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

NCT ID: NCT00236132

Last Updated: 2007-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-08-31

Study Completion Date

2008-12-31

Brief Summary

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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

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Conditions

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Repair of Pectus Excavatum

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

3 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Walter Lorenz Surgical Corporation

UNKNOWN

Sponsor Role collaborator

Children's Health System, Inc.

OTHER

Sponsor Role lead

Principal Investigators

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Robert E Kelly, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of The King's Daughters

Locations

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Yale New Haven Children's Hospital

New Haven, Connecticut, United States

Site Status

All Children's Hospital

St. Petersburg, Florida, United States

Site Status

Kapi'olani Medical Center for Women and Children

Honolulu, Hawaii, United States

Site Status

John Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

The Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Children's Hospital of New York -Presbyterian

New York, New York, United States

Site Status

Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Children's Medical Center Dallas

Dallas, Texas, United States

Site Status

Childern's Hospital of The King's Daughters

Norfolk, Virginia, United States

Site Status

Children's Hospital Of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 24246622 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19047237 (View on PubMed)

Other Identifiers

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IRB #01-02-FB-0032

Identifier Type: -

Identifier Source: org_study_id

NCT00275470

Identifier Type: -

Identifier Source: nct_alias