<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/NCT03031639</url>
  </required_header>
  <id_info>
    <org_study_id>HE591517</org_study_id>
    <nct_id>NCT03031639</nct_id>
  </id_info>
  <brief_title>Khon Kaen University's Thyroidectomy Registry</brief_title>
  <official_title>Khon Kaen University's Thyroidectomy Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Khon Kaen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Khon Kaen University</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 endoscopic thyroidectomy approach is gaining popularity in the surgical field. This&#xD;
      registry tries to collect the outcomes including quality of life and complication for both&#xD;
      endoscopic and conventional thyroidectomy methods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 13, 2017</start_date>
  <completion_date type="Actual">January 12, 2021</completion_date>
  <primary_completion_date type="Actual">January 12, 2021</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>6 Months</target_duration>
  <primary_outcome>
    <measure>Change from Baseline of QOL Score at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Validated quality of life score(SF-36) will be measure at baseline and 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of the symptoms score</measure>
    <time_frame>At 2, 6, 12, and 24 weeks after surgery</time_frame>
    <description>The questionnaire for pain, numbness, voice, swallowing and neck movement function will be given and the patient needs to rate from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>At 2, 6, 12, and 24 weeks after surgery</time_frame>
    <description>Complications after surgery</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">98</enrollment>
  <condition>Thyroid Nodule</condition>
  <condition>Thyroid Neoplasms</condition>
  <condition>Thyroid Cancer</condition>
  <arm_group>
    <arm_group_label>Endoscopic</arm_group_label>
    <description>This group is the patients who underwent endoscopic approaches thyroidectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional</arm_group_label>
    <description>This group is the patients who underwent conventional approach thyroidectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic approach thyroidectomy</intervention_name>
    <description>Thyroid surgery using endoscopy.</description>
    <arm_group_label>Endoscopic</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients who underwent thyroidectomy at Khon Kaen University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients who underwent thyroidectomy at Khon Kaen University&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patorn Piromchai, MD, MSc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Khon Kaen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Otolaryngology, Khonkaen University</name>
      <address>
        <city>Muang</city>
        <state>Khonkaen</state>
        <zip>40002</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <reference>
    <citation>Piromchai P, Vatanasapt P, Reechaipichitkul W, Phuttharak W, Thanaviratananich S. Is the routine pressure dressing after thyroidectomy necessary? A prospective randomized controlled study. BMC Ear Nose Throat Disord. 2008 Mar 20;8:1. doi: 10.1186/1472-6815-8-1.</citation>
    <PMID>18366712</PMID>
  </reference>
  <results_reference>
    <citation>Piromchai P, Wijakkanalan P, Teeramatwanich W, Kasemsiri P, Laohasiriwong S, Ratanaanekchai T. Postauricular-submental approach endoscopic thyroidectomy. Clin Otolaryngol. 2018 Apr;43(2):767-769. doi: 10.1111/coa.12791. Epub 2016 Nov 27. No abstract available.</citation>
    <PMID>27860271</PMID>
  </results_reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>February 17, 2021</last_update_submitted>
  <last_update_submitted_qc>February 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Khon Kaen University</investigator_affiliation>
    <investigator_full_name>Patorn Piromchai</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>endoscopic</keyword>
  <keyword>thyroidectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Nodule</mesh_term>
    <mesh_term>Thyroid Diseases</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/NCT03031639
org study id: HE591517
nct id: NCT03031639
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The endoscopic thyroidectomy approach is gaining popularity in the surgical field. This
      registry tries to collect the outcomes including quality of life and complication for both
      endoscopic and conventional thyroidectomy methods.
observational model: Cohort
time perspective: Prospective
measure: Change from Baseline of QOL Score at 6 months
time frame: 6 months
description: Validated quality of life score(SF-36) will be measure at baseline and 6 months
measure: Change of the symptoms score
time frame: At 2, 6, 12, and 24 weeks after surgery
description: The questionnaire for pain, numbness, voice, swallowing and neck movement function will be given and the patient needs to rate from 0 to 10.
measure: Complication rate
time frame: At 2, 6, 12, and 24 weeks after surgery
description: Complications after surgery
arm group label: Endoscopic
description: This group is the patients who underwent endoscopic approaches thyroidectomy.
arm group label: Conventional
description: This group is the patients who underwent conventional approach thyroidectomy
intervention type: Procedure
intervention name: Endoscopic approach thyroidectomy
description: Thyroid surgery using endoscopy.
arm group label: Endoscopic
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Patorn Piromchai, MD, MSc, PhD
role: Principal Investigator
affiliation: Khon Kaen University
facility: 
country: Thailand
citation: Piromchai P, Vatanasapt P, Reechaipichitkul W, Phuttharak W, Thanaviratananich S. Is the routine pressure dressing after thyroidectomy necessary? A prospective randomized controlled study. BMC Ear Nose Throat Disord. 2008 Mar 20;8:1. doi: 10.1186/1472-6815-8-1.
PMID: 18366712
citation: Piromchai P, Wijakkanalan P, Teeramatwanich W, Kasemsiri P, Laohasiriwong S, Ratanaanekchai T. Postauricular-submental approach endoscopic thyroidectomy. Clin Otolaryngol. 2018 Apr;43(2):767-769. doi: 10.1111/coa.12791. Epub 2016 Nov 27. No abstract available.
PMID: 27860271
responsible party type: Principal Investigator
investigator affiliation: Khon Kaen University
investigator full name: Patorn Piromchai
investigator title: Dr
mesh term: Thyroid Neoplasms
mesh term: Thyroid Nodule
mesh term: Thyroid Diseases
sharing ipd: No