Single-anastomosis Duodeno Ileal Bypass (SADI) Versus Roux-en-Y Gastric Bypass
NCT ID: NCT03610256
Last Updated: 2025-09-09
Study Results
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Basic Information
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COMPLETED
NA
382 participants
INTERVENTIONAL
2018-10-18
2023-12-04
Brief Summary
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Since the laparoscopic Roux-en-Y gastric bypass (RYGB) was described in 1977, this restrictive and malabsorptive procedure has become a gold standard for morbid obesity with an average Excess Weight Loss % (EWL%) of 72% at 2 years, and a strong metabolic effect, especially with regard to type 2 diabetes remission. Nevertheless, failures are observed (up to 20%), particularly in super obese patients, which are then difficult to manage. In this population, biliopancreatic diversion with duodenal switch (BPD-DS) is indicated due to its stronger weight loss and metabolic effect, but is still little performed worldwide because of its higher morbidity, surgical complexity and risk of malnutrition.
A novel technique combining the physiological advantages of pylorus preservation and the technical benefits of single-loop reconstruction was introduced in 2007 by Sanchez-Pernaute, who described the single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) as an evolution of the BPD-DS. With a 2.5-meter common channel, SADI-S seems to offer good results for the treatment of both morbid obesity and its metabolic complications, with an EWL% of up to 95% at 2 years and potentially less nutritional consequences.
To date, there is only one Spanish randomized trial comparing SADI-S to BPD-DS, whereas BPD-DS represents less than 1% of bariatric procedures in France and is only allowed in super obese patients. Thus only preliminary data of poor scientific value exists. Nevertheless, facing very encouraging short-term outcomes, there is a real need for a prospective trial comparing SADI-S to a standard bariatric procedure.
The aim of the investigator's study is to assess weight loss efficiency and the morbi-mortality of the SADI-S in comparison to a standard (RYGB), in order to validate this procedure among bariatric techniques
HYPOTHESIS SADI-S is superior to the standard RYGB for weight loss, increasing the EWL% by 10% (82% vs 72%, respectively) at 2 years.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SADI-S
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).
SADI-S
Laparoscopic SADI-S, recently described as an evolution of the BPD-DS, combining the physiological advantages of pylorus preservation and the technical benefits of single-loop reconstruction, associating a sleeve gastrectomy and a duodeno-ileal bypass at 2.5 meters from the ileo-caecal valve if BMI ≥ 50 kg/m² or at 3 meters if BMI \< 50
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 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).
RYGB
The laparoscopic Roux-en-Y Gastric Bypass will consist of:
* a small gastric pouch (about 30cc)
* an antecolic alimentary limb
* a gastro-jejunal anastomosis using a linear stapler
* a 150cm long alimentary limb
* a 50cm biliary limb
* a latero-lateral jejuno-jejunal anastomosis
* closure of the mesenteric defects
Interventions
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SADI-S
Laparoscopic SADI-S, recently described as an evolution of the BPD-DS, combining the physiological advantages of pylorus preservation and the technical benefits of single-loop reconstruction, associating a sleeve gastrectomy and a duodeno-ileal bypass at 2.5 meters from the ileo-caecal valve if BMI ≥ 50 kg/m² or at 3 meters if BMI \< 50
RYGB
The laparoscopic Roux-en-Y Gastric Bypass will consist of:
* a small gastric pouch (about 30cc)
* an antecolic alimentary limb
* a gastro-jejunal anastomosis using a linear stapler
* a 150cm long alimentary limb
* a 50cm biliary limb
