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New treatment option for Bypass, Gastric
Official title Evaluation of the Fundoplicature of the Excluded Stomach Post Omega Bypass
ClinicalTrials.gov ID: NCT06621979
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years;
- Patient operated for one anastomosis gastric bypass followed by Fundoplicature with stomach excluded for disabling gastroesophageal reflux requiring...
- 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...
You likely can't join if
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cornebarrieu, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cornebarrieu, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.