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NCT01692392 Clinical Trial

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

Quality of Life Clinical Trial

— HRQoL  

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01692392
Other study ID # PECCAR-1
Secondary ID
Status Completed
Phase N/A
First received September 12, 2012
Last updated August 4, 2014
Start date September 2012
Est. completion date November 2013

Study information
Verified date September 2012
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 55 Years
Eligibility Inclusion Criteria:

- all patients undergoing surgery for pectus carinatum

Exclusion Criteria:

- patients without pectus carinatum

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vacular Surgery Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline in health-related quality of life at 6 months 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) From baseline (the day before surgery) to six month follow-up (six months after surgery) No
Secondary Persistent post-surgical pain 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. Six month following surgery No
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