Obesity, MorbidSADISLEEVENCT03610256
Single-anastomosis Duodeno Ileal Bypass (SADI) Versus Roux-en-Y Gastric Bypass
A study testing SADI-S and RYGB in people with Obesity, Morbid, run by Hospices Civils de Lyon at 22 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- SADI-S and RYGB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 22 sitesFrance
- Study dates
- 18 Oct 2018to 4 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
Département de Chirurgie Digestive et Viscérale - Clinique de l'Anjou
Angers, 49000
Service de Chirurgie Digestive et Endocrinienne - Groupe Hospitalier Pellegrin
Bordeaux, 33076
Service de Chirurgie Digestive et Viscérale - Clinique La Parisière
Bourg-de-Péage, 26300
Département de Chirurgie Digestive et Viscérale, Centre Hospitalier Jean Marcel
Brignoles, 83170
Département de Chirurgie Digestive, Centre Hospitalier René Dubos
Cergy-Pontoise, 95303
Département de Chirurgie Digestive et Thoracique, Hôpitaux Civils de Colmar
Colmar, 68024
Service de Chirurgie Générale et Digestive - Hôpital Louis Mourier
Colombes, 92700
Service de Chirurgie Digestive - Centre Hospitalier Intercommunal de Créteil
Créteil, 94000
Département de Chirurgie Digestive - CHU Grenoble
Grenoble, 38043
Service de Chirurgie Générale et Endocrinienne - Hôpital Huriez
Lille, 59037
Service de Chirurgie Digestive et Bariatrique - Hôpital Edouard Herriot - HCL
Lyon, 69437
Service de Chirurgie Digestive et Endocrinienne - Hôtel Dieu
Nantes, 44000
Service de Chirurgie Digestive et Transplantation - Hôpital Archet II
Nice, 06202
Département de Chirurgie Digestive et Hépatobiliaire - Hôpital Pitié Salpétrière
Paris, 75013
Département de Chirurgie Digestive - Institut Mutualiste Montsouris
Paris, 75014
Service de Chirurgie Digestive - Hôpital Bichat
Paris, 75018
Service de Chirurgie Digestive, Générale et Cancérologique - HEGP
Paris, 75908
Service d'Endocrinologie, Diabète et Nutrition - Centre Hospitalier Lyon Sud - HCL
Pierre-Bénite, 69495
Département de Chirurgie Digestive et Hépatobiliaire - Centre Hospitalier Privé Saint Grégoire
Saint-Grégoire, 35760
Département de Chirurgie Digestive et Bariatrique, Clinique Mutualiste de l'Estuaire
Saint-Nazaire, 44600
Service de Chirurgie Digestive, Hôpital Rangueil
Toulouse, 31059
Service de Chirurgie Digestive, Hépatobiliaire et Endocrinienne - Hôpital Brabois adultes
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Prospective Multicentric Randomized Trial Comparing the Efficacy and Safety of Single-anastomosis Duodeno Ileal Bypass With Sleeve Gastrectomy (SADI-S) Versus Roux-en-Y Gastric Bypass (RYGB)
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.
