Ear, Nose and Throat
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18 years or older Inactive tubotympanic chronic suppurative otitis media (CSOM) Dry central tympanic membrane perforation for at least 3 months Conductive hearing loss with no sensorineural component (normal bone conduction) Intact, mobile ossicular chain Normal middle-ear mucosa on otoscopic/endoscopic examination
Exclusion criteria
Exclusion criteria: Unfit for general anaesthesia Cervical-spine disorders limiting operative positioning Active otorrhoea, granulation tissue or mucosal inflammation Atticoantral disease or cholesteatoma Traumatic perforation Previous (revision) ear surgery on the affected ear Otitis externa Sensorineural hearing loss Refusal to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Graft uptake/success (complete vs partial vs failed/re-perforated), assessed by endoscopic otoscopy;Hearing improvement — air–bone gap (ABG) closure to =20 dB or a reduction of =10 dB from baseline, by pure-tone audiometry | — |
Secondary
| Measure | Time frame |
|---|---|
| Early postoperative pain on the Visual Analogue Scale (VAS, 0–10) | — |
Countries
Egypt
Contacts
Resident