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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01726907
First received: November 7, 2012
Last updated: November 11, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
SMG Resection in Comparison to Endoscopic SMG Resection
Device: Robotic SMG resection
Device: Endoscopic SMG resection

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • length of incision [ Time Frame: expected average opeartion time : 60~90 minutes ] [ Designated as safety issue: No ]
    length of incision is measure by a surgical ruler after before skin incision


Secondary Outcome Measures:
  • amount and duration of drainage [ Time Frame: on the day of discharge from hospital (expected average period : postoperative 3 days) ] [ Designated as safety issue: No ]
    duration of drainage, hospital stay and complications are measured on the day of discharge by the charge doctor

  • hospital stay [ Time Frame: on the day of discharge from hospital (expected average period : postoperative 3 days) ] [ Designated as safety issue: No ]
  • complications [ Time Frame: on the day of discharge from hospital (expected average period : postoperative 3 days) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • size of the tumor and SMG [ Time Frame: expected average time : 1 week after surgery ] [ Designated as safety issue: No ]
    size of the tumor and SMG is measure by the pathologist

  • cosmetic satisfaction score [ Time Frame: 2 months after surgery ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726907

Contacts
Contact: Yoon Woo Koh, MD ywkohent@yuhs.ac

Locations
Korea, Republic of
epartment of Otorhinolaryngology, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Yoon Woo Koh, MD       ywkohent@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01726907     History of Changes
Other Study ID Numbers: 4-2011-0819
Study First Received: November 7, 2012
Last Updated: November 11, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
submandibular gland
robotic
endoscopic
face lift
hairline

ClinicalTrials.gov processed this record on October 30, 2014