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

Yonsei University logo

Yonsei University

Status

Withdrawn

Conditions

SMG Resection in Comparison to Endoscopic SMG Resection

Treatments

Device: Endoscopic SMG resection
Device: Robotic SMG resection

Study type

Interventional

Funder types

Other

Identifiers

NCT01726907
4-2011-0819

Details and patient eligibility

About

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.

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Robotic SMG resection
Experimental group
Description:
Robot-assisted SMG resection
Treatment:
Device: Robotic SMG resection
Endoscopic SMG resection
Active Comparator group
Description:
Endoscope-assisted SMG resection
Treatment:
Device: Endoscopic SMG resection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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