Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass

Study Overview
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Brief Summary
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Prospective randomized clinical trial aiming to compare laparoscopic Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) with primary outcome on excess weight loss, and secondary outcomes on nutritional status, glycolipid profile, quality of life and pain assessments.

Detailed Description
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No consensus is proposed by the Medical and Surgical societies to define and / or prioritize surgical procedures in obesity surgery. Indications are based on patient's age, sex, dietary habits, the importance of overweight and associated comorbidities and even if rarely admitted, based on knowledge of surgical teams and the cost of interventions. Given the decrease of gastric banding procedures, Roux-en-Y gastro-jejunal bypass is often considered the reference procedure. The gastric bypass, developed in the 60s, is performed laparoscopically since the early 90s. It allows for a 60% to 70% excess weight loss with control over 75% of comorbidities. It is recommended to follow these patients long-term because late complications can occur. These patients require ongoing information and regular monitoring. They must also have a hyper-protein diet and a vitamin substitute long-term (multivitamins, vitamin B12, calcium ...). The Sleeve gastrectomy (SG) arises as an alternative to RYGB. It was classically proposed to patients with a BMI greater than 60 and significant comorbidities since the procedure let to a significant weight reduction in patients for whom any other procedure was too difficult to perform. The quality of the weight loss achieved in these patients has led many teams to analyze the results of this intervention without conducting an additional procedure. It appears from the literature that even performed alone, SG presents many benefits. To clarify the role of sleeve gastrectomy in the bariatric procedures range, the investigators propose to conduct a prospective randomized study to compare laparoscopic sleeve gastrectomy to Roux-en-Y gastric bypass.

Official Title
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Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass for Morbidly Obese Patients: a Prospective Randomized Clinical Trial

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Laparoscopic sleeve gastrectomy
* Procedure: Laparoscopic Roux-en-Y gastric bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI >40 and < 60 kg/m2 No contraindication to any of the procedures No contraindication to general anesthesia No known addiction Patient able to provide informed consent Exclusion Criteria: Contraindication to general anesthesia Known psychiatric pathology Pregnancy Previous major digestive surgery Immunosuppressive treatment including corticoids Coagulopathy (INR>1.5) or platelets < 50 000/µl Anemia (Hb<10g/dl) Severe comorbidity Malabsorptive disease or gastro-intestinal disease Myocardial infarction in previous year, angina, cardiac failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Sleeve gastrectomy<br>Laparoscopic sleeve gastrectomy | Procedure: Laparoscopic sleeve gastrectomy<br>* Laparoscopic sleeve gastrectomy<br>|
| Experimental: Roux-en-Y gastric bypass<br>Laparoscopic Roux-en-Y gastric bypass | Procedure: Laparoscopic Roux-en-Y gastric bypass<br>* Laparoscopic Roux-en-Y gastric bypass<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excess weight loss at 3 years | % of excess weight loss | At 36 months | 
| Change in excess weight loss | % of excess weight loss | At 1, 3, 6, 12, months and every year for 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status and vitamin deficiency | Albumin | At 1, 3, 6, 12, 18, 24, 30 and 36 months | 
| Nutritional status and vitamin deficiency | Pre-albumin | At 1, 3, 6, 12, 18, 24, 30 and 36 months | 
| Nutritional status and vitamin deficiency | Vitamin A | At 1, 3, 6, 12, 18, 24, 30 and 36 months | 
| Nutritional status and vitamin deficiency | Vitamin D | At 1, 3, 6, 12, 18, 24, 30 and 36 months | 
| Nutritional status and vitamin deficiency | Vitamin B9 | At 1, 3, 6, 12, 18, 24, 30 and 36 months | 
| Nutritional status and vitamin deficiency | Vitamin B12 | At 1, 3, 6, 12, 18, 24, 30 and 36 months | 
| Glycolipid profile | Fasting plasma glucose | At 1, 3, 6, 12, 18, 24, 30 and 36 months | 
| Glycolipid profile | Serum insulin | At 1, 3, 6, 12, 18, 24, 30 and 36 months | 
| Glycolipid profile | HbA1c | At 1, 3, 6, 12, 18, 24, 30 and 36 months | 
| Glycolipid profile | Triglycerides | At 1, 3, 6, 12, 18, 24, 30 and 36 months | 
| Glycolipid profile | Cholesterol (total, HDL, LDL) | At 1, 3, 6, 12, 18, 24, 30 and 36 months | 
| Quality of life (Moorehead-Ardelt II, Gastro-intestinal Quality of Life Index (GIQLI)) | Moorehead-Ardelt II, Gastro-intestinal Quality of Life Index (GIQLI) | At 1, 3, 6, 12, 18, 24, 30 and 36 months | 
| Pain (visual analog scale) | Pain assessment (visual analog scale) | At 1, 3, 6, 12, 18, 24, 30 and 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleeve gastrectomy, Roux-en-Y gastric bypass, Excess weight loss, Quality of life