<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/NCT01726907</url>
  </required_header>
  <id_info>
    <org_study_id>4-2011-0819</org_study_id>
    <nct_id>NCT01726907</nct_id>
  </id_info>
  <brief_title>A Prospective Comparison of Robotic and Endoscopic SMG Resection Via Retroauricular Approach</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Traditional transcervical incision of the upper neck is a safe and effective approach for&#xD;
      resection of the submandibular gland (SMG). However, external scar at the highly visible area&#xD;
      may be a burden for the patients and sometimes may lead to disfiguring hypertrophic scar or&#xD;
      keloid. Recently, the investigators reported our surgical technique of 'endoscope-assisted'&#xD;
      and 'robot-assisted' SMG resection, which was feasible and showed excellent cosmetic outcomes&#xD;
      since the scar was hidden by the auricle and hair. In our previous feasibility study of&#xD;
      robot-assisted SMG resection, the investigators proposed that robot-assisted technique may&#xD;
      overcome the limitations of endoscopic instruments with rigid and straight nature without&#xD;
      articulation and surgical view of two-dimension. In addition, the ergonomically designed&#xD;
      operating system was more convenient for the surgeon considering the frequent collision of&#xD;
      the endoscopic instruments and reversed hand-eye coordination in endoscope-assisted surgery.&#xD;
      However, clinical trial comparing the surgical outcomes of the two techniques has not been&#xD;
      reported in the literature.&#xD;
&#xD;
      In this study, the investigators made a prospective comparative study of robot-assisted&#xD;
      versus endoscope-assisted SMG resection to determine whether robot-assisted technique has&#xD;
      benefits regarding early surgical outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Stopped due to failure to recruit appropriate target patients&#xD;
  </why_stopped>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">February 2013</completion_date>
  <primary_completion_date type="Anticipated">February 2013</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>length of incision</measure>
    <time_frame>expected average opeartion time : 60~90 minutes</time_frame>
    <description>length of incision is measure by a surgical ruler after before skin incision</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>amount and duration of drainage</measure>
    <time_frame>on the day of discharge from hospital (expected average period : postoperative 3 days)</time_frame>
    <description>duration of drainage, hospital stay and complications are measured on the day of discharge by the charge doctor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital stay</measure>
    <time_frame>on the day of discharge from hospital (expected average period : postoperative 3 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complications</measure>
    <time_frame>on the day of discharge from hospital (expected average period : postoperative 3 days)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>size of the tumor and SMG</measure>
    <time_frame>expected average time : 1 week after surgery</time_frame>
    <description>size of the tumor and SMG is measure by the pathologist</description>
  </other_outcome>
  <other_outcome>
    <measure>cosmetic satisfaction score</measure>
    <time_frame>2 months after surgery</time_frame>
    <description>cosmetic satisfaction score is evaluated at the out-patient department during follow up using the questionnaire with scale of 1 (extremely dissatisfied) to 5 (extremely satisfied)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>SMG Resection in Comparison to Endoscopic SMG Resection</condition>
  <arm_group>
    <arm_group_label>Robotic SMG resection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Robot-assisted SMG resection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endoscopic SMG resection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endoscope-assisted SMG resection</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robotic SMG resection</intervention_name>
    <description>The surgical procedure and the considerations for surrounding neurovascular structures were similar to that of the endoscope-assisted SMG resection. The da Vinci surgical system (Intuitive Surgical Inc., Sunnyvale, CA) including a 30° dual channel endoscopic arm and two instrument arms was introduced. The SMG was retracted using the 5-mm Maryland forceps on the left and the dissection was conducted using a 5-mm spatula monopolar cautery or a Harmonic curved shears on the right. A Yankauer suction handled by a bed-side assistant could be used for counter traction of the gland which facilitated the dissection procedure.</description>
    <arm_group_label>Robotic SMG resection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endoscopic SMG resection</intervention_name>
    <description>An assistant held a 10-mm 30° rigid endoscope allowing the operating surgeon to use both hands. Surgical resection tools such as dissector and Harmonic scalpel (Harmonic Ace 23E®; Johnson &amp; Johnson Medical, Cincinnati, OH, USA) was held in the right hand and a Yankauer suction or a Debakey forcep was held on the left for traction of the SMG. The dissection plane between the capsule of the SMG was conducted under magnified endoscopic view using the the blade of the Harmonic scalpel and the endoscopic dissector. Routine identification of the marginal mandibular branch of the facial nerve was unnecessary in SMG resection, since the dissection plane was always deep to the middle layer of the deep cervical fascia which includes the fascia of the gland. The Wharton's duct, facial artery and vein were ligated using the Harmonic scalpel or vascular clip.</description>
