Immediate definitive surgery for perforated duodenal ulcers: a prospective controlled trial.

A prospective, randomized, double-blind trial was conducted in 101 patients to evaluate the safety and benefits of immediate definitive surgery for perforated duodenal ulcers. These patients, who were judged by predefined criteria to be medically fit and to have perforations in chronic ulcers, were randomized to undergo simple closure (35 patients), truncal vagotomy and drainage (VD) (32 patients), or proximal gastric vagotomy with closure (PGV) (34 patients). Patients were followed with endoscopic assessment for up to 39 months. There was no mortality and only a few minor postoperative complications. At 39 months follow-up, the cumulative rates of recurrence were 63.3%, 11.8% and 3.8% after closure, VD, and PGV, respectively (p less than 0.001). With the exception of the one recurrence after PGV, all relapses were symptomatic, and eight of these 18 required reoperation. Relapse rates and Visick scores between VD and PGV were significantly different. Both safe as well as effective, immediate, nonresective, definitive operation is indicated for good-risk patients who have perforations in chronic duodenal ulcers.

RCT Entities:   Population Interventions Outcomes