A study of the laparoscopically-placed adjustable gastric band for the management of obesity in adolescent patients

Study ID
STU 102010-093

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Rita Martin
214-456-9283
rita.barlau@childrens.com

Principal Investigator
Roy Kim

Summary

This is a prospective, non-randomized, single center study of a laparoscopically placed, adjustable gastric band medical device used to induce weight loss. owing to the off-label use of the LaP-BanD[RegisteredTM] in patients under 18 years of age, the study will be conducted under an FDa-approved investigational device exemption (iDe).

Study population
We plan to enroll 30 subjects between the ages of 14 and 17 years at the time of enrollment and at least 14 at the time of surgery with the LaP-BanD[RegisteredTM]. 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[Greater Than][?] 35 kg/m2, and who exhibit significant comorbidities as tabulated in Table 4. Patients must also meet the eligibility criteria listed in Table 5. 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.

Specific aims
1. Test the efficacy and safety of the LaP-BanD[RegisteredTM] for achieving weight loss in obese adolescent patients. We hypothesize that the LaP-BanD will reduce excess weight in severely obese adolescents. The primary endpoint of the study will be BMi z-score assessed at one year post-operation. The comparison will be the BMi z-score at baseline. Procedure safety and adverse events associated with the device will also be monitored as secondary outcomes.
2. Determine the effect of the LaP-BanD[RegisteredTM] on obesity-associated co-morbidities in adolescents. We hypothesize that the LaP-BanD procedure will lead to improvements in insulin resistance, dyslipidemia, hypertension, and other obesity-associated problems. These are secondary endpoints in our study.
3. identify factors which predict favorable outcomes following the LaP-BanD with respect to amount and sustainability of weight loss. We hypothesize that patients with the greatest and most durable weight loss will be those who, at baseline, have fewer disordered eating behaviors, greater social support, and have a lower quality of life as a result of being obese. These will be exploratory analyses which will test whether individual characteristics can predict weight loss success following LaP-BanD. Specifically, weight loss amount and duration will be the dependent variables, and the independent variables will be behaviors, social support, and quality of life.

Participant Eligibility

1. Subjects must be age 14-17 years, male or female, and have the following BMI and at least one of the co-morbidities listed.

BMI >35 and one of the following serious co-morbidities:
Type 2 diabetes mellitus, moderate or severe obstructive sleep apnea (AHI>15 events/hr), pseudotumor cerebri, and severe steatohepatitis

BMI>>40 and one or more of the following co-morbidities:
Mild obstructive sleep apnea (AHI>5 events/hr), hypertension, insulin resistance, glucose intolerance, dyslipidemia, impaired quality of life or activities of daily living

2. Tanner stage 4 or 5
3. Subject must demonstrate understanding of dietary and physical activity changes required for optimal postoperative outcomes
4. Psychosocial factors:
A. Evidence for mature decision-making with appropriate understanding potential risks and benefits of surgery
B. Evidence for appropriate social support without evidence of abuse or and neglect
C. Any psychiatric conditions must be appropriately treated
D. Evidence that family and patient have the ability and motivation to comply with recommended treatments through the pre-and postoperative course.


The patient[Single Quote]s understanding of lifestyle changes will be assessed through clinical interviews performed by the multidisciplinary team. The dietician will evaluate the subject[Single Quote]s understanding of the major dietary changes that must be made and how these change over time. The patient must be able to clearly articulate the needed diet and lifestyle changes, and describe a plan for how to implement changes in these areas from previous baseline.
The patient[Single Quote]s decision making and understanding of the risks and benefits of surgery will be assessed during the psychological interview. Included in this evaluation will be a determination of the cognitive ability of the individual and assessment for presence of thought, mood, personality, or eating disorder. The psychologist (or psychiatrist) will assess patient problem-solving skills and then provide problem-solving training if skills are not present/adequate. The patient will be asked how he/she would respond to several health-related problems, and be asked to demonstrate problem-solving skills in order to address those problems. Any patients rated less than satisfactory would receive problem-solving training and additional instruction and be reassessed.
Evidence for family and patient ability and motivation to comply with the treatments will be determined during the patient[Single Quote]s participation in the monitored weight loss program and from the medical record. Keeping appointments, adherence to diet, physical activity, medications and vitamins will be examined. A 24 hour adherence recall will be conducted as an additional screen for adherence. The multidisciplinary team will make this determination. In particular the the dietician and social worker will be instrumental in this assessment.
In order to facilitate information exchange and discussion about the surgery candidates, the multidisciplinary team will convene a regular meeting to discuss each patient[Single Quote]s appropriateness for the LAP-BAND. Only patients meeting medical and general eligibility criteria will be offered surgery. As appropriate others may be given a plan, such as problem solving training, in order to help meet the eligibility criteria.