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/NCT06002984</url>
    </required_header>
    <id_info>
      <org_study_id>2303-075-1411</org_study_id>
      <nct_id>NCT06002984</nct_id>
    </id_info>
    <brief_title>Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve in Thyroid Surgery</brief_title>
    <official_title>Effectiveness of Intraoperative Neuromonitoring to Identify and Preserve External Branch of 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>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>
        The frequent occurrence of impaired function in the external branch of the superior laryngeal&#xD;
        nerves following thyroid surgery is recognized as a prevalent complication leading to a&#xD;
        diminished quality of life. The objective of this randomized controlled trial (RCT) is to&#xD;
        assess the efficacy of neuromonitoring during thyroid surgery in order to safeguard the&#xD;
        integrity of these nerves.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        With increased interest in quality of life after thyroidectomy, preservation of proper vocal&#xD;
        cord function and voice quality is an important issue in thyroid surgery. External branch of&#xD;
        the superior laryngeal nerve (EBSLN) and recurrent laryngeal nerve (RLN) are crucial organs&#xD;
        for innervation and integration of laryngeal muscular system. The EBSLN innervates the&#xD;
        cricothyroid muscle (CTM), which is important in adjusting the tension and length of the&#xD;
        vocal cords. Damage of the EBSLN leads to CTM dysfunction, resulting in difficulty with high&#xD;
        pitch phonation and decreased pitch range and reduced voice projection, which are important&#xD;
        for voice professionals. As the intraoperative neuromonitoring was utilized as an adjunctive&#xD;
        and objective tool to confirm the nerve presence and integrity, application of the&#xD;
        intraoperative neuromonitoring system to confirm EBSLN function pre- and post-dissection of&#xD;
        the upper thyroid pole can be regarded as an effective method to preserve cricothyroid muscle&#xD;
        function. However, it remains unclear whether there is any intraoperative neuromonitoring&#xD;
        techniques-added value to the clinical outcome of thyroidectomy in terms of identification of&#xD;
        EBSLN and preserved voice performance. Therefore, this study could provide strong evidence of&#xD;
        the application of the intraoperative neuromonitoring during thyroid surgery to identify and&#xD;
        preserve EBSLN function.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</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>Prevention</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Identification rate of EBSLN</measure>
      <time_frame>during operation</time_frame>
      <description>Visual identification rate, Electrostimulatory identification rate</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change of results about questionnaire for quality of voice</measure>
      <time_frame>up to postoperative 1 month, 3 months and 6 months</time_frame>
      <description>Voice Handicap Index-10 [0~40], higher scores mean worse voice disorder</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes of Vocal outcome</measure>
      <time_frame>up to postoperative 1 month, 3 months and 6 months</time_frame>
      <description>Visual Analogue Scales (VAS) [0~100%], 0% = no voice, full disability ; 100% = normal voice</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurements of Vocal function</measure>
      <time_frame>up to postoperative 1 month, 3 months and 6 months</time_frame>
      <description>Maximum Phonation Time (MPT)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vocal evaluation</measure>
      <time_frame>up to postoperative 1 month, 3 months and 6 months</time_frame>
      <description>GRBAS (Grade, Rough, Breathy, Asthenia, and Strain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes of Vocal fold vibration patterns</measure>
      <time_frame>up to postoperative 1 month, 3 months and 6 months</time_frame>
      <description>EGG (electroglottography) assessment of voice</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes of Vocal outcome by Computerized Acoustic Analysis</measure>
      <time_frame>up to postoperative 1 month, 3 months and 6 months</time_frame>
      <description>Multi-Dimensional Voice Program (MDVP)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes of Voice Pitch</measure>
      <time_frame>up to postoperative 1 month, 3 months and 6 months</time_frame>
      <description>Real-time pitch (RTP)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">94</enrollment>
    <condition>Laryngeal Nerve Injuries</condition>
    <condition>Thyroidectomy</condition>
    <condition>Voice Change</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 Intervention Device: Neuromonitoring to find EBSLN</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;
