<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/NCT03295955</url>
  </required_header>
  <id_info>
    <org_study_id>1708-028-875</org_study_id>
    <nct_id>NCT03295955</nct_id>
  </id_info>
  <brief_title>Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy</brief_title>
  <acronym>POTO</acronym>
  <official_title>Comparing Efficacy of Postoperative Antibiotic Use in Transoral Thyroidectomy: a Prospective Randomized Controlled Trial 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transoral endoscopic thyroid surgery is a emerging surgical technique for thyroid surgery.&#xD;
      This study to investigate the need for postoperative antibiotics in transoral endoscopic&#xD;
      thyroid surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To prevent possible infection from the oral cavity flora, most surgeons prescribe&#xD;
      postoperative oral antibiotics more than 3 to 7 days after surgery. Currently, there's no&#xD;
      clinical evidence that postoperative oral antibiotics is necessary or not in transoral&#xD;
      endoscopic thyroid surgery. The investigator will conduct randomization after transoral&#xD;
      thyroid surgery with two groups : postoperative oral antibiotics group versus no oral&#xD;
      antibiotics group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 4, 2017</start_date>
  <completion_date type="Anticipated">December 3, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 3, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>&quot;CDC 1992 SSI table&quot; score</measure>
    <time_frame>Postoperative 1 day</time_frame>
    <description>Clinical evidence of Surgical Site Infection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CBC, CRP</measure>
    <time_frame>Postoperative 1 day</time_frame>
    <description>Laboratory test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of &quot;CDC 1992 SSI table&quot; score</measure>
    <time_frame>Compare the CDC 1992 SSI table score between postoperative 1 day and 2 day/2 weeks.</time_frame>
    <description>Clinical evidence of Surgical Site Infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of CBC, CRP</measure>
    <time_frame>Compare the CBC, CRP between postoperative 1 day and 2 day</time_frame>
    <description>Laboratory test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Surgical Wound Infection</condition>
  <condition>Thyroid Nodule</condition>
  <arm_group>
    <arm_group_label>Postop antibiotics group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prescribe Amoxicillin Clavulanate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No postop antibiotics</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Do not prescribe Amoxicillin Clavulanate</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin Clavulanate</intervention_name>
    <description>Per-oral &quot;Amoxicillin Clavulanate&quot; Given or Non-given, after surgery</description>
    <arm_group_label>Postop antibiotics group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who planned to Transoral endoscopic thyroidectomy&#xD;
&#xD;
          -  Age between 20 to 70&#xD;
&#xD;
          -  Voluntarily consenting to the study and study agreement&#xD;
&#xD;
          -  No local invasion or distant metastasis&#xD;
&#xD;
          -  Normal vocal cord function in laryngoscopic exam&#xD;
&#xD;
          -  No significant abnormalities in preoperative laboratory tests&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Take aspirin or antiplatelet drugs within 7 days before admission&#xD;
&#xD;
          -  Uncontrolled hypertension, diabetes, chronic renal failure, or coagulation disease&#xD;
&#xD;
          -  History of cardiovascular disease (angina pectoris, heart failure, myocardial&#xD;
             infarction, history of coronary artery disease, stroke, transient ischemic attack)&#xD;
&#xD;
          -  Substance abuse and alcohol abuse&#xD;
&#xD;
          -  History of esophageal and airway diseases&#xD;
&#xD;
          -  Patient was participated in other clinical trials within 30 days&#xD;
&#xD;
          -  History of neck irradiation or surgery&#xD;
&#xD;
          -  History of drug allergies&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jin Wook Yi</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin Wook Yi, MD, MS</last_name>
      <phone>+82-2-2072-3243</phone>
      <email>gnsljw@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Anuwong A, Ketwong K, Jitpratoom P, Sasanakietkul T, Duh QY. Safety and Outcomes of the Transoral Endoscopic Thyroidectomy Vestibular Approach. JAMA Surg. 2018 Jan 1;153(1):21-27. doi: 10.1001/jamasurg.2017.3366.</citation>
    <PMID>28877292</PMID>
  </results_reference>
  <results_reference>
    <citation>Anuwong A. Transoral Endoscopic Thyroidectomy Vestibular Approach: A Series of the First 60 Human Cases. World J Surg. 2016 Mar;40(3):491-7. doi: 10.1007/s00268-015-3320-1.</citation>
    <PMID>26546193</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>September 26, 2017</last_update_submitted>
  <last_update_submitted_qc>September 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jin Wook Yi</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Thyroid Nodule</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Clavulanic Acid</mesh_term>
    <mesh_term>Clavulanic Acids</mesh_term>
    <mesh_term>Amoxicillin-Potassium Clavulanate Combination</mesh_term>
  </intervention_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/NCT03295955
org study id: 1708-028-875
nct id: NCT03295955
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Transoral endoscopic thyroid surgery is a emerging surgical technique for thyroid surgery.
      This study to investigate the need for postoperative antibiotics in transoral endoscopic
      thyroid surgery.
To prevent possible infection from the oral cavity flora, most surgeons prescribe
      postoperative oral antibiotics more than 3 to 7 days after surgery. Currently, there's no
      clinical evidence that postoperative oral antibiotics is necessary or not in transoral
      endoscopic thyroid surgery. The investigator will conduct randomization after transoral
      thyroid surgery with two groups : postoperative oral antibiotics group versus no oral
      antibiotics group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: "CDC 1992 SSI table" score
time frame: Postoperative 1 day
description: Clinical evidence of Surgical Site Infection
measure: CBC, CRP
time frame: Postoperative 1 day
description: Laboratory test
measure: Change of "CDC 1992 SSI table" score
time frame: Compare the CDC 1992 SSI table score between postoperative 1 day and 2 day/2 weeks.
description: Clinical evidence of Surgical Site Infection
measure: Change of CBC, CRP
time frame: Compare the CBC, CRP between postoperative 1 day and 2 day
description: Laboratory test
arm group label: Postop antibiotics group
arm group type: Active Comparator
description: Prescribe Amoxicillin Clavulanate
arm group label: No postop antibiotics
arm group type: No Intervention
description: Do not prescribe Amoxicillin Clavulanate
intervention type: Drug
intervention name: Amoxicillin Clavulanate
description: Per-oral "Amoxicillin Clavulanate" Given or Non-given, after surgery
arm group label: Postop antibiotics group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
citation: Anuwong A, Ketwong K, Jitpratoom P, Sasanakietkul T, Duh QY. Safety and Outcomes of the Transoral Endoscopic Thyroidectomy Vestibular Approach. JAMA Surg. 2018 Jan 1;153(1):21-27. doi: 10.1001/jamasurg.2017.3366.
PMID: 28877292
citation: Anuwong A. Transoral Endoscopic Thyroidectomy Vestibular Approach: A Series of the First 60 Human Cases. World J Surg. 2016 Mar;40(3):491-7. doi: 10.1007/s00268-015-3320-1.
PMID: 26546193
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin Wook Yi
investigator title: Clinical Assistant Professor
mesh term: Wound Infection
mesh term: Surgical Wound Infection
mesh term: Thyroid Nodule
mesh term: Surgical Wound
mesh term: Amoxicillin
mesh term: Clavulanic Acid
mesh term: Clavulanic Acids
mesh term: Amoxicillin-Potassium Clavulanate Combination
sharing ipd: Undecided