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Prospective, randomized, multicenter study evaluating safety and efficacy of intragastric dual-balloon in obesity.
MedLine Citation:
PMID:  22951075     Owner:  NLM     Status:  Publisher    
BACKGROUND: Intragastric balloons are designed to occupy space within the stomach and induce satiety. The present study evaluated the safety and efficacy of an intragastric dual balloon as an adjunct to diet and exercise in obese patients compared with diet and exercise alone. METHODS: After approval from the institutional review board, patients provided written consent and were randomized to the treatment group (TG) or control group (CG) in a 2:1 ratio. Three sites randomized a total of 30 patients to the TG (n = 21) or CG (n = 9). Patients randomized to the TG underwent endoscopic placement of the dual balloon. Both groups received similar diet and exercise counseling. After 24 weeks, the device was removed. Patient weight, adverse events, and quality of life data were evaluated throughout the 48-week study duration. RESULTS: Our patient population included 26 women and 4 men aged 26-59 years. At 24 weeks, the mean excess weight loss in the TG and CG was 31.8% ± 21.3% and 18.3% ± 20.9%, respectively (P = .1371). At 48 weeks, 24 weeks after device removal, the TG maintained 64% of their weight loss. No deaths, unanticipated adverse effects, early removals, balloon deflations, or balloon migrations occurred. In the TG, 4 patients were readmitted for severe nausea, 1 had asymptomatic gastritis at balloon removal, and 1 patient experienced transient hypoxia during device removal. CONCLUSION: In the present small study, the dual balloon proved easy to use, was associated with a trend toward greater weight loss than the CG, and demonstrated a good safety profile.
Jaime Ponce; Brian B Quebbemann; Emma J Patterson
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-7-31
Journal Detail:
Title:  Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery     Volume:  -     ISSN:  1878-7533     ISO Abbreviation:  Surg Obes Relat Dis     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-9-6     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101233161     Medline TA:  Surg Obes Relat Dis     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
Hamilton Medical Center, Dalton, Georgia.
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