<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/NCT03239769</url>
  </required_header>
  <id_info>
    <org_study_id>XMa-001</org_study_id>
    <nct_id>NCT03239769</nct_id>
  </id_info>
  <brief_title>Compare the Aesthetic Effect of Different Thyroidectomies</brief_title>
  <official_title>A Study to Evaluate and Compare the Surgical Outcomes, Aesthetic Effects and Incision Length of Different Access Procedures in Patients With DTC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Cancer Hospital &amp; Institute</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>
      One hundred twenty female patients who underwent thyroidectomy were evenly distributed into&#xD;
      three groups: conventional access (CA), aesthetic principles access (APA) and minimally&#xD;
      invasive access (MIA). The Patient and Observer Scar Assessment Scale (POSAS) was used as the&#xD;
      assessment tool for the linear scar. After one year follow-up, the cosmetic outcomes were&#xD;
      assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective study in patients with DTC at the Department of Head and Neck Surgery at&#xD;
      Perking University Cancer Hospital (also called Beijing Cancer hospital). A total of 120&#xD;
      female patients who underwent surgical treatment for DTC were enrolled in the study from June&#xD;
      2012 to June 2014. All patients were diagnosed with DTC through preoperative fine needle&#xD;
      aspiration biopsy pathology. These patients were individually randomly assigned (1:1:1 ratio)&#xD;
      into the conventional access group (CA), the aesthetic principles access group (APA) or the&#xD;
      minimally invasive access group (MIA). Lobectomy plus ipsilateral central lymph node&#xD;
      dissection (CLND) was adopted in each patient. DTC staging was T1N0M0 or T1N1M0. The&#xD;
      investigators retrieved the patients' information, including age, incision length, incision&#xD;
      closure procedure, incidence of complications, and cosmetic assessment from patients' medical&#xD;
      records. Patients with other medical diseases, such as diabetes or obesity, a smoking&#xD;
      history, a keloid tendency, a history of radiotherapy to the head and neck, or with&#xD;
      incomplete information, were excluded. RLN function was evaluated by electronic fiber&#xD;
      laryngoscopy 6 months postoperatively. The follow-up time was 12.3 months. The research was&#xD;
      reviewed and approved by the Ethics Committee of Peking University Cancer Hospital, and&#xD;
      informed consent was obtained from all patients to publish the information/image(s) in an&#xD;
      online open-access publication. The study was open-label with no blinding of patients,&#xD;
      clinicians, or research staff.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2012</start_date>
  <completion_date type="Actual">June 1, 2015</completion_date>
  <primary_completion_date type="Actual">June 1, 2015</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>
    <intervention_model_description>These patients were individually randomly assigned (1:1:1 ratio) into the conventional access group (CA), the aesthetic principles access group (APA) or the minimally invasive access group (MIA).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient and Observer Scar Assessment Scale (POSAS)</measure>
    <time_frame>12 months post-operation</time_frame>
    <description>The POSAS scale is a reliable and feasible tool for linear scar evaluation. The POSAS included the observer scale and the patient scale. The Observer Scar Assessment Scale (OSAS) score was obtained by the same observer; this scale includes 5 items graded on a 10-point scale with 1 indicating normal skin and 10 indicating the worst scar imaginable. A summary score of 5 indicates normal skin, and a summary score of 50 is the worst possible scar result. The Patient Scar Assessment Scale (PSAS) consists of 6 items. All items are graded by the patient on a 10-point scale; a summary score of 6 to 60 represents the range from normal skin to the worst imaginable scar. After scoring the items, the observer and the patients rated the overall scar appearance on a visual analogue scale corresponding to a 10-point scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Scar length</measure>
    <time_frame>12 months post-operation</time_frame>
    <description>Using ruler to measure the length of the scar, accuracy to millimeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operation time</measure>
    <time_frame>Day 1 (on the day of operation)</time_frame>
    <description>From incision to suture completed (record the duration from start of operation to the end of operation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss</measure>
    <time_frame>Day 1 (on the day of operation)</time_frame>
    <description>Blood loss from incision to suture completed (record the blood loss from start of operation to the end of operation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of drainage</measure>
    <time_frame>till extubation, an average of 48 hours post-operation</time_frame>
    <description>Record the amount of the drainage from end of surgical procedure to extubation of drainage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of drainage</measure>
    <time_frame>till extubation, an average of 48 hours post-operation</time_frame>
    <description>Record the duration (days) of the drainage, from end of surgical procedure to extubation of drainage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of CLND</measure>
    <time_frame>up to 2 weeks post-operation</time_frame>
    <description>Record the number of central lymph nodes</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Differentiated Thyroid Carcinoma (DTC)</condition>
  <arm_group>
