xml: <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/NCT05996146</url>
    </required_header>
    <id_info>
      <org_study_id>HA-427</org_study_id>
      <nct_id>NCT05996146</nct_id>
    </id_info>
    <brief_title>Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study</brief_title>
    <acronym>Hoarseness</acronym>
    <official_title>Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seoul National University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Seoul National University Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Early diagnosis and appropriate treatment of hoarseness is known to improve quality of life&#xD;
        and treatment outcomes. Therefore, appropriate research on the incidence of hoarseness after&#xD;
        surgery is necessary. In this study, investigator aim to investigate incidence of hoarseness&#xD;
        after spine surgery and the correlation between the Voice Handicap Index (VHI)-10, used as a&#xD;
        criterion, and acoustic parameters, while also validating the efficacy of our research&#xD;
        methods.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary outcome of this study is the incidence of hoarseness on the day of surgery.&#xD;
  &#xD;
        The secondary outcomes include the incidence of hoarseness at one month after surgery, as&#xD;
        well as examining the correlation between acoustic parameters, risk factors, and the&#xD;
        occurrence of hoarseness.&#xD;
  &#xD;
        Investigator conducted a comparative analysis of risk factor for hoarseness in patients with&#xD;
        different VHI-10 scores on the day of surgery and 30 days after surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 5, 2022</start_date>
    <completion_date type="Actual">July 31, 2023</completion_date>
    <primary_completion_date type="Actual">November 27, 2022</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>1 Month</target_duration>
    <primary_outcome>
      <measure>the primary outcome was to measure the incidence of hoarseness</measure>
      <time_frame>voice recordings six hours after the end of anesthesia</time_frame>
      <description>the primary outcome was to measure the incidence of voice disorders by conducting Voice Handicap Index-10 (minimum score 0 to maximum score 46, lower score is better) scoring and voice recordings six hours after the end of anesthesia</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The secondary outcome involved measuring the incidence of hoarseness one month after the surgery</measure>
      <time_frame>one month after the surgery</time_frame>
      <description>analyzed the correlation between Voice Handicap Index-10 (minimum score 0 to maximum score 46, lower score is better) scores and voice acoustic parameter analysis</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">427</enrollment>
    <condition>Hoarseness</condition>
    <arm_group>
      <arm_group_label>hoarseness group</arm_group_label>
      <description>This study recruited all patients admitted at Seoul National University Hospital.&#xD;
  Age range is 20 to 80 years old. Patients who require surgical treatment for degenerative spine conditions. Patients who voluntarily consent to participate in the study.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Age range is 20 to 80 years old. Patients who require surgical treatment for degenerative&#xD;
          spine conditions and visit at Seoul National University Hospital. Patients who voluntarily&#xD;
          consent to participate in the study&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age range is 20 to 80 years old&#xD;
  &#xD;
            -  degenerative spine conditions&#xD;
  &#xD;
            -  visit at Seoul National University Hospital only&#xD;
  &#xD;
            -  Patients who voluntarily consent to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of surgery around the airway or mediastinum&#xD;
  &#xD;
            -  patients with vocal cord-related disorders&#xD;
  &#xD;
            -  Patients with fractures, bleeding, or other trauma&#xD;
  &#xD;
            -  Patients with neuromuscular diseases, Parkinson's disease, or psychiatric disorders&#xD;
  &#xD;
            -  Patients who cannot be extubated or who are transferred to the ICU after surgery&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  Patients who do not wish to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>SUM KIM, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Neurosurgery, Seoul National University Hospital, Republic of Korea.</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Seoul National University Hospital</name>
        <address>
          <city>Seoul</city>
          <zip>110-744</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
      <investigator_full_name>Chun Kee Chung</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </responsible_party>
    <keyword>hoarseness</keyword>
    <keyword>spine surgery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hoarseness</mesh_term>
      <mesh_term>Dysphonia</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996146
  org study id: HA-427
  nct id: NCT05996146
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Early diagnosis and appropriate treatment of hoarseness is known to improve quality of life
        and treatment outcomes. Therefore, appropriate research on the incidence of hoarseness after
        surgery is necessary. In this study, investigator aim to investigate incidence of hoarseness
        after spine surgery and the correlation between the Voice Handicap Index (VHI)-10, used as a
        criterion, and acoustic parameters, while also validating the efficacy of our research
        methods.
  The primary outcome of this study is the incidence of hoarseness on the day of surgery.
  
        The secondary outcomes include the incidence of hoarseness at one month after surgery, as
        well as examining the correlation between acoustic parameters, risk factors, and the
        occurrence of hoarseness.
  
        Investigator conducted a comparative analysis of risk factor for hoarseness in patients with
        different VHI-10 scores on the day of surgery and 30 days after surgery.
  observational model: Cohort
  time perspective: Prospective
  measure: the primary outcome was to measure the incidence of hoarseness
  time frame: voice recordings six hours after the end of anesthesia
  description: the primary outcome was to measure the incidence of voice disorders by conducting Voice Handicap Index-10 (minimum score 0 to maximum score 46, lower score is better) scoring and voice recordings six hours after the end of anesthesia
  measure: The secondary outcome involved measuring the incidence of hoarseness one month after the surgery
  time frame: one month after the surgery
  description: analyzed the correlation between Voice Handicap Index-10 (minimum score 0 to maximum score 46, lower score is better) scores and voice acoustic parameter analysis
  arm group label: hoarseness group
  description: This study recruited all patients admitted at Seoul National University Hospital.
  Age range is 20 to 80 years old. Patients who require surgical treatment for degenerative spine conditions. Patients who voluntarily consent to participate in the study.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: SUM KIM, Dr
  role: Principal Investigator
  affiliation: Department of Neurosurgery, Seoul National University Hospital, Republic of Korea.
  facility: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Seoul National University Hospital
  investigator full name: Chun Kee Chung
  investigator title: Clinical Professor
  mesh term: Hoarseness
  mesh term: Dysphonia