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

NCT01726907 · Yonsei University · Updated 6 May 2021

What is being tested
Robotic SMG resection; Endoscopic SMG resection
For
SMG Resection in Comparison to Endoscopic SMG Resection
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 20 years to 80 years. The full rules are on the registry page.
Where
South Korea
When
Starts or started Feb 2012, ends Feb 2013. Registered 15 Nov 2012.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT01726907

Sites

  • epartment of Otorhinolaryngology, Yonsei University College of MedicineSeoul, South Korea