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.


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.
Holterman
Ai-Xuan
AX
Division of Pediatric Surgery, Department of Surgery, and the New Hope Pediatric and Adolescent Weight Management Project, University of Illinois at Chicago, USA.
Browne
Allen
A
Dillard
Barney E
BE
Tussing
Lisa
L
Gorodner
Veronica
V
Stahl
Christiane
C
Browne
Nancy
N
Labott
Sue
S
Herdegen
James
J
Guzman
Grace
G
Rink
Andy
A
Nwaffo
Ifeoma
I
Galvani
Carlos
C
Horgan
Santiago
S
Holterman
Mark
M
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