Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach

NCT01488669 | Unknown

• 1 other identifier: 1-2011-0005
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasms

Keywords

head and neck neoplasms; neck dissection; robotics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• amount and duration of drainage

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

• length of hospital stay

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

• satisfaction score

  3 months after operation

• Operation time

  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

Study Arms (2)

Robotic neck dissection

EXPERIMENTAL

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.

Procedure: robot assisted neck dissection via retroauricular approach

Conventional neck dissection

ACTIVE COMPARATOR

Neck dissection is performed after an external transverse skin incision.

Procedure: Conventional neck dissection

Interventions

robot assisted neck dissection via retroauricular approach PROCEDURE

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.

Robotic neck dissection

Conventional neck dissection PROCEDURE

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.

Conventional neck dissection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

Related Publications (14)

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  PMID: 20422693 BACKGROUND

• 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.

  PMID: 16369160 BACKGROUND

• 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.

  PMID: 21755564 BACKGROUND

• 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.

  PMID: 15979931 BACKGROUND

• 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.

  PMID: 10668674 BACKGROUND

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

  PMID: 9525526 BACKGROUND

• 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.

  PMID: 18926464 BACKGROUND

• 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.

  PMID: 16240329 BACKGROUND

• 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.

  PMID: 7930893 BACKGROUND

• 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.

  PMID: 21721012 BACKGROUND

• 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.

  PMID: 20204392 BACKGROUND

• 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.

  PMID: 21459661 RESULT

• 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.

  PMID: 15772957 RESULT

• 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.

  PMID: 21134554 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Yoon Woo Koh, MD, PhD

CONTACT

82-10-9097-0955; ywkohent@yuhs.ac

Hyoung Shin Lee, MD

CONTACT

82-10-2580-6851; hsleeent@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 8, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2013
• Last Updated: December 8, 2011

Record last verified: 2011-12

Locations

KR (1)