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

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University of Aarhus

Status

Unknown

Conditions

Pain, Postoperative

Treatments

Procedure: Minimally invasive repair of pectus excavatum
Procedure: Open surgical repair of pectus carinatum

Study type

Observational

Funder types

Other

Identifiers

NCT01329120
MIRPEX-1

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

7+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,000 participants in 2 patient groups

Pectus excavatum
Description:
Patients who has undergone minimally invasive repair of pectus excavatum
Treatment:
Procedure: Minimally invasive repair of pectus excavatum
Pectus carinatum
Description:
Patients who has undergone open surgical repair of pectus carinatum
Treatment:
Procedure: Open surgical repair of pectus carinatum

Trial contacts and locations

1

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Central trial contact

Hans K Pilegaard, MD; Kasper Grosen, PhD Fellow

Data sourced from clinicaltrials.gov

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