Overview

This trial is active, not recruiting.

Condition morbid obesity
Treatments laparoscopic sleeve gastrectomy, laparoscopic roux-en-y gastric bypass
Sponsor IHU Strasbourg
Collaborator IRCAD
Start date March 2009
End date July 2015
Trial size 100 participants
Trial identifier NCT02475590, 2008-A01590-55

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Laparoscopic sleeve gastrectomy
laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy
(Experimental)
Laparoscopic Roux-en-Y gastric bypass
laparoscopic roux-en-y gastric bypass
Laparoscopic Roux-en-Y gastric bypass

Primary Outcomes

Measure
Excess weight loss at 3 years
time frame: At 36 months
Change in excess weight loss
time frame: At 1, 3, 6, 12, months and every year for 10 years

Secondary Outcomes

Measure
Nutritional status and vitamin deficiency
time frame: 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
Nutritional status and vitamin deficiency
time frame: 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
Nutritional status and vitamin deficiency
time frame: 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
Glycolipid profile
time frame: 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
Glycolipid profile
time frame: 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
Glycolipid profile
time frame: 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
Pain (visual analog scale)
time frame: At 1, 3, 6, 12, 18, 24, 30 and 36 months

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass for Morbidly Obese Patients: a Prospective Randomized Clinical Trial
Principal investigator Jacques Marescaux, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by IHU Strasbourg.