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

Primary Purpose

Obesity, Morbid

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SADI-S
RYGB
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

SADI-S

RYGB

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Albumin
Measurement of albumin will explore the nutritional status of patients. Results will be expressed in g/l
Pre-albumin
Measurement of pre-albumin will explore the nutritional status of patients. Results will be expressed in g/l
Hemoglobin
Measurement of Hemoglobin will explore the nutritional status of patients. Results will be expressed in g/l
Calcium
Measurement of Calcium will explore the nutritional status of patients. Results will be expressed in mmol/l
Ferritin
Measurement of ferritin will explore the nutritional status of patients. Results will be expressed in microg/l
Iron
Measurement of iron will explore the nutritional status of patients. Results will be expressed in micromol/l
% of transferrin saturation
Measurement of % of transferrin saturation will explore the nutritional status of patients. Results will be expressed in %
Vitamin A
Measurement of vitamin A will explore the nutritional status of patients. Results will be expressed in micromol/l
Vitamin B1
Measurement of vitamin B1 will explore the nutritional status of patients. Results will be expressed in nmol/l
Vitamin B12
Measurement of vitamin B12 will explore the nutritional status of patients. Results will be expressed in pmol/l
Vitamin B9
Measurement of vitamin B9 will explore the nutritional status of patients. Results will be expressed in nmol/l
Vitamin D
Measurement of vitamin D will explore the nutritional status of patients. Results will be expressed in nmol/l
Vitamin C
Measurement of vitamin C will explore the nutritional status of patients. Results will be expressed in micromol/l
Vitamin E
Measurement of vitamin E will explore the nutritional status of patients. Results will be expressed in micromol/l
Prothrombin rate
Measurement of prothrombine rate will explore the nutritional status of patients. Results will be expressed in %
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
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
HbA1c
Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in %
Fasting glycemia
Measurement of fasting glycemia will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
HDL
Measurement of HDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
LDL
Measurement of LDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Cholesterol
Measurement of cholesterol will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Triglycerides
Measurement of triglycerides will explore the Metabolic of surgery. Results will be expressed in mmol/l
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.
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.
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.
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.
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.
Readmission of patient
Number of patients readmitted within 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
Overall complication rate
Rate of medical and surgical (> or = grade 3) complications within 24 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.
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).
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).
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.
Absolute weight loss assessment
Weight loss at 1, 3, 6, 12, 18 and 24 months after surgery, according to absolute weight loss (aWL) in kg.
Excess Weight Loss percentage assessment
Weight loss at 1, 3, 6, 12, 18 and 24 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
Excess BMI Loss percentage assessment
Weight loss at 1, 3, 6, 12, 18 and 24 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
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.
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
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
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

Full Information

First Posted
July 10, 2018
Last Updated
April 18, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03610256
Brief Title
Single-anastomosis Duodeno Ileal Bypass (SADI) Versus Roux-en-Y Gastric Bypass
Acronym
SADISLEEVE
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
Obesity, Bariatric surgery, Single-anastomosis duodeno ileal bypass (SADI), Roux-en-Y Gastric Bypass

