Clinical trial NCT01488669: Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Neoplasms
Keywords: head and neck neoplasms
neck dissection
robotics
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Retrieved lymph nodes
timeFrame: when the pathologist examine the specimen which is within 1 week after operation
Secondary outcomes:
measure: amount and duration of drainage
timeFrame: daily, 6AM, until the drain is removed at an expected average of 5 days
measure: length of hospital stay
timeFrame: when the patient leaves the hospital at an an expected average of 9 days
measure: satisfaction score
timeFrame: 3 months after operation
measure: Operation time
timeFrame: 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
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
References:
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