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

Hypertension Clinical Trial

Official title:

Randomized Clinical Trial Comparing Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity and Underlying Metabolic and Hormonal Abnormalities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806506
• Other study ID #: KBN N N403 3882 33
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: November 2013

Study information

• Verified date: January 2013
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Dyslipidemia
• Dyslipidemias
• Hypertension
• Metabolic Syndrome X
• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	Department of General, Transplant and Liver Surgery, Public Central Teaching Hospital, Medical University of Warsaaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life Questionnaire Score	Quality of life questionnaire score at 12 months(WHO-Bref Quality of Life questionnaire)	12 months after surgery
Other	Pulmonary Function Changes at 12 Months	Spirometry and plethysmography results are used to assess pulmonary function before and after surgery.	Baseline and 12 months from surgery
Primary	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	Number of Patients With Complications	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	12 months after surgery
Secondary	Comorbidities Prevalence Changes	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.	Evaluation at baseline and 1, 6 and 12 months after surgery
Secondary	Change in Weight From Baseline	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.	Evaluation at baseline and 12 months after surgery
Secondary	Change in BMI From Baseline	Assessment of Body Mass Index (weight divided by height in meters squared) change from baseline.	Baseline and 12 months after surgery
Secondary	Plasma Total Cholesterol at 12 Months	Fasting plasma total cholesterol concentration in patients 12 months after surgery.	12 months after surgery
Secondary	Plasma HDL at 12 Months	Fasting plasma high density lipoprotein (HDL) cholesterol concentration in patients 12 months after surgery.	12 months after surgery
Secondary	Plasma LDL at 12 Months	Fasting plasma low density lipoprotein (LDL) cholesterol concentration in patients 12 months after surgery.	12 months after surgery
Secondary	Plasma Triglycerides at 12 Months	Fasting plasma triglycerides concentration in patients 12 months after surgery.	12 months after surgery
Secondary	Plasma Glucose at 12 Months	Fasting plasma glucose concentration in patients 12 months after surgery.	12 months after surgery
Secondary	Plasma Insulin at 12 Months	Fasting plasma insulin concentration in patients 12 months after surgery.	12 months after surgery
Secondary	Plasma C-peptide at 12 Months	Fasting plasma C-peptide concentration in patients 12 months after surgery.	12 months after surgery
Secondary	HOMA Index at 12 Months	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	12 months after surgery
Secondary	HbA1c at 12 Months	The proportion of glycosylated hemoglobin (HbA1c) [%] is measured to assesses the average plasma glucose concentration and regulation.	12 months after surgery
Secondary	Plasma CRP at 12 Months	C-reactive protein (CRP) is used as a marker of inflammation. It may be also used in the assessment of heart disease risk.	12 months after surgery
Secondary	Plasma Uric Acid at 12 Months	Hyperuricemia is associated with metabolic syndrome and obesity.	12 months after surgery
Secondary	Plasma Ghrelin at 12 Months	Ghrelin is an appetite-stimulating hormone produced in the fundus of the stomach. Its concentration may change after some bariatric procedures.	12 months after surgery
Secondary	Plasma Leptin at 12 Months	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.	12 months after surgery
Secondary	Plasma Glucagon at 12 Months	Glucagon is synthesized and secreted from alpha cells of the pancreas. It leads to elevation of the plasma glucose.	12 months after surgery
Secondary	Plasma IGF-1 at 12 Months	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.	12 months after surgery
Secondary	AST Level		12 months
Secondary	ALT Level		12 months
Secondary	INR		12 months
Secondary	Albumin Level		12 months
Secondary	GGT Level		12 months
Secondary	ALP Level		12 months
Secondary	LDH Level		12 months

External Links

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