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

Ai Xuan Holterman, Allen Browne, Barney E. Dillard, Lisa Tussing, Veronica Gorodner, Christiane Stahl, Nancy Browne, Sue Labott, James Herdegen, Grace Guzman, Andy Rink, Ifeoma Nwaffo, Carlos Galvani, Santiago Horgan, Mark Holterman

Research output: Contribution to journalArticlepeer-review

52 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)465-473
Number of pages9
JournalJournal of pediatric gastroenterology and nutrition
Volume45
Issue number4
DOIs
StatePublished - Oct 1 2007

Keywords

  • Adolescent obesity
  • Bariatric surgery
  • Comorbidities
  • Health-related quality of life
  • LAP-BAND
  • Laparoscopic adjustable gastric banding

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Gastroenterology

Fingerprint

Dive into the research topics of 'Short-term outcome in the first 10 morbidly obese adolescent patients in the FDA-approved trial for laparoscopic adjustable gastric banding'. Together they form a unique fingerprint.

Cite this