are stapled, the former depend intrinsically on the ability of the surgeon, since their execution requires appropriate introduction of the needle via the layers of the intestinal wall and uniform spacing between passages of the suturing thread, among other maneuvers. In stapling, the anastomosis device performs these procedures in a uniform and automatic manner.

Various procedures may alter the security of a colorectal anastomosis. Protection colostomy,19 epiploplasty, complementary suturing and the performance or otherwise of an integrity test on the anastomosis20 are procedures frequently used by surgeons, but not in a uniform manner. In this review, the great majority of authors (8/9) used such procedures, which could interfere in the final results. It can be considered that when these manipulations are employed, the patients should be analyzed in a stratified manner.

It is possible that the results have been in some way influenced by aspects of a learning curve related to any differences in experience between surgeons participating in these studies. In addition to this learning curve, another factor related to the results from colorectal anastomoses is the adequate functioning of the instrument used. In this systematic review, some authors1,3,11 analyzed this aspect together with the experience of the surgeon. It is accepted that these two parameters, the failure of instruments and the experience of surgeons, should be analyzed independently.16

The question of cost, which was not analyzed in this survey, is related to the length of the operative procedure, length of hospitalization, price of thread and value of devices used, among other factors. This represents a variable of great importance, deserving special attention in studies with that specific objective. It is also considered that a more detailed study of costs in this review would become necessary in the event of evidence that the stapling technique was more advantageous. When only the cost of the material used in the anastomosis is taken into consideration, the stapler is more expensive. The cost of an operative procedure, however, must be analyzed within a wider context involving not only the monetary value of the materials but also the value resulting from the ease of execution, total time consumed, cost of complications related to the method employed, among other factors.

With regard to implications of a practical nature, the evidence encountered is insufficient to demonstrate the superiority of the stapling method over handsewing. The decision on which technique to use must remain at the discretion of an appropriate judgement by the surgeon, i.e. based on his personal experience, circumstantial facts and resources available. From the point of view of clinical research, it will be necessary for clinical trials developed in relation to this question to involve criteria that respect the representativeness of the sample, rigorous definition and standardization of the variables, appropriate statistical treatment of the data and stratification of risky anastomoses.

A more detailed review is published and updated in the Cochrane database of systematic reviews.25

CONCLUSION

The results of the present systematic review of the literature and meta-analysis permit the conclusion that the evidence encountered is insufficient to demonstrate superiority of the stapling method in relation to handsewing in colorectal anastomosis, independent of the level of the colorectal anastomosis.

Biographies

Suzana Angélica da Silva Lustosa, MD. Centro Universitário Fundação Oswaldo Aranha (UniFOA), Volta Redonda, Brazil.

Delcio Matos, MD, PhD. Associate Professor in Surgical Gastroenterology, Universidade Federal de São Paulo/Escola Paulista de Medicina, São Paulo, Brazil.

Álvaro Nagib Atallah, MD, PhD. Associate Professor in Emergency Medicine, Universidade Federal de São Paulo/Escola Paulista de Medicina, São Paulo, Brazil.

Aldemar Araujo Castro, MD. Universidade Federal de São Paulo/Escola Paulista de Medicina, São Paulo, Brazil.

Footnotes

Sources of funding: Discipline of Surgical Gastroenterology, Universidade Federal de São Paulo/Escola Paulista de Medicina, São Paulo, Brazil; and Centro Universitário Fundação Oswaldo Aranha (UniFOA), Volta Redonda, Brazil

Discipline of Surgical Gastroenterology, Universidade Federal de São Paulo/Escola Paulista de Medicina, and Centro Cochrane do Brasil, São Paulo, Brazil

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