Health-related Quality of Life in Patients Undergoing Surgery for Pectus Carinatum (HRQoL)
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.
Quality of Life
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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.|
- 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) ] [ Designated as safety issue: No ]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)
- Persistent post-surgical pain [ Time Frame: Six month following surgery ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Patients who have undergone surgical repair of pectus carinatum.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692392
|Contact: Marie Veje MVK Knudsen, Study MSC in Nursingemail@example.com|
|Contact: Kasper KG Grosen, phD firstname.lastname@example.org|
|Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vacular Surgery||Recruiting|
|Aarhus, Denmark, DK-8000|
|Contact: Marie Veje MVK Knudsen, study MSC in Nursing 0045-78453052 email@example.com|
|Contact: Kasper KG Grosen, phD Student 0045-78453052 firstname.lastname@example.org|