Repair of Pectus ExcavatumNCT00236132
"A Multicenter Study Comparing the Clinical Outcomes of the Nuss and Ravitch Procedures for Repair Of Pediatric Pectus Excavatum
An observational study of Repair of Pectus Excavatum, run by Children's Health System, Inc. at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Repair of Pectus Excavatum
- How many people
- 360 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Aug 2001to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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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Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
John Hopkins Hospital
Baltimore, Maryland, 21205
Children's Hospital Boston
Boston, Massachusetts, 02115
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Medical Center Dallas
Dallas, Texas, 75235
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, 96813
The Children's Mercy Hospital
Kansas City, Missouri, 64108
Children's Hospital Of Wisconsin
Milwaukee, Wisconsin, 53201
Yale New Haven Children's Hospital
New Haven, Connecticut, 06520
Children's Hospital of New York -Presbyterian
New York, New York, 10032
Childern's Hospital of The King's Daughters
Norfolk, Virginia, 23507
All Children's Hospital
St. Petersburg, Florida, 33701
About this study
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.
- Conditions
- Repair of Pectus Excavatum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startAug 2001
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Repair of Pectus ExcavatumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Health System, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Lorenz Surgical Corporation
- Investigators
- Robert E Kelly, Jr., MD, Principal investigator, Children's Hospital of The King's Daughters
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236132
- Sponsor's protocol ID
- IRB #01-02-FB-0032
- Status last verified
- Oct 2007
- First submitted
- 10 Oct 2005
- Last updated
- 12 Oct 2007
- Results posted
- No
Publications
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.
PubMed 24246622Kelly 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.
PubMed 19047237
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " A Multicenter Study Comparing the Clinical Outcomes of the Nuss and Ravitch Procedures for Repair of Pediatric Pectus Excavatum"
- ClinicalTrials.gov ID
- NCT00236132
- Acronym / sponsor ID
- IRB #01-02-FB-0032
- Conditions
- Repair of Pectus Excavatum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Children's Health System, Inc.University, hospital or other
- Collaborators
- Walter Lorenz Surgical Corporation
- Study start
- Aug 2001
- Study completion
- Dec 2008 (estimated)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2007.
- Derived from this study: PubMed 24246622Kelly 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.
- Derived from this study: PubMed 19047237Kelly 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert E Kelly, Jr., MD principal investigator
Children's Hospital of The King's Daughters
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Repair of Pectus Excavatum, run by Children's Health System, Inc. at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00236132, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2007.