FDA Approves Study of Weight Loss Surgery In Teens

obesity surgery Weight loss surgery--more specifically referred to as bariatric surgery and gastric bypass surgery --has been the big buzz word in treating morbidly obese adults for several years now. But can it help--or would it harm--severely overweight teens?

Although one of these popular procedures, gastric banding -- or “lap banding,” as it is commonly known-- has been an accepted practice in controlling weight in obese adults since 2001, the Food and Drug Administration has been reluctant to approve it for the treatment of childhood obesity.

However, as the number of obese children continues to climb, the agency has initiated a tightly controlled study in which three hospitals, New York University Medical Center, New York-Presbyterians’ Morgan Stanley Children’s Hospital, and the University of Illinois at Chicago Medical Center, have been selected to perform clinical trials to examine the safety and efficacy of gastric banding surgery on adolescents.

NYU, which won FDA approval to conduct research back in 2005, has published its findings in the January 2007 issue of the Journal of Pediatric Surgery. Their study, which according to its authors is the first to evaluate lap band surgery in patients this young, consisted of 53 morbidly obese teenagers ranging in age from 13 to 17.


A morbidly obese individual is described as someone who has a body mass index (BMI) of 40 or higher and is approximately 100 pounds overweight. All of the study participants had at least a five-year history of obesity, and many had conditions found in obese adults, like diabetes, high blood pressure and sleep apnea.

The researchers found that the teens lost an average of 50 percent of their weight a year after their surgery without experiencing complications requiring readmission to the hospital. There were some minor complications. The bands in two of the patients slipped, two patients developed hiatal hernias , and the wound in one of the patients became infected. All of these conditions were corrected through outpatient treatments. In addition, there were a few patients who experienced mild hair loss and iron deficiency. They were given nutritional counseling and vitamin supplements.

New York-Presbyterians’ Morgan Stanley Children’s Hospital began its clinical trials in 2006. Their trial is designed for teenagers between the ages of 14 and 18 who have a five-year history of obesity and a BMI of 40 or higher or greater than the 95th weight-for-height percentile. Teens with a BMI of 35 or higher, who have comorbidities like diabetes or hypertension, are also eligible.

The program’s initial phase is comprised of a comprehensive assessment that includes:

-- A medical history

-- A physical exam

-- Extensive blood testing

-- Bone age and bone density studies

-- Evaluation by nutritionists and psychiatrists

-- Stress exercise testing

Patients are then placed on a strict program of diet, exercise, and behavior controls. An integrated team including pediatricians, pediatric endocrinologists, pediatric gastroenterologists, pulmonologists, exercise physiologists, bariatric surgeons, anesthesiologists, and pediatric nurse practitioners oversee this multidisciplinary care. Only if patients fail to lose 20 percent of their excess weight after six months are they then considered for surgery.

In a press release issued by University of Illinois at Chicago Medical Center in February 2005, the hospital outlined its program: “In the current trial, 50 patients ages 14 to 17 will be enrolled in a five-year study to look at weight loss and the long-term medical effects of weight loss after the LAP-BAND procedure.

In addition to surgery, patients will receive nutrition and psychological counseling. They will also be involved in a physical activity and behavior management program. The surgery is available for teens with a body mass index of at least 35 and one or more obesity related conditions such as diabetes, hypertension, sleep apnea, or musculoskeletal, gynecological or psychological problems. It is also available for teens with a body mass index of greater than 40 with no other health problems. Patients must have a history of obesity for at least five years, including failed attempts at diet and medical management of their obesity.”

All three of these trials have a common goal: to find a workable cure for obesity in children. However, in spite of the fact that lap banding shows promise, each facility is proceeding with caution. All of the programs include a thorough initial screening process and follow up after the procedure to ensure that surgery isn’t viewed as a quick fix solution to a problem as complex as morbid obesity.

source FoxNews