CompletedNot Applicable

Hearing Improvement After Making a Hole Surgically in Eardrum With or Without Ventilation Tube in Children With Glue Ears

Pakistan60 participantsStarted 2024-01-01

Plain-language summary

The goal of this clinical trial is to compare the effectiveness of myringotomy with ventilation tube insertion to myringotomy alone in improving hearing in children with glue ear. The main question it aims to answer is: Does adding a ventilation tube to myringotomy lead to greater improvement in hearing compared to myringotomy alone? Researchers will compare these two surgical techniques to determine which offers better outcomes for children with otitis media with effusion. The Participants will: 1. Have their hearing evaluated before surgery 2. Undergo either myringotomy with ventilation tube insertion or myringotomy alone 3. Have their hearing evaluated at follow-up visits at 2 weeks, 1 month, and 3 months post-operatively

Who can participate

Age range5 Years – 14 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * cases of otitis media with effusion * more than 20 decibel (dB) conductive hearing loss on pure tone audiometry * non-responder to medical treatment after three months of medical treatment Exclusion Criteria: * Children having recurrent otitis media * Discharging ears * History of bleeding disorder

What they're measuring

Improvement in hearing

Timeframe: Before and Three months post operatively

Trial details

NCT IDNCT06909084

SponsorAllama Iqbal Teaching Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Otitis Media With Effusion in Children trials