Evaluation of the Fundoplicature of the Excluded Stomach Post Omega Bypass

NCT06621979 | Recruiting

• 1 other identifier: 2023-A02501-44
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Bypass, Gastric

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Gastroesophageal reflux disease

EXPERIMENTAL

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

Procedure: Bypass surgery type one anastomosis gastric bypass

Interventions

Bypass surgery type one anastomosis gastric bypass 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.

Gastroesophageal reflux disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• 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.

You may not qualify if:

• 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 not covered by a social security scheme.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Clinique des Cèdres

Cornebarrieu, 31700, France

RECRUITING

Central Study Contacts

Arnaud LIAGRE, MD

CONTACT

0562132758; arnaud.liagre@orange.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, ambispective, interventional, non-randomized pilot study

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 1, 2024
• Study Start: November 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)