Back to resultsLaparoscopic Adjustable Gastric Banding in Adolescents
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adjustable Gastric Band
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring Lap-Band, morbid obesity, adolescents
Eligibility Criteria
Inclusion Criteria:
- ages 14-17
- BMI > 40
- 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
Sites / Locations
- A I duPont Hospital for Children/Nemours Children's Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gastric Banding
Arm Description
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.
Outcomes
Primary Outcome Measures
Total Weight Loss
Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial
Secondary Outcome Measures
Insulin Resistance
Fasting insulin level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01619488
Brief Title
Laparoscopic Adjustable Gastric Banding in Adolescents
Official Title
Laparoscopic Adjustable Gastric Banding for Treatment of Morbid Obesity in Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 23, 2007 (Actual)
Primary Completion Date
April 4, 2016 (Actual)
Study Completion Date
April 4, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kirk Reichard
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Lap-Band, morbid obesity, adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gastric Banding
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Adjustable Gastric Band
Other Intervention Name(s)
Lap-Band
Intervention Description
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 Measure Information:
Title
Total Weight Loss
Description
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 Outcome Measure Information:
Title
Insulin Resistance
Description
Fasting insulin level
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirk Reichard, MD
Organizational Affiliation
A I duPont Hospital for Children; Nemours Children's Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
A I duPont Hospital for Children/Nemours Children's Clinic
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Laparoscopic Adjustable Gastric Banding in Adolescents
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