Reversible Surgery Gains Favor for Adolescents

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.

“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:

1. Failure for ≥6 months of organized attempts at weight management;

2. At or near physiological maturity;

3. Very severe obesity (BMI ≥40) with serious obesity-related comorbidities or a BMI of ≥50 with less severe comorbidities;

4. Demonstrated commitment to comprehensive medical and psychological evaluations pre- and postoperatively;

5. Agreement to avoid pregnancy for ≥1 year postoperatively;

6. Capability and willingness to adhere to nutritional guidelines postoperatively;

7. Informed consent to surgical treatment;

8. Demonstrated decisional capacity; and

9. A supportive family environment.²

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:

1. The total number of bariatric surgeries increased ninefold during the years 1998–2004, from 13,386 to 121,055.

2. Across all age groups, the fastest growth in bariatric surgeries occurred among adults ages 55–64—a twentyfold increase—from 772 surgeries in 1998 to nearly 16,000 surgeries in 2004.

3. The national inpatient death rate associated with bariatric surgery declined 78.7%, from 0.89% in 1998 to 0.19% in 2004. In 2004, 230 patients died in hospital stays during which bariatric surgery was performed.

4. In 2004, the inpatient death rate for men was 2.8 times higher than the rate among women, down from 6 times higher in 1998.

5. Total national inpatient hospital costs for bariatric surgeries increased by >800%, from $147 million in 1998 to $1.26 billion in 2004 (in 2004 dollars).

6. During 1998–2004, the national average hospital stay cost for performing bariatric surgery decreased 5.2% (in 2004 dollars).

7. Total costs for privately insured patients were 8.9 times higher in 2004 than in 1998—the largest increase among any group. The second-largest increase was for uninsured patients, for whom total costs increased 8.6 times (in 2004 dollars).

8. An increasing number of adolescents (12–17 years) are receiving bariatric surgery, an estimated 349 in 2004.

9. Women accounted for 82% of all bariatric surgeries in 2004.

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.

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:

1. Cincinnati Children's Hospital Medical Center

2. Texas Children's Hospital in Houston

3. University of Alabama in Birmingham

4. University of Pittsburgh

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.