Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach

Yonsei University26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Neoplasms

Interventions

robot assisted neck dissection via retroauricular approachPROCEDURE

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.

Conventional neck dissectionPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Yonsei University Severance Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Number of Retrieved lymph nodes

Number of Retrieved lymph nodes counted from the dissected lymphofatty tissues of the specimen

Time frame: when the pathologist examine the specimen which is within 1 week after operation

Secondary Outcomes

amount and duration of drainage

the amount of drain (ml)is checked from the closed drain bottle.

Time frame: daily, 6AM, until the drain is removed at an expected average of 5 days

length of hospital stay

length of hospital stay (day)

Time frame: 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)

Time frame: 3 months after operation

Operation time

Operation time (minutes) from skin incision to the time point of removing the dissected specimen from the patient

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

Central Contacts

Yoon Woo Koh, MD, PhD

CONTACT

82-10-9097-0955 ywkohent@yuhs.ac

Hyoung Shin Lee, MD

CONTACT

82-10-2580-6851 hsleeent@yuhs.ac

Data from ClinicalTrials.gov

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