Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass
Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass for Morbidly Obese Patients: a Prospective Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Strasbourg, France, 67 000
- Service de Chirurgie Digestive et Endocrinienne
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sleeve gastrectomy
Laparoscopic sleeve gastrectomy
|
Laparoscopic sleeve gastrectomy
|
|
Experimental: Roux-en-Y gastric bypass
Laparoscopic Roux-en-Y gastric bypass
|
Laparoscopic Roux-en-Y gastric bypass
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Excess weight loss at 3 years
Time Frame: At 36 months
|
% of excess weight loss
|
At 36 months
|
|
Change in excess weight loss
Time Frame: At 1, 3, 6, 12, months and every year for 10 years
|
% 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
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
Albumin
|
At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
|
Nutritional status and vitamin deficiency
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
Pre-albumin
|
At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
|
Nutritional status and vitamin deficiency
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
Vitamin A
|
At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
|
Nutritional status and vitamin deficiency
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
Vitamin D
|
At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
|
Nutritional status and vitamin deficiency
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
Vitamin B9
|
At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
|
Nutritional status and vitamin deficiency
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
Vitamin B12
|
At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
|
Glycolipid profile
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
Fasting plasma glucose
|
At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
|
Glycolipid profile
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
Serum insulin
|
At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
|
Glycolipid profile
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
HbA1c
|
At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
|
Glycolipid profile
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
Triglycerides
|
At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
|
Glycolipid profile
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
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))
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
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)
Time Frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
Pain assessment (visual analog scale)
|
At 1, 3, 6, 12, 18, 24, 30 and 36 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jacques Marescaux, MD, Strasbourg university hospital, IRCAD, IHU Strasbourg
Publications and helpful links
General Publications
- Vix M, Liu KH, Diana M, D'Urso A, Mutter D, Marescaux J. Impact of Roux-en-Y gastric bypass versus sleeve gastrectomy on vitamin D metabolism: short-term results from a prospective randomized clinical trial. Surg Endosc. 2014 Mar;28(3):821-6. doi: 10.1007/s00464-013-3276-x. Epub 2013 Nov 7.
- Vix M, Diana M, Liu KH, D'Urso A, Mutter D, Wu HS, Marescaux J. Evolution of glycolipid profile after sleeve gastrectomy vs. Roux-en-Y gastric bypass: results of a prospective randomized clinical trial. Obes Surg. 2013 May;23(5):613-21. doi: 10.1007/s11695-012-0827-5.
- Ignat M, Vix M, Imad I, D'Urso A, Perretta S, Marescaux J, Mutter D. Randomized trial of Roux-en-Y gastric bypass versus sleeve gastrectomy in achieving excess weight loss. Br J Surg. 2017 Feb;104(3):248-256. doi: 10.1002/bjs.10400. Epub 2016 Nov 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-A01590-55
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