Obesity with its consequences such as type 2 diabetes, high blood pressure, dyslipidemia, fatty liver disease, sleep apnea and cancers, remains a major healthcare problem worldwide. Bariatric surgery, combined with nutritional education and close monitoring, has been shown to be the most effective treatment for patients with morbid obesity resulting in significant and lasting weight loss and improvements in co-morbidities . With nearly 50000 procedures per year France ranks third in the world in terms of care for patients suffering from morbid (BMI ≥ 40 kg/m²) and severe (BMI 35-40 kg/m²) obesity. In parallel with the significant increase in the number of patients operated on for obesity in the world, over the past two decades, significant development has been observed in the field of bariatric surgery with a decrease or even disappearance of some procedures and the appearance of others. Performed for more than 40 years, the Roux-en-Y Gastric Bypass (RYGB) is a restrictive and malabsorptive procedure and currently is considered as gold standard procedure for the treatment of morbid obesity and its comorbidities. However, despite the good effectiveness (with an average Excess Weight Loss % (EWL%) of approximatively 70% at 2 years), RYGB is technically demanding procedure with learning curve requiring more than 100 cases and an overall complication rate ranging from 10% to 20% Introduced in 2001, one anastomosis gastric bypass (OAGB) is a modified gastric bypass that consists of a single gastrojejunal anastomosis between a long gastric pouch and a jejunal (biliopancreatic) omega loop. In Sept. 2019, taking into account the results from YOMEGA trial, the French High Authority for Health (Haute Autorité de Santé (HAS)) recommended to ban OAGB with 200 cm or longer BPL and urged to assess the efficacy and safety of OAGB with 150 cm BPL in a randomized controlled trial. Indeed, YOMEGA-2 trial is logical continuity of the YOMEGA trial. The aim of this study is to assess weight loss efficiency and the nutritional safety of the OAGB-150 in comparison to a standard (RYGB). The hypothesis of this study is that the OAGB with a 150 cm BPL could have the same efficacy on weight loss and nutritional complication rate in comparison to the RYGB at 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
368
It is a gastric bypass surgery with a unique gastro-jejunal anastomosis, a long (11-14cm) and narrow (3-4cm) gastric pouch will be created by applying one horizontal 45-mm stapler at the angle of lesser curvature, just above the left branch of the crow's foot, and then four to five vertical 60-mm staple cartridges will be placed upwards to the angle of His, and calibrated along a 32-Fr bougie. Sectioning of the greater omentum into a bivalve will be performed. The jejunum will be measured using pre-measured strip and amounted antecolically at 150 cm from the ligament of Treitz. An end-to-side anastomosis will be performed with the gastric pouch, using a 45-mm linear stapler and an anterior running suture to close gastro-enterotomy.
A small gastric pouch (30cc) will be created using a linear stapler. The alimentary limb will be moved up into an antecolic position after an epiploic transection so as to perform the gastro-jujunal anastomosis. The gastro-jejunostomy will be performed manually or using a linear or circular stapler. An alimentary limb of 150 cm and a biliary limb of 50cm will be measured (using premeasured strip) in order to perform the latero-lateral jejuno-jejunal anastomosis using a linear stapler. All mesenteric defects (Petersen's space and mesenteric defect) will be closed with a non-absorbable running suture
Hôpital Bichat Claude-Bernard
Paris, France
RECRUITINGTo demonstrate that OAGB with 150 cm biliopancreatic limb is not inferior to RYGB on weight loss (efficacy).
For each patient co-primary endpoints will be assessed at 2 years after surgery composed by: Efficacy: Weight loss according to Excess Weight Loss % (EWL%) calculated using the following formula: ((weight 2 years after surgery - initial weight) / (initial weight - ideal weight)) x 100. Ideal weight defined as the weight corresponding to a BMI = 25 kg/m². The assessment of the primary co-endpoint will be standardized between the sites.
Time frame: 2 years after the surgery
To demonstrate that OAGB with 150 cm biliopancreatic limb is not inferior to RYGB on nutritional complication rate (safety)
For each patient co-primary endpoints will be assessed at 2 years after surgery composed by: Safety: Nutritional complications defined by at least one vitamin deficiency (vit. B1 \< 66nmol/l or B12 \< 145pmol/l), malnutrition (albumin \< 30g/l), anemia (hemoglobin \< 10g/dl) or a combination of these. The assessment of the primary co-endpoint will be standardized between the sites.
