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

NCT01409928 | Terminated Results

• 1 other identifier: STU 102010-093
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obesity; adolescent; pediatric; weight loss; bariatric surgery; gastric banding

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Lap-Band

EXPERIMENTAL

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.)

Interventions

LAP-BAND (Allergan, Inc.) DEVICE

Laparoscopic placement of adjustable gastric banding system for the treatment of severe obesity.

Also known as: Lap-Band Adjustable Gastric Banding System

Lap-Band

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Children's Medical Center Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: Olga T. Gupta
• Organization: UTSW

olga.gupta@utsouthwestern.edu

(214) 648-8718

Study Officials

• Perrin White

  UTSW

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 4, 2011
• Study Start: March 1, 2012
• Primary Completion: March 21, 2016
• Study Completion: March 21, 2016
• Last Updated: April 7, 2020
• Results First Posted: April 7, 2020

Record last verified: 2020-04

Locations

US (1)