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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinique des Cèdres
  Cornebarrieu, France Recruiting

Study contacts

• Study coordinator: Arnaud LIAGRE, MD
• Email: arnaud.liagre@orange.fr
• Phone: 0562132758

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.