Laparoscopic Adjustable Gastric Banding in Adolescents
Not Applicable
Completed
- Conditions
- Morbid Obesity
- Interventions
- Device: Adjustable Gastric Band
- Registration Number
- NCT01619488
- Lead Sponsor
- Kirk Reichard
- Brief Summary
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.
- Detailed Description
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
Inclusion Criteria
- ages 14-19
- BMI > 35
- history of obesity for at least 5 years with failed attempts at diet and medical management for at least 6 months.
- confirmation by a pediatric psychologist that the subject is sufficiently mature emotionally and has adequate family support to comply with the study protocol.
Exclusion Criteria
- history of congenital or acquired anomalies of the GI tract.
- history of esophageal motility disorders
- uncontrolled psychiatric problems
- previous esophageal, gastric or bariatric surgery; intestinal obstruction or peritonitis.
- uncontrolled eating disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gastric Banding 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.
- Primary Outcome Measures
Name Time Method Total Weight Loss Up to five years post surgery. Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial
- Secondary Outcome Measures
Name Time Method Insulin Resistance Baseline Fasting insulin level
Trial Locations
- Locations (1)
A I duPont Hospital for Children/Nemours Children's Clinic
🇺🇸Wilmington, Delaware, United States