Fundoplication of the excluded stomach after one‑anastomosis (omega) gastric bypass

Evaluation of Post-Omega Bypass Excluded Stomach Fundoplication to Treat Disabling Gastroesophageal Reflux Disease Resistant to Medical Treatment and Requiring Surgery

This will try fundoplication of the excluded stomach to stop severe reflux in adults who had a one‑anastomosis (omega) gastric bypass and did not get relief from medicines.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 17 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche (Academic / other)
• Locations: 1 site (Cornebarrieu)
• Trial ID: NCT06621979 on ClinicalTrials.gov

What this trial studies

This single-center, ambispective, interventional, non-randomized pilot tests whether fundoplication of the excluded stomach can objectively suppress disabling gastroesophageal reflux after one‑anastomosis gastric bypass. Adults who underwent the bypass and then received the excluded‑stomach fundoplication within two years because medical therapy failed are eligible. The protocol uses comprehensive objective evaluations such as endoscopy, pH‑impedance monitoring, and imaging to measure reflux before and after the procedure. Outcomes include objective reflux control and patient-reported quality of life measures.

Who should consider this trial

Good fit: Adults (≥18) who had a one‑anastomosis gastric bypass, have disabling reflux refractory to medical treatment, underwent fundoplication of the excluded stomach within the prior two years, and have preoperative objective reflux testing are the intended candidates.

Not a fit: Patients converted from one‑anastomosis to Roux‑en‑Y, those without objective evidence of reflux, those who respond to medical therapy, or patients with other non‑reflux causes of symptoms are unlikely to benefit.

Why it matters

Potential benefit: If successful, this procedure could markedly reduce or eliminate disabling reflux symptoms and lower the need for further complex revision surgeries, improving patients' quality of life.

How similar studies have performed: This application of excluded‑stomach fundoplication after omega bypass is relatively novel and supported mainly by small case series with mixed preliminary results.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years;
* Patient operated for one anastomosis gastric bypass followed by Fundoplicature with stomach excluded for disabling gastroesophageal reflux requiring surgery within 2 years prior to inclusion;
* Patient in failure of medical treatment;
* Weight loss greater than 50% of excess weight;
* Patient with preoperative objective investigations (gastrojejunal fibroscopy, ph-impedancemetry, abdominal CT scan) of gastroesophageal reflux disease;
* Patient able to understand study-related information and to complete quality-of-life questionnaires in the opinion of the investigator;
* Patient willing to accept study evaluations;
* For women of childbearing age, effective contraception for the duration of the study or negative blood pregnancy test;
* Patient has been informed and has given free, informed and written consent.

Exclusion Criteria:

* Patient with conversion from one anastomosis gastric bypass to Y bypass for disabling gastroesophageal reflux requiring surgery;
* Patient with concomitant hiatal hernia correction for one anastomosis gastric bypass ;
* Patient with secondary one anastomosis gastric bypass ;
* Patient with a deregulated diet;
* Patient under legal protection, or deprived of liberty by judicial or administrative decision;
* Patient unable to understand study information for linguistic, psychological, cognitive or other reasons;
* Women who are or may become pregnant, of childbearing age, without effective contraception or who are breast-feeding;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial that could interfere with the results of the present study;
* Patient not covered by a social security scheme.

Where this trial is running

Cornebarrieu

• Clinique des Cèdres — Cornebarrieu, France (Recruiting)

Study contacts

• Study coordinator: Arnaud LIAGRE, MD

Conditions Bypass, Gastric