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Stomach stitching may cut reflux after gastric sleeve

NCT ID NCT04994665

Disease control Sponsor: Centre Hospitalier Departemental Vendee Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether adding a stitch (omentopexy) during sleeve gastrectomy reduces new cases of acid reflux. 526 adults with obesity will be randomly assigned to get the standard sleeve or the sleeve plus stitch. Researchers will check reflux symptoms and medication use two years after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sleeve gastrectomy with omentopexy (a surgical procedure where the omentum is stitched to the stomach after sleeve gastrectomy)
What this could lead to
If it works, this could reduce the need for acid-reflux medication after sleeve gastrectomy, improving quality of life for people with obesity.
What could go wrong
This is a surgical technique study, not a new drug. The benefit may be small, and results may not apply to all patients. Risks include surgical complications like infection or bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 526 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient ≥ 18 years old, * Patient to be operated in first intention of a sleeve gastrectomy * Initial BMI between 35Kg/m² and 40 Kg/m² associated with at least one severe comorbidity likely to be improved after surgery according to HAS recommendations. OR initial BMI ≥ 40 Kg/m². * Multidisciplinary follow-up of at least 6 months before surgery * Validation of the surgical intervention in a multidisciplinary consultation meeting * Certificate of no contraindication by a psychiatrist * Patient who has the capacity to understand the protocol and has given consent to participate in the research, * Patient with social security coverage. Exclusion Criteria: * Eating disorder or mental disorder * Misunderstanding of the protocol * Psychiatric contraindication * Initial BMI \<35Kg/m². * Initial BMI between 35Kg/m² and 40 Kg/m² without comorbidities. * Esophagitis of grade B and above on the Oeso-Gastro-Duodenal Fibroscopy * CARLSSON score (score ≥ 4) preoperatively * Presence of a Proton-Pump Inhibitors treatment * Patient to have a 2-stage surgery (first sleeve gastrectomy then gastric bypass or Single Anastomosis Duodeno-Ileal bypass) * Patient participating in another interventional clinical research protocol involving a drug or medical device * Patient who are pregnant, breastfeeding, or who have the potential to become pregnant without effective contraception at the time of inclusion and up to 24 months after surgery * Patient under guardianship, curators or legal protection,P

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder gastroesophageal reflux disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH de la Cote Basque

    RECRUITING

    Bayonne, France

  • CHD Vendée

    RECRUITING

    La Roche-sur-Yon, 85000, France

  • CHU Nantes

    RECRUITING

    Nantes, 44000, France

  • Centre Hospitalier Emile Roux

    RECRUITING

    Le Puy-en-Velay, 43012, France

  • Centre Hospitalier Régional et Universitaire d'Orléans

    RECRUITING

    Orléans, France

  • Clinique Jules Verne

    RECRUITING

    Nantes, 44300, France

  • Clinique Mutualiste de la Sagesse

    NOT_YET_RECRUITING

    Rennes, France

  • Clinique Santé Atlantique

    RECRUITING

    Saint-Herblain, 44800, France

  • Hopital Pontchaillou

    RECRUITING

    Rennes, 35000, France

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