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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Obesity, Morbid

Intervention / Treatment
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* Procedure: SADI-S
* Procedure: RYGB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SADI-S<br>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<br>* 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<br>* Other names: Laparoscopic Single-anastomosis duodeno ileal bypass with Sleeve gastrectomy (SADI-S);|
| Active Comparator: RYGB<br>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<br>* 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<br>* Other names: Roux-en-Y Gastric ByPass;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Albumin | Measurement of albumin will explore the nutritional status of patients. Results will be expressed in g/l | 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 | 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 | 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 | 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 | 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 | 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 % | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 % | 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 | 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 | 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 % | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | End of the hospitalization period | 
| Readmission of patient | Number of patients readmitted within 30 days after surgery. | 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 | 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. | 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). | 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). | 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. | 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. | 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 | 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 | 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. | 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 | 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 | 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 | 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 | 60 and 120 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Bariatric surgery, Single-anastomosis duodeno ileal bypass (SADI), Roux-en-Y Gastric Bypass