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Which weight loss surgery works best? major trial launches

NCT ID NCT04915014

Disease control Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two weight loss surgeries for people with severe obesity: sleeve gastrectomy with transit bipartition (SG+TB) and Roux-en-Y gastric bypass (RYGB). About 320 participants will be followed for two years to see which surgery leads to greater weight loss and fewer side effects. The goal is to find the best surgical option for long-term weight control and health improvement.

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 320 people

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

Started

Jul 2021

Expected to finish

Jul 2026

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 to 65 years

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 who has benefited from a pluridisciplinary evaluation, with a favorable opinion for SG+TB or RYGB as a first intention procedure with BMI ≥40 kg/m2 or BMI ≥ 35 kg/m2 associated with one co-morbidity which will be improved by surgery (according to HAS 2009 recommendation3) OR as a second intention procedure (revisional surgery) after failure of Sleeve gastrectomy (defined as insufficient weight loss at 18 months after surgery (EWL% \<50), or as weight regain (+ 20%)). * Patient who had benefited from an Upper GI Endoscopy with biopsies to look for Helicobacter Pylori (HP) and a HP eradication. * Patient who understands and accepts the need for a long-term follow-up * Patient who agrees to be included in the study and who signs the informed consent form * Patient affiliated to a healthcare insurance plan Exclusion Criteria: * History of previous bariatric surgery, other than a Sleeve Gastrectomy * Patient with current BMI \> 60 kg/m2 * Presence of a severe and evolutive life threatening pathology, unrelated to obesity * History of Chronic inflammatory bowel disease * Type 1 Diabetes * Pregnancy or desire to be pregnant during the study * Nursing woman * Presence of Pylori Helicobacter resistant to medical treatment * Presence of a non-healed gastro-duodenal ulcer or diagnosed less than 2 months previously * Severe esophagitis (grade C of Los Angeles classification) * Hiatal hernia * Patients with unstable psychiatric disorder, under supervision or guardianship * Patient who does not understand French/ is unable to give consent * Patient not affiliated to a French or European healthcare insurance * Patient who has already been included in a trial which has a conflict of interests with the present study * Patient incarcerated

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Conditions

The condition(s) this trial relates to.

Malnutrition metabolic syndrome X morbid obesity type 2 diabetes mellitus

As listed by the trial registrant

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

Severe obesity

Contacts and locations

Locations

  • AP-HP Hôpital Bichat

    Paris, France

  • AP-HP Hôpital Georges Pompidou

    Paris, France

  • CHU Orléans

    Orléans, France

  • CHU de Lyon

    Lyon, France

  • CHU de Nancy

    Vandœuvre-lès-Nancy, France

  • CHU de Nantes

    Nantes, France

  • CHU de Poitiers

    Poitiers, France

  • Hop Claude Huriez Chu Lille

    Lille, 59037, France

More trials for these conditions

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