Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-03-06 @ 3:01 AM
Study NCT ID:
NCT01812395
Status:
UNKNOWN
Last Update Posted:
2014-03-24
First Post:
2013-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thyroidectomy Using Ultrasonic Dissector: Is Superior Laryngeal Nerve Really Safe ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006042', 'term': 'Goiter'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-21', 'studyFirstSubmitDate': '2013-03-08', 'studyFirstSubmitQcDate': '2013-03-13', 'lastUpdatePostDateStruct': {'date': '2014-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of hemorrhage', 'timeFrame': '3 day', 'description': 'Amounts of peroperative and postoperative hemorrhage will be recorded'}], 'primaryOutcomes': [{'measure': 'Assessment of superior laryngeal nerve function', 'timeFrame': '6 months', 'description': 'Patients will be checked for superior laryngeal nerve function by laryngostroboscopy one day after thyroidectomy and 6 months after thyroidectomy.'}], 'secondaryOutcomes': [{'measure': 'Assessment of inferior laryngeal nerve function', 'timeFrame': '6 months', 'description': 'Patients will be checked for inferior laryngeal nerve function by laryngostroboscopy one day after thyroidectomy and 6 months after thyroidectomy.'}, {'measure': 'Assessment of other complications', 'timeFrame': '1 week', 'description': 'Whether patients develop postoperative seroma, haematoma, infection or maceration will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['thyroidectomy', 'ultrasonic dissector', 'harmonic focus device', 'superior laryngeal nerve'], 'conditions': ['Goiter']}, 'referencesModule': {'references': [{'pmid': '21529721', 'type': 'BACKGROUND', 'citation': 'Pardal-Refoyo JL. [Hemostatic systems in thyroid surgery and complications]. Acta Otorrinolaringol Esp. 2011 Sep-Oct;62(5):339-46. doi: 10.1016/j.otorri.2011.03.004. Epub 2011 May 6. Spanish.'}, {'pmid': '21683011', 'type': 'BACKGROUND', 'citation': 'Bove A, Bongarzoni G, Palone G, Di Renzo R, Di Nicola M, Corradetti L, Corbellini L. Comparative study of an electrothermal bipolar vessel sealing system (LigaSure(R)), a harmonic curved shears (Harmonic Focus), and traditional technique in total thyroidectomy. Am Surg. 2010 Jul;76(7):E94-6. No abstract available.'}, {'pmid': '11822946', 'type': 'BACKGROUND', 'citation': 'Siperstein AE, Berber E, Morkoyun E. The use of the harmonic scalpel vs conventional knot tying for vessel ligation in thyroid surgery. Arch Surg. 2002 Feb;137(2):137-42. doi: 10.1001/archsurg.137.2.137.'}, {'pmid': '18324377', 'type': 'BACKGROUND', 'citation': 'Yildirim O, Umit T, Ebru M, Bulent U, Belma K, Betul B, Mete D, Omer C. Ultrasonic harmonic scalpel in total thyroidectomies. Adv Ther. 2008 Mar;25(3):260-5. doi: 10.1007/s12325-008-0024-z.'}, {'pmid': '19308436', 'type': 'BACKGROUND', 'citation': 'Prgomet D, Janjanin S, Bilic M, Prstacic R, Kovac L, Rudes M, Katic V. A prospective observational study of 363 cases operated with three different harmonic scalpels. Eur Arch Otorhinolaryngol. 2009 Dec;266(12):1965-70. doi: 10.1007/s00405-009-0954-3. Epub 2009 Mar 24.'}, {'pmid': '18648850', 'type': 'BACKGROUND', 'citation': 'Sartori PV, De Fina S, Colombo G, Pugliese F, Romano F, Cesana G, Uggeri F. Ligasure versus Ultracision in thyroid surgery: a prospective randomized study. Langenbecks Arch Surg. 2008 Sep;393(5):655-8. doi: 10.1007/s00423-008-0386-3. Epub 2008 Jul 22.'}, {'pmid': '10714624', 'type': 'BACKGROUND', 'citation': 'Voutilainen PE, Haglund CH. Ultrasonically activated shears in thyroidectomies: a randomized trial. Ann Surg. 2000 Mar;231(3):322-8. doi: 10.1097/00000658-200003000-00004.'}, {'pmid': '17014444', 'type': 'BACKGROUND', 'citation': 'Morton RP, Whitfield P, Al-Ali S. Anatomical and surgical considerations of the external branch of the superior laryngeal nerve: a systematic review. Clin Otolaryngol. 2006 Oct;31(5):368-74. doi: 10.1111/j.1749-4486.2006.01266.x.'}, {'pmid': '17022029', 'type': 'BACKGROUND', 'citation': 'Ozlugedik S, Acar HI, Apaydin N, Tekdemir I, Elhan A, Comert A. Surgical anatomy of the external branch of the superior laryngeal nerve. Clin Anat. 2007 May;20(4):387-91. doi: 10.1002/ca.20399.'