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Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach

Primary Purpose

Head and Neck Neoplasms

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

robot assisted neck dissection via retroauricular approach

Conventional neck dissection

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring head and neck neoplasms, neck dissection, robotics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosed as squamous cell carcinoma of the oral cavity
no clinically identified cervical lymph node metastasis
surgery as initial treatment

Exclusion Criteria:

suspicious neck metastasis
radiation or chemotherapy before the surgery
past history of neck surgery

Sites / Locations

Yonsei University Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic neck dissection

Conventional neck dissection

Arm Description

Robotic neck dissection was performed via modified face lift or retroauricular approach using the robotic arms, while conventional neck dissection was conducted after transverse skin incision from the mastoid tip to the midline.

Neck dissection is performed after an external transverse skin incision.

Outcomes

Primary Outcome Measures

Number of Retrieved lymph nodes

Number of Retrieved lymph nodes counted from the dissected lymphofatty tissues of the specimen

Secondary Outcome Measures

amount and duration of drainage

the amount of drain (ml)is checked from the closed drain bottle.

length of hospital stay

length of hospital stay (day)

satisfaction score

satisfaction score (from 1 to 5) is evaluated at the out-patient department (1 = extremely dissatisfied, 2 = dissatisfied, 3 = average, 4 = satisfied, 5 = extremely satisfied)

Operation time

Operation time (minutes) from skin incision to the time point of removing the dissected specimen from the patient

Full Information

NCT ID

NCT01488669

First Posted

December 5, 2011

Last Updated

December 6, 2011

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01488669

Brief Title

Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

5. Study Description

Brief Summary

In this study we introduce and evaluate the feasibility of our surgical technique to hide the external scar of neck dissection using the robotic system via a modified facelift or retroauricular approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Neoplasms

Keywords

head and neck neoplasms, neck dissection, robotics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Robotic neck dissection

Arm Type

Experimental

Arm Description

Arm Title

Conventional neck dissection

Arm Type

Active Comparator

Arm Description

Neck dissection is performed after an external transverse skin incision.

Intervention Type

Procedure

Intervention Name(s)

robot assisted neck dissection via retroauricular approach

Intervention Description

A modified face lift or retroauricular incision is made and subplatysmal skin flap is elevated.The marginal mandibular branch of the facial nerve and spinal accessory nerve is identified and lateral part of level II and III is dissected under direct vision using conventional technique. Then, the robotic arms are inserted and the remaining fibrofatty tissue of level I,II,III are dissected under 3D vision.

Intervention Type

Procedure

Intervention Name(s)

Conventional neck dissection

Intervention Description

A transverse skin incision from the mastoid tip to the midline 2 finger below the mandible is made and subplatysmal skin flap is elevated. The fibrofatty tissue of level I,II,III is dissected while preserving the marginal branch of the facial nerve and the spinal accessory nerve. The vessels are ligated using the conventional tie technique and the Harmonic scalpel.

Primary Outcome Measure Information:

Title

Number of Retrieved lymph nodes

Description

Number of Retrieved lymph nodes counted from the dissected lymphofatty tissues of the specimen

Time Frame

when the pathologist examine the specimen which is within 1 week after operation

Secondary Outcome Measure Information:

Title

amount and duration of drainage

Description

the amount of drain (ml)is checked from the closed drain bottle.

Time Frame

daily, 6AM, until the drain is removed at an expected average of 5 days

Title

length of hospital stay

Description

length of hospital stay (day)

Time Frame

when the patient leaves the hospital at an an expected average of 9 days

Title

satisfaction score

Description

satisfaction score (from 1 to 5) is evaluated at the out-patient department (1 = extremely dissatisfied, 2 = dissatisfied, 3 = average, 4 = satisfied, 5 = extremely satisfied)

Time Frame

3 months after operation

Title

Operation time

Description

Operation time (minutes) from skin incision to the time point of removing the dissected specimen from the patient

Time Frame

when the dissected specimen is removed from the patient at the average of 78 min for conventional group and 157 min for robot-assisted group

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosed as squamous cell carcinoma of the oral cavity no clinically identified cervical lymph node metastasis surgery as initial treatment Exclusion Criteria: suspicious neck metastasis radiation or chemotherapy before the surgery past history of neck surgery

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yoon Woo Koh, MD, PhD

Phone

82-10-9097-0955

ywkohent@yuhs.ac

First Name & Middle Initial & Last Name or Official Title & Degree

Hyoung Shin Lee, MD

Phone

82-10-2580-6851

hsleeent@yuhs.ac

Facility Information:

Facility Name

Yonsei University Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yoon Woo Koh, MD, PhD

Phone

82-10-9097-0955

ywkohent@yuhs.ac

12. IPD Sharing Statement

Citations:

PubMed Identifier

20422693

Citation

Song CM, Jung YH, Sung MW, Kim KH. Endoscopic resection of the submandibular gland via a hairline incision: a new surgical approach. Laryngoscope. 2010 May;120(5):970-4. doi: 10.1002/lary.20865.

