ClinicalTrials.gg
Status unknownNCT00236132Updated Oct 12, 2007

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

An observational study in Repair of Pectus Excavatum, sponsored by Children's Health System, Inc.. Status unknown at 12 sites in 2 countries. Open to participants aged 3 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-10-12.

Sponsored by Children's Health System, Inc. · Observational

The sponsor has not verified this record recently (last verified Oct 2007), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Enrollment
360
Ages
3 Years to 21 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Funnel Chest with a site in United States — 2 open to participants now, 6 under way, none of them phase 3. Funnel Chest · United States.

Started
2001
the only one that year
Observational
9 of 22
1 open now
Registered
1st of 22
by date
Lead sponsor
1 of 22
Children's Health System, Inc.

Among the 22 studies in Funnel Chest with a site in United States, this one is the only one that started in 2001, is one of 9 observational ones, and was the 1st registered.

By phase

22 studies; the count open now beside each. This study's row is marked.

No phase9 · 1 open
Observationalthis study9 · 1 open
Phase 43 · 0 open
Phase 1/21 · 0 open

By the year they started

First in 2001; this study’s year is marked. 1 started in 2001.

What they test

Size and results

Median enrollment 65 across the 13 interventional studies, 348 across the 9 observational. Of the 14 that completed or were terminated, 7 (50%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 22 studies in Funnel Chest with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Repair of Pectus Excavatum

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04

Who can participate

Ages eligible
3 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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 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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Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Enrollment
360 participants (estimated)
06

Study locations

12 sites
  • 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
07

References and documents

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 24246622 ↗
  • 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. PubMed 19047237 ↗
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2001 and a completion of Dec 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2005
First posted
Oct 12, 2005
Start
Aug 2001
CompletionEst.
Dec 2008
Last update
Oct 12, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 12, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00236132
Lead sponsor
Children's Health System, Inc.
Collaborators
Walter Lorenz Surgical Corporation
First posted
Oct 12, 2005
Start date
Aug 2001
Completion
Dec 2008 (estimated)
Last update
Oct 12, 2007

Study contacts

Robert E Kelly, Jr., MD
principal investigator · Children's Hospital of The King's Daughters
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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Discussion

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