Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents
The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents|
- Weight loss [ Time Frame: Every six months ] [ Designated as safety issue: No ]
- Resolution of comorbidities [ Time Frame: every six months ] [ Designated as safety issue: No ]
- Assess the status of comorbidities and changes in quality of life scores from baseline. [ Time Frame: every six months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2004|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Adolescents between the ages 14 through 17 with a BMI of 40 or more or with a BMI of 35 or more and with an obesity related comorbidity will undergo placement of an adjustable gastric band
Device: Placement of an adjustable gastric band
Laparoscopic placement of an adjustable gastric band around the upper portion of the stomach and subsequent adjustments of the band via a subcutaneous port as needed to maintain appropriate restriction.
The aim of this research is to evaluate the safety and efficacy of the use of the Lap-Band system in the morbidly obese adolescent population in the United States. We also propose to take advantage of the opportunity for liver biopsy and the data collected for the FDA study in adolescents to answer several questions: 1) what is the true incidence of non-alcoholic fatty liver disease (NAFLD) and its variants in morbidly obese adolescents; 2) what is the course of the NAFLD disease in adolescents who have undergone weight loss, including the progression from steatosis to NASH/ fibrosis or the progression of NASH to cirrhosis? 3) What are the factors implicated in this progression and 4) Is there a link between the excess visceral fat, MS and NAFLD as assessed by parallel changes in metabolic syndrome (MS) and NAFLD following weight loss intervention. The LAPBAND may provide obese adolescents with a significantly less morbid and reversible surgical option for weight loss.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592202
|United States, Illinois|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Robert Kanard, M.D.||Division of Pediatric Surgery, UIC|