            -  Patients who are scheduled to undergo thyroid surgery&#xD;
  &#xD;
            -  Patients who understand and agree to take part in this study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  If the thyroid tumor is suspected to invade adjacent organs (esophagus, trachea,&#xD;
               carotid artery, jugular vein etc.)&#xD;
  &#xD;
            -  Patients who are required with lateral compartment neck dissection&#xD;
  &#xD;
            -  Patients with recurrent thyroid cancer&#xD;
  &#xD;
            -  Patients with palsy of recurrent laryngeal nerve or superior laryngeal nerve external&#xD;
               branch in the past or present&#xD;
  &#xD;
            -  Patients with a history of vocal cord and larynx disease&#xD;
  &#xD;
            -  History of hyperthyroidism (e.g., Graves' disease)&#xD;
  &#xD;
            -  Taking anticoagulants (aspirin, warfarin, etc.) before surgery&#xD;
  &#xD;
            -  Disorders of coagulation&#xD;
  &#xD;
            -  In the case of women, pregnant women and breastfeeding patients&#xD;
  &#xD;
            -  Patients judged inappropriate by clinical trial researcher&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>79 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Su-Jin Kim, M.D, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Seoul National University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hye Lim Bae, M.D</last_name>
      <phone>82-10-2664-6571</phone>
      <email>gpfla1206@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Seoul National University Hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Su-jin Kim</last_name>
        <email>su.jin.kim.md@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Su-jin Kim</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <reference>
      <citation>Kim SJ, Lee KE, Oh BM, Oh EM, Bae DS, Choi JY, Myong JP, Youn YK. Intraoperative neuromonitoring of the external branch of the superior laryngeal nerve during robotic thyroid surgery: a preliminary prospective study. Ann Surg Treat Res. 2015 Nov;89(5):233-9. doi: 10.4174/astr.2015.89.5.233. Epub 2015 Oct 28.</citation>
      <PMID>26576402</PMID>
    </reference>
    <reference>
      <citation>Kim JI, Kim SJ, Xu Z, Kwak J, Ahn JH, Yu HW, Chai YJ, Choi JY, Lee KE. Efficacy of Intraoperative Neuromonitoring in Reoperation for Recurrent Thyroid Cancer Patients. Endocrinol Metab (Seoul). 2020 Dec;35(4):918-924. doi: 10.3803/EnM.2020.778. Epub 2020 Dec 23.</citation>
      <PMID>33397044</PMID>
    </reference>
    <reference>
      <citation>Potenza AS, Phelan EA, Cernea CR, Slough CM, Kamani DV, Darr A, Zurakowski D, Randolph GW. Normative intra-operative electrophysiologic waveform analysis of superior laryngeal nerve external branch and recurrent laryngeal nerve in patients undergoing thyroid surgery. World J Surg. 2013 Oct;37(10):2336-42. doi: 10.1007/s00268-013-2148-9.</citation>
      <PMID>23838931</PMID>
    </reference>
    <reference>
      <citation>Barczynski M, Konturek A, Stopa M, Honowska A, Nowak W. Randomized controlled trial of visualization versus neuromonitoring of the external branch of the superior laryngeal nerve during thyroidectomy. World J Surg. 2012 Jun;36(6):1340-7. doi: 10.1007/s00268-012-1547-7.</citation>
      <PMID>22402975</PMID>
    </reference>
    <reference>
      <citation>Jonas J, Bahr R. Neuromonitoring of the external branch of the superior laryngeal nerve during thyroid surgery. Am J Surg. 2000 Mar;179(3):234-6. doi: 10.1016/s0002-9610(00)00308-1.</citation>
      <PMID>10827327</PMID>
    </reference>
    <reference>
      <citation>Babinska D, Barczynski M, Oseka T, Sledzinski M, Lachinski AJ. Comparison of perioperative stress in patients undergoing thyroid surgery with and without neuromonitoring-a pilot study. Langenbecks Arch Surg. 2017 Jun;402(4):719-725. doi: 10.1007/s00423-016-1457-5. Epub 2016 Jun 14.</citation>
      <PMID>27299585</PMID>
    </reference>
    <reference>
      <citation>Cirocchi R, Arezzo A, D'Andrea V, Abraha I, Popivanov GI, Avenia N, Gerardi C, Henry BM, Randolph J, Barczynski M. Intraoperative neuromonitoring versus visual nerve identification for prevention of recurrent laryngeal nerve injury in adults undergoing thyroid surgery. Cochrane Database Syst Rev. 2019 Jan 19;1(1):CD012483. doi: 10.1002/14651858.CD012483.pub2.</citation>
      <PMID>30659577</PMID>
    </reference>
    <reference>
      <citation>Dionigi G, Boni L, Rovera F, Bacuzzi A, Dionigi R. Neuromonitoring and video-assisted thyroidectomy: a prospective, randomized case-control evaluation. Surg Endosc. 2009 May;23(5):996-1003. doi: 10.1007/s00464-008-0098-3. Epub 2008 Sep 21.</citation>
      <PMID>18806939</PMID>
    </reference>
    <reference>
