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

NCT01806506 | Completed Results

• 1 other identifier: KBN N N403 3882 33
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (26)

• Number of Patients With Complications

  12 months after surgery

• 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 Total Cholesterol at 12 Months

  12 months after surgery

Other Outcomes (2)

• Quality of Life Questionnaire Score

  12 months after surgery

• Pulmonary Function Changes at 12 Months

  Baseline and 12 months from surgery

Study Arms (2)

Laparoscopic sleeve gastrectomy

EXPERIMENTAL

The group of morbidly obese patients assigned to laparoscopic sleeve gastrectomy.

Procedure: Laparoscopic sleeve gastrectomy

Roux-en-Y Gastric Bypass

EXPERIMENTAL

The group of morbidly obese patients assigned to Roux-en-Y gastric bypass.

Procedure: Roux-en-Y Gastric Bypass

Interventions

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.

Laparoscopic sleeve gastrectomy

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.

Roux-en-Y Gastric Bypass

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI≥40 kg/m2
• BMI≥35 kg/m2 with at least one comorbidity associated with obesity

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

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

Warsaw, 02-097, Poland

Location

Related Publications (1)

• 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.

  PMID: 28767558 DERIVED

Related Links

• Medical University of Warsaw web site
• Chair and Department of General Transplant and Liver Surgery, Medical University of Warsaw

MeSH Terms

Conditions

Obesity, Morbid; Metabolic Syndrome; Diabetes Mellitus; Dyslipidemias; Hypertension; Weight Loss; Insulin Resistance

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases; Body Weight Changes

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Results Point of Contact

• Title: Piotr Kalinowski
• Organization: Department of General, Transplant and Liver Surgery, Medical University of Warsaw

kalip@o2.pl

0048 22 599 2546

Study Officials

• Rafał Paluszkiewicz, Prof. MD,PhD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: March 7, 2013
• Study Start: November 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: November 1, 2013
• Last Updated: February 20, 2019
• Results First Posted: February 20, 2019

Record last verified: 2013-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)