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This is a dual site, prospective study which will compare plicated-Laparoscopic Adjustable Gastric Banding (PLAGB) to standard LABG (SLAGB) to identify significant differences in bariatric surgical outcomes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plicated Gastric Banding |
| ||
| Standard Gastric Banding |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial. | Procedure | PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | 3 years |
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Inclusion Criteria:
Subjects must meet the following criteria to be eligible for study entry:
Age between 18 - 80 years, and
Severely or Morbidly obese:
Without any contraindications to bariatric surgery, and
Without any metabolic or medically correctable causes for obesity (eg. Untreated hypothyroidism, Prader-Willi, etc.)
Patients who have had previous LAGB surgery requiring revision for complications such as slippage, stalled weight loss or weight regain
Exclusion Criteria:
Subjects meeting the following criteria will be excluded from study entry:
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Adult patients between the ages of 18-80 years of age who are severly or morbidly obese and meet NIH and FDA criteria for baratric surgery (BMI>30+ co-morbid disease or BMI>35) who are undergoing baratric surgery at Jacksonville Surgical Associates, P.A. or Ventura Advanced Surgical Associates will be returned. All enrolled patients will be assigned to either the SLAGB (control)group or the PLAGB (study) group.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ventura Advanced Surgical Associates | Ventura | California | 93003 | United States | ||
| Jacksonville Surgical Associates |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Jacksonville |
| Florida |
| 32216 |
| United States |