Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic sleeve gastrectomy | Experimental | The group of morbidly obese patients assigned to laparoscopic sleeve gastrectomy. |
|
| Roux-en-Y Gastric Bypass | Experimental | The group of morbidly obese patients assigned to Roux-en-Y gastric bypass. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic sleeve gastrectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Questionnaire Score | Quality of life questionnaire score at 12 months(WHO-Bref Quality of Life questionnaire) | 12 months after surgery |
| Pulmonary Function Changes at 12 Months | Spirometry and plethysmography results are used to assess pulmonary function before and after surgery. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rafał Paluszkiewicz, Prof. MD,PhD | Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General, Transplant and Liver Surgery, Public Central Teaching Hospital, Medical University of Warsaaw | Warsaw | 02-097 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28767558 | Derived | Kalinowski P, Paluszkiewicz R, Ziarkiewicz-Wroblewska B, Wroblewski T, Remiszewski P, Grodzicki M, Krawczyk M. Liver Function in Patients With Nonalcoholic Fatty Liver Disease Randomized to Roux-en-Y Gastric Bypass Versus Sleeve Gastrectomy: A Secondary Analysis of a Randomized Clinical Trial. Ann Surg. 2017 Nov;266(5):738-745. doi: 10.1097/SLA.0000000000002397. |
| Label | URL |
|---|---|
| Medical University of Warsaw web site | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percentage of EWL | 12 months after surgery |
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric leak | Gastrointestinal disorders | gastric leak | Systematic Assessment | Non-symptomatic gastric leak observed in a water-soluble contrast swallow study. Treated with relparoscopy and drainage with no further complications. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound infection | Surgical and medical procedures | wound infection | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Piotr Kalinowski | Department of General, Transplant and Liver Surgery, Medical University of Warsaw | 0048 22 599 2546 | kalip@o2.pl |
Not provided
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D024821 | Metabolic Syndrome |
| D003920 | Diabetes Mellitus |
| D050171 | Dyslipidemias |
| D006973 | Hypertension |
| D015431 | Weight Loss |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Roux-en-Y Gastric Bypass | Procedure | 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. |
|
| 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. | 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. | 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. | Baseline and 12 months after surgery |
| Plasma Total Cholesterol at 12 Months | Fasting plasma total cholesterol concentration in patients 12 months after surgery. | 12 months after surgery |
| Plasma HDL at 12 Months | Fasting plasma high density lipoprotein (HDL) cholesterol concentration in patients 12 months after surgery. | 12 months after surgery |
| Plasma LDL at 12 Months | Fasting plasma low density lipoprotein (LDL) cholesterol concentration in patients 12 months after surgery. | 12 months after surgery |
| Plasma Triglycerides at 12 Months | Fasting plasma triglycerides concentration in patients 12 months after surgery. | 12 months after surgery |
| Plasma Glucose at 12 Months | Fasting plasma glucose concentration in patients 12 months after surgery. | 12 months after surgery |
| Plasma Insulin at 12 Months | Fasting plasma insulin concentration in patients 12 months after surgery. | 12 months after surgery |
| Plasma C-peptide at 12 Months | Fasting plasma C-peptide concentration in patients 12 months after surgery. | 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 | 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. | 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. | 12 months after surgery |
| Plasma Uric Acid at 12 Months | Hyperuricemia is associated with metabolic syndrome and obesity. | 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. | 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. | 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. | 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. | 12 months after surgery |
| AST Level | 12 months |
| ALT Level | 12 months |
| INR | 12 months |
| Albumin Level | 12 months |
| GGT Level | 12 months |
| ALP Level | 12 months |
| LDH Level | 12 months |
| Baseline and 12 months from surgery |
| Chair and Department of General Transplant and Liver Surgery, Medical University of Warsaw | View source |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. |
|
|
| 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 | Not Posted | 12 months after surgery | Participants |
| 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. | Not Posted | Evaluation at baseline and 1, 6 and 12 months after surgery | Participants |
| 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. | Not Posted | Evaluation at baseline and 12 months after surgery | Participants |
| Secondary | Change in BMI From Baseline | Assessment of Body Mass Index (weight divided by height in meters squared) change from baseline. | Not Posted | Baseline and 12 months after surgery | Participants |
| Secondary | Plasma Total Cholesterol at 12 Months | Fasting plasma total cholesterol concentration in patients 12 months after surgery. | Not Posted | 12 months after surgery | Participants |
| Secondary | Plasma HDL at 12 Months | Fasting plasma high density lipoprotein (HDL) cholesterol concentration in patients 12 months after surgery. | Not Posted | 12 months after surgery | Participants |
| Secondary | Plasma LDL at 12 Months | Fasting plasma low density lipoprotein (LDL) cholesterol concentration in patients 12 months after surgery. | Not Posted | 12 months after surgery | Participants |
| Secondary | Plasma Triglycerides at 12 Months | Fasting plasma triglycerides concentration in patients 12 months after surgery. | Not Posted | 12 months after surgery | Participants |
| Secondary | Plasma Glucose at 12 Months | Fasting plasma glucose concentration in patients 12 months after surgery. | Not Posted | 12 months after surgery | Participants |
| Secondary | Plasma Insulin at 12 Months | Fasting plasma insulin concentration in patients 12 months after surgery. | Not Posted | 12 months after surgery | Participants |
| Secondary | Plasma C-peptide at 12 Months | Fasting plasma C-peptide concentration in patients 12 months after surgery. | Not Posted | 12 months after surgery | Participants |
| 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 | Not Posted | 12 months after surgery | Participants |
| Secondary | HbA1c at 12 Months | The proportion of glycosylated hemoglobin (HbA1c) [%] is measured to assesses the average plasma glucose concentration and regulation. | Not Posted | 12 months after surgery | Participants |
| 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. | Not Posted | 12 months after surgery | Participants |
| Secondary | Plasma Uric Acid at 12 Months | Hyperuricemia is associated with metabolic syndrome and obesity. | Not Posted | 12 months after surgery | Participants |
| 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. | Not Posted | 12 months after surgery | Participants |
| 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. | Not Posted | 12 months after surgery | Participants |
| 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. | Not Posted | 12 months after surgery | Participants |
| 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. | Not Posted | 12 months after surgery | Participants |
| Secondary | AST Level | Not Posted | 12 months | Participants |
| Secondary | ALT Level | Not Posted | 12 months | Participants |
| Secondary | INR | Not Posted | 12 months | Participants |
| Secondary | Albumin Level | Not Posted | 12 months | Participants |
| Secondary | GGT Level | Not Posted | 12 months | Participants |
| Secondary | ALP Level | Not Posted | 12 months | Participants |
| Secondary | LDH Level | Not Posted | 12 months | Participants |
| Other Pre-specified | Quality of Life Questionnaire Score | Quality of life questionnaire score at 12 months(WHO-Bref Quality of Life questionnaire) | Not Posted | 12 months after surgery | Participants |
| Other Pre-specified | Pulmonary Function Changes at 12 Months | Spirometry and plethysmography results are used to assess pulmonary function before and after surgery. | Not Posted | Baseline and 12 months from surgery | Participants |
| 3 |
| 36 |
| 3 |
| 36 |
| EG001 | 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. | 0 | 36 | 6 | 36 |
|
| Bleeding | Gastrointestinal disorders | bleeding | Systematic Assessment | Intragastric bleeding - one case treated laparoscopically, the other required reoperation |
|
| Fluid collection | Surgical and medical procedures | seroma | Systematic Assessment | Seroma |
|
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001836 | Body Weight Changes |
| D005763 |
| Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |