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This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric Banding | Experimental | Surgical placement of an adjustable gastric band around the upper portion of the stomach. Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjustable Gastric Band | Device | Surgical placement of an adjustable gastric band around the upper portion of the stomach. Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Weight Loss | Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial | Up to five years post surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Resistance | Fasting insulin level | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirk Reichard, MD | A I duPont Hospital for Children; Nemours Children's Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A I duPont Hospital for Children/Nemours Children's Clinic | Wilmington | Delaware | 19803 | United States |
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Of 136 eligible patients, 57 completed the pre-intervention program and underwent placement of the gastric band. The remainder opted out of the intervention.
Eligible patients were recruited from the pediatric weight management clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gastric Banding | Surgical placement of an adjustable gastric band around the upper portion of the stomach. Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction. Adjustable Gastric Band: Surgical placement of an adjustable gastric band around the upper portion of the stomach. Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gastric Band | Lap Band Surgery was ultimately performed on 57 patients, the remainder chose alternative management. |
| 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 | Total Weight Loss | Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial | Posted | Mean | Standard Deviation | kilograms | Up to five years post surgery. |
|
|
5 years
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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 | Adverse Events | 2 Adverse events requiring successful removal of band for slipped bands. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Band slippage, leading to removal | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kirk W Reichard, MD, MBA, Surgical Director | Nemours Childrens Health Delaware | 302-651-5999 | kreichar@nemours.org |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | Kilogram |
|
|
| Secondary | Insulin Resistance | Fasting insulin level | Posted | Mean | Standard Deviation | uIU/ml | Baseline |
|
|
|
| 0 |
| 57 |
| 2 |
| 57 |
| 0 |
| 57 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |