Head and Neck NeoplasmsNCT01488669
Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach
A study testing robot assisted neck dissection via retroauricular approach and Conventional neck dissection in people with Head and Neck Neoplasms, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- robot assisted neck dissection via retroauricular approach and Conventional neck dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as squamous cell carcinoma of the oral cavity
- no clinically identified cervical lymph node metastasis
- surgery as initial treatment
Who cannot join
- suspicious neck metastasis
- radiation or chemotherapy before the surgery
- past history of neck surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Severance Hospital
Seoul, 120-752
Yoon Woo Koh, MD, PhD, 82-10-9097-0955, ywkohent@yuhs.ac
About this study
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
- Being tested
- robot assisted neck dissection via retroauricular approach, Conventional neck dissection
- Keywords
- head and neck neoplasms, neck dissection, robotics
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot assisted neck dissection via retroauricular approachProcedure or surgery
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 dissectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: robot assisted neck dissection via retroauricular approach |
| Conventional neck dissection | Active comparator | Neck dissection is performed after an external transverse skin incision. Receives: Procedure: Conventional neck dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Retrieved lymph nodes
Number of Retrieved lymph nodes counted from the dissected lymphofatty tissues of the specimen
Measured: when the pathologist examine the specimen which is within 1 week after operation
Secondary outcomes (4)
amount and duration of drainage
the amount of drain (ml)is checked from the closed drain bottle.
Measured: daily, 6AM, until the drain is removed at an expected average of 5 days
length of hospital stay
length of hospital stay (day)
Measured: when the patient leaves the hospital at an an expected average of 9 days
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)
Measured: 3 months after operation
Operation time
Operation time (minutes) from skin incision to the time point of removing the dissected specimen from the patient
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488669
- Sponsor's protocol ID
- 1-2011-0005
- Status last verified
- Dec 2011
- First submitted
- 5 Dec 2011
- Last updated
- 8 Dec 2011
- Results posted
- No
Publications
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.
PubMed 20422693Roh 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.
PubMed 16369160Rodrigo 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.
PubMed 21755564Wei 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.
PubMed 15979931Pitman 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.
PubMed 10668674Bailey BJ. Selective neck dissection: the challenge of occult metastases. Arch Otolaryngol Head Neck Surg. 1998 Mar;124(3):353. No abstract available.
PubMed 9525526Ferlito 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.
PubMed 18926464Pentenero 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.
PubMed 16240329Terris DJ, Tuffo KM, Fee WE Jr. Modified facelift incision for parotidectomy. J Laryngol Otol. 1994 Jul;108(7):574-8. doi: 10.1017/s002221510012746x.
PubMed 7930893Terris 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.
PubMed 21721012Civantos 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.
PubMed 20204392Fasunla 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.
PubMed 21459661Shiboski 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.
PubMed 15772957Kang 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.
PubMed 21134554
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach
- ClinicalTrials.gov ID
- NCT01488669
- Acronym / sponsor ID
- 1-2011-0005
- Conditions
- Head and Neck Neoplasms
- Keywords
- head and neck neoplasms, neck dissection, robotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2013 (estimated)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic neck dissection | Experimental | Procedure: robot assisted neck dissection via retroauricular approachRobotic 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. |
| Conventional neck dissection | Active comparator | Procedure: Conventional neck dissectionNeck dissection is performed after an external transverse skin incision. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed as squamous cell carcinoma of the oral cavity
- no clinically identified cervical lymph node metastasis
- surgery as initial treatment
Key exclusion criteria (3 listed)
- suspicious neck metastasis
- radiation or chemotherapy before the surgery
- past history of neck surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robot assisted neck dissection via retroauricular approachA 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. | Procedure or surgery | Robotic neck dissection |
| Conventional neck dissectionA 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. | Procedure or surgery | Conventional neck dissection |
Primary outcome
Number of Retrieved lymph nodes
Time frame: when the pathologist examine the specimen which is within 1 week after operation
Number of Retrieved lymph nodes counted from the dissected lymphofatty tissues of the specimen
4 secondary outcomes
amount and duration of drainage
Time frame: daily, 6AM, until the drain is removed at an expected average of 5 days
length of hospital stay
Time frame: when the patient leaves the hospital at an an expected average of 9 days
satisfaction score
Time frame: 3 months after operation
Operation time
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
- Background: PubMed 20422693Song 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.
- Background: PubMed 16369160Roh 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.
- Background: PubMed 21755564Rodrigo 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.
- Background: PubMed 15979931Wei 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.
- Background: PubMed 10668674Pitman 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.
- Background: PubMed 9525526Bailey BJ. Selective neck dissection: the challenge of occult metastases. Arch Otolaryngol Head Neck Surg. 1998 Mar;124(3):353. No abstract available.
- Background: PubMed 18926464Ferlito 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.
- Background: PubMed 16240329Pentenero 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.
- Background: PubMed 7930893Terris DJ, Tuffo KM, Fee WE Jr. Modified facelift incision for parotidectomy. J Laryngol Otol. 1994 Jul;108(7):574-8. doi: 10.1017/s002221510012746x.
- Background: PubMed 21721012Terris 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.
- Background: PubMed 20204392Civantos 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 publication: PubMed 21459661Fasunla 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robot assisted neck dissection via retroauricular approach and Conventional neck dissection in people with Head and Neck Neoplasms, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoon Woo Koh, MD, PhD (82-10-9097-0955, ywkohent@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Retrieved lymph nodes (time frame: when the pathologist examine the specimen which is within 1 week after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01488669, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2011; AzTrials last refreshed its copy on 2 Nov 2026.