Results Reference

background

PubMed Identifier

16369160

Citation

Roh JL. Retroauricular hairline incision for removal of upper neck masses. Laryngoscope. 2005 Dec;115(12):2161-6. doi: 10.1097/01.MLG.0000181496.22493.5A.

Results Reference

background

PubMed Identifier

21755564

Citation

Rodrigo JP, Shah JP, Silver CE, Medina JE, Takes RP, Robbins KT, Rinaldo A, Werner JA, Ferlito A. Management of the clinically negative neck in early-stage head and neck cancers after transoral resection. Head Neck. 2011 Aug;33(8):1210-9. doi: 10.1002/hed.21505. Epub 2010 Dec 6.

Results Reference

background

PubMed Identifier

15979931

Citation

Wei WI, Ferlito A, Rinaldo A, Gourin CG, Lowry J, Ho WK, Leemans CR, Shaha AR, Suarez C, Clayman GL, Robbins KT, Bradley PJ, Silver CE. Management of the N0 neck--reference or preference. Oral Oncol. 2006 Feb;42(2):115-22. doi: 10.1016/j.oraloncology.2005.04.006. Epub 2005 Jun 24.

Results Reference

background

PubMed Identifier

10668674

Citation

Pitman KT. Rationale for elective neck dissection. Am J Otolaryngol. 2000 Jan-Feb;21(1):31-7. doi: 10.1016/s0196-0709(00)80121-0. No abstract available.

Results Reference

background

PubMed Identifier

9525526

Citation

Bailey BJ. Selective neck dissection: the challenge of occult metastases. Arch Otolaryngol Head Neck Surg. 1998 Mar;124(3):353. No abstract available.

Results Reference

background

PubMed Identifier

18926464

Citation

Ferlito A, Rinaldo A, Silver CE, Robbins KT, Medina JE, Rodrigo JP, Shaha AR, Takes RP, Bradley PJ. Neck dissection for laryngeal cancer. J Am Coll Surg. 2008 Oct;207(4):587-93. doi: 10.1016/j.jamcollsurg.2008.06.337. Epub 2008 Aug 5. No abstract available.

Results Reference

background

PubMed Identifier

16240329

Citation

Pentenero M, Gandolfo S, Carrozzo M. Importance of tumor thickness and depth of invasion in nodal involvement and prognosis of oral squamous cell carcinoma: a review of the literature. Head Neck. 2005 Dec;27(12):1080-91. doi: 10.1002/hed.20275.

Results Reference

background

PubMed Identifier

7930893

Citation

Terris DJ, Tuffo KM, Fee WE Jr. Modified facelift incision for parotidectomy. J Laryngol Otol. 1994 Jul;108(7):574-8. doi: 10.1017/s002221510012746x.

Results Reference

background

PubMed Identifier

21721012

Citation

Terris DJ, Singer MC, Seybt MW. Robotic facelift thyroidectomy: II. Clinical feasibility and safety. Laryngoscope. 2011 Aug;121(8):1636-41. doi: 10.1002/lary.21832. Epub 2011 Jun 30.

Results Reference

background

PubMed Identifier

20204392

Citation

Civantos FJ, Stoeckli SJ, Takes RP, Woolgar JA, de Bree R, Paleri V, Devaney KO, Rinaldo A, Silver CE, Mondin V, Werner JA, Ferlito A. What is the role of sentinel lymph node biopsy in the management of oral cancer in 2010? Eur Arch Otorhinolaryngol. 2010 Jun;267(6):839-44. doi: 10.1007/s00405-010-1215-1. Epub 2010 Mar 5. No abstract available.

Results Reference

background

PubMed Identifier

21459661

Citation

Fasunla AJ, Greene BH, Timmesfeld N, Wiegand S, Werner JA, Sesterhenn AM. A meta-analysis of the randomized controlled trials on elective neck dissection versus therapeutic neck dissection in oral cavity cancers with clinically node-negative neck. Oral Oncol. 2011 May;47(5):320-4. doi: 10.1016/j.oraloncology.2011.03.009. Epub 2011 Apr 2.

Results Reference

result

PubMed Identifier

15772957

Citation

Shiboski CH, Schmidt BL, Jordan RC. Tongue and tonsil carcinoma: increasing trends in the U.S. population ages 20-44 years. Cancer. 2005 May 1;103(9):1843-9. doi: 10.1002/cncr.20998.

Results Reference

result

PubMed Identifier

21134554

Citation

Kang SW, Lee SH, Ryu HR, Lee KY, Jeong JJ, Nam KH, Chung WY, Park CS. Initial experience with robot-assisted modified radical neck dissection for the management of thyroid carcinoma with lateral neck node metastasis. Surgery. 2010 Dec;148(6):1214-21. doi: 10.1016/j.surg.2010.09.016.

Results Reference

result

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Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach

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