Back to resultsA Study of the Laparoscopically-placed Adjustable Gastric Band for the Management of Obesity in Adolescent Patients
Primary Purpose
Obesity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LAP-BAND (Allergan, Inc.)
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, adolescent, pediatric, weight loss, bariatric surgery, gastric banding
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
Sites / Locations
- Children's Medical Center Dallas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lap-Band
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01409928
First Posted
August 2, 2011
Last Updated
April 3, 2020
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01409928
Brief Title
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
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Study Start Date
March 2012 (Actual)
Primary Completion Date
March 21, 2016 (Actual)
Study Completion Date
March 21, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, adolescent, pediatric, weight loss, bariatric surgery, gastric banding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lap-Band
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
LAP-BAND (Allergan, Inc.)
Other Intervention Name(s)
Lap-Band Adjustable Gastric Banding System
Intervention Description
Laparoscopic placement of adjustable gastric banding system for the treatment of severe obesity.
Primary Outcome Measure Information:
Title
Change in Body Mass Index Z-score
Description
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.
Time Frame
12 months post operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perrin White
Organizational Affiliation
UTSW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Laparoscopically-placed Adjustable Gastric Band for the Management of Obesity in Adolescent Patients
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