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

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.

Study Overview

• Status: Unknown
• Conditions: Morbid Obesity
• Intervention / Treatment: Procedure: Laparoscopic sleeve gastrectomy; Procedure: Laparoscopic Roux-en-Y gastric bypass

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: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67 000
    • Service de Chirurgie Digestive et Endocrinienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleeve gastrectomy; Laparoscopic sleeve gastrectomy	Procedure: Laparoscopic sleeve gastrectomy; Laparoscopic sleeve gastrectomy
Experimental: Roux-en-Y gastric bypass; Laparoscopic Roux-en-Y gastric bypass	Procedure: 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	% 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

Collaborators and Investigators

• Sponsor: IHU Strasbourg
• Collaborators: IRCAD
• 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): March 1, 2009
• Primary Completion (Actual): July 1, 2015
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: May 26, 2015
• First Submitted That Met QC Criteria: June 15, 2015
• First Posted (Estimate): June 18, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Quality of life; Sleeve gastrectomy; Excess weight loss; Roux-en-Y gastric bypass
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 2008-A01590-55