[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659428":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":20,"interventions":27,"overallOfficials":13,"centralContacts":13,"locations":13,"responsibleParty":32,"collaborators":13,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":40,"acronym":13,"eligibilityCriteria":41,"healthyVolunteers":38,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":13,"studyType":48,"phases":49,"briefSummary":50,"conditions":51,"keywords":55,"overallStatus":62,"whyStopped":13,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":13},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants With Complete Tympanic Membrane Closure","Assessed by otoscopic and microscopic examination. Complete closure is defined as an intact, fully epithelialized, and stable graft without residual perforation, graft retraction, or lateralization.","6 months postoperatively",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE",[21],{"label":22,"type":23,"description":24,"interventionNames":25},"Cartilage Tympanoplasty","EXPERIMENTAL","Pediatric patients aged 8 to 18 years undergoing surgical repair of large, subtotal, or persistent central tympanic membrane perforations using autologous cartilage tympanoplasty to assess anatomical graft uptake and hearing restoration.",[26],"Procedure: Cartilage Tympanoplasty",[28],{"type":29,"name":22,"description":30,"armGroupLabels":31,"otherNames":13},"PROCEDURE","Surgical reconstruction of the tympanic membrane using an autologous cartilage graft in pediatric patients presenting with large, subtotal, or persistent central perforations. The procedure is performed under general anesthesia to achieve complete anatomical closure of the perforation and restore middle-ear sound conduction.",[22],{"type":33,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Hasnaa Hussein Mahmoud","Resident","100659428","outcomes-of-cartilage-tympanoplasty-in-children-100659428",false,"NCT07866222","Outcomes of Cartilage Tympanoplasty in Children","Inclusion Criteria:\n\n* Children aged 8-18 years\n* Large, subtotal central tympanic membrane perforation or persistent same-size central perforation for 6 months before surgery\n* Dry perforation for 6 months duration\n* Conductive hearing loss attributable to tympanic membrane perforation\n* Patients able to undergo preoperative and postoperative audiological assessment\n* Written informed consent obtained from the parent\u002Flegal guardian and assent from the child when appropriate\n\nExclusion Criteria:\n\n* Cholesteatoma\n* Active ear infection at the time of surgery\n* Sensorineural hearing loss unrelated to the tympanic membrane perforation\n* Conductive gap \\> 40 dB (suggestive of ossicular chain pathology)\n* Congenital middle-ear abnormalities affecting the surgical outcome","ALL","8 Years","18 Years",{"count":46,"type":47},35,"ESTIMATED","INTERVENTIONAL",[15],"This study evaluates the anatomical and hearing outcomes of cartilage tympanoplasty in pediatric patients with chronic tympanic membrane perforations.\n\nA perforation (hole) in the eardrum in children can lead to recurrent ear discharge, chronic middle-ear infections, and conductive hearing loss. Cartilage tympanoplasty is a surgical technique that uses autologous cartilage (the patient's own cartilage tissue) to reconstruct and seal the eardrum. Cartilage is known for its rigidity and resistance to retraction, which may offer advantages in children who frequently experience middle-ear pressure and ventilation issues.\n\nChildren aged 8 to 18 years presenting with large, subtotal, or persistent dry central perforations will undergo cartilage tympanoplasty at Assiut University Hospitals. All participants will undergo standardized pre-surgical and post-surgical evaluations, including otological microscopic examinations and pure-tone audiometry tests.\n\nThe main objectives are to evaluate the graft success rate (complete anatomical closure and stability of the eardrum) and to measure functional hearing restoration, specifically changes in air-conduction thresholds and the air-bone gap (ABG).",[52,53,54],"Tympanic Membrane Perforation","Conductive Hearing Loss","Chronic Otitis Media",[56,57,58,59,60,61],"Cartilage tympanoplasty","Pediatric tympanoplasty","Myringoplasty","Tympanic membrane repair","Air-bone gap","Graft take rate","NOT_YET_RECRUITING","2026-10-04",{"date":65,"type":66},"2026-10-08","ACTUAL",{"date":68,"type":47},"2026-11",{"date":70,"type":47},"2027-12",{"name":5,"class":6}]