Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
Study NCT ID:
NCT04396912
Status:
UNKNOWN
Last Update Posted:
2020-05-21
First Post:
2020-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: STROBE - Guided Prospective Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014826', 'term': 'Vocal Cord Paralysis'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000077273', 'term': 'Thyroid Cancer, Papillary'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D016606', 'term': 'Thyroid Nodule'}], 'ancestors': [{'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D020421', 'term': 'Vagus Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000231', 'term': 'Adenocarcinoma, Papillary'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-15', 'studyFirstSubmitDate': '2020-05-15', 'studyFirstSubmitQcDate': '2020-05-15', 'lastUpdatePostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 's/p TT- normal (no complication)', 'timeFrame': 'June 01, 2020-June 01, 2021', 'description': 'TT: total thyroidectomy'}, {'measure': 's/p TT+VCP', 'timeFrame': 'June 01, 2020-June 01, 2021', 'description': 'VCP: vocal cord paralysis'}, {'measure': 's/p TT+H', 'timeFrame': 'June 01, 2020-June 01, 2021', 'description': 'H: hypocalcemia'}, {'measure': 's/p TT+VCP+H', 'timeFrame': 'June 01, 2020-June 01, 2021', 'description': 'Any improvement recorded? VCP? H? vice versa'}], 'secondaryOutcomes': [{'measure': 'Improvement in vocal cord function /serum calcium', 'timeFrame': 'June 01, 2020-June 01, 2021', 'description': 'VCP+H'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total thyroidectomy'], 'conditions': ['Iatrogenic Hypocalcemia', 'Iatrogenic Hypoparathyroidism', 'Vocal Cord Paralysis', 'Vocal Cord Paresis', 'Vocal Cord; Injury, Superficial', 'Thyroid Cancer, Papillary', 'Thyroid Cancer', 'Multinodular Goiter', 'Thyroid Neoplasms', 'Thyroid Nodule', 'Calcium Deficiency', 'PTH']}, 'referencesModule': {'references': [{'pmid': '30930717', 'type': 'RESULT', 'citation': 'Cuschieri S. The STROBE guidelines. Saudi J Anaesth. 2019 Apr;13(Suppl 1):S31-S34. doi: 10.4103/sja.SJA_543_18.'}, {'pmid': '31670633', 'type': 'RESULT', 'citation': 'Giulea C, Enciu O, Toma EA, Calu V, Miron A. The Tubercle of Zuckerkandl is Associated with Increased Rates of Transient Postoperative Hypocalcemia and Recurrent Laryngeal Nerve Palsy After Total Thyroidectomy. Chirurgia (Bucur). 2019 Sept-Oct;114(5):579-585. doi: 10.21614/chirurgia.114.5.579.'}], 'seeAlsoLinks': [{'url': 'https://www.equator-network.org/reporting-guidelines/strobe/', 'label': 'STROBE guidelines'}, {'url': 'https://scholar.google.com.tr/citations?user=6bFlCZwAAAAJ&hl=tr', 'label': 'Ethem Unal, MD, PhD (h-inde 18, i10-index 33)'}, {'url': 'https://www.journalagent.com/ejm/pdfs/EJM-33254-ORIGINAL_ARTICLE-YUKSEKDAG.pdf', 'label': 'VCP'}, {'url': 'https://books.google.com.tr/books?id=MQX59bsB3CwC&pg=PA606&lpg=PA606&dq=recurrent+nerve+palsy+concurrent+hypocalcemia&source=bl&ots=H0OYiolBHv&sig=ACfU3U1_6EiiCEJ0mBCLikHDHHsoniUxkA&hl=tr&sa=X&ved=2ahUKEwiQpePr_rbpAhUlxMQBHYZdBWYQ6AEwAXoECAUQAQ#v=onepage&q=recurrent%20nerve%20palsy%20concurrent%20hypocalcemia&f=false', 'label': 'TT complications'}]}, 'descriptionModule': {'briefSummary': 'In the present study, the severity of recurrent laryngeal nerve injury (RLNI) and hypocalcemia (H) will be followed-up and the probable interrelation between them will be proposed considering the clinical situation of patients, e.g. improvement in hypocalcemia also make a positive effect on voice? (any objective sign? Ca? PTH?), return of voice is parallel with the improvement in hypocalcemia? Postoperative calcium (Ca), parathyroid hormone (PTH), regular vocal cord evaluations by ear-nose-throat (ENT) exams, deterioration-stability-improvement of clinical symptoms regarding both Ca metabolism and vocal cord function will be noted at regular intervals (postoperative day 1-3-first, weekly control/first month, monthly/first 6-month, 3-monthly/6-12 months) at outpatient controls. Serum Ca, PTH, ENT evaluation of vocal cords-noted.', 'detailedDescription': 'Total thyroidectomy is currently the preferred surgical treatment modality for both thyroid carcinomas and benign disorders such as multinodular goitre, since it minimizes the risk of recurrence and eliminates the complication risks of repeat or completion surgery. Vocal cord paralysis due to injury to recurrent laryngeal nerve (RLN) is the most dreaded complication of total thyroidectomy. The reported incidence of temporary RLN injury (RLNI) varies between 0 and 12 %, while the incidence of permanent RLNI has been reported to be much lower (0-3.5 %). In case of bilateral RLNI, respiratory distress and aspiration can develop rapidly and may result in mortality. Therefore, all precautions including close monitoring and tracheostomy should be undertaken without any delay. The best known technique to avoid injury to RLN is meticulous dissection of the nerve throughout its anatomic pathway. However, functional impairment of RLN is not visible macroscopically and intraoperative nerve monitoring (IONM) has been developed to monitor the nerve to avoid unnecessary dissection. Meticulous hemostasis can be achieved with harmonic sealing instrument, since