Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach
|ClinicalTrials.gov Identifier: NCT01488669|
Recruitment Status : Unknown
Verified December 2011 by Yonsei University.
Recruitment status was: Recruiting
First Posted : December 8, 2011
Last Update Posted : December 8, 2011
|Condition or disease||Intervention/treatment|
|Head and Neck Neoplasms||Procedure: robot assisted neck dissection via retroauricular approach Procedure: Conventional neck dissection|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2011|
|Primary Completion Date :||September 2011|
|Estimated Study Completion Date :||September 2013|
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.
- 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
- 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.
- 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)
- 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)
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488669
|Contact: Yoon Woo Koh, MD, PhDemail@example.com|
|Contact: Hyoung Shin Lee, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Yonsei University Severance Hospital||Recruiting|
|Seoul, Korea, Republic of, 120-752|
|Contact: Yoon Woo Koh, MD, PhD 82-10-9097-0955 email@example.com|