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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
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 (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.
Department of General, Transplant and Liver Surgery, Public Central Teaching Hospital, Medical University of Warsaaw
Warsaw, Poland
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.
Time frame: 12 months after surgery
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
Time frame: 12 months after surgery
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.
Time frame: Evaluation at baseline and 1, 6 and 12 months after surgery
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.
Time frame: Evaluation at baseline and 12 months after surgery
Change in BMI From Baseline
Assessment of Body Mass Index (weight divided by height in meters squared) change from baseline.
Time frame: Baseline and 12 months after surgery
Plasma Total Cholesterol at 12 Months
Fasting plasma total cholesterol concentration in patients 12 months after surgery.
Time frame: 12 months after surgery
Plasma HDL at 12 Months
Fasting plasma high density lipoprotein (HDL) cholesterol concentration in patients 12 months after surgery.
Time frame: 12 months after surgery
Plasma LDL at 12 Months
Fasting plasma low density lipoprotein (LDL) cholesterol concentration in patients 12 months after surgery.
Time frame: 12 months after surgery
Plasma Triglycerides at 12 Months
Fasting plasma triglycerides concentration in patients 12 months after surgery.
Time frame: 12 months after surgery
Plasma Glucose at 12 Months
Fasting plasma glucose concentration in patients 12 months after surgery.
Time frame: 12 months after surgery
Plasma Insulin at 12 Months
Fasting plasma insulin concentration in patients 12 months after surgery.
Time frame: 12 months after surgery
Plasma C-peptide at 12 Months
Fasting plasma C-peptide concentration in patients 12 months after surgery.
Time frame: 12 months after surgery
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
Time frame: 12 months after surgery
HbA1c at 12 Months
The proportion of glycosylated hemoglobin (HbA1c) \[%\] is measured to assesses the average plasma glucose concentration and regulation.
Time frame: 12 months after surgery
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.
Time frame: 12 months after surgery
Plasma Uric Acid at 12 Months
Hyperuricemia is associated with metabolic syndrome and obesity.
Time frame: 12 months after surgery
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.
Time frame: 12 months after surgery
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.
Time frame: 12 months after surgery
Plasma Glucagon at 12 Months
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
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.
Time frame: 12 months after surgery
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
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