Time frame: 2 years after the surgery
Measurement of albumin
Measurement of albumin will explore the nutritional status of patients. Results will be expressed in g/l
Time frame: Before and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of pre-albumin
Measurement of pre-albumin will explore the nutritional status of patients. Results will be expressed in g/l
Time frame: Before and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of hemoglobin
Measurement of hemoglobin will explore the nutritional status of patients. Results will be expressed in g/l
Time frame: Before and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of calcium
Measurement of calcium will explore the nutritional status of patients. Results will be expressed in mmol/l
Time frame: Before and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of ferritin
Measurement of ferritin will explore the nutritional status of patients. Results will be expressed in μg/l
Time frame: Before and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of iron
Measurement of iron will explore the nutritional status of patients. Results will be expressed in mmol/l
Time frame: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of % of transferrin saturation
Measurement of % of transferrin saturation will explore the nutritional status of patients. Results will be expressed in %
Time frame: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of zinc
Measurement of zinc will explore the nutritional status of patients. Results will be expressed in mmol/L
Time frame: Before surgery and 6, 12 months and 24 months after surgery
Measurement of vitamin A
Measurement of vitamin A will explore the nutritional status of patients. Results will be expressed in mmol/l
Time frame: Before surgery and 6, 12 and 24 months after surgery
Measurement of 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 and 24 months after surgery
Measurement of 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 and 24 months after surgery
Measurement of 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 and 24 months after surgery
Measurement of vitamin E
Measurement of vitamin E will explore the nutritional status of patients. Results will be expressed in mmol/l
Time frame: Before surgery and 6, 12 and 24 months after surgery
Measurement of 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 and 24 months after surgery
Measurement of prothrombin rate
Measurement of prothrombin 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
Measurement of the 24-hour steatorrhea rate
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: 6 month after surgery
Measurement of HbA1c
Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in %
Time frame: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of fasting glycemia
Measurement of fasting glycemia will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Time frame: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of HDL
Measurement of HDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Time frame: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of LDL
Measurement of LDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Time frame: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of cholesterol
Measurement of cholesterol will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Time frame: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of triglycerides
Measurement of triglycerides will explore the Metabolic of surgery. Results will be expressed in mmol/l
Time frame: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Evaluation of antidiabetic drugs
Assessment of number of antidiabetic medications 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
Evaluation of antilipidemic drugs
Assessment of the number of antilipidemic medications 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
Evaluation of antihypertensive drugs
Assessment of the number of antihypertensive medications 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
Evaluation of the 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 the use or discontinuation of the use of Continuous Positive Airway Pressure machine
Time frame: Before surgery and 6, 12 and 24 months after surgery
Hospitalization length
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: The last day of hospitalization
Number of patients readmitted
Number of patients readmitted within 30 days after surgery.
Time frame: 30 days after surgery
Occurrence of kidney stone
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
Overall complications rate
Rate of medical and surgical (\> or = grade III) complications within 24 months after surgery using the Dindo-Clavien classification, described as : Grade I = Any deviation from the normal postoperative course. Grade II = 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 24 months after surgery
Type of early complications
Type (medical or surgical) of early complications (within 30 days) for each procedure.
Time frame: Within 30 days after surgery
Severity of early complications
Severity of early complications (within 30 days) for each procedure according to the Dindo-Clavien classification
Time frame: Within 30 days after surgery
Type of late complications
Type (medical or surgical) of late complications (after 30 days) for each procedure.
Time frame: Within 2 years after surgery
Severity of late complications
Severity of late complications (after 30 days) for each procedure according to the Dindo-Clavien classification
Time frame: Within 2 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: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
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.
Time frame: 1, 3, 6, 12, 18 and 24 months after surgery
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
Time frame: 1, 3, 6, 12, 18 and 24 months after surgery
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
Time frame: 1, 3, 6, 12, 18 and 24 months after surgery
Quality of life assessed with 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
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
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, 18 and 24 months after surgery
Body composition
Body composition level on a subsample of the total population: By impedancemetry : * Muscle mass index in kg/m2 * Non-fat mass index in kg/m2 * Fat mass index in kg/m2
Time frame: Before and 24 months after surgery.
Sarcopenia level
Sarcopenia level on a subsample of the total population will be assessed by Handgrip Strength
Time frame: Before and 24 months after surgery.
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