Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT03469427
Status:
UNKNOWN
Last Update Posted:
2018-07-06
First Post:
2018-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multislice Computed Tomography in Cases With Facial Nerve Paralysis Due to Temporal Bone Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020330', 'term': 'Bell Palsy'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-04', 'studyFirstSubmitDate': '2018-03-12', 'studyFirstSubmitQcDate': '2018-03-15', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients who suffer from facial nerve paralysis due to temporal bone trauma will be diagnosed by using multislice computed tomography', 'timeFrame': 'up to 2 years', 'description': 'Evaluation the reliability of multislice computed tomography in the assessment of facial nerve paralysis due to temporal bone trauma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Facial Nerve Paralysis']}, 'descriptionModule': {'briefSummary': 'Facial nerve paralysis is a disfiguring complication which occurs in 7-10 % of temporal bone fractures.\n\nThe onset of paralysis may be immediate, delayed or undetermined, the latter of which often occurs in unconscious patients with accompanying life-threatening complications.About one fourth has complete paralysis.', 'detailedDescription': "Facial nerve paralysis might have variable etiologies apart from idiopathic Bell's palsy, Congenital, infectious, inflammatory, neoplastic, neurological, toxic, iatrogenic and atraumatic causes.\n\nSurgical intervention is indicated if 90-95% loss of function is seen at the very early period on Electroneuronography or if there is axonal degeneration on Electromyography lately with no sign of recovery.\n\nHigh-resolution multislice computed tomography of the temporal bone is routinely required for evaluation of traumatic facial paralysis. High-resolution multislice computed tomography is known to be the best method for evaluating the intratemporal course of the facial nerve, but it has some limitations as well. Occasionally, the surgeon may encounter facial nerve injuries which have not been revealed in the preoperative computed tomography.\n\nThere are limited data in recent medical publications evaluating the diagnostic value of temporal bone High-resolution multislice computed tomography in the evaluation of traumatic facial paralysis. Therefore, in this study,the investigators will compare the findings of preoperative high-resolution multislice computed tomography with surgical findings to determine the diagnostic value of computed tomography."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of different age groups presented with facial nerve paralysis due to temporal bone trauma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with temporal bone fracture presented with facial nerve paralysis of immediate onset and meet the criteria of facial nerve exploration regardless of age and sex.\n\nExclusion Criteria:\n\n* Pregnant women.\n* Unfit patients for surgery.\n* Patients refuse surgical intervention.'}, 'identificationModule': {'nctId': 'NCT03469427', 'briefTitle': 'Multislice Computed Tomography in Cases With Facial Nerve Paralysis Due to Temporal Bone Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Reliability of Multislice Computed Tomography Scan in Cases With Facial Nerve Paralysis Due to Temporal Bone Trauma', 'orgStudyIdInfo': {'id': 'RCTFPTBT'}}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sally Hanna, Bachelor', 'role': 'CONTACT', 'email': 'Romleletot15@gmail.com'}], 'facility': 'Assiut university hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mahmoud Mohamed Ragheb, Professor', 'role': 'CONTACT', 'email': 'Mmraghib@aun.edu.eg', 'phone': '00201003317723'}, {'name': 'Mohamed Hosam Eldeen Shokry, Fellow', 'role': 'CONTACT', 'email': 'hosam4hoss@yahoo.com', 'phone': '00201005685075'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Sally S Hanna', 'investigatorAffiliation': 'Assiut University'}}}}