Single-anastomosis Duodeno Ileal Bypass (SADI) Versus Roux-en-Y Gastric Bypass

NCT03610256 | Completed DMC

• 2 other identifiers: 69HCL18_00422018-A01051-54
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 22

Brief Summary

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. Nowadays, France is ranked 3rd in terms of bariatric surgeries performed per year. 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.

Conditions

Obesity, Morbid

Keywords

Obesity; Bariatric surgery; Single-anastomosis duodeno ileal bypass (SADI); Roux-en-Y Gastric Bypass

Outcome Measures

Primary Outcomes (1)

• Excess Weight Loss measurement

  For each surgical procedure, weight loss will be assessed 2 years after surgery using Excess Weight Loss percentage (EWL%), calculated using the following formula: ((weight at 2-year visit - initial weight) / (initial weight - ideal weight)) X 100 The assessment of the primary endpoint will be standardized between the centers and carried out under blind conditions.

  2 years after surgery

Secondary Outcomes (49)

• Albumin

  At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)

• Pre-albumin

  At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)

• Hemoglobin

  At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)

• Calcium

  At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)

• Ferritin

  At each study visit (before surgey and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)

Study Arms (2)

SADI-S

EXPERIMENTAL

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).

Procedure: SADI-S

RYGB

ACTIVE COMPARATOR

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).

Procedure: RYGB

Interventions

SADI-S PROCEDURE

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

Also known as: Laparoscopic Single-anastomosis duodeno ileal bypass with Sleeve gastrectomy (SADI-S)

SADI-S

RYGB PROCEDURE

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

Also known as: Roux-en-Y Gastric ByPass

RYGB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (22)

Département de Chirurgie Digestive et Viscérale - Clinique de l'Anjou

Angers, 49000, France

Location

Service de Chirurgie Digestive et Endocrinienne - Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

Location

Service de Chirurgie Digestive et Viscérale - Clinique La Parisière

Bourg-de-Péage, 26300, France

Location

Département de Chirurgie Digestive et Viscérale, Centre Hospitalier Jean Marcel

Brignoles, 83170, France

Location

Département de Chirurgie Digestive, Centre Hospitalier René Dubos

Cergy-Pontoise, 95303, France

Location

Département de Chirurgie Digestive et Thoracique, Hôpitaux Civils de Colmar

Colmar, 68024, France

Location

Service de Chirurgie Générale et Digestive - Hôpital Louis Mourier

Colombes, 92700, France

Location

Service de Chirurgie Digestive - Centre Hospitalier Intercommunal de Créteil

Créteil, 94000, France

Location

Département de Chirurgie Digestive - CHU Grenoble

Grenoble, 38043, France

Location

Service de Chirurgie Générale et Endocrinienne - Hôpital Huriez

Lille, 59037, France

Location

Service de Chirurgie Digestive et Bariatrique - Hôpital Edouard Herriot - HCL

Lyon, 69437, France

Location

Service de Chirurgie Digestive et Endocrinienne - Hôtel Dieu

Nantes, 44000, France

Location

Service de Chirurgie Digestive et Transplantation - Hôpital Archet II

Nice, 06202, France

Location

Département de Chirurgie Digestive et Hépatobiliaire - Hôpital Pitié Salpétrière

Paris, 75013, France

Location

Département de Chirurgie Digestive - Institut Mutualiste Montsouris

Paris, 75014, France

Location

Service de Chirurgie Digestive - Hôpital Bichat

Paris, 75018, France

Location

Service de Chirurgie Digestive, Générale et Cancérologique - HEGP

Paris, 75908, France

Location

Service d'Endocrinologie, Diabète et Nutrition - Centre Hospitalier Lyon Sud - HCL

Pierre-Bénite, 69495, France

Location

Département de Chirurgie Digestive et Hépatobiliaire - Centre Hospitalier Privé Saint Grégoire

Saint-Grégoire, 35760, France

Location

Département de Chirurgie Digestive et Bariatrique, Clinique Mutualiste de l'Estuaire

Saint-Nazaire, 44600, France

Location

Service de Chirurgie Digestive, Hôpital Rangueil

Toulouse, 31059, France

Location

Service de Chirurgie Digestive, Hépatobiliaire et Endocrinienne - Hôpital Brabois adultes

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (3)

• 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.

  PMID: 32873678 BACKGROUND

• 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.

  PMID: 40849141 RESULT

• 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.

  PMID: 41104829 DERIVED

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 1, 2018
• Study Start: October 18, 2018
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

FR (22)