improper hemostasis is known to increase the risk of RLNI. Despite the lack of evidence to support an advantage of IONM over the standard anatomic dissection of RLN, surgeons have adopted it in increasing ratios. The second most feared compliation of thyroidectomy is iatrogenic hypocalcemia. Transient symptomatic hypocalcemia after total thyroidectomy occurs in approximately 7% to 25% of cases, but permanent hypocalcemia is less common (0.4% to 13.8%). Size and invasion of tumor, operative trauma and vascular compromise determines the severity of symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with benign or malign thyroid diseases, eligable for total thyroidectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with total thyroidectomy indication, for either benign (e.g. multinodular goitre) or malign (e.g. thyroid carcinoma) thyroid disease\n* \\>17 year-old\n* Available for close follow-ups at outpatient clinic\n* Available for close vocal cord exams\n\nExclusion Criteria:\n\n* Patients with recurrent thyroid disease (benign/malign), prepared for a second operation\n* Preferance of thyroid surgery other than total thyroidectomy'}, 'identificationModule': {'nctId': 'NCT04396912', 'briefTitle': 'Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: STROBE - Guided Prospective Cohort', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Umraniye Education and Research Hospital'}, 'officialTitle': 'Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: Prospective, Matched-randomized Observational Cohort Compatible With STROBE Guidelines', 'orgStudyIdInfo': {'id': 'B.10.1TKH.4.34.H.GP0.01/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control, s/p TT, without complication', 'description': 'Control (status/post-s/p total thyroidectomy-TT, without complication- demographics and BMI matched)', 'interventionNames': ['Procedure: Total thyroidectomy']}, {'label': 'Experimental, s/p TT with only VCP', 'description': 'Experimental (s/p TT, with only vocal cord paralysis-VCP, uni or bilateral)', 'interventionNames': ['Procedure: Total thyroidectomy']}, {'label': 'Experimental, s/p TT with only H', 'description': 'Experimental (s/p TT, with only hypocalcemia-H, transient or permanent)', 'interventionNames': ['Procedure: Total thyroidectomy']}, {'label': 'Experimental, s/p TT with both VCP+H', 'description': 'Experimental (s/p TT, with both vocal cord paralysis-VCP and hypocalcemia-H);\n\nSubgroups:\n\n4.1. VCP (Permanent) + H (Permanent) 4.2. VCP (Transient) + H (Transient) 4.3. VCP (Permanent) + H (Transient) 4.4. VCP (Transient) + H (Permanent)\n\nPlease answer:\n\n* Improvement in hypocalcemia also make a positive effect on voice? (any objective sign? Ca? PTH?)\n* Return of voice is parallel with the improvement in hypocalcemia? (any objective sign? Ca? PTH?', 'interventionNames': ['Procedure: Total thyroidectomy']}], 'interventions': [{'name': 'Total thyroidectomy', 'type': 'PROCEDURE', 'description': 'Patients with thyroid diseases either benign (e.g. multinodular goitre) or malign (e.g. thyroid carcinoma) will be prepared for total thyroidectomy procedure and will be enrolled.', 'armGroupLabels': ['Control, s/p TT, without complication', 'Experimental, s/p TT with both VCP+H', 'Experimental, s/p TT with only H', 'Experimental, s/p TT with only VCP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34764', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ethem UNAL, MD, PhD, USMLE & IFSO- Certified Board CSS', 'role': 'CONTACT', 'email': 'drethemunal@gmail.com', 'phone': '0090(216)6321818', 'phoneExt': '1951'}, {'name': 'Kadir M YILDIRAK, MD', 'role': 'CONTACT', 'email': 'kadiryildira@gmail.com', 'phone': '0090(216)6321818', 'phoneExt': '1951'}, {'name': 'Sema YUKSEKDAG, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Umraniye Education and Research Hospital, Health Sciences University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Ethem UNAL, MD, PhD, USMLE & IFSO-Certified, Board CSS', 'role': 'CONTACT', 'email': 'drethemunal@gmail.com', 'phone': '0090(216)6321818', 'phoneExt': '1951'}, {'name': 'Kadir YILDIRAK, MD', 'role': 'CONTACT', 'email': 'kadiryildira@gmail.com', 'phone': '0090(216)6321818', 'phoneExt': '1951'}], 'overallOfficials': [{'name': 'Sema YUKSEKDAG, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instructor in General Surgery'}, {'name': 'Ethem UNAL, MD, PhD, USMLE & IFSO-Certified, Board CSS', 'role': 'STUDY_CHAIR', 'affiliation': 'Assoc. Professor of General Surgery and Surgical Oncology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'From June 01, 2020, for 6 months', 'ipdSharing': 'YES', 'description': 'Study is open to high-volume INTERNATIONAL endocrine surgery centers, eager to join to present STROBE compatible observational study\n\nAvailable upon email requests@drethemunal@gmail.com', 'accessCriteria': 'Contact to drethemunal@gmail.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umraniye Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, USMLE & IFSO-Certified, BCSS, Associated Professor of General Surgery and Surgical Oncology', 'investigatorFullName': 'Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic', 'investigatorAffiliation': 'Umraniye Education and Research Hospital'}}}}