Repair of Pectus Excavatum Clinical Trial
Official title:
" A Multicenter Study Comparing the Clinical Outcomes of the Nuss and Ravitch Procedures for Repair of Pediatric Pectus Excavatum"
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.
| Status | Active, not recruiting |
| Enrollment | 360 |
| Est. completion date | December 2008 |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 3 Years to 21 Years |
| Eligibility |
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. |
N/A
| Country | Name | City | State |
|---|---|---|---|
| Canada | The Hospital for Sick Children | Toronto | Ontario |
| United States | John Hopkins Hospital | Baltimore | Maryland |
| United States | Children's Hospital Boston | Boston | Massachusetts |
| United States | Children's Hospital Medical Center | Cincinnati | Ohio |
| United States | Children's Medical Center Dallas | Dallas | Texas |
| United States | Kapi'olani Medical Center for Women and Children | Honolulu | Hawaii |
| United States | The Children's Mercy Hospital | Kansas City | Missouri |
| United States | Children's Hospital Of Wisconsin | Milwaukee | Wisconsin |
| United States | Yale New Haven Children's Hospital | New Haven | Connecticut |
| United States | Children's Hospital of New York -Presbyterian | New York | New York |
| United States | Childern's Hospital of The King's Daughters | Norfolk | Virginia |
| United States | All Children's Hospital | St Petersburg | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Children's Health System, Inc. | Walter Lorenz Surgical Corporation |
United States, Canada,