A randomized multicenter trial to compare functional outcome and complications of surgical procedures for low rectal cancers

Abstract

Background. The outcomes after different low rectal resection types applied for rectal cancer treatment are still uncertain. The aim of the investigation was to evaluate longterm functional results, the rate of complications and post-operative lethality after rectum low resection operations (connection with J-pouch group: coloplasty-group 2 and "straight" anastomosis-group 3). Patients and methods. In 2003, a randomized study was started and completed on December 2007. The study included 82 patients (38 females and 44 males). The patients were randomized into three groups. They were suffering from cancer stage I-III. Results. There were no postoperative deaths after 82 resections with total mesorectal excision (TME) and low connection. The overall rate of postoperative complications was 28%, and the rate of anastomosis suture leakage was 11%. The rate of postoperative complications was 20.7% (6 patients) in group 1, 28.6% (6 patients) in group 2, 34.3% (11 patients) in group 3. The rate of complications was substantially higher in groups 2 and 3; however, this difference was statistically not significant (p = 0.2636). The functional results after 3, 6, 9, 12 and 24 months showed no statistical difference among the groups; moreover functional results after 24 months in all groups were similar (p = 0.046). Anastomosis with or without pouch does not influence postoperative lethality. The incidence of complications and suture leakage is higher in cases of straight anastomosis; however, this finding is not statistically significant. Necrosis was observed only in patients for whom anastomosis with pouches was performed. Conclusion. Comparison of functional results after 3, 6, 9, 12 and 24 months showed no statistically significant differences among the groups.The necrosis of pulleddown bowel was observed only in the pouch groups.

Meta-analysis of reconstruction techniques after low anterior resection for rectal cancer

“…In all trials except that by Liang et al , who performed laparoscopic hand‐assisted LAR with either colonic J pouch or straight CAA, the operations were accomplished via an open approach. Seventeen of the 21 trials were undertaken in a single centre; the remaining four were multicentre trials, with the number of centres ranging from two to ten.…”

“…gives an overview of the risk of bias assessment. Random sequence generation and allocation concealment were unclear in eight of 21 trials. The remaining 13 used appropriate randomization methods.…”

“…Outcome assessors were blinded in five trials. The risk of attrition bias was low in 11 studies. Information on withdrawals and losses to follow‐up was insufficient in the other ten trials.…”

“…Because none of the trials was preceded by a published protocol, the risk of selective reporting was judged acceptable when the endpoints were defined clearly in the methods section of the individual trials. The risk of selective reporting remained unclear in eight trials.…”

“…Several trials showed better functional outcomes for the colonic J pouch, and a Cochrane review from 2008 supported this suggestion. A number of recent randomized clinical trials (RCTs) have addressed this issue, thus extending the evidence for the individual techniques. The purpose of this study was to analyse the overall evidence in order to identify the ideal technique(s).…”