Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach

Not Applicable

• Conditions: Head and Neck Neoplasms
• Interventions: Procedure: robot assisted neck dissection via retroauricular approach; Procedure: Conventional neck dissection

• Registration Number: NCT01488669
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-09
• Status Verified: 2011-12
• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-06
• Last Update Submitted: 2011-12-06
• Study First Posted: 2011-12-08
• Last Update Posted: 2011-12-08
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic neck dissection	robot assisted neck dissection via retroauricular approach	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.
Conventional neck dissection	Conventional neck dissection	Neck dissection is performed after an external transverse skin incision.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Yonsei University Severance Hospital; 🇰🇷 Seoul, Korea, Republic of