Omentoplasty in the prevention of anastomotic leakage after colonic or rectal resection: a prospective randomized study in 712 patients. French Associations for Surgical Research.

OBJECTIVE To investigate the role of omentoplasty (OP) in the prevention of anastomotic leakage after colonic or rectal resection. SUMMARY BACKGROUND DATA It has been proposed that OP--wrapping the omentum around the colonic or rectal anastomosis--reinforces intestinal sutures with the expectation of lowering the rate of anastomotic leakage. However, there are no prospective, randomized trials to date to prove this. METHODS Between September 1989 and March 1994, a total of 705 patients (347 males and 358 females) with a mean age of 66 +/- 15 years (range, 15-101) originating from 20 centers were randomized to undergo either OP (n = 341) or not (NO, n = 364) to reinforce the colonic anastomosis after colectomy. Patients had carcinoma, benign tumor, colonic Crohn's disease, diverticular disease of the sigmoid colon, or another affliction located anywhere from the right colon to and including the midrectum. Patients undergoing emergency surgery were not included. Random allotment took place once the resection and anastomosis had been performed, the surgeon had tested the anastomosis for airtightness, and the omental flap was deemed feasible. Patients were divided into four strata: ileo- or colocolonic anastomosis, supraperitoneal ileo- or colorectal anastomosis, infraperitoneal ileo- or colorectal anastomosis, and ileo- or coloanal anastomosis. The primary end point was anastomotic leakage. Secondary end points included intra- and extraabdominal related morbidity and mortality. Severity of anastomotic leakage was based on the rate of repeat operations and related deaths. RESULTS Both groups were comparable in terms of preoperative characteristics. Intraoperative findings were similar, except that there were significantly more septic operations and abdominal drainage performed in the NO group (p < 0.05 and p < 0.01, respectively). Thirty-five patients (4.9%) had postoperative anastomotic leakage, 16 in the OP group (4.7%) and 19 in the NO group (5.2%). There were 32 deaths (4.5%), 17 (4.9%) in the OP group and 15 (4.2%) in the NO group. Five patients with anastomotic leakage died (0.8%), 2 of whom had OP. There were 37 repeat operations (30%), 12 (6 in each group) for anastomotic leakage. Repeat operation was associated with fatal outcome in 14% of cases. The rate of these and the other intra- and extraabdominal complications did not differ significantly between the two groups. CONCLUSION OP to reinforce colorectal anastomosis decreases neither the rate nor the severity of anastomotic failure.