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Newer Weight-Loss surgery may beat the gold standard

NCT ID NCT03610256

Disease control Sponsor: Hospices Civils de Lyon 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study compared two types of weight-loss surgery: the newer SADI-S and the standard RYGB. Researchers wanted to see which one leads to more weight loss after two years. The trial involved 382 adults with severe obesity and measured safety and nutritional effects as well.

What this could mean

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

Active substance
SADI-S (single-anastomosis duodeno-ileal bypass with sleeve gastrectomy) and RYGB (Roux-en-Y gastric bypass) surgical procedures
What this could lead to
If SADI-S proves superior, it could become a preferred surgical option for severe obesity, offering greater weight loss with fewer complications.
What could go wrong
This is a completed trial comparing two established surgeries, so results are reliable but may not apply to all patients. Both procedures carry risks like malnutrition and surgical complications.

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

382 people

The number who actually took part.

Started

Oct 2018

Finished

Dec 2023

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 aged between 18 and 65 years old, * Morbid obesity with BMI ≥40 kg/m2 or BMI ≥35 kg/m2 associated with one co-morbidity which will be improved by surgery (high blood pressure, type 2 diabetes mellitus, obstructive sleep apnea, dyslipidemia, arthrosis) * Patient who has benefited from an upper GI endoscopy with biopsies to look for Helicobacter pylori , within the 12 months before surgery, * Patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion for SADI-S or RYGB as a primary surgery or after failure of sleeve gastrectomy (defined as insufficient weight loss at 18 months after surgery (EWL% \<50), or as weight regain (+ 20%)). * 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 with a healthcare insurance plan. Exclusion Criteria: * History of previous bariatric surgery, other than a sleeve gastrectomy, * Presence of a severe and evolutive life threatening pathology, unrelated to obesity, * History of type 1 diabete, * History of chronic inflammatory bowel disease, * Pregnancy or desire to be pregnant during the study, * Presence of Helicobacter pylori resistant to medical treatment, * Presence of a unhealed gastro-duodenal ulcer or diagnosed less than 2 months previously, * Mentally unbalanced patients, 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

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Conditions

The condition(s) this trial relates to.

morbid obesity Obesity

As listed by the trial registrant

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

Obesity, morbid

Contacts and locations

Locations

  • Département de Chirurgie Digestive - CHU Grenoble

    Grenoble, 38043, France

  • Département de Chirurgie Digestive - Institut Mutualiste Montsouris

    Paris, 75014, France

  • Département de Chirurgie Digestive et Bariatrique, Clinique Mutualiste de l'Estuaire

    Saint-Nazaire, 44600, France

  • Département de Chirurgie Digestive et Hépatobiliaire - Centre Hospitalier Privé Saint Grégoire

    Saint-Grégoire, 35760, France

  • Département de Chirurgie Digestive et Hépatobiliaire - Hôpital Pitié Salpétrière

    Paris, 75013, France

  • Département de Chirurgie Digestive et Thoracique, Hôpitaux Civils de Colmar

    Colmar, 68024, France

  • Département de Chirurgie Digestive et Viscérale - Clinique de l'Anjou

    Angers, 49000, France

  • Département de Chirurgie Digestive et Viscérale, Centre Hospitalier Jean Marcel

    Brignoles, 83170, France

  • Département de Chirurgie Digestive, Centre Hospitalier René Dubos

    Cergy-Pontoise, 95303, France

  • Service d'Endocrinologie, Diabète et Nutrition - Centre Hospitalier Lyon Sud - HCL

    Pierre-Bénite, 69495, France

  • Service de Chirurgie Digestive - Centre Hospitalier Intercommunal de Créteil

    Créteil, 94000, France

  • Service de Chirurgie Digestive - Hôpital Bichat

    Paris, 75018, France

  • Service de Chirurgie Digestive et Bariatrique - Hôpital Edouard Herriot - HCL

    Lyon, 69437, France

  • Service de Chirurgie Digestive et Endocrinienne - Groupe Hospitalier Pellegrin

    Bordeaux, 33076, France

  • Service de Chirurgie Digestive et Endocrinienne - Hôtel Dieu

    Nantes, 44000, France

  • Service de Chirurgie Digestive et Transplantation - Hôpital Archet II

    Nice, 06202, France

  • Service de Chirurgie Digestive et Viscérale - Clinique La Parisière

    Bourg-de-Péage, 26300, France

  • Service de Chirurgie Digestive, Générale et Cancérologique - HEGP

    Paris, 75908, France

  • Service de Chirurgie Digestive, Hépatobiliaire et Endocrinienne - Hôpital Brabois adultes

    Vandœuvre-lès-Nancy, 54511, France

  • Service de Chirurgie Digestive, Hôpital Rangueil

    Toulouse, 31059, France

  • Service de Chirurgie Générale et Digestive - Hôpital Louis Mourier

    Colombes, 92700, France

  • Service de Chirurgie Générale et Endocrinienne - Hôpital Huriez

    Lille, 59037, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.