Clincosm LogoSign in Get a demo

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

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT01692392
Collaborator
(none)
40
Enrollment
1
Location
14
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    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.
    Study Start Date :
    Sep 1, 2012
    Actual Primary Completion Date :
    Nov 1, 2013
    Actual Study Completion Date :
    Nov 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Pectus carinatum

    Patients who have undergone surgical repair of pectus carinatum.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • all patients undergoing surgery for pectus carinatum
    Exclusion Criteria:
    • patients without pectus carinatum

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vacular Surgery Aarhus Denmark DK-8000

    Sponsors and Collaborators

    • University of Aarhus

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT01692392
    Other Study ID Numbers:
    • PECCAR-1
    First Posted:
    Sep 25, 2012
    Last Update Posted:
    Aug 5, 2014
    Last Verified:
    Sep 1, 2012
    Keywords provided by University of Aarhus
    Pectus carinatum
    Quality of life
    Pain, postoperative
    Somatosensory disorders
    Additional relevant MeSH terms:
    Pectus Carinatum
    Somatosensory Disorders
    Pain, Postoperative

    Study Results

    No Results Posted as of Aug 5, 2014