}]}, 'descriptionModule': {'briefSummary': "New devices and techniques are coming into use everyday. Ultrasonic dissectors (UDs) are such new devices which is a practical alternative to the usage of scalpel and sutures. UD's cause overheating of neighboring tissues in an area of 1 to 3 millimeters. Due to the generated heat UDs might cause nerve injury. The investigators would like to see if usage of UDs during thyroidectomy poses a risk for superior laryngeal nerve injury compared to conventional thyroidectomy.", 'detailedDescription': 'We see new advances in the practice of surgery nearly everyday. New techniques and devices became available and even newer ones are under developement. Ultrasonic Dissectors (UDs) which are primarily developed for laparoscopic surgery found widespread use in thyroid surgery. UDs while closing the nearby vessels cause overheating of neighboring tissues in a 1-3 mm. area. Due to the generated heat UDs might cause nerve injury. We would like to see if usage of UDs during thyroidectomy poses a risk for superior laryngeal nerve injury compared to conventional thyroidectomy where vessels are first sealed with sutures then cut. To this end patients in both conventional and ultrasonic dissector thyroidectomy arms will be checked for superior laryngeal nerve function the day following operation and six months later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having thyroidectomy\n\nExclusion Criteria:\n\n* Previous neck surgery\n* Thyroid cancers\n* History of superior or inferior laryngeal nerve paralysis\n* History of neck irradiation\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT01812395', 'briefTitle': 'Thyroidectomy Using Ultrasonic Dissector: Is Superior Laryngeal Nerve Really Safe ?', 'organization': {'class': 'OTHER', 'fullName': 'S.B. Konya Education and Research Hospital'}, 'officialTitle': 'Is Superior Laryngeal Nerve Really Safe During Thyroidectomy Using Ultrasonic Dissector.', 'orgStudyIdInfo': {'id': 'KEAH07031301'}, 'secondaryIdInfos': [{'id': 'U1111-1140-3809', 'type': 'OTHER', 'domain': 'WHO Universal Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasonic Dissector Thyroidectomy', 'description': 'Thyroidectomy using harmonic focus (r) device', 'interventionNames': ['Device: Thyroidectomy using harmonic focus (r)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Classic thyroidectomy', 'description': 'Patients having conventional thyroidectomy', 'interventionNames': ['Procedure: Conventional thyroidectomy']}], 'interventions': [{'name': 'Thyroidectomy using harmonic focus (r)', 'type': 'DEVICE', 'otherNames': ['Ethicon(r) Harmonic Focus(r) Curved Shears'], 'description': 'Harmonic focus(r) device is used to seal and cut the vessels during thyroidectomy.', 'armGroupLabels': ['Ultrasonic Dissector Thyroidectomy']}, {'name': 'Conventional thyroidectomy', 'type': 'PROCEDURE', 'description': 'Vessels are ligated with sutures then cut using classic scalpel or scissors.', 'armGroupLabels': ['Classic thyroidectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42040', 'city': 'Meram', 'state': 'Konya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Kemal Arslan, M.D.', 'role': 'CONTACT', 'email': 'arslanka74@hotmail.com', 'phone': '+903322210000', 'phoneExt': '3209'}, {'name': 'Osman Doğru, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kemal Arslan, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Said S Kökçam, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hande Köksal, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ersin Turan, Resident', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Arif Atay, Resident', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gültekin Övet, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Konya Education and Research Hospital', 'geoPoint': {'lat': 37.82985, 'lon': 32.46777}}], 'centralContacts': [{'name': 'Osman DOĞRU, M.D.', 'role': 'CONTACT', 'email': 'konya422003@yahoo.com', 'phone': '+903323236709', 'phoneExt': '2018'}], 'overallOfficials': [{'name': 'Osman DOĞRU, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Konya Education and Research Hospital General Surgery Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'S.B. Konya Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}