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
382 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SADI-S
Arm Type
Experimental
Arm Description
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).
Arm Title
RYGB
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
SADI-S
Other Intervention Name(s)
Laparoscopic Single-anastomosis duodeno ileal bypass with Sleeve gastrectomy (SADI-S)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
RYGB
Other Intervention Name(s)
Roux-en-Y Gastric ByPass
Intervention Description
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
Primary Outcome Measure Information:
Title
Excess Weight Loss measurement
Description
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.
Time Frame
2 years after surgery
Secondary Outcome Measure Information:
Title
Albumin
Description
Measurement of albumin will explore the nutritional status of patients. Results will be expressed in g/l
Time Frame
At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
Title
Pre-albumin
Description
Measurement of pre-albumin will explore the nutritional status of patients. Results will be expressed in g/l
Time Frame
At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
Title
Hemoglobin
Description
Measurement of Hemoglobin will explore the nutritional status of patients. Results will be expressed in g/l
Time Frame
At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
Title
Calcium
Description
Measurement of Calcium will explore the nutritional status of patients. Results will be expressed in mmol/l
Time Frame
At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
Title
Ferritin
Description
Measurement of ferritin will explore the nutritional status of patients. Results will be expressed in microg/l
Time Frame
At each study visit (before surgey and 1, 3, 6, 12, 18 and 24 months after surgery)
Title
Iron
Description
Measurement of iron will explore the nutritional status of patients. Results will be expressed in micromol/l
Time Frame
At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
Title
% of transferrin saturation
Description
Measurement of % of transferrin saturation will explore the nutritional status of patients. Results will be expressed in %
Time Frame
At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
Title
Vitamin A
Description
Measurement of vitamin A will explore the nutritional status of patients. Results will be expressed in micromol/l
Time Frame
Before surgery and 6, 12 and 24 months after surgery
Title
Vitamin B1
Description
Measurement of vitamin B1 will explore the nutritional status of patients. Results will be expressed in nmol/l
Time Frame
Before surgery and 6, 12 and 24 months after surgery
Title
Vitamin B12
Description
Measurement of vitamin B12 will explore the nutritional status of patients. Results will be expressed in pmol/l
Time Frame
Before surgery and 6, 12 and 24 months after surgery
Title
Vitamin B9
Description
Measurement of vitamin B9 will explore the nutritional status of patients. Results will be expressed in nmol/l
Time Frame
Before surgery and 6, 12 and 24 months after surgery
Title
Vitamin D
Description
Measurement of vitamin D will explore the nutritional status of patients. Results will be expressed in nmol/l
Time Frame
Before surgery and 6, 12 and 24 months after surgery
Title
Vitamin C
Description
Measurement of vitamin C will explore the nutritional status of patients. Results will be expressed in micromol/l
Time Frame
Before surgery and 6, 12 and 24 months after surgery
Title
Vitamin E
Description
Measurement of vitamin E will explore the nutritional status of patients. Results will be expressed in micromol/l
Time Frame
Before surgery and 6, 12 and 24 months after surgery
Title
Prothrombin rate
Description
Measurement of prothrombine rate will explore the nutritional status of patients. Results will be expressed in %
Time Frame
Before surgery and 6, 12 and 24 months after surgery
Title
Steatorrhea rate
Description
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
Time Frame
6 month after surgery
Title
Average number of stools per day
Description
Measurement of the average number of stool will explore the nutritional status of patients. Results will be expressed in number of stool/day
Time Frame
At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
Title
HbA1c
Description
Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in %
Time Frame
At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
Title
Fasting glycemia
Description
Measurement of fasting glycemia will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Time Frame
At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
Title
HDL
Description
Measurement of HDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Time Frame
At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
Title
LDL
Description
Measurement of LDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Time Frame
At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
Title
Cholesterol
Description
Measurement of cholesterol will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Time Frame
At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
Title
Triglycerides
Description
Measurement of triglycerides will explore the Metabolic of surgery. Results will be expressed in mmol/l
Time Frame
At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
Title
Antidiabetic drugs
Description
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.
Time Frame
Before surgery and 6, 12 and 24 months after surgery
Title
Antilipidemic drugs
Description
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.
Time Frame
Before surgery and 6, 12 and 24 months after surgery
Title
Antihypertensive drugs
Description
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.
Time Frame
Before surgery and 6, 12 and 24 months after surgery
Title
Use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea
Description