      <citation>Lifante JC, McGill J, Murry T, Aviv JE, Inabnet WB 3rd. A prospective, randomized trial of nerve monitoring of the external branch of the superior laryngeal nerve during thyroidectomy under local/regional anesthesia and IV sedation. Surgery. 2009 Dec;146(6):1167-73. doi: 10.1016/j.surg.2009.09.023.</citation>
      <PMID>19958945</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 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>Su-jin Kim</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>External branch of the superior Laryngeal Nerve</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Laryngeal Nerve Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06002984
  org study id: 2303-075-1411
  nct id: NCT06002984
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The frequent occurrence of impaired function in the external branch of the superior laryngeal
        nerves following thyroid surgery is recognized as a prevalent complication leading to a
        diminished quality of life. The objective of this randomized controlled trial (RCT) is to
        assess the efficacy of neuromonitoring during thyroid surgery in order to safeguard the
        integrity of these nerves.
  With increased interest in quality of life after thyroidectomy, preservation of proper vocal
        cord function and voice quality is an important issue in thyroid surgery. External branch of
        the superior laryngeal nerve (EBSLN) and recurrent laryngeal nerve (RLN) are crucial organs
        for innervation and integration of laryngeal muscular system. The EBSLN innervates the
        cricothyroid muscle (CTM), which is important in adjusting the tension and length of the
        vocal cords. Damage of the EBSLN leads to CTM dysfunction, resulting in difficulty with high
        pitch phonation and decreased pitch range and reduced voice projection, which are important
        for voice professionals. As the intraoperative neuromonitoring was utilized as an adjunctive
        and objective tool to confirm the nerve presence and integrity, application of the
        intraoperative neuromonitoring system to confirm EBSLN function pre- and post-dissection of
        the upper thyroid pole can be regarded as an effective method to preserve cricothyroid muscle
        function. However, it remains unclear whether there is any intraoperative neuromonitoring
        techniques-added value to the clinical outcome of thyroidectomy in terms of identification of
        EBSLN and preserved voice performance. Therefore, this study could provide strong evidence of
        the application of the intraoperative neuromonitoring during thyroid surgery to identify and
        preserve EBSLN function.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  measure: Identification rate of EBSLN
  time frame: during operation
  description: Visual identification rate, Electrostimulatory identification rate
  measure: Change of results about questionnaire for quality of voice
  time frame: up to postoperative 1 month, 3 months and 6 months
  description: Voice Handicap Index-10 [0~40], higher scores mean worse voice disorder
  measure: Changes of Vocal outcome
  time frame: up to postoperative 1 month, 3 months and 6 months
  description: Visual Analogue Scales (VAS) [0~100%], 0% = no voice, full disability ; 100% = normal voice
  measure: Measurements of Vocal function
  time frame: up to postoperative 1 month, 3 months and 6 months
  description: Maximum Phonation Time (MPT)
  measure: Vocal evaluation
  time frame: up to postoperative 1 month, 3 months and 6 months
  description: GRBAS (Grade, Rough, Breathy, Asthenia, and Strain)
  measure: Changes of Vocal fold vibration patterns
  time frame: up to postoperative 1 month, 3 months and 6 months
  description: EGG (electroglottography) assessment of voice
  measure: Changes of Vocal outcome by Computerized Acoustic Analysis
  time frame: up to postoperative 1 month, 3 months and 6 months
  description: Multi-Dimensional Voice Program (MDVP)
  measure: Changes of Voice Pitch
  time frame: up to postoperative 1 month, 3 months and 6 months
  description: Real-time pitch (RTP)
  arm group label: Using neuromonitoring to find EBSLN
  arm group type: Experimental
  description: With neuromonitoring of the EBSLN using nerve monitoring system Intervention Device: Neuromonitoring to find EBSLN
  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: 19 Years
  maximum age: 79 Years
  healthy volunteers: No
  last name: Su-Jin Kim, M.D, Ph.D
  role: Principal Investigator
  affiliation: Seoul National University Hospital
  last name: Hye Lim Bae, M.D
  phone: 82-10-2664-6571
  email: gpfla1206@gmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Korea, Republic of
  citation: Kim SJ, Lee KE, Oh BM, Oh EM, Bae DS, Choi JY, Myong JP, Youn YK. Intraoperative neuromonitoring of the external branch of the superior laryngeal nerve during robotic thyroid surgery: a preliminary prospective study. Ann Surg Treat Res. 2015 Nov;89(5):233-9. doi: 10.4174/astr.2015.89.5.233. Epub 2015 Oct 28.
