Laparoscopic Adjustable Gastric Banding in Adolescents

N/ACompletedNCT01619488

Kirk Reichard57 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Morbid Obesity

Interventions

Adjustable Gastric BandDEVICE

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.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

A I duPont Hospital for Children/Nemours Children's Clinic

Wilmington, Delaware, United States

Outcomes

Primary Outcomes

Total Weight Loss

Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial

Time frame: Up to five years post surgery.

Secondary Outcomes

Insulin Resistance

Fasting insulin level

Time frame: Baseline

Data from ClinicalTrials.gov

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