Evaluation of the Fundoplicature of the Excluded Stomach Post Omega Bypass

NCT ID: NCT06621979

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-24
• Study Completion Date: 2026-12-31

Brief Summary

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.

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.

Conditions

Bypass, Gastric

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Gastroesophageal reflux disease

Disabling post-bypass gastroesophageal reflux, resistant to medical treatment and requiring surgery

Group Type: EXPERIMENTAL

Bypass surgery type one anastomosis gastric bypass

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Euraxi Pharma

INDUSTRY

Sponsor Role: collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique des Cèdres

Cornebarrieu, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Arnaud LIAGRE, MD

Role: CONTACT

arnaud.liagre@orange.fr

0562132758 ext. + 33

Facility Contacts

Arnaud LIAGRE, MD

Role: primary

arnaud.liagre@orange.fr

+ 33 (0)5 62 13 27 58

Other Identifiers

2023-A02501-44

Identifier Type: -

Identifier Source: org_study_id