  PMID: 26576402
  citation: Kim JI, Kim SJ, Xu Z, Kwak J, Ahn JH, Yu HW, Chai YJ, Choi JY, Lee KE. Efficacy of Intraoperative Neuromonitoring in Reoperation for Recurrent Thyroid Cancer Patients. Endocrinol Metab (Seoul). 2020 Dec;35(4):918-924. doi: 10.3803/EnM.2020.778. Epub 2020 Dec 23.
  PMID: 33397044
  citation: Potenza AS, Phelan EA, Cernea CR, Slough CM, Kamani DV, Darr A, Zurakowski D, Randolph GW. Normative intra-operative electrophysiologic waveform analysis of superior laryngeal nerve external branch and recurrent laryngeal nerve in patients undergoing thyroid surgery. World J Surg. 2013 Oct;37(10):2336-42. doi: 10.1007/s00268-013-2148-9.
  PMID: 23838931
  citation: Barczynski M, Konturek A, Stopa M, Honowska A, Nowak W. Randomized controlled trial of visualization versus neuromonitoring of the external branch of the superior laryngeal nerve during thyroidectomy. World J Surg. 2012 Jun;36(6):1340-7. doi: 10.1007/s00268-012-1547-7.
  PMID: 22402975
  citation: Jonas J, Bahr R. Neuromonitoring of the external branch of the superior laryngeal nerve during thyroid surgery. Am J Surg. 2000 Mar;179(3):234-6. doi: 10.1016/s0002-9610(00)00308-1.
  PMID: 10827327
  citation: Babinska D, Barczynski M, Oseka T, Sledzinski M, Lachinski AJ. Comparison of perioperative stress in patients undergoing thyroid surgery with and without neuromonitoring-a pilot study. Langenbecks Arch Surg. 2017 Jun;402(4):719-725. doi: 10.1007/s00423-016-1457-5. Epub 2016 Jun 14.
  PMID: 27299585
  citation: Cirocchi R, Arezzo A, D'Andrea V, Abraha I, Popivanov GI, Avenia N, Gerardi C, Henry BM, Randolph J, Barczynski M. Intraoperative neuromonitoring versus visual nerve identification for prevention of recurrent laryngeal nerve injury in adults undergoing thyroid surgery. Cochrane Database Syst Rev. 2019 Jan 19;1(1):CD012483. doi: 10.1002/14651858.CD012483.pub2.
  PMID: 30659577
  citation: Dionigi G, Boni L, Rovera F, Bacuzzi A, Dionigi R. Neuromonitoring and video-assisted thyroidectomy: a prospective, randomized case-control evaluation. Surg Endosc. 2009 May;23(5):996-1003. doi: 10.1007/s00464-008-0098-3. Epub 2008 Sep 21.
  PMID: 18806939
  citation: Lifante JC, McGill J, Murry T, Aviv JE, Inabnet WB 3rd. A prospective, randomized trial of nerve monitoring of the external branch of the superior laryngeal nerve during thyroidectomy under local/regional anesthesia and IV sedation. Surgery. 2009 Dec;146(6):1167-73. doi: 10.1016/j.surg.2009.09.023.
  PMID: 19958945
  responsible party type: Principal Investigator
  investigator affiliation: Seoul National University Hospital
  investigator full name: Su-jin Kim
  investigator title: Associate Professor
  mesh term: Laryngeal Nerve Injuries
  sharing ipd: No