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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Morbid Obesity
Metabolic Syndrome X
Diabetes Mellitus
Dyslipidemia
Hypertension
Interventions Procedure: Laparoscopic sleeve gastrectomy
Procedure: Roux-en-Y Gastric Bypass
Enrollment 72
Recruitment Details The patients were recruited from the population of patients referred for bariatric consultation to the outpatient clinic of the Department of General, Transplant and Liver Surgery, Medical University of Warsaw, Poland. The recruitment started in November 2008 and finished when the planned number of patients had been recruited for the study.
Pre-assignment Details Eighty six patients meeting the general criteria for bariatric surgery were evaluated for eligibility for the study. Six patients did not meet eligibility criteria (age > 60 years in 5 patients, suspicion of malignancy in 1 patient) and 8 patients decided not to participate in the study.
Arm/Group Title Laparoscopic Sleeve Gastrectomy Roux-en-Y Gastric Bypass
Hide Arm/Group Description

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

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.

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

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.

Period Title: Overall Study
Started 36 36
1 Month 36 36
3 Months 35 [1] 36
6 Months 34 [1] 36
9 Months 34 35 [1]
Completed 34 35
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             2             1
[1]
1 patient (reason - lost contact)
Arm/Group Title Laparoscopic Sleeve Gastrectomy Roux-en-Y Gastric Bypass Total
Hide Arm/Group Description

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

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.

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

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.

Total of all reporting groups
Overall Number of Baseline Participants 36 36 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
36
 100.0%
36
 100.0%
72
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 36 participants 72 participants
44.9  (10.6) 43.9  (10.8) 44.4  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
Female
26
  72.2%
23
  63.9%
49
  68.1%
Male
10
  27.8%
13
  36.1%
23
  31.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Poland Number Analyzed 36 participants 36 participants 72 participants
36 36 72
1.Primary Outcome
Title Excess Weight Loss From Baseline
Hide Description 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.
Time Frame 12 months after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laparoscopic Sleeve Gastrectomy Roux-en-Y Gastric Bypass
Hide Arm/Group Description:

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

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.

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

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.

Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: percentage of EWL
67.8  (19.3) 64.2  (18.5)
2.Secondary Outcome
Title Number of Patients With Complications
Hide Description 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
Time Frame 12 months after surgery
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Comorbidities Prevalence Changes
Hide Description 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.
Time Frame Evaluation at baseline and 1, 6 and 12 months after surgery
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Change in Weight From Baseline
Hide Description 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.
Time Frame Evaluation at baseline and 12 months after surgery
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change in BMI From Baseline
Hide Description Assessment of Body Mass Index (weight divided by height in meters squared) change from baseline.
Time Frame Baseline and 12 months after surgery
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Plasma Total Cholesterol at 12 Months
Hide Description Fasting plasma total cholesterol concentration in patients 12 months after surgery.
Time Frame 12 months after surgery
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Plasma HDL at 12 Months
Hide Description Fasting plasma high density lipoprotein (HDL) cholesterol concentration in patients 12 months after surgery.
Time Frame 12 months after surgery
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Plasma LDL at 12 Months
Hide Description Fasting plasma low density lipoprotein (LDL) cholesterol concentration in patients 12 months after surgery.
Time Frame 12 months after surgery
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Plasma Triglycerides at 12 Months
Hide Description Fasting plasma triglycerides concentration in patients 12 months after surgery.
Time Frame 12 months after surgery
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Plasma Glucose at 12 Months
Hide Description Fasting plasma glucose concentration in patients 12 months after surgery.
Time Frame 12 months after surgery
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Plasma Insulin at 12 Months
Hide Description Fasting plasma insulin concentration in patients 12 months after surgery.
Time Frame 12 months after surgery
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Plasma C-peptide at 12 Months
Hide Description Fasting plasma C-peptide concentration in patients 12 months after surgery.
Time Frame 12 months after surgery
Outcome Measure Data Not Reported
13.Secondary Outcome
Title HOMA Index at 12 Months
Hide Description 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
Time Frame 12 months after surgery
Outcome Measure Data Not Reported
14.Secondary Outcome
Title HbA1c at 12 Months
Hide Description The proportion of glycosylated hemoglobin (HbA1c) [%] is measured to assesses the average plasma glucose concentration and regulation.
Time Frame 12 months after surgery
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Plasma CRP at 12 Months
Hide Description C-reactive protein (CRP) is used as a marker of inflammation. It may be also used in the assessment of heart disease risk.
Time Frame 12 months after surgery
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Plasma Uric Acid at 12 Months
Hide Description Hyperuricemia is associated with metabolic syndrome and obesity.
Time Frame 12 months after surgery
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Plasma Ghrelin at 12 Months
Hide Description Ghrelin is an appetite-stimulating hormone produced in the fundus of the stomach. Its concentration may change after some bariatric procedures.
Time Frame 12 months after surgery
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Plasma Leptin at 12 Months
Hide Description 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.
Time Frame 12 months after surgery
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Plasma Glucagon at 12 Months
Hide Description Glucagon is synthesized and secreted from alpha cells of the pancreas. It leads to elevation of the plasma glucose.
Time Frame 12 months after surgery
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Plasma IGF-1 at 12 Months
Hide Description 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.
Time Frame 12 months after surgery
Outcome Measure Data Not Reported
21.Secondary Outcome
Title AST Level
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
22.Secondary Outcome
Title ALT Level
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
23.Secondary Outcome
Title INR
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
24.Secondary Outcome
Title Albumin Level
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
25.Secondary Outcome
Title GGT Level
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
26.Secondary Outcome
Title ALP Level
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
27.Secondary Outcome
Title LDH Level
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
28.Other Pre-specified Outcome
Title Quality of Life Questionnaire Score
Hide Description Quality of life questionnaire score at 12 months(WHO-Bref Quality of Life questionnaire)
Time Frame 12 months after surgery
Outcome Measure Data Not Reported
29.Other Pre-specified Outcome
Title Pulmonary Function Changes at 12 Months
Hide Description Spirometry and plethysmography results are used to assess pulmonary function before and after surgery.
Time Frame Baseline and 12 months from surgery
Outcome Measure Data Not Reported
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Laparoscopic Sleeve Gastrectomy Roux-en-Y Gastric Bypass
Hide Arm/Group Description

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

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.

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

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.

All-Cause Mortality
Laparoscopic Sleeve Gastrectomy Roux-en-Y Gastric Bypass
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Laparoscopic Sleeve Gastrectomy Roux-en-Y Gastric Bypass
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/36 (8.33%)      0/36 (0.00%)    
Gastrointestinal disorders     
Gastric leak  1 [1]  1/36 (2.78%)  1 0/36 (0.00%)  0
Bleeding  2 [2]  2/36 (5.56%)  2 0/36 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, gastric leak
2
Term from vocabulary, bleeding
[1]
Non-symptomatic gastric leak observed in a water-soluble contrast swallow study. Treated with relparoscopy and drainage with no further complications.
[2]
Intragastric bleeding - one case treated laparoscopically, the other required reoperation
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Laparoscopic Sleeve Gastrectomy Roux-en-Y Gastric Bypass
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/36 (8.33%)      6/36 (16.67%)    
Surgical and medical procedures     
Wound infection  1  1/36 (2.78%)  1 2/36 (5.56%)  2
Fluid collection  2 [1]  2/36 (5.56%)  2 4/36 (11.11%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, wound infection
2
Term from vocabulary, seroma
[1]
Seroma
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Piotr Kalinowski
Organization: Department of General, Transplant and Liver Surgery, Medical University of Warsaw
Phone: 0048 22 599 2546
EMail: kalip@o2.pl
Layout table for additonal information
Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01806506    
Other Study ID Numbers: KBN N N403 3882 33
First Submitted: January 31, 2013
First Posted: March 7, 2013
Results First Submitted: October 8, 2018
Results First Posted: February 20, 2019
Last Update Posted: February 20, 2019