    <arm_group_label>conventional access group (CA)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A 4- to 5-cm incision was created, subplatysmal flaps were raised, and the strap muscles were mobilized. Then, the superior pole of the thyroid gland was exposed and the gland was delivered through the surgical incision, and the thyroid isthmus was divided. Finally, CLND was performed. The strap muscles were re-approximated with No.1 silk suture. The full-thickness skin was closed with interrupted monofilament.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>aesthetic principles access group (APA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The key difference focused on the disposal incision using aesthetic principles, which are depicted below. The incision was protected by Vaseline ointment. Excessive skin traction was avoided to prevent the injury on the skin edge. Bleeding was stanched with a low-power bipolar coagulation device. The surgical field does not have to be pulled in every direction to show the full operation field. The cervical linea alba was closed by continuous sutures with 3-0 absorbable Vicryl sutures. Interrupted sutures of 4-0 Vicryl were used to re-approximate the subcutaneous tissues. The epidermis was fixed with 3M steri-strip elastic skin closures rather than skin sutures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>minimally invasive access group (MIA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>With the MIA approach, a shorter incision of between 3 and 4 cm was created. The procedure used the Harmonic scalpel as an auxiliary device. First, the isthmus was divided. Second, the lower pole of the thyroid was dissected from the adipose tissue, and the inferior thyroid vessels were divided close to the thyroid gland for mobilization. The RLN and parathyroid glands were carefully dissected. Third, the superior pole of the thyroid gland was disconnected. Finally, CLND was performed. The closure procedure for the incision was similar to that for APA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>thyroidectomy</intervention_name>
    <description>Thyroidectomies have different approaches. The aim of this study was to evaluate and compare the aesthetic effects of different access procedures in patients with differentiated thyroid carcinoma (DTC).</description>
    <arm_group_label>aesthetic principles access group (APA)</arm_group_label>
    <arm_group_label>conventional access group (CA)</arm_group_label>
    <arm_group_label>minimally invasive access group (MIA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with DTC through preoperative fine needle aspiration biopsy&#xD;
             pathology.&#xD;
&#xD;
          -  DTC staging was T1N0M0 or T1N1M0.&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Age over 18 years&#xD;
&#xD;
          -  Subjects who fully understand the study process, participate voluntarily&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with other medical diseases, such as diabetes or obesity, a smoking history,&#xD;
             a keloid tendency, a history of radiotherapy to the head and neck, or with incomplete&#xD;
             information.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiao Ma, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University Cancer Hospital &amp; Institute</investigator_affiliation>
    <investigator_full_name>Xiao Ma</investigator_full_name>
    <investigator_title>Associate chief physician</investigator_title>
  </responsible_party>
  <keyword>Thyroid surgery</keyword>
  <keyword>Thyroidectomy</keyword>
  <keyword>Minimally invasive access</keyword>
  <keyword>Aesthetic principle</keyword>
  <keyword>POSAS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 11, 2017</submitted>
    <returned>February 15, 2018</returned>
  </pending_results>
  <!-- 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/NCT03239769
org study id: XMa-001
nct id: NCT03239769
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
One hundred twenty female patients who underwent thyroidectomy were evenly distributed into
      three groups: conventional access (CA), aesthetic principles access (APA) and minimally
      invasive access (MIA). The Patient and Observer Scar Assessment Scale (POSAS) was used as the
      assessment tool for the linear scar. After one year follow-up, the cosmetic outcomes were
      assessed.
A prospective study in patients with DTC at the Department of Head and Neck Surgery at
      Perking University Cancer Hospital (also called Beijing Cancer hospital). A total of 120
      female patients who underwent surgical treatment for DTC were enrolled in the study from June
      2012 to June 2014. All patients were diagnosed with DTC through preoperative fine needle
      aspiration biopsy pathology. These patients were individually randomly assigned (1:1:1 ratio)
      into the conventional access group (CA), the aesthetic principles access group (APA) or the
      minimally invasive access group (MIA). Lobectomy plus ipsilateral central lymph node
      dissection (CLND) was adopted in each patient. DTC staging was T1N0M0 or T1N1M0. The
      investigators retrieved the patients' information, including age, incision length, incision
      closure procedure, incidence of complications, and cosmetic assessment from patients' medical
      records. Patients with other medical diseases, such as diabetes or obesity, a smoking
      history, a keloid tendency, a history of radiotherapy to the head and neck, or with
      incomplete information, were excluded. RLN function was evaluated by electronic fiber
      laryngoscopy 6 months postoperatively. The follow-up time was 12.3 months. The research was
      reviewed and approved by the Ethics Committee of Peking University Cancer Hospital, and
      informed consent was obtained from all patients to publish the information/image(s) in an
      online open-access publication. The study was open-label with no blinding of patients,
      clinicians, or research staff.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: These patients were individually randomly assigned (1:1:1 ratio) into the conventional access group (CA), the aesthetic principles access group (APA) or the minimally invasive access group (MIA).
