Clinical trial NCT01726907: A Prospective Comparison of Robotic and Endoscopic SMG Resection Via Retroauricular Approach
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: SMG Resection in Comparison to Endoscopic SMG Resection
Keywords: submandibular gland
robotic
endoscopic
face lift
hairline
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: length of incision
timeFrame: expected average opeartion time : 60~90 minutes
Secondary outcomes:
measure: amount and duration of drainage
timeFrame: on the day of discharge from hospital (expected average period : postoperative 3 days)
measure: hospital stay
timeFrame: on the day of discharge from hospital (expected average period : postoperative 3 days)
measure: complications
timeFrame: on the day of discharge from hospital (expected average period : postoperative 3 days)
Other outcomes:
measure: size of the tumor and SMG
timeFrame: expected average time : 1 week after surgery
measure: cosmetic satisfaction score
timeFrame: 2 months after surgery
Locations:
city: Seoul
country: Korea, Republic of
facility: epartment of Otorhinolaryngology, Yonsei University College of Medicine
Study officials:
References: