title: Short-term outcome in the first 10 morbidly obese adolescent patients in the FDA-approved trial for laparoscopic adjustable gastric banding.
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.
  
  
  OBJECTIVE
  To report the short-term results of LAGB in the first 10 adolescents with complete 9 months of follow-up.
  
  
  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.
authors.affiliation: Division of Pediatric Surgery, Department of Surgery, and the New Hope Pediatric and Adolescent Weight Management Project, University of Illinois at Chicago, USA.
authors.forename: Ai-Xuan
authors.initials: AX
authors.lastname: Holterman
authors.forename: Allen
authors.initials: A
authors.lastname: Browne
authors.forename: Barney E
authors.initials: BE
authors.lastname: Dillard
authors.forename: Lisa
authors.initials: L
authors.lastname: Tussing
authors.forename: Veronica
authors.initials: V
authors.lastname: Gorodner
authors.forename: Christiane
authors.initials: C
authors.lastname: Stahl
authors.forename: Nancy
authors.initials: N
authors.lastname: Browne
authors.forename: Sue
authors.initials: S
authors.lastname: Labott
authors.forename: James
authors.initials: J
authors.lastname: Herdegen
authors.forename: Grace
authors.initials: G
authors.lastname: Guzman
authors.forename: Andy
authors.initials: A
authors.lastname: Rink
authors.forename: Ifeoma
authors.initials: I
authors.lastname: Nwaffo
authors.forename: Carlos
authors.initials: C
authors.lastname: Galvani
authors.forename: Santiago
authors.initials: S
authors.lastname: Horgan
authors.forename: Mark
authors.initials: M
authors.lastname: Holterman
mesh_terms: D000293:Adolescent; D015992:Body Mass Index; D015897:Comorbidity; D003681:Dehydration / Q000209:etiology; D003866:Depressive Disorder / Q000453:epidemiology; D050171:Dyslipidemias / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D015391:Gastroplasty / Q000009:adverse effects* / Q000379:methods / Q000706:statistics & numerical data*; D006505:Hepatitis / Q000453:epidemiology; D006801:Humans; D006973:Hypertension / Q000453:epidemiology; D007333:Insulin Resistance; D010535:Laparoscopy / Q000009:adverse effects* / Q000379:methods / Q000706:statistics & numerical data*; D007902:Length of Stay; D008137:Longitudinal Studies; D024821:Metabolic Syndrome / Q000453:epidemiology; D009767:Obesity, Morbid / Q000453:epidemiology / Q000601:surgery*; D011183:Postoperative Complications; D011446:Prospective Studies; D011788:Quality of Life; D012891:Sleep Apnea Syndromes / Q000453:epidemiology; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration; D015431:Weight Loss