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

Not Applicable

Withdrawn

• Conditions: SMG Resection in Comparison to Endoscopic SMG Resection
• Interventions: Device: Robotic SMG resection; Device: Endoscopic SMG resection

• Registration Number: NCT01726907
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-11-07
• Study First Submitted QC: 2012-11-11
• Study First Posted: 2012-11-15
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients diagnosed as pleomorphic adenoma or chronic sialadenitis from preoperative ultrasound-guided fine needle aspiration biopsy (FNAB)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic SMG resection	Robotic SMG resection	Robot-assisted SMG resection
Endoscopic SMG resection	Endoscopic SMG resection	Endoscope-assisted SMG resection

Primary Outcome Measures

Name	Time	Method
length of incision	expected average opeartion time : 60~90 minutes	length of incision is measure by a surgical ruler after before skin incision

Secondary Outcome Measures

Name	Time	Method
amount and duration of drainage	on the day of discharge from hospital (expected average period : postoperative 3 days)	duration of drainage, hospital stay and complications are measured on the day of discharge by the charge doctor
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)

Trial Locations

Locations (1)

epartment of Otorhinolaryngology, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of