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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
382
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
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
Département de Chirurgie Digestive et Viscérale - Clinique de l'Anjou
Angers, France
Service de Chirurgie Digestive et Endocrinienne - Groupe Hospitalier Pellegrin
Bordeaux, France
Service de Chirurgie Digestive et Viscérale - Clinique La Parisière
Bourg-de-Péage, France
Département de Chirurgie Digestive et Viscérale, Centre Hospitalier Jean Marcel
Brignoles, France
Département de Chirurgie Digestive, Centre Hospitalier René Dubos
Cergy-Pontoise, France
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.
Time frame: 2 years after surgery
Albumin
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, 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 %
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 %
Time frame: 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
Time frame: 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
Time frame: 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 %
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: End of the hospitalization period
Readmission of patient
Number of patients readmitted within 30 days after surgery.
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
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
Weight loss at 1, 3, 6, 12, 18, 24, 60 and 120 months after surgery, according to absolute weight loss (aWL) in kg.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 60 and 120 months after surgery
Number of reflux episodes
Number of reflux episodes for assessment of severe GastroEsophageal Reflux Disease by pHmetry
Time frame: 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
Time frame: 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
Time frame: 60 and 120 months after surgery
Number of acid refluxes
Number of acid refluxes for assessment of severe GastroEsophageal Reflux Disease by pH- impedancemetry
Time frame: 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
Time frame: 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
Time frame: 60 and 120 months after surgery
Association with symptoms
Positive association with symptoms for assessment of severe GastroEsophageal Reflux Disease by pH- impedancemetry
Time frame: 60 and 120 months after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Département de Chirurgie Digestive et Thoracique, Hôpitaux Civils de Colmar
Colmar, France
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...and 12 more locations