Bypass, Gastric
Conditions
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& 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.
Interventions
PROCEDUREBypass surgery type one anastomosis gastric bypass
Adult 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.
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Euraxi Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
Single-center, ambispective, interventional, non-randomized pilot study
Intervention model description
This is a pilot study that aims to objectively assess the resolution of gastroesophageal reflux following fundoplication with gastric exclusion in the following specific context: the treatment of debilitating gastroesophageal reflux requiring post-Omega bypass surgery. This is not a comparative study of treatment arms. However, the study aims to compare data from pre- and post-operative examinations in order to observe the effect of the procedure on the objective assessment of gastroesophageal reflux symptoms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate after Fundoplicature with stomach excluded | 2 years | 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. |
Countries
France
Contacts
CONTACTArnaud LIAGRE, MD
Outcome results
None listed