"A Multicenter Study Comparing the Clinical Outcomes of the Nuss and Ravitch Procedures for Repair Of Pediatric Pectus Excavatum
" A Multicenter Study Comparing the Clinical Outcomes of the Nuss and Ravitch Procedures for Repair of Pediatric Pectus Excavatum"
1 other identifier
observational
360
2 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2001
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
October 10, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedOctober 12, 2007
October 1, 2007
October 10, 2005
October 11, 2007
Conditions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Health System, Inc.lead
- Walter Lorenz Surgical Corporationcollaborator
Study Sites (12)
Yale New Haven Children's Hospital
New Haven, Connecticut, 06520, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, 96813, United States
John Hopkins Hospital
Baltimore, Maryland, 21205, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
The Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Children's Hospital of New York -Presbyterian
New York, New York, 10032, United States
Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
Childern's Hospital of The King's Daughters
Norfolk, Virginia, 23507, United States
Children's Hospital Of Wisconsin
Milwaukee, Wisconsin, 53201, United States
The Hospital for Sick Children
Toronto, Ontario, M5G1X8, Canada
Related Publications (2)
Kelly RE Jr, Mellins RB, Shamberger RC, Mitchell KK, Lawson ML, Oldham KT, Azizkhan RG, Hebra AV, Nuss D, Goretsky MJ, Sharp RJ, Holcomb GW 3rd, Shim WK, Megison SM, Moss RL, Fecteau AH, Colombani PM, Cooper D, Bagley T, Quinn A, Moskowitz AB, Paulson JF. Multicenter study of pectus excavatum, final report: complications, static/exercise pulmonary function, and anatomic outcomes. J Am Coll Surg. 2013 Dec;217(6):1080-9. doi: 10.1016/j.jamcollsurg.2013.06.019.
PMID: 24246622DERIVEDKelly RE Jr, Cash TF, Shamberger RC, Mitchell KK, Mellins RB, Lawson ML, Oldham K, Azizkhan RG, Hebra AV, Nuss D, Goretsky MJ, Sharp RJ, Holcomb GW 3rd, Shim WK, Megison SM, Moss RL, Fecteau AH, Colombani PM, Bagley T, Quinn A, Moskowitz AB. Surgical repair of pectus excavatum markedly improves body image and perceived ability for physical activity: multicenter study. Pediatrics. 2008 Dec;122(6):1218-22. doi: 10.1542/peds.2007-2723.
PMID: 19047237DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Robert E Kelly, Jr., MD
Children's Hospital of The King's Daughters