Emergency surgical treatment for bleeding duodenal ulcer: oversewing plus vagotomy versus gastric resection, a controlled randomized trial. French Associations for Surgical Research.

The best surgical procedure to treat bleeding bulbar peptic ulcer is unknown. The rates of postoperative bleeding recurrence, duodenal leakage, and mortality were compared in patients undergoing oversewing plus vagotomy (O+V) or gastric resection (GR) with ulcer excision. Of 202 patients undergoing emergency surgery for massive, persistent, or recurrent bleeding from bulbar peptic ulcer, 120 patients were enrolled in a prospective randomized trial. Fifty-nine were assigned to O+V and 61 to GR. One patient in each group was excluded after randomization. The two groups were well matched with respect to clinical and prognostic factors. The rate of postoperative bleeding recurrence was 17% after O+V and 3% after GR (p < 0.05). The duodenal leak rate was higher after GR than after O+V (13% vs. 3%) (p < 0.10) but was not different when the morbidity of reoperations for bleeding recurrence after O+V was considered on an "intention to treat" basis (12% vs. 13%). Overall postoperative mortality was similar: 22% (O+V) versus 23% (GR). Sixteen deaths were unrelated to the surgical procedure itself. Of 82 nonrandomized patients, 10 were not analyzed. In the 72 other nonrandomized patients, bleeding recurrence, duodenal leakage, and postoperative mortality rates were consistent with the results of the controlled trial, as they were 29% (O+V 32%; GR 0.7%), 16% (O+V 0.7%; GR 26%) and 27% (O+V 18%; GR 33.3%), respectively. We conclude that GR with ulcer excision is the procedure of choice for the emergency surgical treatment of bleeding duodenal ulcer because postoperative bleeding recurrence is lower, and the overall rates of mortality and duodenal leakage are the same as with O+V.

RCT Entities:   Population Interventions Outcomes