Read more
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
- Being tested
- SADI-S, RYGB
- Keywords
- Obesity, Bariatric surgery, Single-anastomosis duodeno ileal bypass (SADI), Roux-en-Y Gastric Bypass
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SADI-SProcedure or surgery
Also called Laparoscopic Single-anastomosis duodeno ileal bypass with Sleeve gastrectomy (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
RYGBProcedure or surgery
Also called Roux-en-Y Gastric ByPass
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Procedure: RYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years after surgery
Secondary outcomes (49)
Albumin
Measurement of albumin will explore the nutritional status of patients. Results will be expressed in g/l
Measured: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Pre-albumin
Measurement of pre-albumin will explore the nutritional status of patients. Results will be expressed in g/l
Measured: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Hemoglobin
Measurement of Hemoglobin will explore the nutritional status of patients. Results will be expressed in g/l
Measured: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Calcium
Measurement of Calcium will explore the nutritional status of patients. Results will be expressed in mmol/l
Measured: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Ferritin
Measurement of ferritin will explore the nutritional status of patients. Results will be expressed in microg/l
Measured: At each study visit (before surgey and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Iron
Measurement of iron will explore the nutritional status of patients. Results will be expressed in micromol/l
Measured: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
% of transferrin saturation
Measurement of % of transferrin saturation will explore the nutritional status of patients. Results will be expressed in %
Measured: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Vitamin A
Measurement of vitamin A will explore the nutritional status of patients. Results will be expressed in micromol/l
Measured: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Vitamin B1
Measurement of vitamin B1 will explore the nutritional status of patients. Results will be expressed in nmol/l
Measured: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Vitamin B12
Measurement of vitamin B12 will explore the nutritional status of patients. Results will be expressed in pmol/l
Measured: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Vitamin B9
Measurement of vitamin B9 will explore the nutritional status of patients. Results will be expressed in nmol/l
Measured: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Vitamin D
Measurement of vitamin D will explore the nutritional status of patients. Results will be expressed in nmol/l
Measured: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Vitamin C
Measurement of vitamin C will explore the nutritional status of patients. Results will be expressed in micromol/l
Measured: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Vitamin E
Measurement of vitamin E will explore the nutritional status of patients. Results will be expressed in micromol/l
Measured: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Prothrombin rate
Measurement of prothrombine rate will explore the nutritional status of patients. Results will be expressed in %
Measured: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Steatorrhea rate
Measurement of the 24-hour steatorrhea rate will explore the nutritional status of patients. Results will be expressed in grams of lipids /100g of stools
Measured: 6 month after surgery
Average number of stools per day
Measurement of the average number of stool will explore the nutritional status of patients. Results will be expressed in number of stool/day
Measured: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
HbA1c
Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in %
Measured: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Fasting glycemia
Measurement of fasting glycemia will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Measured: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
HDL
Measurement of HDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Measured: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
LDL
Measurement of LDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Measured: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Cholesterol
Measurement of cholesterol will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Measured: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Triglycerides
Measurement of triglycerides will explore the Metabolic of surgery. Results will be expressed in mmol/l
Measured: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Antidiabetic drugs
Evolution of antidiabetic drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.
Measured: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Antilipidemic drugs
Evolution of antilipidemic drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.
Measured: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Antihypertensive drugs
Evolution of antihypertensive drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.
Measured: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea
Evolution of the use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of persistence or not of obstructive sleep apnea.
Measured: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Length of stay
The Length of stay (in days) is based on the number of days of hospitalization from surgery (day of surgery = D0) until the end of hospitalization.
Measured: End of the hospitalization period
Readmission of patient
Number of patients readmitted within 30 days after surgery.
Measured: 30 days after surgery
Occurrence of kidney stones
For each visit after the surgery, the presence or not of kidney stones will be documented and if applicable the treatment will be noted
Measured: Within 10 years after surgery
Overall complication rate
Rate of medical and surgical (> or = grade 3) complications within 120 months after surgery using the Dindo-Clavien classification, described as :
Grade I = Any deviation from the normal postoperative course. Grade 2 = Requiring pharmacological treatment with drugs other than such allowed for grade I complications.
Grade III = Requiring surgical, endoscopic or radiological intervention, not under (Grade IIIa) or under general anesthesia (Grade IIIb) Grade IV = Life-threatening complication with single organ (Grade IVa) or Multiorgan dysfunction (Grade IVb) Grade V = Death of a patient.
Measured: Within 10 years after surgery
Type and severity of early complications
Type (medical or surgical) and severity of early complications (within 30 days) for each procedure according to the Dindo-Clavien classification (description of this classification was made in outcome 32).
Measured: Within 30 days after surgery
Type and severity of late complications
Type (medical or surgical) and severity of late complications (after 30 days) for each procedure according to the Dindo-Clavien classification (description of this classification was made in outcome 32).
Measured: Within 10 years after surgery
Gastroesophageal reflux assessment
Evolution of gastroesophageal reflux will be assessed at each study visit, before and after surgery. This outcome will be expressed in terms of improvement, aggravation or onset.
Measured: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Absolute weight loss assessment
Weight loss at 1, 3, 6, 12, 18, 24, 60 and 120 months after surgery, according to absolute weight loss (aWL) in kg.
