Outcomes of Cartilage Tympanoplasty in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorAssiut University
About this trial
This study evaluates the anatomical and hearing outcomes of cartilage tympanoplasty in pediatric patients with chronic tympanic membrane perforations.
A 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.
Children 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.
The 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 8-18 years
Large, subtotal central tympanic membrane perforation or persistent same-size central perforation for 6 months before surgery
Dry perforation for 6 months duration
Conductive hearing loss attributable to tympanic membrane perforation
Disqualifiers
Cholesteatoma
Active ear infection at the time of surgery
Sensorineural hearing loss unrelated to the tympanic membrane perforation
Conductive gap > 40 dB (suggestive of ossicular chain pathology)
Trial design
Design model
Single group
Treatments tested in this trial
Cartilage Tympanoplasty
Procedure/SurgerySurgical 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.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Cartilage TympanoplastyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months postoperativelyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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