Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02475590
• Other study ID #: 2008-A01590-55
• Status: Active, not recruiting
• Phase: N/A
• First received: May 26, 2015
• Last updated: February 27, 2018
• Start date: March 2009
• Est. completion date: July 2022

Study information

• Verified date: February 2018
• Source: IHU Strasbourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2022
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy
• Laparoscopic Roux-en-Y gastric bypass
Laparoscopic Roux-en-Y gastric bypass

Locations

Country	Name	City	State
France	Service de Chirurgie Digestive et Endocrinienne	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
IHU Strasbourg	IRCAD

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excess weight loss at 3 years	% of excess weight loss	At 36 months
Primary	Change in excess weight loss	% of excess weight loss	At 1, 3, 6, 12, months and every year for 10 years
Secondary	Nutritional status and vitamin deficiency	Albumin	At 1, 3, 6, 12, 18, 24, 30 and 36 months
Secondary	Nutritional status and vitamin deficiency	Pre-albumin	At 1, 3, 6, 12, 18, 24, 30 and 36 months
Secondary	Nutritional status and vitamin deficiency	Vitamin A	At 1, 3, 6, 12, 18, 24, 30 and 36 months
Secondary	Nutritional status and vitamin deficiency	Vitamin D	At 1, 3, 6, 12, 18, 24, 30 and 36 months
Secondary	Nutritional status and vitamin deficiency	Vitamin B9	At 1, 3, 6, 12, 18, 24, 30 and 36 months
Secondary	Nutritional status and vitamin deficiency	Vitamin B12	At 1, 3, 6, 12, 18, 24, 30 and 36 months
Secondary	Glycolipid profile	Fasting plasma glucose	At 1, 3, 6, 12, 18, 24, 30 and 36 months
Secondary	Glycolipid profile	Serum insulin	At 1, 3, 6, 12, 18, 24, 30 and 36 months
Secondary	Glycolipid profile	HbA1c	At 1, 3, 6, 12, 18, 24, 30 and 36 months
Secondary	Glycolipid profile	Triglycerides	At 1, 3, 6, 12, 18, 24, 30 and 36 months
Secondary	Glycolipid profile	Cholesterol (total, HDL, LDL)	At 1, 3, 6, 12, 18, 24, 30 and 36 months
Secondary	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
Secondary	Pain (visual analog scale)	Pain assessment (visual analog scale)	At 1, 3, 6, 12, 18, 24, 30 and 36 months