RecruitingNAINTERVENTIONAL

Evaluation of the Fundoplicature of the Excluded Stomach Post Omega Bypass

This study is investigating a specific surgical approach for adults who have previously undergone a type of weight-loss operation called a one-anastomosis gastric bypass. Sometimes, after this bypass surgery, people can experience very troubling acid reflux that medication can't fix. The study aims to see how effective an additional procedure, called a fundoplication, is in stopping this severe reflux. In this fundoplication, doctors wrap a part of the stomach that's been left out of the main food path. They want to objectively measure if this second operation successfully reduces the reflux symptoms, helping people feel better after their initial weight-loss surgery.

At a glance

Status

Recruiting

Phase

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Enrolment target

Start

24 Nov 2025

Estimated completion

31 Dec 2026

Bypass, Gastric

What is this study about?

This study is designed for people who have had a particular type of weight-loss surgery called a one-anastomosis gastric bypass. While this surgery is very effective for weight loss, a small number of people might later develop significant problems with acid reflux, where stomach acid flows back up into the food pipe, causing discomfort and pain, even with medication.

Doctors are exploring if a special follow-up operation, known as a fundoplication, can effectively treat this severe reflux. During this procedure, a portion of the stomach that was excluded from the main digestive route during the initial bypass surgery is carefully wrapped around the lower part of the food pipe. The aim is to create a new valve and strengthen the barrier to prevent acid from coming up.

The main goal of this study is to thoroughly check how well this fundoplication procedure works to stop the acid reflux. They will use different tests to objectively measure the reflux before and after the surgery, rather than just relying on how a patient feels. This helps them understand if this combined surgical approach can be a good solution for people struggling with severe reflux after their weight-loss bypass surgery.

Key takeaways

This study evaluates an operation for acid reflux after weight-loss surgery.
It's for people who've already had a 'one-anastomosis gastric bypass' and then a 'fundoplication' for severe reflux.
The goal is to objectively measure how well the fundoplication stopped the reflux.
It helps doctors understand better treatments for patients with ongoing reflux problems.
Your participation helps improve care for others in the future.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. You must have had a one-anastomosis gastric bypass surgery within the last two years, followed by the special fundoplication procedure to treat severe acid reflux that couldn't be controlled with medicines. Your reflux must have been severe enough to require surgery in the first place, and you should have lost more than half of your original excess weight.

Before your fundoplication, doctors would have done objective tests (like scopes or pH monitoring) to check your acid reflux. You'll need to be able to understand the study information, fill out questionnaires about your quality of life, and be willing to come for follow-up checks. If you're a woman of childbearing age, you'll need to be using effective contraception.

You cannot join if you needed a different type of bypass surgery (Y-bypass) for your reflux, or if you had a repair for a hiatal hernia at the same time as your bypass. Also, if you're already in another clinical trial, have issues with your diet, or have difficulty understanding information for various reasons, you won't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Did you have a one-anastomosis gastric bypass *and* then a fundoplication for severe reflux within the last two years?
Did medical treatments not work for your reflux before your fundoplication?
Have you lost more than half of your original excess weight?
Can you understand study information and fill out questionnaires?
If you're a woman of childbearing age, are you using effective birth control?

Answer every question to see your result.

What does participation involve?

This study is taking place at a single medical centre. If you join, your doctors will follow your health and the effects of the fundoplication procedure. They will collect information from your existing medical records and objective tests (like gastroscopy, pH monitoring, and CT scans) that were done shortly before joining the study to assess your reflux. You will also be asked to complete quality-of-life questionnaires. While the study itself doesn't involve new medications or a new operation, it looks at the results of the fundoplication procedure you've already had. The total duration of your participation will depend on the follow-up schedule set by the study, but it will be after the fundoplication surgery which occurred within the last two years.

Potential risks and benefits

Participating in this study might help us understand more about effective treatments for severe acid reflux after weight-loss surgery, potentially benefiting future patients. Since the study looks at a procedure you've already had, there aren't new surgical risks involved with *participating* in the study itself. However, as with any medical procedure, the fundoplication operation you've undergone carried its own risks, which your surgical team would have discussed with you at the time. You have the right to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Clinique des Cèdres
Verified postcode
Cornebarrieu, France· Recruiting

Common questions

What is 'one-anastomosis gastric bypass'?

It's a type of weight-loss surgery where a smaller stomach pouch is created and connected to a loop of your small intestine.

What is 'acid reflux'?

This is when stomach acid flows back up into your food pipe, causing heartburn, discomfort, or other symptoms.

What is 'fundoplication'?

It's an operation where part of your stomach is wrapped around the bottom of your food pipe to tighten it and prevent acid reflux.

Will I have to take new medicines for this study?

No, this study is about evaluating a surgery you've already had, not testing new medicines.

Will this study change my current medical care?

No, your medical care will not be affected by your participation in this study.

How to find out more

Arnaud LIAGRE, MD

arnaud.liagre@orange.fr 0562132758 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.