Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT04687995
Status:
UNKNOWN
Last Update Posted:
2021-01-05
First Post:
2020-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tragal Perichondrium Versus Pretragal Fascial (SMAS) Graft for Endoscopic Myringoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018058', 'term': 'Tympanic Membrane Perforation'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-01', 'studyFirstSubmitDate': '2020-09-26', 'studyFirstSubmitQcDate': '2020-12-24', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison of tragal perichondrium versus pretragal fascial (SMAS) graft for endoscopic myringoplasty', 'timeFrame': 'Baseline', 'description': 'comparison of results when using tragal perichondrium versus pretragal fascial (SMAS) graft for endoscopic myringoplasty success rate by audiological evaluation by using audiotympanogram'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tympanic Membrane Perforation']}, 'referencesModule': {'references': [{'pmid': '32080032', 'type': 'BACKGROUND', 'citation': 'Lin MY, Chang TS, Liao JB. The Pretragal Superficial Musculoaponeurotic System Fascia: A New Graft Material for Transcanal Tympanoplasty. Otol Neurotol. 2020 Jun;41(5):644-653. doi: 10.1097/MAO.0000000000002599.'}]}, 'descriptionModule': {'briefSummary': '1. Examine the treatment outcomes of the pretragal (SMAS) fascia as a new graft when used in endoscopic myringoplasty.\n2. Compare the results when using the tragal pericondrium as a graft in endoscopic myringoplasty regarding donor site and success.', 'detailedDescription': 'The exclusive transcanal endoscopic tympanoplasty technique emerged in the1990s : it provides a more direct and wider surgical viewing angle, largely reduces the necessity for a traumatic postauricular incision. Some otolgists have adopted this technique using the nearby tragal perichondrium/cartilage graft. The tragus has a pivotal function in reconstruction in ear surgery. The superficial musculoaponeurotic system (SMAS) was first introduced by Mits and Peyroniein1976. It is located in the mid-face overlying the parotid gland and mimic muscles, It connects the dermis and the muscles, acting as a unique motor unit to produce facial expressions. The SMAS graft has great potential because it is accessible from the least invasive transcanal route of tympanoplasty, and is located away from the vital structures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Above 16 yrs old and less than 50 yrs old.\n2. Clinically diagnosed central tympanic membrane perforations or chronic suppurative otitis media (tubo-tympanic).\n3. Dry ear: no otorrhea without medication for at least 1 month.\n4. Hearing loss gap not more than 50dB\n\nExclusion Criteria:\n\n1. Age less than 16 or more than 50.\n2. Discharging (active) central perforations.\n3. Unsafe CSOM with cholesteatoma.\n4. Suspected ossicular pathology in safe CSOM if the gap \\> 50dB.\n5. Previous ear surgery.\n6. Patients unfit for surgery or having chronic medical illness.'}, 'identificationModule': {'nctId': 'NCT04687995', 'briefTitle': 'Tragal Perichondrium Versus Pretragal Fascial (SMAS) Graft for Endoscopic Myringoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Tragal Perichondrium Versus the Pretragal Fascial Grafts for Endoscopic Myringoplasty: Comparative Study', 'orgStudyIdInfo': {'id': 'Endoscopic myringoplasty'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tragal preichondrium graft', 'description': 'Tragal perichodrium graft for endoscopic myringoplasty as a reference graft', 'interventionNames': ['Procedure: Endoscopic myringoplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pretragal ( SMAS) fascia graft', 'description': 'pretragal ( SMAS) fascia graft for endoscopic myringoplasty as a new graft', 'interventionNames': ['Procedure: Endoscopic myringoplasty']}], 'interventions': [{'name': 'Endoscopic myringoplasty', 'type': 'PROCEDURE', 'description': 'Endoscopic myringoplasty by using two different grafts one each time', 'armGroupLabels': ['Tragal preichondrium graft', 'pretragal ( SMAS) fascia graft']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hazem Gamal Noreldin, Resident', 'role': 'CONTACT', 'email': 'hazzmnoreldin@gmail.com', 'phone': '01024806122'}, {'name': 'Mahmoud Mohamed Ragheb, Professor', 'role': 'CONTACT', 'email': 'mahmoud.elsherief@med.au.edu.eg', 'phone': '01003317723'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor in otolaryngology', 'investigatorFullName': 'Hazem Gamal Noreldein', 'investigatorAffiliation': 'Assiut University'}}}}