Clinical trial NCT01409928: A Study of the Laparoscopically-placed Adjustable Gastric Band for the Management of Obesity in Adolescent Patients
Official title: A Study of the Laparoscopically-placed Adjustable Gastric Band for the Management of Obesity in Adolescent Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: obesity
adolescent
pediatric
weight loss
bariatric surgery
gastric banding
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 16
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Body Mass Index Z-score
timeFrame: 12 months post operation
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
Study officials:
affiliation: UTSW
name: Perrin White
role: PRINCIPAL_INVESTIGATOR
References: