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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
Bypass surgery type one anastomosis gastric bypass
Procedure/SurgeryAdult 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead sponsor
Euraxi Pharma
Collaborator