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Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University of Illinois
ClinicalTrials.gov Identifier:
NCT00592202
First received: December 27, 2007
Last updated: January 21, 2010
Last verified: January 2010
History of Changes
  Purpose

The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.


Condition Intervention
Morbid Obesity
 Procedure: Placement of an adjustable gastric band

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by University of Illinois:

Primary Outcome Measures:
  • Weight loss [ Time Frame: Every six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: December 2004
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
 Procedure: 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.

  Eligibility

Ages Eligible for Study:   14 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 14 through 17
  • BMI greater than 40
  • BMI 35 to 40 and also having an obesity related comorbidity
  • Have a history of working in a multidisciplinary weight loss program utilizing nutritional training, behavior modification, and activity training

Exclusion Criteria:

  • Subject history of congenital or acquired anomalies fo the gastrointestinal tract
  • Severe cardiopulmonary or other serious organic disease
  • Severe coagulopathy
  • Hepatic insufficiency or cirrhosis
  • History of bariatric gastric or esophageal surgery
  • History of intestinal obstruction or adhesive peritonitis
  • History of esophageal motility disorders
  • Type I diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592202

Locations
United States, Illinois
UIMC
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois
Investigators
Principal Investigator: Mark J Holterman, M.D. Division of Pediatric Surgery, UIC
  More Information

No publications provided

Responsible Party: Holterman, Mark, MD, Division of Pediatric Surgery, UIC
ClinicalTrials.gov Identifier: NCT00592202     History of Changes
Other Study ID Numbers: 2004-0732
Study First Received: December 27, 2007
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Illinois:
Morbid obesity
Adolescents
Gastric restrictive procedure
Adjustable gastric band
Treatment

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013