Clinical trial NCT01806506: Randomized Comparison of Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity
Official title: Randomized Clinical Trial Comparing Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity and Underlying Metabolic and Hormonal Abnormalities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Metabolic Syndrome X
Diabetes Mellitus
Dyslipidemia
Hypertension
Keywords: Bariatric surgery
Gastric bypass
Sleeve gastrectomy
Weight loss
Lipoproteins
Insulin resistance
Incretins
Quality of life
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2013-03-07
Enrollment: 72
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: 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.

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

Primary outcomes:
measure: Excess Weight Loss From Baseline
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Number of Patients With Complications
timeFrame: 12 months after surgery
measure: Comorbidities Prevalence Changes
timeFrame: Evaluation at baseline and 1, 6 and 12 months after surgery
measure: Change in Weight From Baseline
timeFrame: Evaluation at baseline and 12 months after surgery
measure: Change in BMI From Baseline
timeFrame: Baseline and 12 months after surgery
measure: Plasma Total Cholesterol at 12 Months
timeFrame: 12 months after surgery
measure: Plasma HDL at 12 Months
timeFrame: 12 months after surgery
measure: Plasma LDL at 12 Months
timeFrame: 12 months after surgery
measure: Plasma Triglycerides at 12 Months
timeFrame: 12 months after surgery
measure: Plasma Glucose at 12 Months
timeFrame: 12 months after surgery
measure: Plasma Insulin at 12 Months
timeFrame: 12 months after surgery
measure: Plasma C-peptide at 12 Months
timeFrame: 12 months after surgery
measure: HOMA Index at 12 Months
timeFrame: 12 months after surgery
measure: HbA1c at 12 Months
timeFrame: 12 months after surgery
measure: Plasma CRP at 12 Months
timeFrame: 12 months after surgery
measure: Plasma Uric Acid at 12 Months
timeFrame: 12 months after surgery
measure: Plasma Ghrelin at 12 Months
timeFrame: 12 months after surgery
measure: Plasma Leptin at 12 Months
timeFrame: 12 months after surgery
measure: Plasma Glucagon at 12 Months
timeFrame: 12 months after surgery
measure: Plasma IGF-1 at 12 Months
timeFrame: 12 months after surgery
measure: AST Level
timeFrame: 12 months
measure: ALT Level
timeFrame: 12 months
measure: INR
timeFrame: 12 months
measure: Albumin Level
timeFrame: 12 months
measure: GGT Level
timeFrame: 12 months
measure: ALP Level
timeFrame: 12 months
measure: LDH Level
timeFrame: 12 months
Other outcomes:
measure: Quality of Life Questionnaire Score
timeFrame: 12 months after surgery
measure: Pulmonary Function Changes at 12 Months
timeFrame: Baseline and 12 months from surgery
Locations:
city: Warsaw
country: Poland
facility: Department of General, Transplant and Liver Surgery, Public Central Teaching Hospital, Medical University of Warsaaw
Study officials:
affiliation: Medical University of Warsaw
name: Rafał Paluszkiewicz, Prof. MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.