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Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach

This study is currently recruiting participants.
Verified December 2011 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01488669
First received: December 5, 2011
Last updated: December 6, 2011
Last verified: December 2011
History of Changes
  Purpose

In this study we introduce and evaluate the feasibility of our surgical technique to hide the external scar of neck dissection using the robotic system via a modified facelift or retroauricular approach.


Condition Intervention
Head and Neck Neoplasms
 Procedure: robot assisted neck dissection via retroauricular approach
Procedure: Conventional neck dissection

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Number of Retrieved lymph nodes [ Time Frame: when the pathologist examine the specimen which is within 1 week after operation ] [ Designated as safety issue: Yes ]
    Number of Retrieved lymph nodes counted from the dissected lymphofatty tissues of the specimen


Secondary Outcome Measures:
  • amount and duration of drainage [ Time Frame: daily, 6AM, until the drain is removed at an expected average of 5 days ] [ Designated as safety issue: Yes ]
    the amount of drain (ml)is checked from the closed drain bottle.

  • length of hospital stay [ Time Frame: when the patient leaves the hospital at an an expected average of 9 days ] [ Designated as safety issue: Yes ]
    length of hospital stay (day)

  • satisfaction score [ Time Frame: 3 months after operation ] [ Designated as safety issue: No ]

    satisfaction score (from 1 to 5) is evaluated at the out-patient department

    (1 = extremely dissatisfied, 2 = dissatisfied, 3 = average, 4 = satisfied, 5 = extremely satisfied)


  • Operation time [ Time Frame: when the dissected specimen is removed from the patient at the average of 78 min for conventional group and 157 min for robot-assisted group ] [ Designated as safety issue: Yes ]
    Operation time (minutes) from skin incision to the time point of removing the dissected specimen from the patient


Estimated Enrollment: 26
Study Start Date: January 2011
Estimated Study Completion Date: September 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Robotic neck dissection
Robotic neck dissection was performed via modified face lift or retroauricular approach using the robotic arms, while conventional neck dissection was conducted after transverse skin incision from the mastoid tip to the midline.
 Procedure: robot assisted neck dissection via retroauricular approach
A modified face lift or retroauricular incision is made and subplatysmal skin flap is elevated.The marginal mandibular branch of the facial nerve and spinal accessory nerve is identified and lateral part of level II and III is dissected under direct vision using conventional technique. Then, the robotic arms are inserted and the remaining fibrofatty tissue of level I,II,III are dissected under 3D vision.
Active Comparator: Conventional neck dissection
Neck dissection is performed after an external transverse skin incision.
 Procedure: Conventional neck dissection
A transverse skin incision from the mastoid tip to the midline 2 finger below the mandible is made and subplatysmal skin flap is elevated. The fibrofatty tissue of level I,II,III is dissected while preserving the marginal branch of the facial nerve and the spinal accessory nerve. The vessels are ligated using the conventional tie technique and the Harmonic scalpel.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed as squamous cell carcinoma of the oral cavity
  • no clinically identified cervical lymph node metastasis
  • surgery as initial treatment

Exclusion Criteria:

  • suspicious neck metastasis
  • radiation or chemotherapy before the surgery
  • past history of neck surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488669

Contacts
Contact: Yoon Woo Koh, MD, PhD 82-10-9097-0955 ywkohent@yuhs.ac
Contact: Hyoung Shin Lee, MD 82-10-2580-6851 hsleeent@yuhs.ac

Locations
Korea, Republic of
Yonsei University Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Yoon Woo Koh, MD, PhD     82-10-9097-0955     ywkohent@yuhs.ac    
Sponsors and Collaborators
Yonsei University
  More Information

Publications:

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01488669     History of Changes
Other Study ID Numbers: 1-2011-0005
Study First Received: December 5, 2011
Last Updated: December 6, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
head and neck neoplasms
neck dissection
robotics

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 23, 2013