Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-27 @ 10:05 PM
Study NCT ID:
NCT03158961
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2017-05-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Feasibility and Safety of the TOETVA for Benign Thyroid Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2017-05-15', 'studyFirstSubmitQcDate': '2017-05-16', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The complication rate after TOETVA in 12 months', 'timeFrame': '12 months', 'description': 'To record any complication of surgery in every post-operation visit after 12 months. The record will be used for the calculation of complication rate.'}], 'secondaryOutcomes': [{'measure': 'The open conversion rate of TOETVA', 'timeFrame': '12 months', 'description': 'To record any cases which need to apply open surgery necessary during the procedure of TOETVA'}, {'measure': 'The wound infection rate after TOETVA', 'timeFrame': '12 months', 'description': 'To record the situation of wound infection after surgery'}, {'measure': 'The hematoma rate after TOETVA', 'timeFrame': '12 months', 'description': 'To record the situation of hematoma after surgery'}, {'measure': 'The vocal cord palsy rate after TOETVA', 'timeFrame': '12 months', 'description': 'To calculate the vocal cord situation after surgery within 12 months'}, {'measure': 'The hypoparathyroidism rate after TOETVA', 'timeFrame': '12 months', 'description': 'To record the thyroid function from blood test in 12 months after surgery and calculate the rate of hypo-parathyroid function'}, {'measure': 'The pain score of patient after TOETVA', 'timeFrame': '12 months', 'description': 'The pain scoring with 0-10 to assess the pain level of having TOETVA'}, {'measure': 'The satisfaction of patients after having TOETVA in 12 months', 'timeFrame': '12 months', 'description': 'The satisfaction in 0-10 scoring after the surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thyroid', 'Thyroidectomy', 'Transoral', 'Endoscopic', 'Surgery'], 'conditions': ['Thyroid Diseases']}, 'referencesModule': {'references': [{'pmid': '12588812', 'type': 'BACKGROUND', 'citation': 'Hegedus L, Bonnema SJ, Bennedbaek FN. Management of simple nodular goiter: current status and future perspectives. Endocr Rev. 2003 Feb;24(1):102-32. doi: 10.1210/er.2002-0016.'}, {'pmid': '17121528', 'type': 'BACKGROUND', 'citation': 'Erdogan MF, Gursoy A, Erdogan G. Natural course of benign thyroid nodules in a moderately iodine-deficient area. Clin Endocrinol (Oxf). 2006 Dec;65(6):767-71. doi: 10.1111/j.1365-2265.2006.02664.x.'}, {'pmid': '18633639', 'type': 'BACKGROUND', 'citation': 'Bergenfelz A, Jansson S, Kristoffersson A, Martensson H, Reihner E, Wallin G, Lausen I. Complications to thyroid surgery: results as reported in a database from a multicenter audit comprising 3,660 patients. Langenbecks Arch Surg. 2008 Sep;393(5):667-73. doi: 10.1007/s00423-008-0366-7. Epub 2008 Jul 17.'}, {'pmid': '20919522', 'type': 'BACKGROUND', 'citation': 'Lang BH. Minimally invasive thyroid and parathyroid operations: surgical techniques and pearls. Adv Surg. 2010;44:185-98. doi: 10.1016/j.yasu.2010.05.012.'}, {'pmid': '16402290', 'type': 'BACKGROUND', 'citation': 'Rattner D, Kalloo A; ASGE/SAGES Working Group. ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery. October 2005. Surg Endosc. 2006 Feb;20(2):329-33. doi: 10.1007/s00464-005-3006-0. No abstract available.'}, {'pmid': '22720153', 'type': 'BACKGROUND', 'citation': 'Clark MP, Qayed ES, Kooby DA, Maithel SK, Willingham FF. Natural orifice translumenal endoscopic surgery in humans: a review. Minim Invasive Surg. 2012;2012:189296. doi: 10.1155/2012/189296. Epub 2012 Jun 6.'}, {'pmid': '18163167', 'type': 'BACKGROUND', 'citation': 'Witzel K, von Rahden BH, Kaminski C, Stein HJ. Transoral access for endoscopic thyroid resection. Surg Endosc. 2008 Aug;22(8):1871-5. doi: 10.1007/s00464-007-9734-6. Epub 2007 Dec 28.'}, {'pmid': '19263151', 'type': 'BACKGROUND', 'citation': 'Benhidjeb T, Wilhelm T, Harlaar J, Kleinrensink GJ, Schneider TA, Stark M. Natural orifice surgery on thyroid gland: totally transoral video-assisted thyroidectomy (TOVAT): report of first experimental results of a new surgical method. Surg Endosc. 2009 May;23(5):1119-20. doi: 10.1007/s00464-009-0347-0. Epub 2009 Mar 5.'