Health-related Quality of Life in Patients Undergoing Surgery for Pectus Carinatum (HRQoL)
This study is currently recruiting participants.
Verified September 2012 by University of Aarhus
Sponsor:
University of Aarhus
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01692392
First received: September 12, 2012
Last updated: September 20, 2012
Last verified: September 2012
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Purpose
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.
| Condition |
|---|
|
Pectus Carinatum Quality of Life Pain, Postoperative Somatosensory Disorders |
| Study Type: | Observational |
| 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. |
Further study details as provided by University of Aarhus:
Primary Outcome Measures:
- 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)
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 40 |
| 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) |
| Groups/Cohorts |
|---|
|
Pectus carinatum
Patients who have undergone surgical repair of pectus carinatum.
|
Eligibility| Ages Eligible for Study: | 10 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
All patients referred to the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby for the purpose of surgery for pectus carinatum from May 1, 2012 to May 1, 2013 are invited to participated in the study
Criteria
Inclusion Criteria:
- all patients undergoing surgery for pectus carinatum
Exclusion Criteria:
- patients without pectus carinatum
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692392
Contacts
| Contact: Marie Veje MVK Knudsen, Study MSC in Nursing | 0045-78453052 | marie.veje.knudsen@studcur.au.dk |
| Contact: Kasper KG Grosen, phD student | 0045-78453052 | kasper.grosen@ki.au.dk |
Locations
| Denmark | |
| 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 marie.veje.knudsen@studcur.au.dk | |
| Contact: Kasper KG Grosen, phD Student 0045-78453052 kasper.grosen@ki.au.dk | |
Sponsors and Collaborators
University of Aarhus
More Information
No publications provided
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT01692392 History of Changes |
| Other Study ID Numbers: | PECCAR-1 |
| Study First Received: | September 12, 2012 |
| Last Updated: | September 20, 2012 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
Keywords provided by University of Aarhus:
|
Pectus carinatum Quality of life Pain, postoperative Somatosensory disorders |
Additional relevant MeSH terms:
|
Pain, Postoperative Somatosensory Disorders Postoperative Complications Pathologic Processes Pain |
Signs and Symptoms Sensation Disorders Neurologic Manifestations Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013