"A Multicenter Study Comparing the Clinical Outcomes of the Nuss and Ravitch Procedures for Repair Of Pediatric Pectus Excavatum
This trial is active, not recruiting.
|Condition||repair of pectus excavatum|
|Sponsor||Children's Health System, Inc.|
|Collaborator||Walter Lorenz Surgical Corporation|
|Start date||August 2001|
|End date||December 2008|
|Trial size||360 participants|
|Trial identifier||NCT00236132, IRB #01-02-FB-0032, NCT00275470|
The main goal of the pectus multicenter outcomes study is to document the utility of PEx repair in improving health and quality of life and to test the prevailing belief that the two predominant surgical procedures currently in use for PEx repair are essentially equivalent in terms of long-term outcomes.
We believe the uncertainty about the impact of PEx on cardiopulmonary function is due to part to the fact that the previous studies have not measured the physiological parameters mostly likely affected by the defect. A protocol to test this was developed. Thus, we propose to use these measures as well as conventional output of progressive exercise test to examine cardiopulmonary function before and after surgical repair of PEx within the context of the original study.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|New Haven, CT||Yale New Haven Children's Hospital||no longer recruiting|
|St Petersburg, FL||All Children's Hospital||no longer recruiting|
|Honolulu, HI||Kapi'olani Medical Center for Women and Children||no longer recruiting|
|Baltimore, MD||John Hopkins Hospital||no longer recruiting|
|Boston, MA||Children's Hospital Boston||no longer recruiting|
|Kansas City, MO||The Children's Mercy Hospital||no longer recruiting|
|New York, NY||Children's Hospital of New York -Presbyterian||no longer recruiting|
|Cincinnati, OH||Children's Hospital Medical Center||no longer recruiting|
|Dallas, TX||Children's Medical Center Dallas||no longer recruiting|
|Norfolk, VA||Childern's Hospital of The King's Daughters||no longer recruiting|
|Milwaukee, WI||Children's Hospital Of Wisconsin||no longer recruiting|
|Toronto, Canada||The Hospital for Sick Children||no longer recruiting|
Male or female participants from 3 years up to 21 years old.
Inclusion Criteria:Haller index by thoracic computed tomography (CT) scan of 3.2 or greater, has decided to have surgery to repair PEx, Written informed consent obtained from the parent or guardian of the subject,or, fro subjects 18-21 years, from the subject him(her)self, and assent of the child. - Exclusion Criteria:Pectus carinatum, Poland's syndrome or other comlex chest wall anomaly,Previous repair of PEx by any technique, Previous thoracic surgery, Congenital heart disease, Bleeding dyscrasia, History of major anesthetic risk factors such as malignant hyperthermia, Pregnancy, Surgical repair to be performed with bar other than stainless steel. -
|Official title||" A Multicenter Study Comparing the Clinical Outcomes of the Nuss and Ravitch Procedures for Repair of Pediatric Pectus Excavatum"|
|Principal investigator||Robert E Kelly, Jr., MD|
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