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Completed

NCT Number: NCT01806506

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

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.

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Key information

Conditions

Morbid Obesity Body Weight Body Weight Changes Cardiovascular Diseases Diabetes Mellitus Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Hypertension Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases Weight Loss

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of General, Transplant and Liver Surgery, Public Central Teaching Hospital, Medical University of Warsaaw

Warsaw, 02-097, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic sleeve gastrectomy

Procedure

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.

Roux-en-Y gastric bypass

Procedure

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

  1. 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

  1. Number of Patients With Complications

    Time frame: 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

  2. Comorbidities Prevalence Changes

    Time frame: 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.

  3. Change in Weight From Baseline

    Time frame: 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.

  4. Change in BMI From Baseline

    Time frame: Baseline and 12 months after surgery

    Assessment of Body Mass Index (weight divided by height in meters squared) change from baseline.

  5. Plasma Total Cholesterol at 12 Months

    Time frame: 12 months after surgery

    Fasting plasma total cholesterol concentration in patients 12 months after surgery.

  6. Plasma HDL at 12 Months

    Time frame: 12 months after surgery

    Fasting plasma high density lipoprotein (HDL) cholesterol concentration in patients 12 months after surgery.

  7. Plasma LDL at 12 Months

    Time frame: 12 months after surgery

    Fasting plasma low density lipoprotein (LDL) cholesterol concentration in patients 12 months after surgery.

  8. Plasma Triglycerides at 12 Months

    Time frame: 12 months after surgery

    Fasting plasma triglycerides concentration in patients 12 months after surgery.

  9. Plasma Glucose at 12 Months

    Time frame: 12 months after surgery

    Fasting plasma glucose concentration in patients 12 months after surgery.

  10. Plasma Insulin at 12 Months

    Time frame: 12 months after surgery

    Fasting plasma insulin concentration in patients 12 months after surgery.

  11. Plasma C-peptide at 12 Months

    Time frame: 12 months after surgery

    Fasting plasma C-peptide concentration in patients 12 months after surgery.

  12. HOMA Index at 12 Months

    Time frame: 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

  13. HbA1c at 12 Months

    Time frame: 12 months after surgery

    The proportion of glycosylated hemoglobin (HbA1c) [%] is measured to assesses the average plasma glucose concentration and regulation.

  14. Plasma CRP at 12 Months

    Time frame: 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.

  15. Plasma Uric Acid at 12 Months

    Time frame: 12 months after surgery

    Hyperuricemia is associated with metabolic syndrome and obesity.

  16. Plasma Ghrelin at 12 Months

    Time frame: 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.

  17. Plasma Leptin at 12 Months

    Time frame: 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.

  18. Plasma Glucagon at 12 Months

    Time frame: 12 months after surgery

    Glucagon is synthesized and secreted from alpha cells of the pancreas. It leads to elevation of the plasma glucose.

  19. Plasma IGF-1 at 12 Months

    Time frame: 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.

  20. AST Level

    Time frame: 12 months

  21. ALT Level

    Time frame: 12 months

  22. INR

    Time frame: 12 months

  23. Albumin Level

    Time frame: 12 months

  24. GGT Level

    Time frame: 12 months

  25. ALP Level

    Time frame: 12 months

  26. LDH Level

    Time frame: 12 months

Other outcomes

  1. Quality of Life Questionnaire Score

    Time frame: 12 months after surgery

    Quality of life questionnaire score at 12 months(WHO-Bref Quality of Life questionnaire)

  2. Pulmonary Function Changes at 12 Months

    Time frame: Baseline and 12 months from surgery

    Spirometry and plethysmography results are used to assess pulmonary function before and after surgery.

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Mar 7, 2013
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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