<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01692392</url>
  </required_header>
  <id_info>
    <org_study_id>PECCAR-1</org_study_id>
    <nct_id>NCT01692392</nct_id>
  </id_info>
  <brief_title>Health-related Quality of Life in Patients Undergoing Surgery for Pectus Carinatum</brief_title>
  <acronym>HRQoL</acronym>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to assess changes in health-related quality of life in patients&#xD;
      undergoing surgical correction of pectus carinatum. In addition, the study assessed long-term&#xD;
      effects of surgical intervention in relation to the development of persistent postoperative&#xD;
      pain and / or sensory disturbances in the surgical field.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in health-related quality of life at 6 months</measure>
    <time_frame>From baseline (the day before surgery) to six month follow-up (six months after surgery)</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Persistent post-surgical pain</measure>
    <time_frame>Six month following surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Pectus Carinatum</condition>
  <condition>Quality of Life</condition>
  <condition>Pain, Postoperative</condition>
  <condition>Somatosensory Disorders</condition>
  <arm_group>
    <arm_group_label>Pectus carinatum</arm_group_label>
    <description>Patients who have undergone surgical repair of pectus carinatum.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients referred to the Department of Cardiothoracic and Vascular Surgery, Aarhus&#xD;
        University Hospital, Skejby for the purpose of surgery for pectus carinatum from May 1,&#xD;
        2012 to May 1, 2013 are invited to participated in the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients undergoing surgery for pectus carinatum&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients without pectus carinatum&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vacular Surgery</name>
      <address>
        <city>Aarhus</city>
        <zip>DK-8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>August 4, 2014</last_update_submitted>
  <last_update_submitted_qc>August 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pectus carinatum</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Pain, postoperative</keyword>
  <keyword>Somatosensory disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pectus Carinatum</mesh_term>
    <mesh_term>Somatosensory Disorders</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01692392
org study id: PECCAR-1
nct id: NCT01692392
lead sponsor: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
measure: 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)
description: 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)
measure: Persistent post-surgical pain
time frame: Six month following surgery
description: 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.
arm group label: Pectus carinatum
description: Patients who have undergone surgical repair of pectus carinatum.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Pectus Carinatum
mesh term: Somatosensory Disorders
mesh term: Pain, Postoperative