<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/NCT03035383</url>
  </required_header>
  <id_info>
    <org_study_id>DCiptoMGHAKurnia</org_study_id>
    <nct_id>NCT03035383</nct_id>
  </id_info>
  <brief_title>Purse String Suture for the Closure of Large Thyroidectomy Resulted in Better Cosmetics</brief_title>
  <official_title>Purse String Suture for the Closure of Large Thyroidectomy Resulted in Better Cosmetics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Cipto Mangunkusumo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dr Cipto Mangunkusumo General 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>
      Thyroidectomy for large thyroid tumor poses a problem of cosmetics, especially in terms of&#xD;
      wide post-operative scar and prominent neck wrinkles. In this manuscript, we performed&#xD;
      purse-string suture for the first time for the closure of skin defect after thyroidectomy of&#xD;
      large thyroid tumors which resulted in better cosmetics as compared to the conventional&#xD;
      suturing method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Increasing demand for better cosmetics following thyroidectomy for large thyroid tumor of &gt; 6&#xD;
      cm diameter created a necessity to find an alternative to the conventional technique (CT),&#xD;
      which could be addressed by purse string technique (PST). A non-randomized controlled trial&#xD;
      was conducted to new thyroid tumor patients at Cipto Mangunkusumo Hospital (RSCM) from&#xD;
      October 2013 until December 2014. Thirty patients grouped into two intervention arms of&#xD;
      thyroidectomy with PST and CT were assessed for post-operative scar outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2013</start_date>
  <completion_date type="Actual">December 31, 2014</completion_date>
  <primary_completion_date type="Actual">December 31, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Non-randomized controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Length of scar</measure>
    <time_frame>8 to 12 weeks following thyroidectomy</time_frame>
    <description>Length of scar in milimeter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Width of scar</measure>
    <time_frame>8 to 12 weeks following thyroidectomy</time_frame>
    <description>Width of scar in milimeter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wrinkle</measure>
    <time_frame>8 to 12 weeks following thyroidectomy</time_frame>
    <description>Presence of wrinkle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient's satisfaction</measure>
    <time_frame>8 to 12 weeks following thyroidectomy</time_frame>
    <description>Patient's satisfaction assessed using Likert scale of 1 to 10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of surgery</measure>
    <time_frame>During surgery</time_frame>
    <description>Duration of surgery in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>During surgery</time_frame>
    <description>Volume of bleeding during surgery in cc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative hospital stay</measure>
    <time_frame>1 week following thyroidectomy</time_frame>
    <description>Post operative hospital stay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Thyroidectomy</condition>
  <arm_group>
    <arm_group_label>Purse String Technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thyroidectomy closure is performed using purse string technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Thyroidectomy closure is performed using conventional technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Purse string technique</intervention_name>
    <description>Thyroidectomy closure is performed using purse string suturing technique.</description>
    <arm_group_label>Purse String Technique</arm_group_label>
    <other_name>PST</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional technique</intervention_name>
    <description>Thyroidectomy closure is performed using conventional suturing technique.</description>
    <arm_group_label>Conventional technique</arm_group_label>
    <other_name>CT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New cases of thyroid tumor in Doctor Cipto Mangunkusumo General Hospital&#xD;
&#xD;
          -  Tumor diameter &gt; 6 cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous surgery in the anterior neck area&#xD;
&#xD;
          -  Local involvement of lymph nodes requiring nodes dissection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 22, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dr Cipto Mangunkusumo General Hospital</investigator_affiliation>
    <investigator_full_name>Ahmad Kurnia</investigator_full_name>
    <investigator_title>Head of Surgical Oncology</investigator_title>
  </responsible_party>
  <keyword>Large thyroid</keyword>
  <keyword>purse string suture</keyword>
  <keyword>thyroidectomy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share IPD.</ipd_description>
  </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/NCT03035383
org study id: DCiptoMGHAKurnia
nct id: NCT03035383
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Thyroidectomy for large thyroid tumor poses a problem of cosmetics, especially in terms of
      wide post-operative scar and prominent neck wrinkles. In this manuscript, we performed
      purse-string suture for the first time for the closure of skin defect after thyroidectomy of
      large thyroid tumors which resulted in better cosmetics as compared to the conventional
      suturing method.
Increasing demand for better cosmetics following thyroidectomy for large thyroid tumor of > 6
      cm diameter created a necessity to find an alternative to the conventional technique (CT),
      which could be addressed by purse string technique (PST). A non-randomized controlled trial
      was conducted to new thyroid tumor patients at Cipto Mangunkusumo Hospital (RSCM) from
      October 2013 until December 2014. Thirty patients grouped into two intervention arms of
      thyroidectomy with PST and CT were assessed for post-operative scar outcomes.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Non-randomized controlled study
primary purpose: Treatment
masking: None (Open Label)
masking description: No masking
measure: Length of scar
time frame: 8 to 12 weeks following thyroidectomy
description: Length of scar in milimeter
measure: Width of scar
time frame: 8 to 12 weeks following thyroidectomy
description: Width of scar in milimeter
measure: Wrinkle
time frame: 8 to 12 weeks following thyroidectomy
description: Presence of wrinkle
measure: Patient's satisfaction
time frame: 8 to 12 weeks following thyroidectomy
description: Patient's satisfaction assessed using Likert scale of 1 to 10
measure: Duration of surgery
time frame: During surgery
description: Duration of surgery in minutes
measure: Bleeding
time frame: During surgery
description: Volume of bleeding during surgery in cc
measure: Post operative hospital stay
time frame: 1 week following thyroidectomy
description: Post operative hospital stay
arm group label: Purse String Technique
arm group type: Experimental
description: Thyroidectomy closure is performed using purse string technique.
arm group label: Conventional technique
arm group type: Active Comparator
description: Thyroidectomy closure is performed using conventional technique.
intervention type: Procedure
intervention name: Purse string technique
description: Thyroidectomy closure is performed using purse string suturing technique.
arm group label: Purse String Technique
other name: PST
intervention type: Procedure
intervention name: Conventional technique
description: Thyroidectomy closure is performed using conventional suturing technique.
arm group label: Conventional technique
other name: CT
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Dr Cipto Mangunkusumo General Hospital
investigator full name: Ahmad Kurnia
investigator title: Head of Surgical Oncology
sharing ipd: No
ipd description: No plan to share IPD.