Short and Long-term Effects of Surgical Repair of Pectus Deformities

NCT ID: NCT01329120

Last Updated: 2015-06-02

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

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2015-12-31

Brief Summary

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A large number of institutions have reported their early results with minimally invasive repair of pectus excavatum and open repair of pectus carinatum, but only few have addressed the outcomes relevant to the concerns of the patients and even fewer have reported long-term results following bar removal. Even fewer studies have investigated the prevalence and characteristics of long term persistent post-surgical pain following surgical repair of pectus deformities. The reasons as to why acute postoperative pain in some patients persists and becomes chronic whereas in others the pain dies down shortly after wound healing are largely unknown, and why some patients complain of loss of sensibility in wide regions of their chest following surgery also remains unclear.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pectus excavatum

Patients who has undergone minimally invasive repair of pectus excavatum

Minimally invasive repair of pectus excavatum

Intervention Type PROCEDURE

Minimally invasive surgical technique basically consisting of inserting one or more convex steel bars under the sternum through small bilateral incisions in the thoracic wall

Pectus carinatum

Patients who has undergone open surgical repair of pectus carinatum

Open surgical repair of pectus carinatum

Intervention Type PROCEDURE

Open surgical removal the affected cartilages bilaterally and the excess cartilage over the sternum

Interventions

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Minimally invasive repair of pectus excavatum

Minimally invasive surgical technique basically consisting of inserting one or more convex steel bars under the sternum through small bilateral incisions in the thoracic wall

Intervention Type PROCEDURE

Open surgical repair of pectus carinatum

Open surgical removal the affected cartilages bilaterally and the excess cartilage over the sternum

Intervention Type PROCEDURE

Other Intervention Names

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Nuss procedure Ravitch procedure

Eligibility Criteria

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Inclusion Criteria

* Minimally invasive repair of pectus excavatum from 2001 throughout 2010.
* Open surgical repair of pectus carinatum from 2001 throughout 2010.

Exclusion Criteria

* Not being able to fill in detailed questionnaires in Danish
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kasper Grosen, PhD Fellow

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital Skejby

Hans K Pilegaard, MD

Role: STUDY_DIRECTOR

Aarhus University Hospital Skejby

Mogens Pfeiffer-Jensen, MD, PhD

Role: STUDY_CHAIR

Aarhus University Hospital, Aarhus Sygehus

Vibeke E Hjortdal, Prof., MD, PhD

Role: STUDY_CHAIR

Aarhus University Hospital Skejby

Locations

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Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vascular Surgery

Aarhus, , Denmark

Site Status

Countries

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Denmark

Central Contacts

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Kasper Grosen, PhD Fellow

Role: CONTACT

+4589495443

Hans K Pilegaard, MD

Role: CONTACT

+4589495403

Facility Contacts

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Kasper Grosen, PhD Fellow

Role: primary

+4589495443

Hans K Pilegaard, MD

Role: backup

+4589495403

Other Identifiers

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MIRPEX-1

Identifier Type: -

Identifier Source: org_study_id

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