Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass

Status Active, not recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02475590
Study type	Interventional
Source	IHU Strasbourg
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 2009
Completion date	July 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03657927` - A Comparison of McGrath MAC Versus C-MAC Videolaryngoscopes in Morbidly Obese Patients	N/A
Recruiting	`NCT04934826` - Comparison of the Absorption of Hydrolyzed or Intact Proteins in Morbid Obese Patients After the Roux Y Gastric Bypass	N/A
Completed	`NCT03181347` - The Microbiology of Bariatric Surgery	N/A
Completed	`NCT03886870` - Obesity, Lifestyle and Work Intervention	N/A
Active, not recruiting	`NCT04433338` - The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery	N/A
Completed	`NCT03553849` - Utilization of Very Low Calorie Diet in Obese General Surgery Patients	N/A
Completed	`NCT05854875` - Diabetes Remission After RYGBP and RYGBP With Fundus Resection	N/A
Not yet recruiting	`NCT03203161` - Registry on Obesity Surgery in Adolescents
Not yet recruiting	`NCT03601273` - Bariatric Embolization Trial for the Obese Nonsurgical	Phase 1
Recruiting	`NCT02129296` - Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study	Phase 1/Phase 2
Active, not recruiting	`NCT01564732` - Multicenter Prospective Randomized Controlled Trial of Plicated Laparoscopic Adjustable Gastric Banding	N/A
Completed	`NCT02033265` - Ultrasound-Guided Axillary Brachial Plexus Block: Influence of Obesity
Not yet recruiting	`NCT01652105` - Randomized Trial of Preoperative Diets Before Bariatric Surgery	N/A
Completed	`NCT01963637` - Gastric Volumetry by Gastric Tomodensitometry With Gas	N/A
Completed	`NCT01149512` - Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program	N/A
Terminated	`NCT01759550` - Prospective Case-Series of Ligasure Advance Pistol Grip and LigaSure Blunt Tip
Completed	`NCT01955993` - Fentanyl Metabolism in Obese Adolescents	N/A
Recruiting	`NCT01685177` - Single Anastomosis Duodeno-Ileal Bypass vs Standard Duodenal Switch as a Second Step After Sleeve Gastrectomy in the Super-Morbid Obese Patient	N/A
Completed	`NCT01675713` - Lifestyleintervention for the Treatment of Severe Obesity	N/A
Terminated	`NCT01041261` - Effects of a Novel Dietary Intervention on Body Composition After Laparoscopic Gastric Bypass Surgery	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.