Single-anastomosis Duodeno Ileal Bypass (SADI) Versus Roux-en-Y Gastric Bypass (SADISLEEVE)
Obesity, Morbid
About this trial
This is an interventional treatment trial for Obesity, Morbid focused on measuring Obesity, Bariatric surgery, Single-anastomosis duodeno ileal bypass (SADI), Roux-en-Y Gastric Bypass
Eligibility Criteria
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
Sites / Locations
- Département de Chirurgie Digestive et Viscérale - Clinique de l'Anjou
- Service de Chirurgie Digestive et Endocrinienne - Groupe Hospitalier Pellegrin
- Service de Chirurgie Digestive et Viscérale - Clinique La Parisière
- Département de Chirurgie Digestive et Viscérale, Centre Hospitalier Jean Marcel
- Département de Chirurgie Digestive, Centre Hospitalier René Dubos
- Département de Chirurgie Digestive et Thoracique, Hôpitaux Civils de Colmar
- Service de Chirurgie Générale et Digestive - Hôpital Louis Mourier
- Service de Chirurgie Digestive - Centre Hospitalier Intercommunal de Créteil
- Département de Chirurgie Digestive - CHU Grenoble
- Service de Chirurgie Générale et Endocrinienne - Hôpital Huriez
- Service de Chirurgie Digestive et Bariatrique - Hôpital Edouard Herriot - HCL
- Service de Chirurgie Générale, Digestive et Endocrinienne - Hôpital Nord
- Service de Chirurgie Digestive et Endocrinienne - Hôtel Dieu
- Service de Chirurgie Digestive et Transplantation - Hôpital Archet II
- Département de Chirurgie Digestive et Hépatobiliaire - Hôpital Pitié Salpétrière
- Département de Chirurgie Digestive - Institut Mutualiste Montsouris
- Service de Chirurgie Digestive - Hôpital Bichat
- Service de Chirurgie Digestive, Générale et Cancérologique - HEGP
- Service d'Endocrinologie, Diabète et Nutrition - Centre Hospitalier Lyon Sud - HCL
- Département de Chirurgie Digestive et Bariatrique, Clinique Mutualiste de l'Estuaire
- Département de Chirurgie Digestive et Hépatobiliaire - Centre Hospitalier Privé Saint Grégoire
- Service de Chirurgie Digestive, Hôpital Rangueil
- Service de Chirurgie Générale et Digestive - Hôpital Purpan
- Service de Chirurgie Digestive, Hépatobiliaire et Endocrinienne - Hôpital Brabois adultes
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
SADI-S
RYGB
This corresponds to obese patients (BMI ≥40 kg/m2 or BMI ≥35 kg/m2 +/- co-morbidities (high blood pressure, dyslipidemia, obstructive sleep apnea, type 2 diabetes mellitus, arthrosis)) benefiting from a laparoscopic SADI-S (laparoscopic Single-anastomosis duodeno ileal bypass with Sleeve gastrectomy). SADI-S will be performed as a primary procedure or after failure of sleeve gastrectomy, defined as insufficient weight loss at 18 months after surgery (EWL% <50), or as weight regain (+ 20% of nadir weight).
This corresponds to obese patients (BMI ≥40 kg/m2 or BMI ≥35 kg/m2 +/- co-morbidities (high blood pressure, dyslipidemia, obstructive sleep apnea, type 2 diabetes mellitus, arthrosis)) benefiting from a laparoscopic RYGB (laparoscopic Roux-en-Y Gastric ByPass). Similarly to the experimental group, RYGB will be performed as a primary procedure or after failure of sleeve gastrectomy, which is defined as insufficient weight loss at 18 months after surgery (EWL% <50), or as weight regain (+ 20% of nadir weight).