Prospective controlled vagotomy trial for duodenal ulcer: primary results, sequelae, acid secretion, and recurrence rates two to five years after operation.

In a prospective, controlled clinical trial, vagotomies for duodenal, pyloric, and prepyloric ulcers were performed on 259 patients. Eighty-three patients were randomly selected for truncal vagotomy and drainage (TV + D), 93 patients were randomly selected for selective gastric vagotomy and drainage (SV + D) and 83 patients were randomly selected for parietal cell vagotomy without drainage (PCV). This interim report deals with the primary results, reduction in acid secretion, sequelae, and recurrence rates two to five years after the operation. One patient died after the operation. Postoperative complications were evenly distributed between the three operations. No differences in spontaneous acid secretion (BAO), peak acid output after pentagastrin stimulation (PAOP), or peak acid output after insulin stimulation (PAOI) were found. Patients with recurrent ulcers ahd smaller reductions in BAO than patients without ulcer recurrences, although not significantly. Patients with ulcer recurrences after TV + D had, in contrast to ulcer recurrences after SV + D and PCV, a significantly smaller reduction in PAOP than patients without recurrences. The overall recurrence rate was 13%: 10% after TV + D, 14% after SV + D and 16% after PCV. The risk of ulcer recurrence within the first three years, calculated by an actuarial method, was found to be significantly higher after PCV (0.52% per month) than after TV + D (0.32% per month), but not different from SV + D (0.42% per month). In contrast to TV + D and SV + D, no recurrences after PCV occurred after three years--25% of the patients were followed for five years. It is concluded that the trial, at present, does not point to any evident superiority of PCV.

RCT Entities:   Population Interventions Outcomes