A Study of the Laparoscopically-placed Adjustable Gastric Band for the Management of Obesity in Adolescent Patients

April 3, 2020 updated by: University of Texas Southwestern Medical Center
This is a prospective, non-randomized, single center study of a laparoscopically placed, adjustable gastric band medical device for the treatment of adolescent obesity.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Study population We plan to enroll 30 subjects between the ages of 14 and 17 years with the LAP-BAND®. The inclusion criteria are in accordance with recent evidence-based indications for the surgical management of severe obesity in the pediatric population (Pratt, Lenders et al. 2009). The enrollees will be children who have a body-mass index in the 99th percentile, corresponding to a BMI>= 35 kg/m2, and who exhibit significant comorbidities.

This sample size will provide over 90% power to detect a 15% change in body mass index with a standard deviation of 6, two-tailed alpha of 0.05, and allow for 20% loss to follow-up, using a paired design.

Study Type

Interventional

Enrollment (Actual)

16

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
    • Texas
      • Dallas, Texas, United States, 75390
        • Children's Medical Center Dallas

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)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI >= 35 kg/m2 and at least one serious comorbidity (type 2 diabetes mellitus, moderate or severe obstructive sleep apnea, pseudotumor cerebri, and severe steatohepatitis)
  • BMI => 40 kg/m2 and a serious comorbidity (as listed above or at least one other comorbidity (mild obstructive sleep apnea, hypertension, insulin resistance, glucose intolerance, dyslipidemia, impaired quality of life or activities of daily living)
  • Must live in Dallas/Fort Worth area so that necessary follow-up can be ensured.

Exclusion Criteria:

  • Intention to have another surgical procedure for weight reduction within 12 months of LAP-BAND® placement
  • History of pregnancy, or the intention to become pregnant within the next 12 months
  • History of substance abuse within one year prior to surgery
  • Obesity caused by medically correctable condition
  • History of gastric or esophageal surgery, or the presence of an esophageal dysmotility disorder
  • Eating disorder that is untreated
  • Chronic use of aspirin and/or nonsteroidal anti-inflammatory medications and unwillingness to discontinue the use of these medications
  • History of previous bariatric surgery, intestinal obstruction, or peritonitis
  • Presence of localized or systemic infection at the time of surgery
  • History of congenital or acquired anomalies of the gastrointestinal tract
  • History of immunocompromise, or auto-immune, hematologic or dermatologic condition that increases risk of bleeding, breakdown of skin integrity (due to port), or infection.
  • Planning to or having high likelihood of moving out of region within 2 years
  • Portal Hypertension or Cirrhosis
  • Uncorrectable coagulopathy or severe bleeding disorder
  • Use of weight loss medications within 6 weeks of procedure

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lap-Band
Placement of the LAP-BAND® system will be performed laparoscopically under general anesthesia, using the pars flaccida technique. The device will be placed by surgeons from the University of Texas Southwestern Medical Center Obesity Management Program at Children's Medical Center Dallas. Surgeons will be fully trained in the placement of the LAP-BAND® device, in accordance with FDA approval of the device for the placement in adults. As is current practice in adults undergoing the procedure, incidentally discovered hiatal hernias are repaired at the time of band placement, to reduce the incidence of post-operative reflux. Children receive prophylactic antibiotics, and are observed overnight after surgery. Patients are generally discharged from the hospital the next day. The band will initially be left empty at the end of the placement procedure.
Device: LAP-BAND (Allergan, Inc.)
Laparoscopic placement of adjustable gastric banding system for the treatment of severe obesity.
Other Names:
  • Lap-Band Adjustable Gastric Banding System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index Z-score
Time Frame: 12 months post operation
Measure of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
12 months post operation

Collaborators and Investigators

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

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Perrin White, UTSW

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)

March 1, 2012

Primary Completion (Actual)

March 21, 2016

Study Completion (Actual)

March 21, 2016

Study Registration Dates

First Submitted

August 2, 2011

First Submitted That Met QC Criteria

August 2, 2011

First Posted (Estimate)

August 4, 2011

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 102010-093

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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