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| Name | Class |
|---|---|
| Alberta Health services | OTHER |
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The majority of data documenting the outcomes for the adjustable gastric band (LAGB) originate from non-publicly funded surgical centres. The investigators aim to investigate the clinical outcomes of LAGB from a publicly funded Canadian obesity management program. This program recognized obesity as a chronic disease, providing extensive pre-operative multidisciplinary assessment and long term patient follow-up. Patients are selected for surgical management carefully by a multidisciplinary team and the LAGB is presented as one option to surgical management. Further, the investigators will investigate the operational impacts, including direct and indirect costs related the LAGB, to determine long term impacts on publicly funded hospitals within Canada.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAGB patients in Weight Wise Program | All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage Total Body Weight Loss | the percent total body weight loss between Baseline and 1 year the percent total body weight loss between Baseline and 2 years the percent total body weight loss between Baseline and 3 years | baseline to 1 year, baseline to 2 years, baseline to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| % of Excess Body Weight Loss | the percent of excess body weight loss between Baseline and 1 year the percent of excess body weight loss between Baseline and 2 years the percent of excess body weight loss between Baseline and 3 years | baseline to 1 year, baseline to 2 years, baseline to 3 years |
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Inclusion Criteria:
Exclusion criteria:
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All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for the Advancement of Minimally Invasive Surgery & Weight Wise Program | Edmonton | Alberta | T5H 3V9 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | LAGB Patients in Weight Wise Program | All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LAGB Patients in Weight Wise Program | All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis. |
| 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 | Mean Percentage Total Body Weight Loss | the percent total body weight loss between Baseline and 1 year the percent total body weight loss between Baseline and 2 years the percent total body weight loss between Baseline and 3 years | Three patients' weight data were not included in the weight loss analysis owing to early removal of band (n = 1) and complication or pregnancy affecting weight (n = 2) before 1-year follow-up. 79 patients reached 2 year follow up time point and 38 patients reached 3 year follow up time point. | Posted | Mean | Standard Deviation | % of total body weight loss | baseline to 1 year, baseline to 2 years, baseline to 3 years |
|
3-year follow-up
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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 | LAGB Patients in Weight Wise Program | All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| postoperative nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xinzhe Shi | Royal Alexandra Hospital | 7807356735 | xinzhe.shi@ahs.ca |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| initial BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Secondary | % of Excess Body Weight Loss | the percent of excess body weight loss between Baseline and 1 year the percent of excess body weight loss between Baseline and 2 years the percent of excess body weight loss between Baseline and 3 years | 3 not included the same reason as above. | Posted | Mean | Standard Deviation | % of excessive weight loss | baseline to 1 year, baseline to 2 years, baseline to 3 years |
|
|
|
| 0 |
| 178 |
| 50 |
| 178 |
| band migration | Surgical and medical procedures | Systematic Assessment |
|
| port site complications | Surgical and medical procedures | Systematic Assessment |
|
| band leakage | Surgical and medical procedures | Systematic Assessment |
|
| incisional hernia | Surgical and medical procedures | Systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Baseline to 3 years |
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