Informations générales (source: ClinicalTrials.gov)

NCT04915014 En recrutement IDF
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
  • Obésité
  • Obésité morbide
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.
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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 En recrutement IDF 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 En recrutement IDF Contact (sur clinicalTrials)
AP-HP - Hôpital Europeen Georges Pompidou Lionel Rebibo, MD, PhD En recrutement IDF 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 En recrutement Contact (sur clinicalTrials)
CHU de Nancy - Vandœuvre-lès-Nancy - France Laurent Brunaud, MD, PhD En recrutement Contact (sur clinicalTrials)
CHU de Nantes - Nantes - France Claire Blanchard, MD, PhD En recrutement Contact (sur clinicalTrials)
CHU de Poitiers - Poitiers - France Jean-Pierre Faure, MD, PhD En recrutement Contact (sur clinicalTrials)
CHU Orléans - Orléans - France Adel Abou Mrad, MD, PhD En recrutement Contact (sur clinicalTrials)
Hop Claude Huriez Chu Lille - 59037 - Lille - France En recrutement 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



- 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