Simpler Weight-Loss surgery put to the test against gold standard
NCT ID NCT06057597
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two types of gastric bypass surgery for people with severe obesity: the standard Roux-en-Y and a simpler omega (one-anastomosis) bypass with a shorter intestinal loop. Researchers want to see if the omega procedure is just as good at helping patients lose weight and has a similar rate of nutritional problems. About 368 adults will be followed for 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
- Gastric bypass surgery (omega or Roux-en-Y)
- What this could lead to
- If successful, this could offer a simpler, equally effective surgical option for weight loss with fewer complications.
- What could go wrong
- This is a non-inferiority trial, so it may only show the omega bypass is not worse, not better. Results are at 2 years, and long-term effects are unknown.
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
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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
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About 368 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 aged from 18 to 65 years old * Type III obesity (BMI ≥ 40 kg/m²), or Type II obesity BMI 35-40 kg/m2 associated with at least one co-morbidity which will be improved by surgery (high blood pressure, type 2 diabetes mellitus, obstructive sleep apnea, dyslipidemia, arthrosis) * Patient who had benefited from an Upper GI Endoscopy with biopsies to look for Helicobacter pylori within 12 months before surgery * Patient who has benefited from a multidisciplinary evaluation at least 6 months, with a favorable opinion for a gastric bypass * Patient who understood and accepted the need for a long-term follow-up * Patient who agreed to be included in the study and who signed the informed consent form * Patient affiliated to a social security scheme * For child-bearing aged women, efficient contraception Exclusion Criteria: * History of previous bariatric surgery * History of chronic inflammatory bowel disease * Presence of chronic diarrhea * Presence of a severe and evolutive life threatening pathology * Presence of dysplastic modifications of the gastric mucosa, chronic atrophic gastritis or history of gastric cancer * Presence of an unhealed gastro-duodenal ulcer * Presence of Helicobacter pylori resistant to medical treatment * Presence of esophagitis * Pregnancy or desire to be pregnant during the study * Mentally unbalanced patients, under supervision or guardianship * Patients who don't understand French and not able to give consent * Patient included and followed in another interventional trial * Unable to consent, under tutelage or curatorship, or judiciary safeguard * Presence of type 1 diabetes
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Hôpital Bichat Claude-Bernard
RECRUITINGParis, France
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