Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-29 @ 12:33 AM
Study NCT ID:
NCT01488669
Status:
UNKNOWN
Last Update Posted:
2011-12-08
First Post:
2011-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-06', 'studyFirstSubmitDate': '2011-12-05', 'studyFirstSubmitQcDate': '2011-12-06', 'lastUpdatePostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Retrieved lymph nodes', 'timeFrame': 'when the pathologist examine the specimen which is within 1 week after operation', 'description': 'Number of Retrieved lymph nodes counted from the dissected lymphofatty tissues of the specimen'}], 'secondaryOutcomes': [{'measure': 'amount and duration of drainage', 'timeFrame': 'daily, 6AM, until the drain is removed at an expected average of 5 days', 'description': 'the amount of drain (ml)is checked from the closed drain bottle.'}, {'measure': 'length of hospital stay', 'timeFrame': 'when the patient leaves the hospital at an an expected average of 9 days', 'description': 'length of hospital stay (day)'}, {'measure': 'satisfaction score', 'timeFrame': '3 months after operation', 'description': 'satisfaction score (from 1 to 5) is evaluated at the out-patient department\n\n(1 = extremely dissatisfied, 2 = dissatisfied, 3 = average, 4 = satisfied, 5 = extremely satisfied)'}, {'measure': 'Operation time', 'timeFrame': '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', 'description': 'Operation time (minutes) from skin incision to the time point of removing the dissected specimen from the patient'}]}, 'conditionsModule': {'keywords': ['head and neck neoplasms', 'neck dissection', 'robotics'], 'conditions': ['Head and Neck Neoplasms']}, 'referencesModule': {'references': [{'pmid': '20422693', 'type': 'BACKGROUND', '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.'}, {'pmid': '16369160', 'type': 'BACKGROUND', '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.'}, {'pmid': '21755564', 'type': 'BACKGROUND', '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.'}, {'pmid': '15979931', 'type': 'BACKGROUND', '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.'}, {'pmid': '10668674', 'type': 'BACKGROUND', '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.'}, {'pmid': '9525526', 'type': 'BACKGROUND', 'citation': 'Bailey BJ. Selective neck dissection: the challenge of occult metastases. Arch Otolaryngol Head Neck Surg. 1998 Mar;124(3):353. No abstract available.'}, {'pmid': '18926464', 'type': 'BACKGROUND', '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.'}, {'pmid': '16240329', 'type': 'BACKGROUND', '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.'}, {'pmid': '7930893', 'type': 'BACKGROUND', '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.'}, {'pmid': '21721012', 'type': 'BACKGROUND', '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.'}, {'pmid': '20204392', 'type': 'BACKGROUND', '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.'}, {'pmid': '21459661', 'type': 'RESULT', '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.'}, {'pmid': '15772957', 'type': 'RESULT', '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.'}, {'pmid': '21134554', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed as squamous cell carcinoma of the oral cavity\n* no clinically identified cervical lymph node metastasis\n* surgery as initial treatment\n\nExclusion Criteria:\n\n* suspicious neck metastasis\n* radiation or chemotherapy before the surgery\n* past history of neck surgery'}, 'identificationModule': {'nctId': 'NCT01488669', 'briefTitle': 'Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '1-2011-0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robotic neck dissection', '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.', 'interventionNames': ['Procedure: robot assisted neck dissection via retroauricular approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional neck dissection', 'description': 'Neck dissection is performed after an external transverse skin incision.', 'interventionNames': ['Procedure: Conventional neck dissection']}], 'interventions': [{'name': 'robot assisted neck dissection via retroauricular approach', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['Robotic neck dissection']}, {'name': 'Conventional neck dissection', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['Conventional neck dissection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yoon Woo Koh, MD, PhD', 'role': 'CONTACT', 'email': 'ywkohent@yuhs.ac', 'phone': '82-10-9097-0955'}], 'facility': 'Yonsei University Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Yoon Woo Koh, MD, PhD', 'role': 'CONTACT', 'email': 'ywkohent@yuhs.ac', 'phone': '82-10-9097-0955'}, {'name': 'Hyoung Shin Lee, MD', 'role': 'CONTACT', 'email': 'hsleeent@yuhs.ac', 'phone': '82-10-2580-6851'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}