<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/NCT02240576</url>
  </required_header>
  <id_info>
    <org_study_id>nose fracture study</org_study_id>
    <nct_id>NCT02240576</nct_id>
  </id_info>
  <brief_title>Possible Manifestation of Rhinitis After Nasal Fracture</brief_title>
  <official_title>Possible Manifestation of Rhinitis After Nasal Fracture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We would like to investigate our hypothesis of a higher prevalence of nasal fracture in the&#xD;
      history of idiopathic rhinitis (IR) patients compared to healthy controls. Therefore a&#xD;
      retrospective analysis of 310 patients with a nasal fracture in the past would be useful to&#xD;
      investigate the incidence of IR in this cohort afterwards (5-10 y later).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patient population will be recruited by sending patient questionnaires (form in addendum)&#xD;
      to patients who suffered a nasal fracture five to ten years ago (time period 2005-2013) with&#xD;
      nose reposition afterwards under general anaesthesia in the chirurgical day care centre (CDC)&#xD;
      of university hospital (UZ) Leuven.&#xD;
&#xD;
      The control population (HC) will be recruited by sending a slightly adapted questionnaire&#xD;
      (form in addendum) to patients who had surgery of the vocal cords under general anaesthesia&#xD;
      in the CDC of UZ Leuven in the same period as the patient group. The control group will be&#xD;
      age and sex-matched with the patient group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of the incidence of IR after nasal fracture in the patient population with the incidence of IR in the control group.</measure>
    <time_frame>at least 1 year after surgery</time_frame>
    <description>Comparison of the incidence of IR after nasal fracture in the patient population with the incidence of IR in the control group.&#xD;
outcome measurement: percentage of participants</description>
  </primary_outcome>
  <enrollment type="Anticipated">310</enrollment>
  <condition>Nasal Fracture</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients who suffered a nasal fracture five to ten years ago (time period 2005-2013) with&#xD;
        nose reposition afterwards under general anaesthesia in the chirurgical day care centre&#xD;
        (CDC) of Gasthuisberg.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of nasal fracture in 2005-2013 and&#xD;
&#xD;
          -  Diagnosis ascertained by a Ear-Nose-Throat (ENT) specialist and&#xD;
&#xD;
          -  Followed by nose reposition surgery under general anaesthesia and&#xD;
&#xD;
          -  Described in the clinical operation report as &quot;mobile nose bones&quot; OR Available&#xD;
             radiography&#xD;
&#xD;
        Inclusion criteria of the control group:&#xD;
&#xD;
          -  Presence of problem on vocal cords without previous nasal fracture&#xD;
&#xD;
          -  Surgery of the vocal cords under general anaesthesia in 2005-2013&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Hellings, Prof Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven ENT</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>emily dekimpe, msc</last_name>
      <phone>003216340757</phone>
      <email>emily.dekimpe@uzleuven.be</email>
    </contact>
    <investigator>
      <last_name>Peter Hellings, Prof Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>December 2, 2015</last_update_submitted>
  <last_update_submitted_qc>December 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>surgery for nasal fracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Fractures, Bone</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/NCT02240576
org study id: nose fracture study
nct id: NCT02240576
lead sponsor: 
has dmc: No
We would like to investigate our hypothesis of a higher prevalence of nasal fracture in the
      history of idiopathic rhinitis (IR) patients compared to healthy controls. Therefore a
      retrospective analysis of 310 patients with a nasal fracture in the past would be useful to
      investigate the incidence of IR in this cohort afterwards (5-10 y later).
The patient population will be recruited by sending patient questionnaires (form in addendum)
      to patients who suffered a nasal fracture five to ten years ago (time period 2005-2013) with
      nose reposition afterwards under general anaesthesia in the chirurgical day care centre (CDC)
      of university hospital (UZ) Leuven.

      The control population (HC) will be recruited by sending a slightly adapted questionnaire
      (form in addendum) to patients who had surgery of the vocal cords under general anaesthesia
      in the CDC of UZ Leuven in the same period as the patient group. The control group will be
      age and sex-matched with the patient group.
observational model: Case-Control
time perspective: Retrospective
measure: Comparison of the incidence of IR after nasal fracture in the patient population with the incidence of IR in the control group.
time frame: at least 1 year after surgery
description: Comparison of the incidence of IR after nasal fracture in the patient population with the incidence of IR in the control group.
outcome measurement: percentage of participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Peter Hellings, Prof Dr
role: Principal Investigator
affiliation: UZ Leuven
facility: 
status: Recruiting
contact: 
investigator: 
country: Belgium
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Fractures, Bone