Measured: 1, 3, 6, 12, 18, 24, 60 and 120 months after surgery
Excess Weight Loss percentage assessment
Weight loss at 1, 3, 6, 12, 18, 24, 60 and 120 months after surgery, according to Excess Weight Loss percentage (EWL%), calculated using the following formula:
((weight at visit X - initial weight) / (initial weight - ideal weight)) X 100
Measured: 1, 3, 6, 12, 18, 24, 60 and 120 months after surgery
Excess BMI Loss percentage assessment
Weight loss at 1, 3, 6, 12, 18, 24, 60 and 120 months after surgery, according Excess BMI Loss percentage (EBL%), according to the formula :
((BMI at visit X - initial BMI) / (initial BMI - ideal BMI)) X 100 with Ideal BMI = 25 kg/m²
Measured: 1, 3, 6, 12, 18, 24, 60 and 120 months after surgery
Quality of life assessed with GIQLI questionnaire
Before surgery and at 6, 12 and 24 months after surgery, according to the GIQLI questionnaire.
This questionnaire consists of 36 items exploring 5 dimensions or subscales: symptoms, physical condition, emotions, social integration and the effect of any medical treatment. For each item, 5 responses will be proposed to the patients and for each answer, a score ranging from 0 to 4 (highest score = 144) will be assigned. A high score defines a more favorable health state.
Measured: Before surgery and at 6, 12 and 24 months after surgery
Quality of life assessed with SF36 questionnaire
Before surgery and at 6, 12 and 24 months after surgery, according to the SF36 questionnaire.
This questionnaire taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/tiredness, and general health perceptions. It also includes a single item that provides an indication of a perceived change in health
Measured: Before surgery and at 6, 12 and 24 months after surgery
Quality of life assessed with Sigstad questionnaire
Sigstad questionnaire for all postoperative study visits (except 18 months after surgery).
The Sigstad questionnaire allows the identification and diagnosis of postoperative dumping syndrome and early hypoglycaemia: a score >7 suggests a dumping syndrome
Measured: Before surgery and at 1, 3, 6, 12, 24, 60 and 120 months after surgery
Evolution of food choices and preferences within 2 years after surgery
The evolution of food choices and preferences will be measured before surgery and 3, 12 and 24 months after surgery using a computerized test: the "Leeds Food Preference Questionnaire (LFPQ).
The Leed Food Preference Questionnaire provides measurements of different components of food preference and food reward, and is a computerized questionnaire. Participants are presented with an array of pictures of individual food items common in the diet. Foods are chosen from a validated database to be either predominantly high (>50% energy) or low (<20% energy) in fat but similar in familiarity, protein content, sweet or not-sweet taste and palatability. Responses are recorded and used to compute mean scores for high fat, low fat, sweet or savory food types (and different fat-taste combinations).
This assessment will be performed only in the coordinating center
Measured: Before surgery and 3, 12 and 24 months after surgery
Modifications of the gastric and esophageal mucosa
Macroscopic data and Histological modifications of the gastric and esophageal mucosa based on upper GI endoscopy with biopsies of the gastric and esophageal mucosa
Measured: 60 and 120 months after surgery
Number of reflux episodes
Number of reflux episodes for assessment of severe GastroEsophageal Reflux Disease by pHmetry
Measured: 60 and 120 months after surgery
Number of reflux episodes lasting more than 5 minutes
Number of reflux episodes lasting more than 5 minutes for assessment of severe GastroEsophageal Reflux Disease by pHmetry
Measured: 60 and 120 months after surgery
Exposure time with pH < 4
% of exposure time with pH < 4 for assessment of severe GastroEsophageal Reflux Disease by pHmetry
Measured: 60 and 120 months after surgery
Number of acid refluxes
Number of acid refluxes for assessment of severe GastroEsophageal Reflux Disease by pH- impedancemetry
Measured: 60 and 120 months after surgery
Number of non-acid refluxes
Number of non-acid refluxes for assessment of severe GastroEsophageal Reflux Disease by pH- impedancemetry
Measured: 60 and 120 months after surgery
Number of poor acid reflux
Number of poor acid reflux for assessment of severe GastroEsophageal Reflux Disease by pH- impedancemetry
Measured: 60 and 120 months after surgery
Association with symptoms
Positive association with symptoms for assessment of severe GastroEsophageal Reflux Disease by pH- impedancemetry
Measured: 60 and 120 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start18 Oct 2018
- Primary completion4 Dec 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610256
- Sponsor's protocol ID
- 69HCL18_0042
- Other IDs
- 2018-A01051-54
- Acronym
- SADISLEEVE
- Status last verified
- Sep 2025
- First submitted
- 10 Jul 2018
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32873678Robert 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.
