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| Name | Class |
|---|---|
| Alberta Health services | OTHER |
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This is a prospective case series study; all morbidly obese patients that need surgical management in Royal Alexandra Hospital will be provided 3 surgical options: Laparoscopic Sleeve Gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LR-en-Y), and laparoscopic gastric banding (LGB), safety and effectiveness will be compared among the 3 groups. The outcome measures will be percentage of excess weight loss, BMI, operative time, hospital stays, complications and improvement of comorbidities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LSG | Laparoscopic Sleeve Gastrectomy | ||
| LRYGB | Laparoscopic Roux-en-Y Gastric Bypass | ||
| LAGB | Laparoscopic Adjustable Gastric Banding |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Change of body weight in Kilograms measured at follow-up visits two year after surgery | baseline to 2-year postoperation |
| Change in BMI | Patients' weight and height were measured at follow up visit 2 years post operation. BMI was calculated using the formula: weight (kg)/height(meter)^2 | from baseline to 2-year postoperation |
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Inclusion Criteria:
Exclusion Criteria:
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Morbidly obese patients aged from 18 to 65.
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| ID | Title | Description |
|---|---|---|
| FG000 | Laparoscopic Sleeve Gastrectomy | Patient who had Laparoscopic Sleeve Gastrectomy for their morbid obesity |
| FG001 | Laparoscopic Roux-en-Y Gastric Bypass | Patients who had Laparoscopic Roux-en-Y Gastric Bypass for their morbid obesity |
| FG002 | Laparoscopic Adjustable Gastric Banding | Patients who had Laparoscopic Adjustable Gastric Banding for their morbid obesity |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LSG (Lap SG) | Laparoscopic Sleeve Gastrectomy |
| BG001 | LRYGB | Laparoscopic Roux-en-Y Gastric Bypass |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Body Weight | Change of body weight in Kilograms measured at follow-up visits two year after surgery | Posted | Mean | Standard Deviation | kg | baseline to 2-year postoperation |
|
|
2 year after surgery.
Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.
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| 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastrointestinal/staple line leak | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xinzhe Shi | Royal Alexandra Hospital | 7807356735 | xinzhe.shi@ahs.ca |
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| BG002 |
| LAGB |
Laparoscopic Adjustable Gastric Banding |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Change in BMI | Patients' weight and height were measured at follow up visit 2 years post operation. BMI was calculated using the formula: weight (kg)/height(meter)^2 | Posted | Mean | Standard Deviation | kg/m^2 | from baseline to 2-year postoperation |
|
|
|
| 5 |
| 51 |
| 0 |
| 0 |
| EG001 | Laparoscopic Roux-en-Y Gastric Bypass | 10 | 51 | 0 | 0 |
| EG002 | Laparoscopic Adjustable Gastric Banding | 7 | 48 | 0 | 0 |
| gastrointestinal/staple line bleed | Surgical and medical procedures | Systematic Assessment |
|
| anastamotic ulcer | Surgical and medical procedures | Systematic Assessment |
|
| stricture | Surgical and medical procedures | Systematic Assessment |
|
| band slippage | Surgical and medical procedures | Systematic Assessment |
|
| intraabdominal abscess | Surgical and medical procedures | Systematic Assessment |
|
| hernia | Surgical and medical procedures | Systematic Assessment |
|
| transfusion | Surgical and medical procedures | Systematic Assessment |
|
| transient renal insufficiency | Renal and urinary disorders | Systematic Assessment |
|
| NSTEMI/STEMI/arrhythmia | Cardiac disorders | Systematic Assessment |
|
| intravenous hydration for hypovolemia | Vascular disorders | Systematic Assessment |
|
| pulmonary embolus | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |