<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/NCT02230423</url>
  </required_header>
  <id_info>
    <org_study_id>SM_31_01_2014</org_study_id>
    <secondary_id>KEK-ZH-Nr: 2013-0545</secondary_id>
    <nct_id>NCT02230423</nct_id>
  </id_info>
  <brief_title>Trigeminal Endonasal Perception: A Predictor for Septoplasty Outcome</brief_title>
  <official_title>Trigeminale Endonasale Perzeption, Ein Prädiktor für Das Outcome Einer Septumplastik - Eine Prospektive Kohortenstudie Mit Klinischen Und Biologischen Untersuchungen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates wether patients with increased trigeminal perception threshold and&#xD;
      low expression of TRP channels have more often nasal blockage despite functionally successful&#xD;
      nasal surgery (TRP channel = transient receptor potential channel).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to find out wether patients with high trigeminal perception&#xD;
      threshold (=decreased intranasal sensibility) and low expression of TRP channels of the&#xD;
      mucosa suffer more often from impaired nasal breathing after surgery. This could lead to the&#xD;
      identification of prognostic factors and therefore prevention of nasal surgery with bad&#xD;
      outcome.&#xD;
&#xD;
      Further, differences between patients with empty nose syndrome and asymptomatic patients&#xD;
      after extended intranasal surgery, concerning trigeminal perception and TRP channel&#xD;
      expression will be investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of subjective nasal breathing impairment after surgery depending on trigeminal perception threshold and TRP channel expression</measure>
    <time_frame>Up to 1 year post-surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences between trigeminal perception threshold as as well as TRP expression levels in patients with postoperative empty nose syndrome and patients with subjectively unimpaired nasal breathing after extended intranasal surgery</measure>
    <time_frame>Up to 1 year post-op</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Empty Nose Syndrome</condition>
  <arm_group>
    <arm_group_label>Patients receiving nose surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in need of nose surgery, before and after surgery; or only after successful surgery, then with or without &quot;Empty Nose Syndrome&quot;.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Nasal surgery</intervention_name>
    <arm_group_label>Patients receiving nose surgery</arm_group_label>
    <other_name>Septoplasty</other_name>
    <other_name>Turbinoplasty</other_name>
    <other_name>Removal of turbinates and septum parts</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing a primary septoplasty and/or turbinoplasty&#xD;
&#xD;
          -  Patients suffering from empty nose syndrome after measurably successful nasal surgery&#xD;
&#xD;
          -  Patients with removed turbinates and/or septum, not suffering from ENS (i.e. tumor&#xD;
             patients)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known neurologic disorders that could compromise perception threshold&#xD;
             measurements&#xD;
&#xD;
          -  Patients with known allergies/intolerance to test agents that are used to measure&#xD;
             perception thresholds (Cineol=Eucalypt; Menthol, CO2= Carbon Dioxide)&#xD;
&#xD;
          -  Inability to judge or understand the testing or the informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Soyka, Dr.med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zurich University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zurich University Hospital</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>April 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>October 11, 2018</last_update_submitted>
  <last_update_submitted_qc>October 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Functional nasal surgery</keyword>
  <keyword>Empty Nose Syndrome (ENS)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02230423
org study id: SM_31_01_2014
secondary id: KEK-ZH-Nr: 2013-0545
nct id: NCT02230423
lead sponsor: 
has dmc: No
This study investigates wether patients with increased trigeminal perception threshold and
      low expression of TRP channels have more often nasal blockage despite functionally successful
      nasal surgery (TRP channel = transient receptor potential channel).
The aim of this study is to find out wether patients with high trigeminal perception
      threshold (=decreased intranasal sensibility) and low expression of TRP channels of the
      mucosa suffer more often from impaired nasal breathing after surgery. This could lead to the
      identification of prognostic factors and therefore prevention of nasal surgery with bad
      outcome.

      Further, differences between patients with empty nose syndrome and asymptomatic patients
      after extended intranasal surgery, concerning trigeminal perception and TRP channel
      expression will be investigated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Measurement of subjective nasal breathing impairment after surgery depending on trigeminal perception threshold and TRP channel expression
time frame: Up to 1 year post-surgery
measure: Differences between trigeminal perception threshold as as well as TRP expression levels in patients with postoperative empty nose syndrome and patients with subjectively unimpaired nasal breathing after extended intranasal surgery
time frame: Up to 1 year post-op
arm group label: Patients receiving nose surgery
arm group type: Experimental
description: Patients in need of nose surgery, before and after surgery; or only after successful surgery, then with or without "Empty Nose Syndrome".
intervention type: Procedure
intervention name: Nasal surgery
arm group label: Patients receiving nose surgery
other name: Septoplasty
other name: Turbinoplasty
other name: Removal of turbinates and septum parts
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Michael Soyka, Dr.med.
role: Principal Investigator
affiliation: Zurich University Hospital
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Syndrome
sharing ipd: No