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

Not Applicable

Completed

Conditions: Dyslipidemia
Diabetes Mellitus
Hypertension
Metabolic Syndrome X
Morbid Obesity

Interventions: Procedure: Laparoscopic sleeve gastrectomy
Procedure: Roux-en-Y Gastric Bypass

Registration Number: NCT01806506

Lead Sponsor: Medical University of Warsaw

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 72

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic sleeve gastrectomy	Laparoscopic sleeve gastrectomy	The group of morbidly obese patients assigned to laparoscopic sleeve gastrectomy.
Roux-en-Y Gastric Bypass	Roux-en-Y Gastric Bypass	The group of morbidly obese patients assigned to Roux-en-Y gastric bypass.

Primary Outcome Measures

Name	Time	Method
Excess Weight Loss From Baseline	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 Outcome Measures

Name	Time	Method
Number of Patients With Complications	12 months after surgery	Complications are defined as any negative deviation from the normal postoperative course. Complications of bariatric surgery include but are not limited to: gastrointestinal leak, intrabdominal bleeding, gastrointestinal bleeding, gastrointestinal stricture, gastrointestinal fistula, marginal ulceration, internal hernia, bowel obstruction, deep vein thrombosis, pulmonary embolism, wound infection, seroma, fascial dehiscence, abdominal hernia, gallstone formation, dehydration, nutritional deficiencies
Plasma HDL at 12 Months	12 months after surgery	Fasting plasma high density lipoprotein (HDL) cholesterol concentration in patients 12 months after surgery.
Plasma Glucose at 12 Months	12 months after surgery	Fasting plasma glucose concentration in patients 12 months after surgery.
HOMA Index at 12 Months	12 months after surgery	Insulin resistance (IR) measured with the homeostatic model assessment (HOMA) method. In the published studies the HOMA model correlated with estimates using the reference euglycemic clamp method. The following equation is used: HOMA-IR = (fasting plasma glucose concentration \[mmol/L\] x fasting plasma insulin concentration \[miliunits/L\])/22.5
HbA1c at 12 Months	12 months after surgery	The proportion of glycosylated hemoglobin (HbA1c) \[%\] is measured to assesses the average plasma glucose concentration and regulation.
Plasma Glucagon at 12 Months	12 months after surgery	Glucagon is synthesized and secreted from alpha cells of the pancreas. It leads to elevation of the plasma glucose.
GGT Level	12 months
ALP Level	12 months
Comorbidities Prevalence Changes	Evaluation at baseline and 1, 6 and 12 months after surgery	Number of patients with comorbidities such as: type 2 diabetes mellitus, arterial hypertension, dyslipidemia, obstructive sleep apnea, degenerative arthritis, gallbladder disease, gastro-esophageal reflux disease.
Change in Weight From Baseline	Evaluation at baseline and 12 months after surgery	Absolute weight loss (in kilograms) is evaluated. It is one of the most commonly used and accepted outcome measures in clinical trials evaluating bariatric surgery. It is more dependent on the initial weight of a study participant.
Change in BMI From Baseline	Baseline and 12 months after surgery	Assessment of Body Mass Index (weight divided by height in meters squared) change from baseline.
Plasma LDL at 12 Months	12 months after surgery	Fasting plasma low density lipoprotein (LDL) cholesterol concentration in patients 12 months after surgery.
Plasma CRP at 12 Months	12 months after surgery	C-reactive protein (CRP) is used as a marker of inflammation. It may be also used in the assessment of heart disease risk.
Plasma Uric Acid at 12 Months	12 months after surgery	Hyperuricemia is associated with metabolic syndrome and obesity.
Plasma Ghrelin at 12 Months	12 months after surgery	Ghrelin is an appetite-stimulating hormone produced in the fundus of the stomach. Its concentration may change after some bariatric procedures.
ALT Level	12 months
Albumin Level	12 months
Plasma Total Cholesterol at 12 Months	12 months after surgery	Fasting plasma total cholesterol concentration in patients 12 months after surgery.
Plasma Insulin at 12 Months	12 months after surgery	Fasting plasma insulin concentration in patients 12 months after surgery.
Plasma Leptin at 12 Months	12 months after surgery	Leptin is one of the adipose-derived hormones that causes inhibition of appetite. Elevated leptin levels are associated with obesity, inflammation, metabolic syndrome and cardiovascular disease. Weight loss leads to a decline in leptin concentrations.
Plasma IGF-1 at 12 Months	12 months after surgery	Insulin like growth factor 1 (IGF-1) is similar in structure to insulin. It has anabolic effects. Its levels may be related to BMI and level of nutrition.
AST Level	12 months
INR	12 months
Plasma Triglycerides at 12 Months	12 months after surgery	Fasting plasma triglycerides concentration in patients 12 months after surgery.
Plasma C-peptide at 12 Months	12 months after surgery	Fasting plasma C-peptide concentration in patients 12 months after surgery.
LDH Level	12 months

Trial Locations

Locations (1): Department of General, Transplant and Liver Surgery, Public Central Teaching Hospital, Medical University of Warsaaw
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Warsaw, Poland