Trial Outcomes & Findings for Randomized Comparison of Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity (NCT NCT01806506)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

12 months after surgery

Results posted on

2019-02-20

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Laparoscopic Sleeve Gastrectomy 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.	Roux-en-Y Gastric Bypass 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 Study STARTED	36	36
Overall Study 1 Month	36	36
Overall Study 3 Months	35	36
Overall Study 6 Months	34	36
Overall Study 9 Months	34	35
Overall Study COMPLETED	34	35
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Laparoscopic Sleeve Gastrectomy 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.	Roux-en-Y Gastric Bypass 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 Study Lost to Follow-up	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laparoscopic Sleeve Gastrectomy n=36 Participants 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.	Roux-en-Y Gastric Bypass n=36 Participants 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 n=72 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	44.9 years STANDARD_DEVIATION 10.6 • n=5 Participants	43.9 years STANDARD_DEVIATION 10.8 • n=7 Participants	44.4 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment Poland	36 participants n=5 Participants	36 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Laparoscopic Sleeve Gastrectomy n=36 Participants 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.	Roux-en-Y Gastric Bypass n=36 Participants 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.
Excess Weight Loss From Baseline	67.8 percentage of EWL Standard Deviation 19.3	64.2 percentage of EWL Standard Deviation 18.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 months after surgery

Assessment of Body Mass Index (weight divided by height in meters squared) change from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after surgery

Fasting plasma total cholesterol concentration in patients 12 months after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after surgery

Fasting plasma high density lipoprotein (HDL) cholesterol concentration in patients 12 months after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after surgery

Fasting plasma low density lipoprotein (LDL) cholesterol concentration in patients 12 months after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after surgery

Fasting plasma triglycerides concentration in patients 12 months after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after surgery

Fasting plasma glucose concentration in patients 12 months after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after surgery

Fasting plasma insulin concentration in patients 12 months after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after surgery

Fasting plasma C-peptide concentration in patients 12 months after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after surgery

The proportion of glycosylated hemoglobin (HbA1c) \[%\] is measured to assesses the average plasma glucose concentration and regulation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after surgery

Hyperuricemia is associated with metabolic syndrome and obesity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after surgery

Glucagon is synthesized and secreted from alpha cells of the pancreas. It leads to elevation of the plasma glucose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months after surgery

Quality of life questionnaire score at 12 months(WHO-Bref Quality of Life questionnaire)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12 months from surgery

Spirometry and plethysmography results are used to assess pulmonary function before and after surgery.

Outcome measures

Outcome data not reported

Adverse Events

Laparoscopic Sleeve Gastrectomy

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Roux-en-Y Gastric Bypass

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Laparoscopic Sleeve Gastrectomy n=36 participants at risk 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.	Roux-en-Y Gastric Bypass n=36 participants at risk 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.
Gastrointestinal disorders Gastric leak	2.8% 1/36 • Number of events 1 • 12 months	0.00% 0/36 • 12 months
Gastrointestinal disorders Bleeding	5.6% 2/36 • Number of events 2 • 12 months	0.00% 0/36 • 12 months

Other adverse events

Other adverse events
Measure	Laparoscopic Sleeve Gastrectomy n=36 participants at risk 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.	Roux-en-Y Gastric Bypass n=36 participants at risk 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.
Surgical and medical procedures Wound infection	2.8% 1/36 • Number of events 1 • 12 months	5.6% 2/36 • Number of events 2 • 12 months
Surgical and medical procedures Fluid collection	5.6% 2/36 • Number of events 2 • 12 months	11.1% 4/36 • Number of events 4 • 12 months

Additional Information

Piotr Kalinowski

Department of General, Transplant and Liver Surgery, Medical University of Warsaw

Phone: 0048 22 599 2546

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place