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Obese adolescents soon may have another tool available to fight the war on obesity: an inflatable silicon ring. The device—a key component of laparoscopic adjustable gastric bandings (LAGB)—enabled 53 morbidly obese teen subjects (defined as having a body mass index [BMI] of >40) enrolled in a study at New York University (NYU) School of Medicine in Manhattan to lose an average of half their weight 1 year following surgery. Adverse side effects were minimal, with none of the teens requiring hospital readmission. Study results were published in the January 2007 Journal of Pediatric Surgery.1
LAGB surgery, the reversible weight loss option approved for adults by the Food and Drug Administration (FDA) in 2001, has yet to gain approval for patients <18 years. However, the scientists who conducted the study suggest that their findings, coupled with those of studies under way in other weight loss centers around the country, may help sway the FDA to approve the surgery for adolescents who meet certain criteria. They believe the surgical option could restore not only physical health of the adolescents, but psychological health, too.
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"I hope our study, the first to show LAP-BAND® [adjustable gastric banding system] is safe and efficacious in this age group, is the first step in getting enough experience and evidence for [FDA] approval. It's probably going to be a couple of years before it's approved. But when the FDA sees this experience isn't solely restricted to our center, they'll see fit to approve it," says Evan Nadler, MD, principal investigator of the study and director of pediatric minimally invasive surgery at NYU School of Medicine.
It's important to note that this form of bariatric surgery is also reversible, which may facilitate FDA approval. "Whenever you offer surgery to adolescents, you have to think about what effect it's going to have 30, 40 years down the line," says Nadler. "You don't know what's going to happen to patients; you don't know whether there's going to be a better solution."
CONSIDER THE CRITERIA
As LAGB surgery for adolescents is tested more widely, questions concerning
acceptance criteria for potential candidates remain a top concern. At the
onset of the study conducted by Nadler and associates, all subjects were
morbidly obese—with a BMI of 
40 and an average BMI of 47.6. All were
required to have attempted and failed at other medically supervised attempts
at weight loss; they also had to have been obese for 5 years.
Researchers also employed a less objective criteria to weigh patients' candidacy for the surgical procedure: a supportive family structure. Those who lack such support were strongly discouraged from undergoing the surgery. Nadler calls family support a "huge contributor" to patients' success. Patients also needed to demonstrate a commitment to follow through on recommendations from pre- and postoperative evaluations.
The criteria used in this study were comparable to the widely respected guidelines for adolescent bariatric surgery published in 2004 in the journal Pediatrics.2 "They are the most recognized guidelines at this point. I think they're very conservative," says Scott Gee, MD, medical director of Prevention and Health Information at Kaiser Permanente-Northern California in Oakland.
SCIENTISTS SUGGEST THAT THEIR FINDINGS, COUPLED WITH THOSE OF OTHER STUDIES, MAY HELP SWAY THE FDA TO APPROVE THE SURGERY FOR ADOLESCENTS WHO MEET CERTAIN CRITERIA.
The criteria proposed in the guidelines, authored by several pediatric specialists with experience in adolescent bariatric surgery, include the following:
6 months of organized attempts at weight management; 40) with serious obesity-related comorbidities
or a BMI of 50 with less severe comorbidities; 1 year postoperatively; Thomas H. Inge, MD, surgical director of the Comprehensive Weight Management Program at Cincinnati Children's Hospital Medical Center and lead author of the guidelines, notes that they were intentionally designed to be more conservative than those for adults. "An adult with a BMI of 35 or higher would be a candidate [for bariatric surgery]. For adolescents, it's 40 or higher. As pediatric specialists, we thought the guidelines should be more conservative because of the unknowns," says Inge.
He emphasizes that guidelines need not govern the decision-making process. "They should never be used to manage a specific patient. They are not intended to be an absolute prescription," he says. At Cincinnati Children's Hospital Weight Management Center, approximately 75 patients have undergone bariatric surgery in the form of gastric bypass. Inge explains that, since the FDA has no authority over surgery requirements (although devices such as the one used in the LAGB procedure must have FDA approval), weight loss centers have been able to provide the gastric bypass procedure to adolescents outside a testing environment.
PSYCHOSOCIAL IMPROVEMENTS
Health care providers know that severely obese adolescents suffer disproportionately from medical conditions such as diabetes, cardiovascular disease, and sleep apnea. But quality of life issues may be equally prevalent and damaging. "Obese adolescents describe their quality of life scales at about the level of a cancer patient getting chemotherapy," Nadler says.
For severely obese adolescents who have been unsuccessful at other weight loss methods, the promise of LAGB surgery—both to minimize associated medical conditions and to improve overall quality of life—makes it an attractive option.
"The data we're seeing in terms of quality of life is that bariatric
surgery dramatically turns around the lives of these kids who are victimized
by their peers, often excluded from extracurricular activities, and
unmercifully teased," adds Inge. 
Stats Support Surgical Options
A January 2007 statistical brief from the Agency for Healthcare Research and Quality, published in conjunction with the Healthcare Cost and Utilization Project, offers highlights on outcomes data for bariatric surgery:
Source: Zhao Y, Encinosa W: Bariatric surgery utilization and outcomes in 1998 and 2004. Available online at www.hcup-us.ahrq.gov.reports/statbriefs/sb23.pdf. Accessed April 4, 2007.
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Assessing the Risk of Adolescent Bariatrics
The Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) is built on the framework of the Longitudinal Assessment of Bariatric Surgery (LABS) consortium, a group of physicians, surgeons, and scientists focused on the study of adult bariatric surgical outcomes.
The goal for Teen-LABS is to facilitate clinical, epidemiological, and behavioral research for adolescent bariatric surgery. Common clinical protocols and a bariatric surgery database will collect information from participating clinical centers performing bariatric surgery on teens.
Teen-LABS will pool the necessary clinical and administrative resources to conduct multiple clinical studies in a timely, efficient manner. Standard definitions, shared protocols, and data collection instruments will be developed to produce evidence-based recommendations for patient evaluation, selection, and follow-up care.
Teen-LABS was funded in June 2006 through an agreement with the National Institute of Diabetes, Digestive and Kidney Disorders.
Consortium members of Teen-LABS include:
Research objectives were developed for the following areas: cardiovascular risk factors and disease, endocrine changes, sleep disorders, weight loss and body composition, renal disease, liver function and size, risks of bariatric surgery, nutrient deficiencies, nutritional supplement adherence, and psychological factors.
For more information about Teen-LABS, contact the Data Coordinating Center in Cincinnati, telephone 513-636-0163. Or access the Teen-LABS Web site: www.cincinnatichildrens.org/research/project/teen-labs.
Footnotes
In 2004, the American Society for Bariatric Surgery published a consensus statement on bariatric surgery, which includes the topic of adolescents and bariatric surgery. To read the statement, go to www.asbs.org/html/about/hcp.html.
For a list of articles, statistics, resources on overweight and obesity among teens, including a list of weight loss programs, visit www.overweightteen.com.
References
2. Inge TH, Krebs NF, Garcia VF, et al.: Bariatric surgery for
severely overweight adolescents: Concerns and recommendations.
Pediatrics 114:217–223, 2004.
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