Clinical trial NCT02475590: Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass
Official title: Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass for Morbidly Obese Patients: a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Keywords: Sleeve gastrectomy
Roux-en-Y gastric bypass
Excess weight loss
Quality of life
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
Collaborators: name: IRCAD
First posted: 2015-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Excess weight loss at 3 years
timeFrame: At 36 months
measure: Change in excess weight loss
timeFrame: At 1, 3, 6, 12, months and every year for 10 years
Secondary outcomes:
measure: Nutritional status and vitamin deficiency
timeFrame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
measure: Nutritional status and vitamin deficiency
timeFrame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
measure: Nutritional status and vitamin deficiency
timeFrame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
measure: Nutritional status and vitamin deficiency
timeFrame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
measure: Nutritional status and vitamin deficiency
timeFrame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
measure: Nutritional status and vitamin deficiency
timeFrame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
measure: Glycolipid profile
timeFrame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
measure: Glycolipid profile
timeFrame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
measure: Glycolipid profile
timeFrame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
measure: Glycolipid profile
timeFrame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
measure: Glycolipid profile
timeFrame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
measure: Quality of life (Moorehead-Ardelt II, Gastro-intestinal Quality of Life Index (GIQLI))
timeFrame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
measure: Pain (visual analog scale)
timeFrame: At 1, 3, 6, 12, 18, 24, 30 and 36 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne
Study officials:
affiliation: Strasbourg university hospital, IRCAD, IHU Strasbourg
name: Jacques Marescaux, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.