CClinicalTrials.gg
RecruitingNCT06621979FEE-RGOICUpdated Jul 2, 2026

Evaluation of the Fundoplicature of the Excluded Stomach Post Omega Bypass

An interventional study of Bypass surgery type one anastomosis gastric bypass in Bypass, Gastric, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bypass, Gastric
03

In context

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 198 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (estimated)

Study arms

  • Experimental
    Gastroesophageal reflux disease

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

    Procedure: Bypass surgery type one anastomosis gastric bypass

Interventions

  • ProcedureBypass 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.

06

What researchers measure

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.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Clinique des Cèdres
    Cornebarrieu, 31700, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06621979
Lead sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Collaborators
Euraxi Pharma
Responsible party
Sponsor
First posted
Oct 1, 2024
Start date
Nov 24, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 2, 2026

Study contacts

Arnaud LIAGRE, MD
Contact
arnaud.liagre@orange.fr
0562132758 ext. + 33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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