Study of Fundoplication on the Excluded Stomach to Treat Severe Reflux After One-Anastomosis Gastric Bypass Surgery

What this Trial Is About

This research aims to evaluate the effectiveness of fundoplication with the stomach excluded in reducing severe gastroesophageal reflux that requires surgery in patients who have previously undergone one anastomosis gastric bypass. The study focuses on adults who experience disabling reflux after this type of gastric bypass and seeks to provide a thorough and objective assessment of reflux suppression. It is designed as a single-center, interventional, non-randomized pilot study conducted at one site. Participants will have undergone one anastomosis gastric bypass surgery followed by fundoplication of the excluded stomach specifically to treat disabling gastroesophageal reflux that has not responded to medical treatment and requires surgical intervention. This procedure is the main intervention being evaluated. The study includes patients treated within two years prior to enrollment, and the intervention aims at reflux suppression in this particular surgical context. Throughout the study, participants will undergo objective evaluations including gastrojejunal fibroscopy, ph-impedancemetry, and abdominal CT scans to assess reflux disease. Quality-of-life questionnaires will be completed, and pregnancy tests or contraception use will be monitored for women of childbearing age. The primary outcome measured is the response rate following fundoplication over a 2-year period. Participants will be followed until the study ends in December 2026, with assessments to evaluate reflux control and safety.

Evaluation of the Fundoplicature of the Excluded Stomach Post Omega Bypass