Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-02-24 @ 2:08 PM
Study NCT ID:
NCT03922295
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2019-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Tympanoplasty: Single Versus Double Flap Technique
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-20', 'size': 340738, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-18T12:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-06', 'studyFirstSubmitDate': '2019-04-16', 'studyFirstSubmitQcDate': '2019-04-18', 'lastUpdatePostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healing or graft take rate', 'timeFrame': '3 months after surgery', 'description': 'closure of tympanic membrane perforation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tympanic Membrane Perforation']}, 'referencesModule': {'references': [{'pmid': '32691232', 'type': 'DERIVED', 'citation': 'El-Kholy NA, Salem MA, Rakha AM. Endoscopic single versus double flap tympanoplasty: a randomized clinical trial. Eur Arch Otorhinolaryngol. 2021 May;278(5):1395-1401. doi: 10.1007/s00405-020-06212-3. Epub 2020 Jul 20.'}]}, 'descriptionModule': {'briefSummary': 'Aim of this study is to compare results of double and single flap techniques for tympanoplasty in chronic suppurative otitis media patients. Inclusion criteria include total or subtotal tympanic membrane perforations with limited anterior remnant and should be dry for at least 3 months. Patients with persistent discharge, cholesteatoma, ossicular affection or those with recurrent perforations after previous myringoplasty were excluded. Also, patients with uncontrolled diabetes, chronic liver and kidney diseases and immuno-compromised patients are not included in this study. Patients are divided into two groups, endoscopic double flap group and endoscopic single flap group. Healing and hearing outcomes were evaluated 3 months postoperative. Also, post-operative pain scores and complications were assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic suppurative otitis media with total or subtotal tympanic membrane perforation with limited anterior remnant.\n* dry perforation for at least 3 months.\n\nExclusion Criteria:\n\n* Recurrent perforation after previous myringoplasty.\n* Ossicular disruption or fixation.\n* immune-compromised patients including uncontrolled diabetics, chronic liver and kidney diseases.'}, 'identificationModule': {'nctId': 'NCT03922295', 'briefTitle': 'Endoscopic Tympanoplasty: Single Versus Double Flap Technique', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Endoscopic Tympanoplasty: Single Versus Double Flap Technique', 'orgStudyIdInfo': {'id': '1ORL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'endoscopic double flap group', 'interventionNames': ['Procedure: Endoscopic tympanoplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'endoscopic single flap group', 'interventionNames': ['Procedure: Endoscopic tympanoplasty']}], 'interventions': [{'name': 'Endoscopic tympanoplasty', 'type': 'PROCEDURE', 'description': 'In the double flap group, graft is placed via elevation of both posterior and anterior flaps.\n\nIn the single flap group, graft is placed via elevation of posterior flap only', 'armGroupLabels': ['endoscopic double flap group', 'endoscopic single flap group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'ElDakahlia', 'country': 'Egypt', 'facility': 'ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Noha A Elkholy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ORL-HNS department, Faculty of Medicine, Mansoura University'}, {'name': 'Mohammed A Salem', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ORL-HNS department, Faculty of Medicine, Mansoura University'}, {'name': 'Abdelwahab M Rakha', 'role': 'STUDY_CHAIR', 'affiliation': 'ORL-HNS department, Faculty of Medicine, Mansoura University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ORL-HNS Resident', 'investigatorFullName': 'Noha A.Elkholy', 'investigatorAffiliation': 'Mansoura University'}}}}