Immediate definitive surgery for perforated duodenal ulcer does not increase operative mortality: A prospective controlled trial

One hundred and sixty‐two patients with nonsealed perforated duodenal ulcer have been studied prospectively. These patients were randomized to undergo simple closure (83 patients) or closure and vagotomy (79 patients); the vagotomy was either a truncal vagotomy (71 patients) or a proximal gastric vagotomy (8 patients). One operative death was recorded in the simple closure group, that of a 92‐year‐old woman operated 36 hours after the onset of perforation, who died on the seventh postoperative day of infectious pulmonary complications. There were no deaths in the vagotomy group. The mortality in the 2 groups, simple closure and vagotomy, can be assumed to be similar according to a decision‐making rule based on confidence interval limits ( p < 0.05). Complications and postoperative course were similar in both groups except for wound infection, which was more frequent in the vagotomy group than in the simple closure group ( p < 0.05). Two previous prospective clinical trials have shown that relief of symptoms was better in the group treated by definitive surgery than in the control group treated by simple closure. Demonstration of similar mortality rates in simple closure and vagotomy groups failed in these 2 trials because of a high type II error. We conclude therefore, that because of equal postoperative mortality ( p < 0.05) and better long‐term results, definitive surgery is better than simple closure in the treatment of nonsealed perforated duodenal ulcer .