Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach

Head and Neck Neoplasms Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01488669
• Other study ID #: 1-2011-0005
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2011
• Last updated: December 6, 2011
• Start date: January 2011
• Est. completion date: September 2013

Study information

• Verified date: December 2011
• Source: Yonsei University
• Contact: Yoon Woo Koh, MD, PhD
• Phone: 82-10-9097-0955
• Email: ywkohent[@]yuhs.ac
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: September 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Procedure:
• robot assisted neck dissection via retroauricular approach
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.
• Conventional neck dissection
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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (14)

Bailey BJ. Selective neck dissection: the challenge of occult metastases. Arch Otolaryngol Head Neck Surg. 1998 Mar;124(3):353. — View 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. — View 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 On — View 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. Review. — View 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: — View 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. Review. — View Citation

Pitman KT. Rationale for elective neck dissection. Am J Otolaryngol. 2000 Jan-Feb;21(1):31-7. Review. — View 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. Review. — View Citation

Roh JL. Retroauricular hairline incision for removal of upper neck masses. Laryngoscope. 2005 Dec;115(12):2161-6. — View 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. — View 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. — View 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. — View Citation

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

Wei WI, Ferlito A, Rinaldo A, Gourin CG, Lowry J, Ho WK, Leemans CR, Shaha AR, Suárez 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. Epub 2005 Jun 24. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Retrieved lymph nodes	Number of Retrieved lymph nodes counted from the dissected lymphofatty tissues of the specimen	when the pathologist examine the specimen which is within 1 week after operation	Yes
Secondary	amount and duration of drainage	the amount of drain (ml)is checked from the closed drain bottle.	daily, 6AM, until the drain is removed at an expected average of 5 days	Yes
Secondary	length of hospital stay	length of hospital stay (day)	when the patient leaves the hospital at an an expected average of 9 days	Yes
Secondary	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)	3 months after operation	No
Secondary	Operation time	Operation time (minutes) from skin incision to the time point of removing the dissected specimen from the patient	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	Yes