💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
💊
What it tests
- Bypass surgery type one anastomosis gastric bypass
Clinique des Cèdres
Cornebarrieu, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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