"A Multicenter Study Comparing the Clinical Outcomes of the Nuss and Ravitch Procedures for Repair Of Pediatric Pectus Excavatum

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Children's Health System, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Walter Lorenz Surgical Corporation
Information provided by:
Children's Health System, Inc.
ClinicalTrials.gov Identifier:
NCT00236132
First received: October 10, 2005
Last updated: October 11, 2007
Last verified: October 2007
  Purpose

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.


Condition
Repair of Pectus Excavatum

Study Type: Observational
Official Title: " A Multicenter Study Comparing the Clinical Outcomes of the Nuss and Ravitch Procedures for Repair of Pediatric Pectus Excavatum"

Further study details as provided by Children's Health System, Inc.:

Estimated Enrollment: 360
Study Start Date: August 2001
Estimated Study Completion Date: December 2008
  Eligibility

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00236132

Locations
United States, Connecticut
Yale New Haven Children's Hospital
New Haven, Connecticut, United States, 06520
United States, Florida
All Children's Hospital
St Petersburg, Florida, United States, 33701
United States, Hawaii
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96813
United States, Maryland
John Hopkins Hospital
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Missouri
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, New York
Children's Hospital of New York -Presbyterian
New York, New York, United States, 10032
United States, Ohio
Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Texas
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
United States, Virginia
Childern's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Children's Hospital Of Wisconsin
Milwaukee, Wisconsin, United States, 53201
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
Children's Health System, Inc.
Walter Lorenz Surgical Corporation
Investigators
Principal Investigator: Robert E Kelly, Jr., MD Children's Hospital of The King's Daughters
  More Information

No publications provided by Children's Health System, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00236132     History of Changes
Obsolete Identifiers: NCT00275470
Other Study ID Numbers: IRB #01-02-FB-0032
Study First Received: October 10, 2005
Last Updated: October 11, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Funnel Chest
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 18, 2014