Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach

Sponsor

Yonsei University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01488669

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Head and Neck Neoplasms	Procedure: robot assisted neck dissection via retroauricular approach Procedure: Conventional neck dissection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Sep 1, 2011

Anticipated Study Completion Date :

Sep 1, 2013

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of Retrieved lymph nodes [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

Secondary Outcome Measures

amount and duration of drainage [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 [when the patient leaves the hospital at an an expected average of 9 days]
length of hospital stay (day)
satisfaction score [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Severance Hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT01488669

Other Study ID Numbers:

1-2011-0005

First Posted:

Dec 8, 2011

Last Update Posted:

Dec 8, 2011

Last Verified:

Dec 1, 2011

Keywords provided by Yonsei University

head and neck neoplasms

neck dissection

robotics

Additional relevant MeSH terms:

Head and Neck Neoplasms

Study Results

No Results Posted as of Dec 8, 2011