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 range

5 Years – 14 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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