NCT04915014Active, not recruiting
Sleeve Gastrectomy With Transit Bipartition(SG+TB) Versus Roux-en-Y Gastric Bypass (RYGB) for Type 3 Obesity
Prospective Multicentric Randomized Trial Comparing the Efficacy and Safety of Sleeve Gastrectomy With Transit Bipartition (SG+TB) Versus Roux-en-Y Gastric Bypass (RYGB)
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
Obesity is a major public health problem worldwide. Bariatric surgery has proved to be the most effective treatment of morbid obesity in terms of weight reduction and remission of co-morbid conditions during long-term follow-up. Sleeve Gastrectomy (SG) has become the most performed intervention either worldwide or in France, where SG represents more than 60% of bariatric interventions and 114,817 patients operated between 2013 and 2016. Maximum Excess weight loss (%EWL) after SG is obtained at one-year post surgery. Then it has been largely reported in the literature that patients could present mild, moderate or important (notably in the super obese patients) weight regain associated with comorbidity relapse motivating redo surgery. Like in revisional surgery, operating super-obese patient (BMI ≥50 kg/m2) is a challenge. It has been shown that achieving significant weight loss was more difficult in patients with a BMI ≥ 50 compared to lower BMIs.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 19 May 2021
- Start date
- 23 Jul 2021
- Primary completion date
- Jul 2026
- Lead sponsor
- University Hospital, Lille
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT04915014
What you commit to
- Study type: Interventional
- Planned participants: 320
- From 23 Jul 2021 to the primary completion date, Jul 2026
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous bariatric surgery, other than a Sleeve Gastrectomy
- Presence of a non-healed gastro-duodenal ulcer or diagnosed less than 2 months previously
Other illness
- History of Chronic inflammatory bowel disease
- Type 1 Diabetes
- Patients with unstable psychiatric disorder, under supervision or guardianship
Other
- Patient with current BMI \> 60 kg/m2
- Presence of a severe and evolutive life threatening pathology, unrelated to obesity
- Pregnancy or desire to be pregnant during the study
- Nursing woman
- Presence of Pylori Helicobacter resistant to medical treatment
- Severe esophagitis (grade C of Los Angeles classification)
- Hiatal hernia
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hop Claude Huriez Chu Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| CHU de Lyon Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| CHU de Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| CHU Orléans Coordinator of this site? Confirm its status | Orléans | France | Unknown status |
| AP-HP Hôpital Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| AP-HP Hôpital Bichat Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| CHU de Nancy Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.