Clinical trial NCT00236132: "A Multicenter Study Comparing the Clinical Outcomes of the Nuss and Ravitch Procedures for Repair Of Pediatric Pectus Excavatum
Official title: " A Multicenter Study Comparing the Clinical Outcomes of the Nuss and Ravitch Procedures for Repair of Pediatric Pectus Excavatum"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Repair of Pectus Excavatum
Lead sponsor: Children's Health System, Inc.
Sponsor class: OTHER
Collaborators: name: Walter Lorenz Surgical Corporation
First posted: 2005-10-12
Enrollment: 360
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes

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.


Eligibility criteria: 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.

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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.

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Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Children's Hospital
state: Connecticut
city: St Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Honolulu
country: United States
facility: Kapi'olani Medical Center for Women and Children
state: Hawaii
city: Baltimore
country: United States
facility: John Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
city: New York
country: United States
facility: Children's Hospital of New York -Presbyterian
state: New York
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center
state: Ohio
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
city: Norfolk
country: United States
facility: Childern's Hospital of The King's Daughters
state: Virginia
city: Milwaukee
country: United States
facility: Children's Hospital Of Wisconsin
state: Wisconsin
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Children's Hospital of The King's Daughters
name: Robert E Kelly, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kelly 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.