* a latero-lateral jejuno-jejunal anastomosis
* closure of the mesenteric defects
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Département de Chirurgie Digestive et Viscérale - Clinique de l'Anjou
Angers, , France
Service de Chirurgie Digestive et Endocrinienne - Groupe Hospitalier Pellegrin
Bordeaux, , France
Service de Chirurgie Digestive et Viscérale - Clinique La Parisière
Bourg-de-Péage, , France
Département de Chirurgie Digestive et Viscérale, Centre Hospitalier Jean Marcel
Brignoles, , France
Département de Chirurgie Digestive, Centre Hospitalier René Dubos
Cergy-Pontoise, , France
Département de Chirurgie Digestive et Thoracique, Hôpitaux Civils de Colmar
Colmar, , France
Service de Chirurgie Générale et Digestive - Hôpital Louis Mourier
Colombes, , France
Service de Chirurgie Digestive - Centre Hospitalier Intercommunal de Créteil
Créteil, , France
Département de Chirurgie Digestive - CHU Grenoble
Grenoble, , France
Service de Chirurgie Générale et Endocrinienne - Hôpital Huriez
Lille, , France
Service de Chirurgie Digestive et Bariatrique - Hôpital Edouard Herriot - HCL
Lyon, , France
Service de Chirurgie Digestive et Endocrinienne - Hôtel Dieu
Nantes, , France
Service de Chirurgie Digestive et Transplantation - Hôpital Archet II
Nice, , France
Département de Chirurgie Digestive et Hépatobiliaire - Hôpital Pitié Salpétrière
Paris, , France
Département de Chirurgie Digestive - Institut Mutualiste Montsouris
Paris, , France
Service de Chirurgie Digestive - Hôpital Bichat
Paris, , France
Service de Chirurgie Digestive, Générale et Cancérologique - HEGP
Paris, , France
Service d'Endocrinologie, Diabète et Nutrition - Centre Hospitalier Lyon Sud - HCL
Pierre-Bénite, , France
Département de Chirurgie Digestive et Hépatobiliaire - Centre Hospitalier Privé Saint Grégoire
Saint-Grégoire, , France
Département de Chirurgie Digestive et Bariatrique, Clinique Mutualiste de l'Estuaire
Saint-Nazaire, , France
Service de Chirurgie Digestive, Hôpital Rangueil
Toulouse, , France
Service de Chirurgie Digestive, Hépatobiliaire et Endocrinienne - Hôpital Brabois adultes
Vandœuvre-lès-Nancy, , France
Countries
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References
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Robert M, Poghosyan T, Delaunay D, Pelascini E, Iceta S, Sterkers A, Barsamian C, Khamphommala L, Bin Dorel S, Maucort-Boulch D, Czernichow S, Disse E. Prospective multicentre randomised trial comparing the efficacy and safety of single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) versus Roux-en-Y gastric bypass (RYGB): SADISLEEVE study protocol. BMJ Open. 2020 Sep 1;10(9):e037576. doi: 10.1136/bmjopen-2020-037576.
Robert M, Poghosyan T, Romain-Scelle N, Czernichow S, Delaunay D, Sterkers A, Khamphommala L, Lazzati A, Blanchard C, Caiazzo R, Pattou F, Disse E; SADISLEEVE Collaborative Group. Efficacy and safety of single-anastomosis duodeno-ileal bypass with sleeve gastrectomy versus Roux-en-Y gastric bypass in France (SADISLEEVE): results of a randomised, open-label, superiority trial at 2 years of follow-up. Lancet. 2025 Aug 23;406(10505):846-859. doi: 10.1016/S0140-6736(25)01070-0.
Osorio J, Lazzara C, Guimaraes M, Torres A, Turrado-Rodriguez V, Ibarzabal A, Sobrino L, Nora M, Vilarrassa N, de Hollanda A, Rubio-Herrera MA, Vidal J, Moize V, Yarnoz C, Fernandez-Falop I, Portillo M, Sanchez-Pernaute A. A randomized open-label multicentre clinical trial comparing single-anastomosis duodenal switch (SADI-S) versus Roux-en-Y gastric bypass for the treatment of severe obesity: BYPSADIS study protocol. Scand J Surg. 2025 Oct 17:14574969251385873. doi: 10.1177/14574969251385873. Online ahead of print.
Other Identifiers
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2018-A01051-54
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL18_0042
Identifier Type: -
Identifier Source: org_study_id
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