Six-year results of a prospective, randomized trial of selective proximal vagotomy with and without pyloroplasty in the treatment of duodenal, pyloric, and prepyloric ulcers.

In a consecutive series of patients with uncomplicated prepyloric, pyloric, or duodenal ulcer, 39 patients were randomly allocated to selective proximal vagotomy with pyloroplasty, and 40 patients to selective proximal vagotomy alone with no operative mortality. Before surgery, all patients had undergone H2-receptor antagonist treatment. No patient was lost for follow-up. At an average follow-up of 6 years, recurrent ulcer was recorded in 15% and 20%, respectively, after selective proximal vagotomy with and without pyloroplasty. Three of 14 recurrent ulcers were asymptomatic. Epigastric pain with or without ulcer was significantly less common after selective proximal vagotomy with (13%) than without pyloroplasty (40%). Mild diarrhea or mild dumping was recorded in a few patients. The overall results were very good or good (Visick I or II) in 77% and 55% (significant difference) after vagotomy with and without pyloroplasty, respectively, and in 82% and 58%, if asymptomatic ulcers were graded as Visick I or II results. Of the 27 patients with Visick III or IV results, three patients needed no treatment (asymptomatic ulcers), and 10 patients had no symptoms during medical treatment. Two patients with vagotomy and pyloroplasty and nine with vagotomy alone were reoperated. There were no deaths, and the results were graded as Visick I or II in 10 patients and as Visick III in one patient. The authors conclude that selective proximal vagotomy with pyloroplasty is superior to vagotomy alone for the treatment of prepyloric-pyloric and duodenal ulcer. Recurrent ulcer after vagotomy has a benign course and responds well to ranitidine treatment.

RCT Entities:   Population Interventions Outcomes