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
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Condition or disease | Intervention/treatment | Phase |
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Morbid Obesity Metabolic Syndrome X Diabetes Mellitus Dyslipidemia Hypertension | Procedure: Laparoscopic sleeve gastrectomy Procedure: Roux-en-Y Gastric Bypass | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | November 2013 |

Arm | Intervention/treatment |
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Experimental: Laparoscopic sleeve gastrectomy
The group of morbidly obese patients assigned to laparoscopic sleeve gastrectomy.
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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.
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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. |
- 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.
- 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 ]
- 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.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806506
Poland | |
Department of General, Transplant and Liver Surgery, Public Central Teaching Hospital, Medical University of Warsaaw | |
Warsaw, Poland, 02-097 |
Principal Investigator: | Rafał Paluszkiewicz, Prof. MD,PhD | Medical University of Warsaw |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Medical University of Warsaw |
ClinicalTrials.gov Identifier: | NCT01806506 |
Other Study ID Numbers: |
KBN N N403 3882 33 |
First Posted: | March 7, 2013 Key Record Dates |
Results First Posted: | February 20, 2019 |
Last Update Posted: | February 20, 2019 |
Last Verified: | January 2013 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Bariatric surgery Gastric bypass Sleeve gastrectomy Weight loss |
Lipoproteins Insulin resistance Incretins Quality of life |
Obesity Obesity, Morbid Metabolic Syndrome Dyslipidemias Overnutrition Nutrition Disorders Overweight |
Body Weight Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Lipid Metabolism Disorders |