}, {'pmid': '20035350', 'type': 'BACKGROUND', 'citation': 'Wilhelm T, Metzig A. Video. Endoscopic minimally invasive thyroidectomy: first clinical experience. Surg Endosc. 2010 Jul;24(7):1757-8. doi: 10.1007/s00464-009-0820-9. Epub 2009 Dec 25.'}, {'pmid': '21088839', 'type': 'BACKGROUND', 'citation': 'Wilhelm T, Metzig A. Endoscopic minimally invasive thyroidectomy (eMIT): a prospective proof-of-concept study in humans. World J Surg. 2011 Mar;35(3):543-51. doi: 10.1007/s00268-010-0846-0.'}, {'pmid': '26546193', 'type': 'BACKGROUND', 'citation': 'Anuwong A. Transoral Endoscopic Thyroidectomy Vestibular Approach: A Series of the First 60 Human Cases. World J Surg. 2016 Mar;40(3):491-7. doi: 10.1007/s00268-015-3320-1.'}, {'pmid': '27834022', 'type': 'BACKGROUND', 'citation': 'Inabnet WB 3rd, Suh H, Fernandez-Ranvier G. Transoral endoscopic thyroidectomy vestibular approach with intraoperative nerve monitoring. Surg Endosc. 2017 Jul;31(7):3030. doi: 10.1007/s00464-016-5322-y. Epub 2016 Nov 10.'}, {'pmid': '27649533', 'type': 'BACKGROUND', 'citation': 'Udelsman R, Anuwong A, Oprea AD, Rhodes A, Prasad M, Sansone M, Brooks C, Donovan PI, Jannitto C, Carling T. Trans-oral Vestibular Endocrine Surgery: A New Technique in the United States. Ann Surg. 2016 Dec;264(6):e13-e16. doi: 10.1097/SLA.0000000000002001. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Thyroid surgery has been developed as a new technique for zero scar in surgery by applying transoral endoscopic thyroidectomy with sublingual approach. The new technique is locating the surgery which pierced through floor of mouth, cause severe tissue damage, high complication, and conversion rates to open surgery and surgical difficulties due to limitation of movement. Nevertheless, each report is still including small number of patients. Recently, the transoral endoscopic thyroidectomy vestibular approach (TOETVA) has been proven feasible and safe in several overseas centers. Moreover, a successful TOETVA case was reported in local media in the late last year. Hence, this study is for evaluating the feasibility and safety of the TOETVA prospectively at a tertiary referral center in Hong Kong.\n\nThe following are the procedure of the study:\n\n1. Recruit patients from the clinic.\n2. Patients will receive treatment within 3 months\n3. Patients will have different assessments like Ultrasonography assessment, Fine needle biopsy, Direct laryngoscopy, and Cosmectic scoring in Pre-operation, post-operation 2 week, post 1 month, post 3 month, post 6 month and post 12 month.\n4. Patients will be monitoring by the same team after the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have a cyst, nodule or a goiter which has been shown to be benign on fine needle aspiration cytology,\n* need to undergo a unilateral thyroid resection,\n* have a nodule size no larger than 4cm in largest diameter,\n* willing to undergo this new approach rather than the traditional open approach.\n\nExclusion Criteria:\n\n* unfit for surgery,\n* has had previous surgery or radiation at the neck,\n* unable to tolerate a general anesthesia,\n* wearing dental braces,\n* absence of vocal cord mobility at laryngoscopy.'}, 'identificationModule': {'nctId': 'NCT03158961', 'briefTitle': 'The Feasibility and Safety of the TOETVA for Benign Thyroid Nodules', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'A Prospective Evaluation of the Feasibility and Safety of the Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) as a Treatment for Benign Thyroid Nodules', 'orgStudyIdInfo': {'id': 'UW 17-144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TOETVA', 'description': 'a new approach in surgery which can treat the thyroid disease', 'interventionNames': ['Procedure: Transoral endoscopic thyroidectomy vestibular approach']}], 'interventions': [{'name': 'Transoral endoscopic thyroidectomy vestibular approach', 'type': 'PROCEDURE', 'description': 'TOVETA is a new approach in surgery of thyroidectomy no longer open on the neck', 'armGroupLabels': ['TOETVA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Hung Hin, Brian Lang, MBBS(Hons)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Dr. Lang Hung Hin, Brian', 'investigatorAffiliation': 'The University of Hong Kong'}}}}