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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Clinical Trial Comparing Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity and Underlying Metabolic and Hormonal Abnormalities

Conditions
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Morbid Obesity, Metabolic Syndrome X, Diabetes Mellitus, Dyslipidemia, Hypertension

Intervention / Treatment
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* Procedure: Laparoscopic sleeve gastrectomy
* Procedure: Roux-en-Y Gastric Bypass


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic sleeve gastrectomy<br>The group of morbidly obese patients assigned to laparoscopic sleeve gastrectomy. | Procedure: Laparoscopic sleeve gastrectomy<br>* 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.<br>|
| Experimental: Roux-en-Y Gastric Bypass<br>The group of morbidly obese patients assigned to Roux-en-Y gastric bypass. | Procedure: Roux-en-Y Gastric Bypass<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excess Weight Loss From Baseline | 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. | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Complications | 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 | 12 months after surgery | 
| Comorbidities Prevalence Changes | 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. | Evaluation at baseline and 1, 6 and 12 months after surgery | 
| Change in Weight From Baseline | 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. | Evaluation at baseline and 12 months after surgery | 
| Change in BMI From Baseline | Assessment of Body Mass Index (weight divided by height in meters squared) change from baseline. | Baseline and 12 months after surgery | 
| Plasma Total Cholesterol at 12 Months | Fasting plasma total cholesterol concentration in patients 12 months after surgery. | 12 months after surgery | 
| Plasma HDL at 12 Months | Fasting plasma high density lipoprotein (HDL) cholesterol concentration in patients 12 months after surgery. | 12 months after surgery | 
| Plasma LDL at 12 Months | Fasting plasma low density lipoprotein (LDL) cholesterol concentration in patients 12 months after surgery. | 12 months after surgery | 
| Plasma Triglycerides at 12 Months | Fasting plasma triglycerides concentration in patients 12 months after surgery. | 12 months after surgery | 
| Plasma Glucose at 12 Months | Fasting plasma glucose concentration in patients 12 months after surgery. | 12 months after surgery | 
| Plasma Insulin at 12 Months | Fasting plasma insulin concentration in patients 12 months after surgery. | 12 months after surgery | 
| Plasma C-peptide at 12 Months | Fasting plasma C-peptide concentration in patients 12 months after surgery. | 12 months after surgery | 
| HOMA Index at 12 Months | 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 | 12 months after surgery | 
| HbA1c at 12 Months | The proportion of glycosylated hemoglobin (HbA1c) [%] is measured to assesses the average plasma glucose concentration and regulation. | 12 months after surgery | 
| Plasma CRP at 12 Months | C-reactive protein (CRP) is used as a marker of inflammation. It may be also used in the assessment of heart disease risk. | 12 months after surgery | 
| Plasma Uric Acid at 12 Months | Hyperuricemia is associated with metabolic syndrome and obesity. | 12 months after surgery | 
| Plasma Ghrelin at 12 Months | Ghrelin is an appetite-stimulating hormone produced in the fundus of the stomach. Its concentration may change after some bariatric procedures. | 12 months after surgery | 
| Plasma Leptin at 12 Months | 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. | 12 months after surgery | 
| Plasma Glucagon at 12 Months | Glucagon is synthesized and secreted from alpha cells of the pancreas. It leads to elevation of the plasma glucose. | 12 months after surgery | 
| Plasma IGF-1 at 12 Months | 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. | 12 months after surgery | 
| AST Level |  | 12 months | 
| ALT Level |  | 12 months | 
| INR |  | 12 months | 
| Albumin Level |  | 12 months | 
| GGT Level |  | 12 months | 
| ALP Level |  | 12 months | 
| LDH Level |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric surgery, Gastric bypass, Sleeve gastrectomy, Weight loss, Lipoproteins, Insulin resistance, Incretins, Quality of life