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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01806506
First received: January 31, 2013
Last updated: March 6, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Morbid Obesity
Metabolic Syndrome X
Diabetes Mellitus
Dyslipidemia
Hypertension
Procedure: Laparoscopic sleeve gastrectomy
Procedure: Roux-en-Y Gastric Bypass

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity and Underlying Metabolic and Hormonal Abnormalities

Resource links provided by NLM:


Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • Excess weight loss from baseline [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    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:
  • Number of patients with complications [ Time Frame: 12 months after surgery ] [ Designated as safety issue: Yes ]
    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

  • Comorbidities prevalence changes [ Time Frame: Evaluation at baseline and 12 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: Evaluation at baseline and 12 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 12 months after surgery ] [ Designated as safety issue: No ]
    Assessment of Body Mass Index (weight divided by height in meters squared) change from baseline.

  • Plasma total cholesterol at 12 months [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Fasting plasma total cholesterol concentration in patients 12 months after surgery.

  • Plasma HDL at 12 months [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Fasting plasma high density lipoprotein (HDL) cholesterol concentration in patients 12 months after surgery.

  • Plasma LDL at 12 months [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Fasting plasma low density lipoprotein (LDL) cholesterol concentration in patients 12 months after surgery.

  • Plasma triglycerides at 12 months [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Fasting plasma triglycerides concentration in patients 12 months after surgery.

  • Plasma glucose at 12 months [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Fasting plasma glucose concentration in patients 12 months after surgery.

  • Plasma insulin at 12 months [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Fasting plasma insulin concentration in patients 12 months after surgery.

  • Plasma C-peptide at 12 months [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Fasting plasma C-peptide concentration in patients 12 months after surgery.

  • HOMA index at 12 months [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    The proportion of glycosylated hemoglobin (HbA1c) [%] is measured to assesses the average plasma glucose concentration and regulation.

  • Plasma CRP at 12 months [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Hyperuricemia is associated with metabolic syndrome and obesity.

  • Plasma ghrelin at 12 months [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Ghrelin is an appetite-stimulating hormone produced in the fundus of the stomach. Its concentration may change after some bariatric procedures.

  • Plasma leptin at 12 months [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    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 glucagon at 12 months [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Glucagon is synthesized and secreted from alpha cells of the pancreas. It leads to elevation of the plasma glucose.

  • Plasma IGF-1 at 12 months [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Quality of life questionnaire score [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Quality of life questionnaire score at 12 months(WHO-Bref Quality of Life questionnaire)

  • Pulmonary function changes at 12 months [ Time Frame: Baseline and 12 months from surgery ] [ Designated as safety issue: No ]
    Spirometry and plethysmography results are used to assess pulmonary function before and after surgery.


Enrollment: 72
Study Start Date: November 2008
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laparoscopic sleeve gastrectomy
The group of morbidly obese patients assigned to laparoscopic sleeve gastrectomy.
Procedure: Laparoscopic sleeve gastrectomy
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.
Experimental: Roux-en-Y Gastric Bypass
The group of morbidly obese patients assigned to Roux-en-Y gastric bypass.
Procedure: Roux-en-Y Gastric Bypass
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.

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806506

Locations
Poland
Department of General, Transplant and Liver Surgery, Public Central Teaching Hospital, Medical University of Warsaaw
Warsaw, Poland, 02-097
Sponsors and Collaborators
Medical University of Warsaw
Investigators
Principal Investigator: Rafał Paluszkiewicz, Prof. MD,PhD Medical University of Warsaw
  More Information

Additional Information:
No publications provided

Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01806506     History of Changes
Other Study ID Numbers: KBN N N403 3882 33
Study First Received: January 31, 2013
Last Updated: March 6, 2013
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Medical University of Warsaw:
Bariatric surgery
Gastric bypass
Sleeve gastrectomy
Weight loss
Lipoproteins
Insulin resistance
Incretins
Quality of life

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Insulin Resistance
Hypertension
Obesity
Obesity, Morbid
Dyslipidemias
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism

ClinicalTrials.gov processed this record on July 23, 2014