Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-03-27 @ 8:41 AM
Study NCT ID:
NCT05699304
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2023-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complications After Thyroid Surgeries: 10 Years' Experience
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D006996', 'term': 'Hypocalcemia'}, {'id': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013965', 'term': 'Thyroidectomy'}], 'ancestors': [{'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 241}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-21', 'studyFirstSubmitDate': '2023-01-16', 'studyFirstSubmitQcDate': '2023-01-16', 'lastUpdatePostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent Laryngeal nerve injury', 'timeFrame': '1 week', 'description': 'Recurrent Laryngeal nerve injury'}, {'measure': 'Bleeding', 'timeFrame': '2 days', 'description': 'intraoperative or post operative bleeding.'}, {'measure': 'Hypocalcemia', 'timeFrame': '6 months', 'description': 'Clinically significant low serum calcium level/'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thyroidectomy', 'Hypocalcemia', 'Stridor', 'Bleeding', 'Recurrent Laryngeal Nerve'], 'conditions': ['Thyroid']}, 'referencesModule': {'references': [{'pmid': '21966659', 'type': 'BACKGROUND', 'citation': 'Ogbera AO, Kuku SF. Epidemiology of thyroid diseases in Africa. Indian J Endocrinol Metab. 2011 Jul;15(Suppl 2):S82-8. doi: 10.4103/2230-8210.83331.'}, {'pmid': '22714849', 'type': 'BACKGROUND', 'citation': 'Ernandes-Neto M, Tagliarini JV, Lopez BE, Padovani CR, Marques Mde A, Castilho EC, Mazeto GM. Factors influencing thyroidectomy complications. Braz J Otorhinolaryngol. 2012 Jun;78(3):63-9. doi: 10.1590/S1808-86942012000300012.'}, {'pmid': '15213613', 'type': 'BACKGROUND', 'citation': 'Zambudio AR, Rodriguez J, Riquelme J, Soria T, Canteras M, Parrilla P. Prospective study of postoperative complications after total thyroidectomy for multinodular goiters by surgeons with experience in endocrine surgery. Ann Surg. 2004 Jul;240(1):18-25. doi: 10.1097/01.sla.0000129357.58265.3c.'}, {'pmid': '21409907', 'type': 'BACKGROUND', 'citation': 'Khanzada TW, Samad A, Memon W, Kumar B. Post thyroidectomy complications: the Hyderabad experience. J Ayub Med Coll Abbottabad. 2010 Jan-Mar;22(1):65-8.'}, {'pmid': '29142848', 'type': 'BACKGROUND', 'citation': 'Potenza AS, Araujo Filho VJF, Cernea CR. Injury of the external branch of the superior laryngeal nerve in thyroid surgery. Gland Surg. 2017 Oct;6(5):552-562. doi: 10.21037/gs.2017.06.15.'}]}, 'descriptionModule': {'briefSummary': 'Thyroidectomy is one of the commonest elective surgeries in surgical practice nowadays. It is associated with wide range of complications, from unnoticed events up to lifelong problems and even life-threatening complications. The most troublesome are bleeding, nerve injury and hypocalcemia. The current study was conducted to report the incidence and predictive factors for perioperative complications, aiming to point out preventive measures.', 'detailedDescription': 'All files of all patients that had thyroidectomy in the hospital in the last 10 yeas will be reviewed. All demographic and peri-operative data will be collected, tabulated and analyzed.\n\nIncidence and pre-operative predictive factors of every single complication will pointed out and discussed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients had thyroid diseases and had thyroidectomy in our hospital in last 10 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients had thyroid disease and performed thyroidectomy in the last 10 years in our hospital.\n\nExclusion Criteria:\n\n* Uncompleted files.'}, 'identificationModule': {'nctId': 'NCT05699304', 'briefTitle': "Complications After Thyroid Surgeries: 10 Years' Experience", 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': "Complications After Thyroid Surgeries: 10 Years' Experience", 'orgStudyIdInfo': {'id': 'SVU-MED-SUR011-4-22-12-515'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Thyroidectomy', 'type': 'PROCEDURE', 'description': 'Thyroidectomy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qina', 'country': 'Egypt', 'facility': 'Qena Faculty of Medicine, South Valley University Hospitals', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}], 'overallOfficials': [{'name': 'Abdallah M Taha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Valley University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Abdallah Mohamed Taha Aly', 'investigatorAffiliation': 'South Valley University'}}}}