Obesity
Conditions
Keywords
obesity, adolescent, pediatric, weight loss, bariatric surgery, gastric banding
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.
Interventions
DEVICELAP-BAND (Allergan, Inc.)
Laparoscopic placement of adjustable gastric banding system for the treatment of severe obesity.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index Z-score | 12 months post operation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lap-Band 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.
LAP-BAND (Allergan, Inc.): Laparoscopic placement of adjustable gastric banding system for the treatment of severe obesity. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 12 |
Baseline characteristics
| Characteristic | Lap-Band |
|---|---|
| Age, Categorical <=18 years | 16 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
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.
Time frame: 12 months post operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lap-Band | Change in Body Mass Index Z-score | -0.26 Z-score | Standard Deviation 0.21 |