Short-term outcome in the first 10 morbidly obese adolescent patients in the FDA-approved trial for laparoscopic adjustable gastric banding

BACKGROUND: We received the LAP-BAND Investigational Device Exemption (IDE) from the US Food and Drug Administration in December 2004 to conduct a prospective longitudinal trial examining the safety and efficacy of laparoscopic adjustable gastric banding (LAGB) in morbidly obese adolescents ages 14 to 17 years. OBJECTIVES: To report the short-term results of LAGB in the first 10 adolescents with complete 9 months of follow-up. PATIENTS AND METHODS: Baseline characteristics and outcome data were analyzed in 10 patients enrolled between March 2005 and February 2006. RESULTS: All of the patients were girls. Their mean body mass index (±SD) was 50 ± 13 kg/m, and excess weight was 171 ± 79 pounds. Comorbidities included depression (3 patients), sleep apnea (3), hypertension (6), dyslipidemia (7), insulin resistance (9), metabolic syndrome (9), and steatohepatitis (in 4 of 5 patients with liver biopsy). Operative time was 45 ± 9 minutes, and discharges were within 23 hours of surgery. Band-related complications were as follows: 2 dehydration, 1 pouch dilation, and 1 port revision. All of the patients lost weight, with a 9-month excess weight loss of 30% ± 16% (range 14%-57%). Hypertension and the metabolic syndrome were resolved in 100% of patients (P = 0.04) and 80% of the patients (P = 0.01), respectively, along with significant improvement in the Pediatric Quality of Life and Beck Depression Inventory scores and a trend toward improvement in high-density lipoprotein cholesterol abnormalities (P = 0.08). CONCLUSIONS: At short-term follow-up, weight loss occurred with minimal complications, leading to early resolution of major obesity-related comorbidities. Continued evaluation of the long-term safety and efficacy of LAGB as a surgical adjunct to a comprehensive obesity treatment program is warranted.