Laparoscopic Adjustable Gastric Banding in Adolescents

July 27, 2023 updated by: Kirk Reichard

Laparoscopic Adjustable Gastric Banding for Treatment of Morbid Obesity in Adolescents

This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • A I duPont Hospital for Children/Nemours Children's Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gastric Banding

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.
Device: 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.

Other Names:
  • Lap-Band

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Weight Loss
Time Frame: Up to five years post surgery.
Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial
Up to five years post surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Resistance
Time Frame: Baseline
Fasting insulin level
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirk Reichard

Investigators

  • Principal Investigator: Kirk Reichard, MD, A I duPont Hospital for Children; Nemours Children's Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2007

Primary Completion (Actual)

April 4, 2016

Study Completion (Actual)

April 4, 2016

Study Registration Dates

First Submitted

June 7, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (Estimated)

June 14, 2012

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0082295

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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