<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/NCT03773120</url>
  </required_header>
  <id_info>
    <org_study_id>1708-125-880</org_study_id>
    <nct_id>NCT03773120</nct_id>
  </id_info>
  <brief_title>Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve During Thyroid Surgery</brief_title>
  <official_title>Effectiveness of Intraoperative Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroid Surgery</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>No</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>
      The paralysis of the external branch of superior laryngeal nerves after thyroid surgery is&#xD;
      known to be a common complication resulting in poor quality of life. Aim of this randomized&#xD;
      control trial(RCT) is to evaluate effectiveness of neuromonitoring during thyroid surgery for&#xD;
      the preservation of these nerves.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The external branch of superior laryngeal nerves(EBSLNs) are important for voice quality.&#xD;
      Injury to this nerve during thyroid surgery can manifest as ipsilateral paralysis of the&#xD;
      cricothyroid muscle. Clinical symptoms may include: hoarseness, breathy voice, an increase in&#xD;
      the rate of throat clearing, vocal fatigue, or diminished vocal frequency range, especially&#xD;
      with regards to raising pitch. The amount of EBSLNs identified intraoperatively varies from&#xD;
      10% to 80%, while the rate of EBSLN injury reported in the literature is between 5% and 28%,&#xD;
      depending on different evaluation methods. Advances in intraoperative neuromonitoring&#xD;
      techniques would allow for EBSLN identification during thyroid surgery. However, there is&#xD;
      controversy regarding usefulness in preserving EBSLN function using nerve monitoring system.&#xD;
      The aim of the study is to evaluate effectiveness of neuromonitoring during thyroid surgery&#xD;
      for the preservation of EBSLNs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Major study protocol changes&#xD;
  </why_stopped>
  <start_date type="Actual">April 6, 2018</start_date>
  <completion_date type="Actual">July 23, 2019</completion_date>
  <primary_completion_date type="Actual">July 23, 2019</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Identification of EBSLN during thyroid surgery</measure>
    <time_frame>up to postoperative 12 months</time_frame>
    <description>Identification rate of EBSLN</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Location of EBSLN</measure>
    <time_frame>up to postoperative 12 months</time_frame>
    <description>Classification of EBSLN according to Cernea classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vocal outcome</measure>
    <time_frame>up to postoperative 12 months</time_frame>
    <description>Voice assessment using voice lab</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Carcinoma, Papillary, Follicular</condition>
  <arm_group>
    <arm_group_label>Using Neuromonitoring to find EBSLN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>With Neuromonitoring of the EBSLN using nerve monitoring system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Using Neuromonitoring to find EBSLN</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Without Neuromonitoring of the EBSLN using nerve monitoring system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Using Neuromonitoring to find EBSLN</intervention_name>
    <description>intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery</description>
    <arm_group_label>Using Neuromonitoring to find EBSLN</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  planned open thyroidectomy&#xD;
&#xD;
          -  acceptable clinical laboratory tests&#xD;
&#xD;
          -  understand clinical trials&#xD;
&#xD;
          -  no significant past medical history&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  planned radical neck dissection&#xD;
&#xD;
          -  hyperthyroidism history&#xD;
&#xD;
          -  history of laryngeal nerve palsy&#xD;
&#xD;
          -  laryngeal disease history&#xD;
&#xD;
          -  uncontrolled hypertension or diabetes mellitus or heart disease&#xD;
&#xD;
          -  anticoagulation or antiplatelet medication&#xD;
&#xD;
          -  stroke history&#xD;
&#xD;
          -  participated another clinical trials in 30days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>January 2022</verification_date>
  <study_first_submitted>April 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>January 13, 2022</last_update_submitted>
  <last_update_submitted_qc>January 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Su-jin Kim</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>superior laryngeal nerve</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Papillary</mesh_term>
    <mesh_term>Carcinoma, Papillary, Follicular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03773120
org study id: 1708-125-880
nct id: NCT03773120
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The paralysis of the external branch of superior laryngeal nerves after thyroid surgery is
      known to be a common complication resulting in poor quality of life. Aim of this randomized
      control trial(RCT) is to evaluate effectiveness of neuromonitoring during thyroid surgery for
      the preservation of these nerves.
The external branch of superior laryngeal nerves(EBSLNs) are important for voice quality.
      Injury to this nerve during thyroid surgery can manifest as ipsilateral paralysis of the
      cricothyroid muscle. Clinical symptoms may include: hoarseness, breathy voice, an increase in
      the rate of throat clearing, vocal fatigue, or diminished vocal frequency range, especially
      with regards to raising pitch. The amount of EBSLNs identified intraoperatively varies from
      10% to 80%, while the rate of EBSLN injury reported in the literature is between 5% and 28%,
      depending on different evaluation methods. Advances in intraoperative neuromonitoring
      techniques would allow for EBSLN identification during thyroid surgery. However, there is
      controversy regarding usefulness in preserving EBSLN function using nerve monitoring system.
      The aim of the study is to evaluate effectiveness of neuromonitoring during thyroid surgery
      for the preservation of EBSLNs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Identification of EBSLN during thyroid surgery
time frame: up to postoperative 12 months
description: Identification rate of EBSLN
measure: Location of EBSLN
time frame: up to postoperative 12 months
description: Classification of EBSLN according to Cernea classification
measure: Vocal outcome
time frame: up to postoperative 12 months
description: Voice assessment using voice lab
arm group label: Using Neuromonitoring to find EBSLN
arm group type: Experimental
description: With Neuromonitoring of the EBSLN using nerve monitoring system
arm group label: No Using Neuromonitoring to find EBSLN
arm group type: No Intervention
description: Without Neuromonitoring of the EBSLN using nerve monitoring system
intervention type: Device
intervention name: Using Neuromonitoring to find EBSLN
description: intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery
arm group label: Using Neuromonitoring to find EBSLN
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Su-jin Kim
investigator title: Associate professor
mesh term: Carcinoma, Papillary
mesh term: Carcinoma, Papillary, Follicular
sharing ipd: Undecided