"A Multicenter Study Comparing the Clinical Outcomes of the Nuss and Ravitch Procedures for Repair Of Pediatric Pectus Excavatum
- Conditions
- Repair of Pectus Excavatum
- Registration Number
- NCT00236132
- Lead Sponsor
- Children's Health System, Inc.
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 360
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Children's Hospital Of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
All Children's Hospital
🇺🇸St Petersburg, Florida, United States
Kapi'olani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
John Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Children's Hospital of New York -Presbyterian
🇺🇸New York, New York, United States
Children's Medical Center Dallas
🇺🇸Dallas, Texas, United States
Childern's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
The Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Yale New Haven Children's Hospital
🇺🇸New Haven, Connecticut, United States