A Prospective Comparison of Robotic and Endoscopic SMG Resection Via Retroauricular Approach

Study Overview
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Brief Summary
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Traditional transcervical incision of the upper neck is a safe and effective approach for resection of the submandibular gland (SMG). However, external scar at the highly visible area may be a burden for the patients and sometimes may lead to disfiguring hypertrophic scar or keloid. Recently, the investigators reported our surgical technique of 'endoscope-assisted' and 'robot-assisted' SMG resection, which was feasible and showed excellent cosmetic outcomes since the scar was hidden by the auricle and hair. In our previous feasibility study of robot-assisted SMG resection, the investigators proposed that robot-assisted technique may overcome the limitations of endoscopic instruments with rigid and straight nature without articulation and surgical view of two-dimension. In addition, the ergonomically designed operating system was more convenient for the surgeon considering the frequent collision of the endoscopic instruments and reversed hand-eye coordination in endoscope-assisted surgery. However, clinical trial comparing the surgical outcomes of the two techniques has not been reported in the literature. In this study, the investigators made a prospective comparative study of robot-assisted versus endoscope-assisted SMG resection to determine whether robot-assisted technique has benefits regarding early surgical outcomes.

Conditions
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SMG Resection in Comparison to Endoscopic SMG Resection

Intervention / Treatment
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* Device: Robotic SMG resection
* Device: Endoscopic SMG resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed as pleomorphic adenoma or chronic sialadenitis from preoperative ultrasound-guided fine needle aspiration biopsy (FNAB) Exclusion Criteria: Past history of neck surgery or radiation Possible malignancy expected from FNAB or image study Gland with severe adhesion to surrounding tissue on preoperative physical examination

Ages Eligible for Study
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Minimum Age: 20 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 SMG resection<br>Robot-assisted SMG resection | Device: Robotic SMG resection<br>* The surgical procedure and the considerations for surrounding neurovascular structures were similar to that of the endoscope-assisted SMG resection. The da Vinci surgical system (Intuitive Surgical Inc., Sunnyvale, CA) including a 30° dual channel endoscopic arm and two instrument arms was introduced. The SMG was retracted using the 5-mm Maryland forceps on the left and the dissection was conducted using a 5-mm spatula monopolar cautery or a Harmonic curved shears on the right. A Yankauer suction handled by a bed-side assistant could be used for counter traction of the gland which facilitated the dissection procedure.<br>|
| Active Comparator: Endoscopic SMG resection<br>Endoscope-assisted SMG resection | Device: Endoscopic SMG resection<br>* An assistant held a 10-mm 30° rigid endoscope allowing the operating surgeon to use both hands. Surgical resection tools such as dissector and Harmonic scalpel (Harmonic Ace 23E®; Johnson & Johnson Medical, Cincinnati, OH, USA) was held in the right hand and a Yankauer suction or a Debakey forcep was held on the left for traction of the SMG. The dissection plane between the capsule of the SMG was conducted under magnified endoscopic view using the the blade of the Harmonic scalpel and the endoscopic dissector. Routine identification of the marginal mandibular branch of the facial nerve was unnecessary in SMG resection, since the dissection plane was always deep to the middle layer of the deep cervical fascia which includes the fascia of the gland. The Wharton's duct, facial artery and vein were ligated using the Harmonic scalpel or vascular clip.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of incision | length of incision is measure by a surgical ruler after before skin incision | expected average opeartion time : 60 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount and duration of drainage | duration of drainage, hospital stay and complications are measured on the day of discharge by the charge doctor | on the day of discharge from hospital (expected average period : postoperative 3 days) | 
| hospital stay |  | on the day of discharge from hospital (expected average period : postoperative 3 days) | 
| complications |  | on the day of discharge from hospital (expected average period : postoperative 3 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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submandibular gland, robotic, endoscopic, face lift, hairline