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NCT03203161 · ClinicalTrials.gov record · last posted 2019-02-12

Registry on Obesity Surgery in Adolescents

Study acronym: ROSA
StatusNot Yet Recruiting
PhaseNot specified
Started2019-09
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from the ClinicalTrials.gov record
While bariatric surgery is established as a safe and effective alternative with well-defined risks for severely obese adults, little has been published on its use in children. There are many unresolved questions concerning the long-term metabolic and psychological consequences of bariatric surgery in adolescents, and the difference with the adult population. The appropriate timing for bariatric surgery in young people, and the predictors of success and safety still need to be determined. The aim of this long-term prospective study is therefore to establish the safety and efficacy profile of surgical procedures and to clarify whether reductions in morbidity and mortality outweigh the risks of serious surgical complications and lifelong nutritional deficiencies.

Amendment record 4 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 4 times since 2017-06-28; most recent amendment 2019-02-11. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

Trial Details
NCT Number NCT03203161
Lead Sponsor Queen Fabiola Children's University Hospital
Conditions Morbid Obesity, Bariatric Surgery, Adolescent Obesity
Enrollment 50 participants
Start Date 2019-09
Primary Completion 2029-09 (estimated)
Study Completion 2029-09 (estimated)
Updated on ClinicalTrials.gov 2019-02-12