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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01692392
First received: September 12, 2012
Last updated: August 4, 2014
Last verified: September 2012
  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.

Resource links provided by NLM:


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
Study Completion Date: November 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692392

Locations
Denmark
Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vacular Surgery
Aarhus, Denmark, DK-8000
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: August 4, 2014
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 October 16, 2014