Randomized Clinical Trial Comparing Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity and Underlying Metabolic and Hormonal Abnormalities
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Morbid Obesity
- Sponsor
- Medical University of Warsaw
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Excess Weight Loss From Baseline
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Excess Weight Loss From Baseline
Time Frame: 12 months after surgery
Weight loss measured as a percentage of excess weight lost is one of the most commonly used and accepted outcome measure in clinical trials evaluating bariatric surgery.
Secondary Outcomes
- Number of Patients With Complications(12 months after surgery)
- Plasma HDL at 12 Months(12 months after surgery)
- Plasma Glucose at 12 Months(12 months after surgery)
- HOMA Index at 12 Months(12 months after surgery)
- HbA1c at 12 Months(12 months after surgery)
- Plasma Glucagon at 12 Months(12 months after surgery)
- GGT Level(12 months)
- ALP Level(12 months)
- Comorbidities Prevalence Changes(Evaluation at baseline and 1, 6 and 12 months after surgery)
- Change in Weight From Baseline(Evaluation at baseline and 12 months after surgery)
- Change in BMI From Baseline(Baseline and 12 months after surgery)
- Plasma LDL at 12 Months(12 months after surgery)
- Plasma CRP at 12 Months(12 months after surgery)
- Plasma Uric Acid at 12 Months(12 months after surgery)
- Plasma Total Cholesterol at 12 Months(12 months after surgery)
- Plasma Insulin at 12 Months(12 months after surgery)
- Plasma Leptin at 12 Months(12 months after surgery)
- Plasma IGF-1 at 12 Months(12 months after surgery)
- AST Level(12 months)
- INR(12 months)
- Plasma Triglycerides at 12 Months(12 months after surgery)
- Plasma C-peptide at 12 Months(12 months after surgery)
- Plasma Ghrelin at 12 Months(12 months after surgery)
- ALT Level(12 months)
- Albumin Level(12 months)
- LDH Level(12 months)