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.
Time Frame
Before surgery and 6, 12 and 24 months after surgery
Title
Length of stay
Description
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.
Time Frame
End of the hospitalization period
Title
Readmission of patient
Description
Number of patients readmitted within 30 days after surgery.
Time Frame
30 days after surgery
Title
Occurrence of kidney stones
Description
For each visit after the surgery, the presence or not of kidney stones will be documented and if applicable the treatment will be noted
Time Frame
Within 2 years after surgery
Title
Overall complication rate
Description
Rate of medical and surgical (> or = grade 3) complications within 24 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.
Time Frame
Within 2 years after surgery
Title
Type and severity of early complications
Description
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).
Time Frame
Within 30 days after surgery
Title
Type and severity of late complications
Description
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).
Time Frame
Within 2 years after surgery
Title
Gastroesophageal reflux assessment
Description
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.
Time Frame
At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
Title
Absolute weight loss assessment
Description
Weight loss at 1, 3, 6, 12, 18 and 24 months after surgery, according to absolute weight loss (aWL) in kg.
Time Frame
1, 3, 6, 12, 18 and 24 months after surgery
Title
Excess Weight Loss percentage assessment
Description
Weight loss at 1, 3, 6, 12, 18 and 24 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
Time Frame
1, 3, 6, 12, 18 and 24 months after surgery
Title
Excess BMI Loss percentage assessment
Description
Weight loss at 1, 3, 6, 12, 18 and 24 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
Time Frame
1, 3, 6, 12, 18 and 24 months after surgery
Title
Quality of life assessed with GIQLI questionnaire
Description
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.
Time Frame
Before surgery and at 6, 12 and 24 months after surgery
Title
Quality of life assessed with SF36 questionnaire
Description
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
Time Frame
Before surgery and at 6, 12 and 24 months after surgery
Title
Quality of life assessed with Sigstad questionnaire
Description
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
Time Frame
Before surgery and at 1, 3, 6, 12 and 24 months after surgery
Title
Evolution of food choices and preferences within 2 years after surgery
Description
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
Time Frame
Before surgery and 3, 12 and 24 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Département de Chirurgie Digestive et Viscérale - Clinique de l'Anjou
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Service de Chirurgie Digestive et Endocrinienne - Groupe Hospitalier Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Service de Chirurgie Digestive et Viscérale - Clinique La Parisière
City
Bourg-de-Péage
ZIP/Postal Code
26300
Country
France
Facility Name
Département de Chirurgie Digestive et Viscérale, Centre Hospitalier Jean Marcel
City
Brignoles
ZIP/Postal Code
83170
Country
France
Facility Name
Département de Chirurgie Digestive, Centre Hospitalier René Dubos
City
Cergy-Pontoise
ZIP/Postal Code
95303
Country
France
Facility Name
Département de Chirurgie Digestive et Thoracique, Hôpitaux Civils de Colmar
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Service de Chirurgie Générale et Digestive - Hôpital Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
Service de Chirurgie Digestive - Centre Hospitalier Intercommunal de Créteil
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Département de Chirurgie Digestive - CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Service de Chirurgie Générale et Endocrinienne - Hôpital Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Service de Chirurgie Digestive et Bariatrique - Hôpital Edouard Herriot - HCL
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Service de Chirurgie Générale, Digestive et Endocrinienne - Hôpital Nord
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Service de Chirurgie Digestive et Endocrinienne - Hôtel Dieu
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Service de Chirurgie Digestive et Transplantation - Hôpital Archet II
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Département de Chirurgie Digestive et Hépatobiliaire - Hôpital Pitié Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Département de Chirurgie Digestive - Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Service de Chirurgie Digestive - Hôpital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Service de Chirurgie Digestive, Générale et Cancérologique - HEGP
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Service d'Endocrinologie, Diabète et Nutrition - Centre Hospitalier Lyon Sud - HCL
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Département de Chirurgie Digestive et Bariatrique, Clinique Mutualiste de l'Estuaire
City
Saint Nazaire
ZIP/Postal Code
44600
Country
France
Facility Name
Département de Chirurgie Digestive et Hépatobiliaire - Centre Hospitalier Privé Saint Grégoire
City
Saint-Grégoire
ZIP/Postal Code
35760
Country
France
Facility Name
Service de Chirurgie Digestive, Hôpital Rangueil
City
TOULOUSE Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Service de Chirurgie Générale et Digestive - Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Service de Chirurgie Digestive, Hépatobiliaire et Endocrinienne - Hôpital Brabois adultes
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32873678
Citation
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.
Results Reference
derived

Learn more about this trial

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

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