Status:
UNKNOWN
"A Multicenter Study Comparing the Clinical Outcomes of the Nuss and Ravitch Procedures for Repair Of Pediatric Pectus Excavatum
Lead Sponsor:
Children's Health System, Inc.
Collaborating Sponsors:
Walter Lorenz Surgical Corporation
Conditions:
Repair of Pectus Excavatum
Eligibility:
All Genders
3-21 years
Brief Summary
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 surgi...
Eligibility Criteria
Inclusion
- 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.
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Exclusion
- 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.
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Key Trial Info
Start Date :
August 1 2001
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00236132
Start Date
August 1 2001
End Date
December 1 2008
Last Update
October 12 2007
Active Locations (12)
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1
Yale New Haven Children's Hospital
New Haven, Connecticut, United States, 06520
2
All Children's Hospital
St. Petersburg, Florida, United States, 33701
3
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96813
4
John Hopkins Hospital
Baltimore, Maryland, United States, 21205