Health-related Quality of Life in Patients Undergoing Surgery for Pectus Carinatum

Completed

• Conditions: Somatosensory Disorders; Pectus Carinatum; Pain, Postoperative; Quality of Life

• Registration Number: NCT01692392
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-09
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-25
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• all patients undergoing surgery for pectus carinatum

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Exclusion Criteria

• patients without pectus carinatum

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline in health-related quality of life at 6 months	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 Outcome Measures

Name	Time	Method
Persistent post-surgical pain	Six month following surgery	In this study persistent post-surgical pain is defined as pain developing after pectus surgery and lasting for at least 4 months. Other causes of pain (e.g. infection) and pain continuing from a pre-existing pain problem will be excluded.

Trial Locations

Locations (1)

Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vacular Surgery; 🇩🇰 Aarhus, Denmark