Overview

This trial is active, not recruiting.

Conditions morbid obesity, metabolic syndrome x, diabetes mellitus, dyslipidemia, hypertension
Treatments laparoscopic sleeve gastrectomy, roux-en-y gastric bypass
Sponsor Medical University of Warsaw
Start date November 2008
End date March 2012
Trial size 72 participants
Trial identifier NCT01806506, KBN N N403 3882 33

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The group of morbidly obese patients assigned to laparoscopic sleeve gastrectomy.
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.
(Experimental)
The group of morbidly obese patients assigned to Roux-en-Y gastric bypass.
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.

Primary Outcomes

Measure
Excess weight loss from baseline
time frame: 12 months after surgery

Secondary Outcomes

Measure
Number of patients with complications
time frame: 12 months after surgery
Comorbidities prevalence changes
time frame: Evaluation at baseline and 12 months after surgery
Change in weight from baseline
time frame: Evaluation at baseline and 12 months after surgery
Change in BMI from baseline
time frame: Baseline and 12 months after surgery
Plasma total cholesterol at 12 months
time frame: 12 months after surgery
Plasma HDL at 12 months
time frame: 12 months after surgery
Plasma LDL at 12 months
time frame: 12 months after surgery
Plasma triglycerides at 12 months
time frame: 12 months after surgery
Plasma glucose at 12 months
time frame: 12 months after surgery
Plasma insulin at 12 months
time frame: 12 months after surgery
Plasma C-peptide at 12 months
time frame: 12 months after surgery
HOMA index at 12 months
time frame: 12 months after surgery
HbA1c at 12 months
time frame: 12 months after surgery
Plasma CRP at 12 months
time frame: 12 months after surgery
Plasma uric acid at 12 months
time frame: 12 months after surgery
Plasma ghrelin at 12 months
time frame: 12 months after surgery
Plasma leptin at 12 months
time frame: 12 months after surgery
Plasma glucagon at 12 months
time frame: 12 months after surgery
Plasma IGF-1 at 12 months
time frame: 12 months after surgery

Eligibility Criteria

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

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

Additional Information

Official title Randomized Clinical Trial Comparing Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity and Underlying Metabolic and Hormonal Abnormalities
Principal investigator Rafał Paluszkiewicz, Prof. MD,PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Medical University of Warsaw.