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

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ClinicalTrials.gov Identifier: NCT01806506
Recruitment Status : Completed
First Posted : March 7, 2013
Results First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

Tracking Information
First Submitted Date  ICMJE January 31, 2013
First Posted Date  ICMJE March 7, 2013
Results First Submitted Date  ICMJE October 8, 2018
Results First Posted Date  ICMJE February 20, 2019
Last Update Posted Date February 20, 2019
Study Start Date  ICMJE November 2008
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2018)
  • 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
  • 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.
  • 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.
  • 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.
  • Plasma Total Cholesterol at 12 Months [ Time Frame: 12 months after surgery ]
    Fasting plasma total cholesterol concentration in patients 12 months after surgery.
  • 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.
  • 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.
  • Plasma Triglycerides at 12 Months [ Time Frame: 12 months after surgery ]
    Fasting plasma triglycerides concentration in patients 12 months after surgery.
  • Plasma Glucose at 12 Months [ Time Frame: 12 months after surgery ]
    Fasting plasma glucose concentration in patients 12 months after surgery.
  • Plasma Insulin at 12 Months [ Time Frame: 12 months after surgery ]
    Fasting plasma insulin concentration in patients 12 months after surgery.
  • Plasma C-peptide at 12 Months [ Time Frame: 12 months after surgery ]
    Fasting plasma C-peptide concentration in patients 12 months after surgery.
  • 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
  • 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.
  • 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.
  • Plasma Uric Acid at 12 Months [ Time Frame: 12 months after surgery ]
    Hyperuricemia is associated with metabolic syndrome and obesity.
  • 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.
  • 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.
  • 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.
  • 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.
  • AST Level [ Time Frame: 12 months ]
  • ALT Level [ Time Frame: 12 months ]
  • INR [ Time Frame: 12 months ]
  • Albumin Level [ Time Frame: 12 months ]
  • GGT Level [ Time Frame: 12 months ]
  • ALP Level [ Time Frame: 12 months ]
  • LDH Level [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
  • 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
  • Comorbidities prevalence changes [ Time Frame: Evaluation at baseline 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 [ 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.
  • 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.
  • Plasma total cholesterol at 12 months [ Time Frame: 12 months after surgery ]
    Fasting plasma total cholesterol concentration in patients 12 months after surgery.
  • 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.
  • 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.
  • Plasma triglycerides at 12 months [ Time Frame: 12 months after surgery ]
    Fasting plasma triglycerides concentration in patients 12 months after surgery.
  • Plasma glucose at 12 months [ Time Frame: 12 months after surgery ]
    Fasting plasma glucose concentration in patients 12 months after surgery.
  • Plasma insulin at 12 months [ Time Frame: 12 months after surgery ]
    Fasting plasma insulin concentration in patients 12 months after surgery.
  • Plasma C-peptide at 12 months [ Time Frame: 12 months after surgery ]
    Fasting plasma C-peptide concentration in patients 12 months after surgery.
  • 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
  • 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.
  • 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.
  • Plasma uric acid at 12 months [ Time Frame: 12 months after surgery ]
    Hyperuricemia is associated with metabolic syndrome and obesity.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: October 8, 2018)
  • 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)
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: March 6, 2013)
  • 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)
  • 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.
 
Descriptive Information
Brief Title  ICMJE Randomized Comparison of Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity
Official Title  ICMJE Randomized Clinical Trial Comparing Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity and Underlying Metabolic and Hormonal Abnormalities
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Morbid Obesity
  • Metabolic Syndrome X
  • Diabetes Mellitus
  • Dyslipidemia
  • Hypertension
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Laparoscopic sleeve gastrectomy
    The group of morbidly obese patients assigned to laparoscopic sleeve gastrectomy.
    Intervention: Procedure: Laparoscopic sleeve gastrectomy
  • Experimental: Roux-en-Y Gastric Bypass
    The group of morbidly obese patients assigned to Roux-en-Y gastric bypass.
    Intervention: Procedure: Roux-en-Y Gastric Bypass
Publications * Kalinowski P, Paluszkiewicz R, Ziarkiewicz-Wróblewska B, Wróblewski 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2013)
72
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01806506
Other Study ID Numbers  ICMJE KBN N N403 3882 33
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medical University of Warsaw
Study Sponsor  ICMJE Medical University of Warsaw
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rafał Paluszkiewicz, Prof. MD,PhD Medical University of Warsaw
PRS Account Medical University of Warsaw
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP