About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Bypass surgery type one anastomosis gastric bypass
Treatment groups
Sponsors and collaborators
GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead sponsor
Euraxi Pharma
Collaborator