Evaluation of the Fundoplicature of the Excluded Stomach Post Omega Bypass (FEE-RGOIC)

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

The purpose of this study is to evaluate the efficacy of fundoplication with stomach excluded in the suppression of disabling gastroesophageal reflux requiring surgery in patients who have undergone one anastomosis gastric bypass, with complete objective evaluation of reflux.

Study Overview

• Status: Recruiting
• Conditions: Bypass, Gastric
• Intervention / Treatment: Procedure: Bypass surgery type one anastomosis gastric bypass

Detailed Description

The FEE& RGOIC trial is a single-center, ambispective, interventional, non-randomized pilot study to evaluate the efficacy of Fundoplicature with stomach excluded objectively and comprehensively in the treatment of disabling gastroesophageal reflux requiring gastric bypass after anastomosis.

The strategy under study is objective reflux suppression after fundoplication with the stomach excluded in the following specific context: treatment of disabling gastroesophageal reflux requiring post-bypass surgery in Omega.

The eligible study population will be any adult patient at the investigating center who has undergone one-anastomosis gastric bypass surgery followed by fundoplication of the excluded stomach as part of treatment for disabling post-bypass gastro-oesophageal reflux, resistant to medical treatment and requiring surgery.

• Study Type: Interventional
• Enrollment (Estimated): 17
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arnaud LIAGRE, MD; Phone Number: + 33 0562132758; Email: arnaud.liagre@orange.fr

Study Locations

• France
  • Cornebarrieu, France, 31700
    • Recruiting
    • Clinique des Cèdres
    • Contact: Arnaud LIAGRE, MD; Phone Number: + 33 (0)5 62 13 27 58; Email: arnaud.liagre@orange.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gastroesophageal reflux disease; Disabling post-bypass gastroesophageal reflux, resistant to medical treatment and requiring surgery	Procedure: Bypass surgery type one anastomosis gastric bypass; Adult patients who have undergone single-anastomosis gastric bypass followed by fundoplication of the excluded stomach for the treatment of disabling post-bypass gastroesophageal reflux, resistant to medical treatment and requiring surgical intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate after Fundoplicature with stomach excluded	The primary endpoint is the long-term efficacy of Fundoplicature with stomach excluded in the treatment of disabling Gastroesophageal Reflux Disease requiring Omega post-bypass surgery after surgery.	2 years

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Collaborators: Euraxi Pharma

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2023-A02501-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No