<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/NCT02231216</url>
  </required_header>
  <id_info>
    <org_study_id>130516</org_study_id>
    <nct_id>NCT02231216</nct_id>
  </id_info>
  <brief_title>Quality of Life Study About the Role of Turbinectomy in Rhinoseptoplasty</brief_title>
  <acronym>WHOQOL-BREF</acronym>
  <official_title>The Role of Turbinectomy in Rhinoseptoplasty: a Randomized Clinical Trial With Evaluation of Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Research Question: Performing partial turbinectomy associated with rhinoseptoplasty is&#xD;
      responsible for an increase in quality of life related to nasal obstruction when compared to&#xD;
      no intervention in rhinoseptoplasty inferior turbinate?&#xD;
&#xD;
        -  Population: patients eligible for functional rhinoseptoplasty and / or aesthetic&#xD;
&#xD;
        -  Intervention: surgery, turbinectomy of inferior turbinates&#xD;
&#xD;
        -  Comparison: the absence of intervention in inferior turbinates&#xD;
&#xD;
        -  Primary endpoint: Quality of life related to nasal obstruction&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life related to nasal obstruction</measure>
    <time_frame>3 months</time_frame>
    <description>Quality of life will be evaluated by the WHOQOL-BREF instrument, that comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nasal sneezing</measure>
    <time_frame>3 MONTHS</time_frame>
    <description>At 90 posoperative day patients were asked if they had nasal sneezing for more than one hour a day on most days, or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal Rhinorrhea</measure>
    <time_frame>3 MONTHS</time_frame>
    <description>At 90 posoperative day patients were asked if they had nasal rhinorrhea for more than one hour a day on most days, or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal Pruritis</measure>
    <time_frame>3 MONTHS</time_frame>
    <description>At 90 posoperative day patients were asked if they had nasal pruritis for more than one hour a day on most days, or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Allergic Conjunctivitis</measure>
    <time_frame>3 months</time_frame>
    <description>At 90 posoperative day patients were asked if they had allergic conjunctivitis for more than one hour a day on most days, or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Topical Nasal Corticosteroids</measure>
    <time_frame>3 MONTHS</time_frame>
    <description>At 90 posoperative day patients were asked if they were using topic nasal corticosteroids or not</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral antihistamine</measure>
    <time_frame>3 months</time_frame>
    <description>At 90 posoperative day patients were asked if they had used oral antihistamine in the past 30 days or not</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Deviated Nasal Septum</condition>
  <condition>Nasal Septal Defect</condition>
  <condition>Nasal Septum, Irregular</condition>
  <arm_group>
    <arm_group_label>Rhinoseptoplasty and turbinectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rhinoseptoplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients submitted only to rhinoseptoplasty, without turbinectomy procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Rhinoseptoplasty</intervention_name>
    <description>Rhinoseptoplasty without turbinectomy procedure</description>
    <arm_group_label>Rhinoseptoplasty</arm_group_label>
    <arm_group_label>Rhinoseptoplasty and turbinectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Partial turbinectomy</intervention_name>
    <description>After medial dislocation of the inferior turbinate, proceed partial resection of the inferior turbinate in all its inferior extension in range. Possible bleeding is cauterized.</description>
    <arm_group_label>Rhinoseptoplasty and turbinectomy</arm_group_label>
    <other_name>Turbinectomy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic partial turbinectomy</intervention_name>
    <description>Endoscopy to medial dislocation of the inferior turbinate with instrument</description>
    <arm_group_label>Rhinoseptoplasty and turbinectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible patients to rhinoseptoplasty&#xD;
&#xD;
          -  Patients who agreed to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of symptoms of nasal obstruction in the absence of septal deviation, poor&#xD;
             support of the nasal tip or clamping of the nasal valve;&#xD;
&#xD;
          -  Presence of hypertrophic and obstructive inferior turbinates;&#xD;
&#xD;
          -  Presence of sinonasal tumors;&#xD;
&#xD;
          -  Patients undergoing treatment of other concomitant rhinoplasty entities such as&#xD;
             inflammatory sinus pathology, adenoid hypertrophy, septal perforation, otoplasty and&#xD;
             blepharoplasty.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bianca H Moura, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michelle Lavinsky, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>January 16, 2019</last_update_submitted>
  <last_update_submitted_qc>January 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rhinoseptoplasty</keyword>
  <!-- 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/NCT02231216
org study id: 130516
nct id: NCT02231216
lead sponsor: 
has dmc: No
Research Question: Performing partial turbinectomy associated with rhinoseptoplasty is
      responsible for an increase in quality of life related to nasal obstruction when compared to
      no intervention in rhinoseptoplasty inferior turbinate?

        -  Population: patients eligible for functional rhinoseptoplasty and / or aesthetic

        -  Intervention: surgery, turbinectomy of inferior turbinates

        -  Comparison: the absence of intervention in inferior turbinates

        -  Primary endpoint: Quality of life related to nasal obstruction
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Quality of life related to nasal obstruction
time frame: 3 months
description: Quality of life will be evaluated by the WHOQOL-BREF instrument, that comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.
measure: Nasal sneezing
time frame: 3 MONTHS
description: At 90 posoperative day patients were asked if they had nasal sneezing for more than one hour a day on most days, or not.
measure: Nasal Rhinorrhea
time frame: 3 MONTHS
description: At 90 posoperative day patients were asked if they had nasal rhinorrhea for more than one hour a day on most days, or not.
measure: Nasal Pruritis
time frame: 3 MONTHS
description: At 90 posoperative day patients were asked if they had nasal pruritis for more than one hour a day on most days, or not.
measure: Allergic Conjunctivitis
time frame: 3 months
description: At 90 posoperative day patients were asked if they had allergic conjunctivitis for more than one hour a day on most days, or not.
measure: Topical Nasal Corticosteroids
time frame: 3 MONTHS
description: At 90 posoperative day patients were asked if they were using topic nasal corticosteroids or not
measure: Oral antihistamine
time frame: 3 months
description: At 90 posoperative day patients were asked if they had used oral antihistamine in the past 30 days or not
arm group label: Rhinoseptoplasty and turbinectomy
arm group type: Experimental
description: Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.
arm group label: Rhinoseptoplasty
arm group type: Active Comparator
description: Patients submitted only to rhinoseptoplasty, without turbinectomy procedure.
intervention type: Procedure
intervention name: Rhinoseptoplasty
description: Rhinoseptoplasty without turbinectomy procedure
arm group label: Rhinoseptoplasty
arm group label: Rhinoseptoplasty and turbinectomy
intervention type: Procedure
intervention name: Partial turbinectomy
description: After medial dislocation of the inferior turbinate, proceed partial resection of the inferior turbinate in all its inferior extension in range. Possible bleeding is cauterized.
arm group label: Rhinoseptoplasty and turbinectomy
other name: Turbinectomy
intervention type: Procedure
intervention name: Endoscopic partial turbinectomy
description: Endoscopy to medial dislocation of the inferior turbinate with instrument
arm group label: Rhinoseptoplasty and turbinectomy
criteria: 
gender: All
minimum age: 6 Months
maximum age: 90 Years
healthy volunteers: No
last name: Bianca H Moura, MD
role: Principal Investigator
affiliation: Hospital de Clínicas de Porto Alegre
last name: Michelle Lavinsky, PhD
role: Principal Investigator
affiliation: Hospital de Clínicas de Porto Alegre
facility: 
country: Brazil
responsible party type: Sponsor