Randomized Comparison of Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity

NCT ID: NCT01806506

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2013-11-30

Brief Summary

Bariatric surgery is the most effective treatment for morbid obesity. Roux-en-Y gastric bypass (RYGB) is a bariatric procedure with known safety and effectiveness. Laparoscopic sleeve gastrectomy (LSG) is a newer procedure gaining popularity. The aim of the study is to compare outcomes of these two surgical methods in terms of weight loss, improvement of common comorbidities of obesity and influence on metabolic and hormonal status.

Detailed Description

Authors of the study believe that a more detailed head-to-head comparison of RYGB and LSG is necessary. The former method is the established "gold standard" procedure with good outcomes reported in many studies. However it is much more complex and the learning curve is longer. The latter method was introduced as an initial procedure in superobese patients because of its relative simplicity. It produced good outcomes in this population of superobese patients and surgeons in some centers started to use it as a primary bariatric procedure. RYGB is a restrictive and partially malabsorptive procedure and it is believed to have additional benefits in patients with metabolic disorders such as type 2 diabetes and dyslipidemia. Purely restrictive procedures such as LSG are theoretically less beneficial in this group of patients. In the present study authors will look at weight loss as well as improvement in comorbidities and several biochemical parameters and indices to assess also metabolic action of these two procedures.

Conditions

Morbid Obesity; Metabolic Syndrome X; Diabetes Mellitus; Dyslipidemia; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic sleeve gastrectomy

The group of morbidly obese patients assigned to laparoscopic sleeve gastrectomy.

Group Type: EXPERIMENTAL

Laparoscopic sleeve gastrectomy

Intervention Type: PROCEDURE

Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric procedure. LSG involves resection of a large part of the body and fundus of the stomach starting from the antrum up to the angle of His. The remaining part of the stomach (the gastric sleeve) is calibrated with a 36 French bougie.

Roux-en-Y Gastric Bypass

The group of morbidly obese patients assigned to Roux-en-Y gastric bypass.

Group Type: EXPERIMENTAL

Roux-en-Y Gastric Bypass

Intervention Type: PROCEDURE

Roux-en-Y gastric bypass (RYGB) is an intermediate (restrictive and malabsorptive) operation. RYGB involves creation of a 15-20 mL gastric pouch that is anastomosed to a 100cm Roux limb created at 100cm from the ligament of Treitz.

Interventions

Laparoscopic sleeve gastrectomy

Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric procedure. LSG involves resection of a large part of the body and fundus of the stomach starting from the antrum up to the angle of His. The remaining part of the stomach (the gastric sleeve) is calibrated with a 36 French bougie.

Intervention Type: PROCEDURE

Roux-en-Y Gastric Bypass

Roux-en-Y gastric bypass (RYGB) is an intermediate (restrictive and malabsorptive) operation. RYGB involves creation of a 15-20 mL gastric pouch that is anastomosed to a 100cm Roux limb created at 100cm from the ligament of Treitz.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• BMI≥40 kg/m2
• BMI≥35 kg/m2 with at least one comorbidity associated with obesity

Exclusion Criteria

• BMI > 60 kg/m2
• poorly controlled significant medical or psychiatric disorders
• active alcohol or substance abuse
• active duodenal/gastric ulcer disease
• difficult to treat gastro-esophageal reflux disease with a large hiatal hernia
• previous major gastrointestinal surgery
• diagnosed or suspected malignancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rafał Paluszkiewicz, Prof. MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Locations

Department of General, Transplant and Liver Surgery, Public Central Teaching Hospital, Medical University of Warsaaw

Warsaw, , Poland

Countries

Poland

References

Kalinowski P, Paluszkiewicz R, Ziarkiewicz-Wroblewska B, Wroblewski T, Remiszewski P, Grodzicki M, Krawczyk M. Liver Function in Patients With Nonalcoholic Fatty Liver Disease Randomized to Roux-en-Y Gastric Bypass Versus Sleeve Gastrectomy: A Secondary Analysis of a Randomized Clinical Trial. Ann Surg. 2017 Nov;266(5):738-745. doi: 10.1097/SLA.0000000000002397.

Reference Type: DERIVED

PMID: 28767558 (View on PubMed)

Related Links

http://www.wum.edu.pl

Medical University of Warsaw web site

https://hepaclin.wum.edu.pl/en

Chair and Department of General Transplant and Liver Surgery, Medical University of Warsaw

Other Identifiers

KBN N N403 3882 33

Identifier Type: -

Identifier Source: org_study_id