Clinical trial NCT06621979: Evaluation of the Fundoplicature of the Excluded Stomach Post Omega Bypass
Official title: Evaluation of Post-Omega Bypass Excluded Stomach Fundoplication to Treat Disabling Gastroesophageal Reflux Disease Resistant to Medical Treatment and Requiring Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bypass, Gastric
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2024-10-01
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Single-center, ambispective, interventional, non-randomized pilot study
Primary purpose: PREVENTION

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\&amp; 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.

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.

Primary outcomes:
measure: Response rate after Fundoplicature with stomach excluded
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cornebarrieu
country: France
facility: Clinique des Cèdres
Study officials:
References: