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

BACKGROUND Randomized controlled trials comparing stapled with handsewn colorectal anastomosis have not shown either technique to be superior, perhaps because individual studies lacked statistical power. A systematic review, with pooled analysis of results, might provide a more definitive answer. OBJECTIVES To compare the safety and effectiveness of stapled and handsewn colorectal anastomosis. The following primary hypothesis was tested: the stapled technique is more effective because it decreases the level of complications. SEARCH STRATEGY The RCT register of the Cochrane Review Group was searched for any trial or reference to a relevant trial (published, in-press, or in progress). All publications were sought through computerised searches of EMBASE, LILACS, MEDLINE, the Cochrane Controlled Clinical Trials Database, and through letters to industrial companies and authors. There were no limits upon language, date, or other criteria. SELECTION CRITERIA STUDIES All randomized clinical trials (RCTs) in which stapled and handsewn colorectal anastomosis were compared. PARTICIPANTS Adult patients submitted electively to colorectal anastomosis. INTERVENTIONS Endoluminal circular stapler and handsewn colorectal anastomosis. OUTCOMES a) Mortality b) Overall Anastomotic Dehiscence c) Clinical Anastomotic Dehiscence d) Radiological Anastomotic Dehiscence e) Stricture f) Anastomotic Haemorrhage g) Reoperation h) Wound Infection i) Anastomosis Duration j) Hospital Stay. DATA COLLECTION AND ANALYSIS Data were independently extracted by the two reviewers (SASL, DM) and cross-checked. The methodological quality of each trial was assessed by the same two reviewers. Details of the randomization (generation and concealment), blinding, whether an intention-to-treat analysis was done, and the number of patients lost to follow-up were recorded. The results of each RCT were summarised on an intention-to-treat basis in 2 x 2 tables for each outcome. External validity was defined by characteristics of the participants, the interventions and the outcomes. The RCTs were stratified according to the level of colorectal anastomosis. The Risk Difference method (random effects model) and NNT for dichotomous outcomes measures and weighted mean difference for continuous outcomes measures, with the corresponding 95% confidence interval, were presented in this review. Statistical heterogeneity was evaluated by using funnel plot and chi-square testing. MAIN RESULTS Of the 1233 patients enrolled ( in 9 trials), 622 were treated with stapled, and 611 with manual, suture. The following main results were obtained: a) Mortality: result based on 901 patients; Risk Difference - 0.6% Confidence Interval -2.8% to +1.6%. b) Overall Dehiscence: result based on 1233 patients; Risk Difference 0.2%, 95% Confidence Interval -5.0% to +5.3%. c) Clinical Anastomotic Dehiscence : result based on 1233 patients; Risk Difference -1.4%, 95% Confidence Interval -5.2 to +2.3%. d) Radiological Anastomotic Dehiscence : result based on 825 patients; Risk Difference 1.2%, 95% Confidence Interval -4.8% to +7.3%. e) Stricture: result based on 1042 patients; Risk Difference 4.6%, 95% Confidence Interval 1.2% to 8.1%. Number needed to treat 17, 95% confidence interval 12 to 31. f) Anastomotic Hemorrhage: result based on 662 patients; Risk Difference 2.7%, 95% Confidence Interval - 0.1% to +5.5%. g) Reoperation: result based on 544 patients; Risk Difference 3.9%, 95% Confidence Interval 0.3% to 7.4%. h) Wound Infection: result based on 567 patients; Risk Difference 1.0%, 95% Confidence Interval -2.2% to +4.3%. i) Anastomosis duration: result based on one study (159 patients); Weighted Mean Difference -7.6 minutes, 95% Confidence Interval -12.9 to -2.2 minutes. j) Hospital Stay: result based on one study (159 patients), Weighted Mean Difference 2.0 days, 95% Confidence Interval -3.27 to +7.2 days. REVIEWER'S CONCLUSIONS The evidence found was insufficient to demonstrate any superiority of stapled over handsewn techniques in colorectal anastomosis, regardless of the level of anastomosis.

[1]  R. McLeod,et al.  Handsewnvs. stapled anastomoses in colon and rectal surgery , 1998, Diseases of the colon and rectum.

[2]  W. Stremmel,et al.  Prospective study of hand‐sutured anastomosis after colorectal resection , 1996, The British journal of surgery.

[3]  A. Fingerhut,et al.  Supraperitoneal colorectal anastomosis: hand-sewn versus circular staples--a controlled clinical trial. French Associations for Surgical Research. , 1995, Surgery.

[4]  R. J. Hayes,et al.  Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. , 1995, JAMA.

[5]  R. Heald,et al.  Leakage from stapled low anastomosis after total mesorectal excision for carcinoma of the rectum , 1994, The British journal of surgery.

[6]  S. K. Sarker,et al.  A comparison of stapled vs handsewn anastomosis in anterior resection for carcinoma rectum. , 1994, Indian journal of cancer.

[7]  K. Mealy,et al.  Anterior resection without a defunctioning colostomy: questions of safety , 1992, The British journal of surgery.

[8]  W. George,et al.  Suturing or stapling in gastrointestinal surgery: A prospective randomized study , 1991, The British journal of surgery.

[9]  M. Kracht [The best anastomoses after colonic resection]. , 1991, Annales de chirurgie.

[10]  R. Sayers,et al.  Intraoperative air testing of colorectal anastomoses: A prospective, randomized trial , 1990, The British journal of surgery.

[11]  G. Compagno,et al.  Advantages and disadvantages of mechanical vs. manual anastomosis in colorectal surgery. A prospective study. , 1990, Acta chirurgica Scandinavica.

[12]  R. Sanz,et al.  Results of surgery for cancer of the rectum with sphincter conservation. A randomized study on instrumental versus manual anastomosis. , 1989 .

[13]  P. Clifford,et al.  Staples or sutures for low colorectal anastomoses: A prospective randomized trial , 1985, The British journal of surgery.

[14]  H. Poser,et al.  [Technic of rectum anastomoses in rectum resection. A controlled study: instrumental suture versus hand suture]. , 1984, Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen.

[15]  R. Heald,et al.  The low stapled anastomosis , 1981, The British journal of surgery.

[16]  R. Beart,et al.  Randomized prospective evaluation of the EEA stapler for colorectal anastomoses. , 1981, American journal of surgery.

[17]  J. Bowen,et al.  Experience with the EEA stapling device. , 1980, American Journal of Surgery.

[18]  M. Ravitch,et al.  A Stapling Instrument for End‐to-end Inverting Anastomoses in the Gastrointestinal Tract , 1979, Annals of surgery.

[19]  L. Morgenstern,et al.  Use of a mechanical suturing apparatus in low colorectal anastomosis. , 1975, Archives of surgery.

[20]  W. G. Everett A comparison of one layer and two layer techniques for colorectal anastomosis , 1975, The British journal of surgery.

[21]  E. Odeblad,et al.  Autoradiography with Isotopes Emitting Internal Conversion Electrons and Auger Electrons , 1964 .