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Clinical Trials/NCT01692392
NCT01692392
Completed
Not Applicable

Short and Long-term Effects of Surgical Repair of Pectus Carinatum - A Questionnaire Study of Health-related Quality of Life, Persisten Post-surgical Pain and Sensory Disturbances.

University of Aarhus1 site in 1 country40 target enrollmentSeptember 2012
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ConditionsPectus CarinatumQuality of LifePain, PostoperativeSomatosensory Disorders

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pectus Carinatum
Sponsor
University of Aarhus
Enrollment
40
Locations
1
Primary Endpoint
Change from Baseline in health-related quality of life at 6 months
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of the study is to assess changes in health-related quality of life in patients undergoing surgical correction of pectus carinatum. In addition, the study assessed long-term effects of surgical intervention in relation to the development of persistent postoperative pain and / or sensory disturbances in the surgical field.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
November 2013
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •all patients undergoing surgery for pectus carinatum

Exclusion Criteria

  • •patients without pectus carinatum

Outcomes

Primary Outcomes

Change from Baseline in health-related quality of life at 6 months

Time Frame: From baseline (the day before surgery) to six month follow-up (six months after surgery)

Health-related Quality of Life (HRQoL) will be assessed by means of a validated Danish version of the Short-Form 36 Health Survey (SF-36)

Secondary Outcomes

  • Persistent post-surgical pain(Six month following surgery)

Study Sites (1)

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