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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01409928
• Other study ID #: STU 102010-093
• Status: Terminated
• Phase: N/A
• Start date: March 2012
• Est. completion date: March 21, 2016

Study information

• Verified date: April 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, non-randomized, single center study of a laparoscopically placed, adjustable gastric band medical device for the treatment of adolescent obesity.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: March 21, 2016
• Est. primary completion date: March 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• LAP-BAND (Allergan, Inc.)
Laparoscopic placement of adjustable gastric banding system for the treatment of severe obesity.

Locations

Country	Name	City	State
United States	Children's Medical Center Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Mass Index Z-score	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