P4. The Short Term Outcome of the First 10 Morbidly Obese Adolescent Patients in the FDA-Approved Trial for Laparoscopic Adjustable Gastric Banding

Abstract

Department of Pathology, University of Illinois at ChicagoABSTRACTBackground: We received the LAP-BAND InvestigationalDevice Exemption (IDE) from the US Food and DrugAdministration in December 2004 to conduct a prospectivelongitudinal trial examining the safety and efficacy oflaparoscopic adjustable gastric banding (LAGB) in morbidlyobese adolescents ages 14 to 17 years.Objectives: To report the short-term results of LAGB in the first10 adolescents with complete 9 months of follow-up.Patients and Methods: Baseline characteristics and outcomedata were analyzed in 10 patients enrolled between March 2005and February 2006.Results: All of the patients were girls. Their mean body massindex ( 2SD) was 50 13 kg/m , and excess weight was 17179 pounds. Comorbidities included depression (3 patients), sleepapnea (3), hypertension (6), dyslipidemia (7), insulin resistance(9),metabolicsyndrome(9),andsteatohepatitis(in4of5patientswith liver biopsy). Operative time was 45 9 minutes, anddischarges were within 23 hours of surgery. Band-relatedcomplications were as follows: 2 dehydration, 1 pouchdilation, 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 resolvedin100%ofpatients(P¼0.04)and80%ofthepatients(P¼0.01),respectively, along with significant improvement in the PediatricQualityofLifeandBeckDepressionInventoryscoresandatrendtoward improvement in high-density lipoprotein cholesterolabnormalities (P¼0.08).Conclusions: Atshort-termfollow-up,weightlossoccurredwithminimal complications, leading to early resolution of majorobesity-related comorbidities. Continued evaluation of thelong-term safety and efficacy of LAGB as a surgical adjunct toa comprehensive obesity treatment program is warranted. JPGN45:465–473, 2007. Key Words: Laparoscopic adjustablegastric banding—LAP-BAND—Adolescent obesity—Bariatricsurgery—Comorbidities—Health-related quality of life.