Evaluation of Post-Omega Bypass Excluded Stomach Fundoplication to Treat Disabling Gastroesophageal Reflux Disease Resistant to Medical Treatment and Requiring Surgery

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Clinique des Cèdres
RECRUITING
Cornebarrieu
Contact Information
Primary
Arnaud LIAGRE, MD
arnaud.liagre@orange.fr
0562132758
Time Frame
Start Date: 2025-11-24
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 17
Treatments
Experimental: Gastroesophageal reflux disease
Disabling post-bypass gastroesophageal reflux, resistant to medical treatment and requiring surgery
Sponsors
Leads: GCS Ramsay Santé pour l'Enseignement et la Recherche
Collaborators: Euraxi Pharma

This content was sourced from clinicaltrials.gov