Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-03 @ 11:40 AM
Study NCT ID:
NCT03079193
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2014-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Thyroidectomy Endoscopic Laryngeal Examination :Is it Mandatory?
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-08', 'studyFirstSubmitDate': '2014-03-13', 'studyFirstSubmitQcDate': '2017-03-08', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endoscopic laryngeal examination post thyroidectomy', 'timeFrame': '3 years', 'description': 'usefulness of endoscopic laryngeal examination post thyroidectomy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['post thyroidectomy', 'laryngeoscopic examination'], 'conditions': ['Thyroid']}, 'descriptionModule': {'briefSummary': 'Post thyroidectomy laryngeal nerve injuries are frequently encountered specially in total and near total thyroidectomy some unilateral injuries are not clinically evident and asymptomatic.\n\nThe aim of this study is to compare mandatory versus selective post-thyroidectomy endoscopic examination of larynx to detect laryngeal nerve injuries.', 'detailedDescription': '100 patients were randomly divided into two groups, group I for whom mandatory post thyroidectomy endoscopic laryngoscopic examination and the other group of only symptomatic patients selected for direct laryngoscopic examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '100 patients post thyroidectomy will be randomly divided into two groups group I for whom mandatory vedioscopic laryngeal examination is done while the other group II patients for whom no routine vedioscopic laryngeal examination done only if symptoms developed', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all post thyroidectomy patients\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03079193', 'briefTitle': 'Post Thyroidectomy Endoscopic Laryngeal Examination :Is it Mandatory?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Khamis Mushayt General Hospital'}, 'officialTitle': 'Post Thyroidectomy Endoscopic Laryngeal Examination :Is it Mandatory?', 'orgStudyIdInfo': {'id': 'khamisMGH WA1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'videoscopic laryngeal examination', 'description': '50 patients post thyroidectomy will do mandatory post thyroidectomy videoscopic examination of the larynx'}, {'label': 'No vedioscopic larygeoscopic examination', 'description': '50 patients post thyroidectomy will be followed up and will not do vedeoscopic videoscopic laryngeal examination routinely they will do it if indicated'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khamis Mushayt General Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Mansoura University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor of general surgery', 'investigatorFullName': 'wagih ghnnam', 'investigatorAffiliation': 'Khamis Mushayt General Hospital'}}}}