PubMed 40849141Osorio 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. 2026 Mar;115(1):119-128. doi: 10.1177/14574969251385873. Epub 2025 Oct 17.
PubMed 41104829
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentric Randomized Trial Comparing the Efficacy and Safety of Single-anastomosis Duodeno Ileal Bypass With Sleeve Gastrectomy (SADI-S) Versus Roux-en-Y Gastric Bypass (RYGB)
- ClinicalTrials.gov ID
- NCT03610256
- Acronym / sponsor ID
- SADISLEEVE / 69HCL18_0042
- Conditions
- Obesity, Morbid
- Keywords
- Obesity, Bariatric surgery, Single-anastomosis duodeno ileal bypass (SADI), Roux-en-Y Gastric Bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SADI-S | Experimental | Procedure: SADI-SThis 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). |
| RYGB | Active comparator | Procedure: RYGBThis 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SADI-SAlso: Laparoscopic Single-anastomosis duodeno ileal bypass with Sleeve gastrectomy (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 | Procedure or surgery | SADI-S |
| RYGBAlso: Roux-en-Y Gastric ByPassThe 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 | Procedure or surgery | RYGB |
Primary outcome
Excess Weight Loss measurement
Time frame: 2 years after surgery
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.
49 secondary outcomes
Albumin
Time frame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Pre-albumin
Time frame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Hemoglobin
Time frame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Calcium
Time frame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Ferritin
Time frame: At each study visit (before surgey and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Iron
Time frame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
% of transferrin saturation
Time frame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Vitamin A
Time frame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Vitamin B1
Time frame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Vitamin B12
Time frame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Vitamin B9
Time frame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Vitamin D
Time frame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Vitamin C
Time frame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Vitamin E
Time frame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Prothrombin rate
Time frame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Steatorrhea rate
Time frame: 6 month after surgery
Average number of stools per day
Time frame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
HbA1c
Time frame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Fasting glycemia
Time frame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
HDL
Time frame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
LDL
Time frame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Cholesterol
Time frame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Triglycerides
Time frame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Antidiabetic drugs
Time frame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Antilipidemic drugs
Time frame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Antihypertensive drugs
Time frame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea
Time frame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
Length of stay
Time frame: End of the hospitalization period
Readmission of patient
Time frame: 30 days after surgery
Occurrence of kidney stones
Time frame: Within 10 years after surgery
Overall complication rate
Time frame: Within 10 years after surgery
Type and severity of early complications
Time frame: Within 30 days after surgery
Type and severity of late complications
Time frame: Within 10 years after surgery
Gastroesophageal reflux assessment
Time frame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
Absolute weight loss assessment
Time frame: 1, 3, 6, 12, 18, 24, 60 and 120 months after surgery
Excess Weight Loss percentage assessment
Time frame: 1, 3, 6, 12, 18, 24, 60 and 120 months after surgery
Excess BMI Loss percentage assessment
Time frame: 1, 3, 6, 12, 18, 24, 60 and 120 months after surgery
Quality of life assessed with GIQLI questionnaire
Time frame: Before surgery and at 6, 12 and 24 months after surgery
Quality of life assessed with SF36 questionnaire
Time frame: Before surgery and at 6, 12 and 24 months after surgery
Quality of life assessed with Sigstad questionnaire
Time frame: Before surgery and at 1, 3, 6, 12, 24, 60 and 120 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Background: PubMed 32873678Robert 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.
- Results publication: PubMed 40849141Robert 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.
- Derived from this study: PubMed 41104829Osorio 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. 2026 Mar;115(1):119-128. doi: 10.1177/14574969251385873. Epub 2025 Oct 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SADI-S and RYGB in people with Obesity, Morbid, run by Hospices Civils de Lyon at 22 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excess Weight Loss measurement (time frame: 2 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03610256, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.