Informations générales (source: ClinicalTrials.gov)
Prospective Multicentric Randomized Trial Comparing the Efficacy and Safety of Sleeve Gastrectomy With Transit Bipartition (SG+TB) Versus Roux-en-Y Gastric Bypass (RYGB) (BIPASS)
Interventional
N/A
University Hospital, Lille (Voir sur ClinicalTrials)
juillet 2021
juillet 2025
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | ANDREA LAZZATI | 29/03/2024 01:29:53 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Bichat | Tigran Poghosyan, MD, PhD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Europeen Georges Pompidou | Lionel Rebibo, MD, PhD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Lyon - Lyon - France | Maud RoberT, MD, PhD | Contact (sur clinicalTrials) | |||
| CHU de Nancy - Vandœuvre-lès-Nancy - France | Laurent Brunaud, MD, PhD | Contact (sur clinicalTrials) | |||
| CHU de Nantes - Nantes - France | Claire Blanchard, MD, PhD | Contact (sur clinicalTrials) | |||
| CHU de Poitiers - Poitiers - France | Jean-Pierre Faure, MD, PhD | Contact (sur clinicalTrials) | |||
| CHU Orléans - Orléans - France | Adel Abou Mrad, MD, PhD | Contact (sur clinicalTrials) | |||
| Hop Claude Huriez Chu Lille - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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