Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Adolescent Bariatrics: Assessing Health Benefits and Risk
This trial is active, not recruiting.
|Sponsor||Children's Hospital Medical Center, Cincinnati|
|Collaborator||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Start date||March 2007|
|End date||August 2016|
|Trial size||200 participants|
|Trial identifier||NCT00474318, 2UM1DK072493-06, CCHMC IRB# 2008-1634|
The five Teen-LABS clinical centers use standardized techniques to assess the short and longer-term safety and efficacy of bariatric surgery in adolescents compared to adults.
Evaluate the efficacy and safety outcomes of bariatric surgery in adolescents relative to adults, using a prospective, observational cohort design.
time frame: Initially funded in 2006 then refunded with extension to 2016. Completed Enrollment 242 participants by 12/31/11 with final surgery done 2/29/12.
Male or female participants from 12 years up to 18 years old.
Inclusion Criteria: - Adolescents up to age 19 - Approved for bariatric surgery - Agreement to participate in Teen-LABS Study/ understand and sign Informed Consent/Assent Exclusion Criteria: - Age 19 or greater - Not approved for bariatric surgery - Unable to sign Informed Consent/Assent
|Official title||Adolescent Bariatrics: Assessing Health Benefits and Risks|
|Principal investigator||Mary L Brandt, MD|
|Description||The goal of Teen-LABS is to facilitate coordinated clinical, epidemiological and behavioral research in the field of adolescent bariatric surgery, through the cooperative development of common clinical protocols and a bariatric surgery database that will collect information from participating clinical centers performing bariatric surgery on teenagers. Teen-LABS will help pool the necessary clinical expertise and administrative resources to facilitate the conduct of multiple clinical studies in a timely, efficient manner. Also, the use of standardized definitions, shared clinical protocols and data collection instruments will enhance investigators' ability to provide meaningful evidence-based recommendations for patient evaluation, selection and follow-up care. In addition to investigating surgical outcomes, another broader goal of Teen-LABS is to better understand the etiology, pathophysiology, and behavioral aspects of severe obesity in youth and how this condition affects human beings over time.|
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