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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01726907
Recruitment Status : Unknown
Verified November 2012 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : November 15, 2012
Last Update Posted : November 15, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
SMG Resection in Comparison to Endoscopic SMG Resection Device: Robotic SMG resection Device: Endoscopic SMG resection Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2012
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. length of incision [ Time Frame: expected average opeartion time : 60~90 minutes ]
    length of incision is measure by a surgical ruler after before skin incision

Secondary Outcome Measures :
  1. amount and duration of drainage [ Time Frame: 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

  2. hospital stay [ Time Frame: on the day of discharge from hospital (expected average period : postoperative 3 days) ]
  3. complications [ Time Frame: on the day of discharge from hospital (expected average period : postoperative 3 days) ]

Other Outcome Measures:
  1. size of the tumor and SMG [ Time Frame: expected average time : 1 week after surgery ]
    size of the tumor and SMG is measure by the pathologist

  2. cosmetic satisfaction score [ Time Frame: 2 months after surgery ]
    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)

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01726907

Contact: Yoon Woo Koh, MD

Korea, Republic of
epartment of Otorhinolaryngology, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Yoon Woo Koh, MD   
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University Identifier: NCT01726907     History of Changes
Other Study ID Numbers: 4-2011-0819
First Posted: November 15, 2012    Key Record Dates
Last Update Posted: November 15, 2012
Last Verified: November 2012

Keywords provided by Yonsei University:
submandibular gland
face lift