Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach

Study Overview
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Brief Summary
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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.

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Procedure: robot assisted neck dissection via retroauricular approach
* Procedure: Conventional neck dissection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic neck dissection<br>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<br>* 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.<br>|
| Active Comparator: Conventional neck dissection<br>Neck dissection is performed after an external transverse skin incision. | Procedure: Conventional neck dissection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Retrieved lymph nodes | 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 | 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 | length of hospital stay (day) | when the patient leaves the hospital at an an expected average of 9 days | 
| satisfaction score | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck neoplasms, neck dissection, robotics