Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach

December 6, 2011 updated by: Yonsei University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yoon Woo Koh, MD, PhD
  • Phone Number: 82-10-9097-0955
  • Email: ywkohent@yuhs.ac

Study Contact Backup

  • Name: Hyoung Shin Lee, MD
  • Phone Number: 82-10-2580-6851
  • Email: hsleeent@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Yonsei University Severance Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Retrieved lymph nodes
Time Frame: when the pathologist examine the specimen which is within 1 week after operation
Number of Retrieved lymph nodes counted from the dissected lymphofatty tissues of the specimen
when the pathologist examine the specimen which is within 1 week after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount and duration of drainage
Time Frame: daily, 6AM, until the drain is removed at an expected average of 5 days
the amount of drain (ml)is checked from the closed drain bottle.
daily, 6AM, until the drain is removed at an expected average of 5 days
length of hospital stay
Time Frame: when the patient leaves the hospital at an an expected average of 9 days
length of hospital stay (day)
when the patient leaves the hospital at an an expected average of 9 days
satisfaction score
Time Frame: 3 months after operation

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)
3 months after operation
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
Operation time (minutes) from skin incision to the time point of removing the dissected specimen from the patient
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 6, 2011

First Posted (Estimate)

December 8, 2011

Study Record Updates

Last Update Posted (Estimate)

December 8, 2011

Last Update Submitted That Met QC Criteria

December 6, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2011-0005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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