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

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.

Study Overview

• Status: Withdrawn
• Conditions: SMG Resection in Comparison to Endoscopic SMG Resection
• Intervention / Treatment: Device: Robotic SMG resection; Device: Endoscopic SMG resection

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • epartment of Otorhinolaryngology, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Robotic SMG resection; Robot-assisted SMG resection	Device: Robotic SMG resection; 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.
ACTIVE_COMPARATOR: Endoscopic SMG resection; Endoscope-assisted SMG resection	Device: Endoscopic SMG resection; 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.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
size of the tumor and SMG	size of the tumor and SMG is measure by the pathologist	expected average time : 1 week after surgery
cosmetic satisfaction score	cosmetic satisfaction score is evaluated at the out-patient department during follow up using the questionnaire with scale of 1 (extremely dissatisfied) to 5 (extremely satisfied)	2 months after surgery

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ANTICIPATED): February 1, 2013
• Study Completion (ANTICIPATED): February 1, 2013

Study Registration Dates

• First Submitted: November 7, 2012
• First Submitted That Met QC Criteria: November 11, 2012
• First Posted (ESTIMATE): November 15, 2012

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: robotic; endoscopic; face lift; submandibular gland; hairline
• Other Study ID Numbers: 4-2011-0819