primary purpose: Treatment
masking: None (Open Label)
measure: Patient and Observer Scar Assessment Scale (POSAS)
time frame: 12 months post-operation
description: The POSAS scale is a reliable and feasible tool for linear scar evaluation. The POSAS included the observer scale and the patient scale. The Observer Scar Assessment Scale (OSAS) score was obtained by the same observer; this scale includes 5 items graded on a 10-point scale with 1 indicating normal skin and 10 indicating the worst scar imaginable. A summary score of 5 indicates normal skin, and a summary score of 50 is the worst possible scar result. The Patient Scar Assessment Scale (PSAS) consists of 6 items. All items are graded by the patient on a 10-point scale; a summary score of 6 to 60 represents the range from normal skin to the worst imaginable scar. After scoring the items, the observer and the patients rated the overall scar appearance on a visual analogue scale corresponding to a 10-point scale.
measure: Scar length
time frame: 12 months post-operation
description: Using ruler to measure the length of the scar, accuracy to millimeter
measure: Operation time
time frame: Day 1 (on the day of operation)
description: From incision to suture completed (record the duration from start of operation to the end of operation)
measure: Blood loss
time frame: Day 1 (on the day of operation)
description: Blood loss from incision to suture completed (record the blood loss from start of operation to the end of operation)
measure: Amount of drainage
time frame: till extubation, an average of 48 hours post-operation
description: Record the amount of the drainage from end of surgical procedure to extubation of drainage
measure: Duration of drainage
time frame: till extubation, an average of 48 hours post-operation
description: Record the duration (days) of the drainage, from end of surgical procedure to extubation of drainage
measure: Number of CLND
time frame: up to 2 weeks post-operation
description: Record the number of central lymph nodes
arm group label: conventional access group (CA)
arm group type: Active Comparator
description: A 4- to 5-cm incision was created, subplatysmal flaps were raised, and the strap muscles were mobilized. Then, the superior pole of the thyroid gland was exposed and the gland was delivered through the surgical incision, and the thyroid isthmus was divided. Finally, CLND was performed. The strap muscles were re-approximated with No.1 silk suture. The full-thickness skin was closed with interrupted monofilament.
arm group label: aesthetic principles access group (APA)
arm group type: Experimental
description: The key difference focused on the disposal incision using aesthetic principles, which are depicted below. The incision was protected by Vaseline ointment. Excessive skin traction was avoided to prevent the injury on the skin edge. Bleeding was stanched with a low-power bipolar coagulation device. The surgical field does not have to be pulled in every direction to show the full operation field. The cervical linea alba was closed by continuous sutures with 3-0 absorbable Vicryl sutures. Interrupted sutures of 4-0 Vicryl were used to re-approximate the subcutaneous tissues. The epidermis was fixed with 3M steri-strip elastic skin closures rather than skin sutures.
arm group label: minimally invasive access group (MIA)
arm group type: Experimental
description: With the MIA approach, a shorter incision of between 3 and 4 cm was created. The procedure used the Harmonic scalpel as an auxiliary device. First, the isthmus was divided. Second, the lower pole of the thyroid was dissected from the adipose tissue, and the inferior thyroid vessels were divided close to the thyroid gland for mobilization. The RLN and parathyroid glands were carefully dissected. Third, the superior pole of the thyroid gland was disconnected. Finally, CLND was performed. The closure procedure for the incision was similar to that for APA.
intervention type: Procedure
intervention name: thyroidectomy
description: Thyroidectomies have different approaches. The aim of this study was to evaluate and compare the aesthetic effects of different access procedures in patients with differentiated thyroid carcinoma (DTC).
arm group label: aesthetic principles access group (APA)
arm group label: conventional access group (CA)
arm group label: minimally invasive access group (MIA)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xiao Ma, Doctor
role: Principal Investigator
affiliation: Peking University Cancer Hospital & Institute
responsible party type: Principal Investigator
investigator affiliation: Peking University Cancer Hospital & Institute
investigator full name: Xiao Ma
investigator title: Associate chief physician
mesh term: Thyroid Neoplasms
sharing ipd: No
submitted: August 11, 2017
returned: February 15, 2018