    <arm_group_label>Endoscopic SMG resection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed as pleomorphic adenoma or chronic sialadenitis from preoperative&#xD;
             ultrasound-guided fine needle aspiration biopsy (FNAB)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Past history of neck surgery or radiation&#xD;
&#xD;
          -  Possible malignancy expected from FNAB or image study&#xD;
&#xD;
          -  Gland with severe adhesion to surrounding tissue on preoperative physical examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>epartment of Otorhinolaryngology, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>May 3, 2021</last_update_submitted>
  <last_update_submitted_qc>May 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>submandibular gland</keyword>
  <keyword>robotic</keyword>
  <keyword>endoscopic</keyword>
  <keyword>face lift</keyword>
  <keyword>hairline</keyword>
  <!-- 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/NCT01726907
org study id: 4-2011-0819
nct id: NCT01726907
lead sponsor: 
has dmc: No
Traditional transcervical incision of the upper neck is a safe and effective approach for
      resection of the submandibular gland (SMG). However, external scar at the highly visible area
      may be a burden for the patients and sometimes may lead to disfiguring hypertrophic scar or
      keloid. Recently, the investigators reported our surgical technique of 'endoscope-assisted'
      and 'robot-assisted' SMG resection, which was feasible and showed excellent cosmetic outcomes
      since the scar was hidden by the auricle and hair. In our previous feasibility study of
      robot-assisted SMG resection, the investigators proposed that robot-assisted technique may
      overcome the limitations of endoscopic instruments with rigid and straight nature without
      articulation and surgical view of two-dimension. In addition, the ergonomically designed
      operating system was more convenient for the surgeon considering the frequent collision of
      the endoscopic instruments and reversed hand-eye coordination in endoscope-assisted surgery.
      However, clinical trial comparing the surgical outcomes of the two techniques has not been
      reported in the literature.

      In this study, the investigators made a prospective comparative study of robot-assisted
      versus endoscope-assisted SMG resection to determine whether robot-assisted technique has
      benefits regarding early surgical outcomes.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: length of incision
time frame: expected average opeartion time : 60~90 minutes
description: length of incision is measure by a surgical ruler after before skin incision
measure: amount and duration of drainage
time frame: on the day of discharge from hospital (expected average period : postoperative 3 days)
description: duration of drainage, hospital stay and complications are measured on the day of discharge by the charge doctor
measure: hospital stay
time frame: on the day of discharge from hospital (expected average period : postoperative 3 days)
measure: complications
time frame: on the day of discharge from hospital (expected average period : postoperative 3 days)
measure: size of the tumor and SMG
time frame: expected average time : 1 week after surgery
description: size of the tumor and SMG is measure by the pathologist
measure: cosmetic satisfaction score
time frame: 2 months after surgery
description: cosmetic satisfaction score is evaluated at the out-patient department during follow up using the questionnaire with scale of 1 (extremely dissatisfied) to 5 (extremely satisfied)
arm group label: Robotic SMG resection
arm group type: Experimental
description: Robot-assisted SMG resection
arm group label: Endoscopic SMG resection
arm group type: Active Comparator
description: Endoscope-assisted SMG resection
intervention type: Device
intervention name: Robotic SMG resection
description: The surgical procedure and the considerations for surrounding neurovascular structures were similar to that of the endoscope-assisted SMG resection. The da Vinci surgical system (Intuitive Surgical Inc., Sunnyvale, CA) including a 30° dual channel endoscopic arm and two instrument arms was introduced. The SMG was retracted using the 5-mm Maryland forceps on the left and the dissection was conducted using a 5-mm spatula monopolar cautery or a Harmonic curved shears on the right. A Yankauer suction handled by a bed-side assistant could be used for counter traction of the gland which facilitated the dissection procedure.
arm group label: Robotic SMG resection
intervention type: Device
intervention name: Endoscopic SMG resection
description: An assistant held a 10-mm 30° rigid endoscope allowing the operating surgeon to use both hands. Surgical resection tools such as dissector and Harmonic scalpel (Harmonic Ace 23E®; Johnson & Johnson Medical, Cincinnati, OH, USA) was held in the right hand and a Yankauer suction or a Debakey forcep was held on the left for traction of the SMG. The dissection plane between the capsule of the SMG was conducted under magnified endoscopic view using the the blade of the Harmonic scalpel and the endoscopic dissector. Routine identification of the marginal mandibular branch of the facial nerve was unnecessary in SMG resection, since the dissection plane was always deep to the middle layer of the deep cervical fascia which includes the fascia of the gland. The Wharton's duct, facial artery and vein were ligated using the Harmonic scalpel or vascular clip.
arm group label: Endoscopic SMG resection
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor