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NCT07866222
Outcomes of Cartilage Tympanoplasty in Children
Conditions: Tympanic Membrane Perforation, Conductive Hearing Loss, Chronic Otitis Media
Sex: All
Ages: 8 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 35
Sponsor: Assiut University
Summary
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
Inclusion Criteria:
* 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
* Patients able to undergo preoperative and postoperative audiological assessment
* Written informed consent obtained from the parent/legal guardian and assent from the child when appropriate
Exclusion Criteria:
* 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)
* Congenital middle-ear abnormalities affecting the surgical outcome
Source: ClinicalTrials.gov (NCT07866222). StuddyBuddy aggregates publicly available trial information.