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

Allama Iqbal Teaching Hospital

Status: Completed

Conditions: Hearing Loss; Otitis Media With Effusion in Children

Treatments: Procedure: Myringotomy with ventilation tube; Procedure: Myringotomy alone

Study type: Interventional

Funder types: Other

Identifiers

NCT06909084

U1111-1317-1361

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 5 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Myringotomy with Ventilation tube

Experimental group

Description:

A tympanostomy tube (Shepard tube) of appropriate size will be placed in the incision and canal will be packed with bismuth iodoform paraffin paste (BIPP)

Treatment:

Procedure: Myringotomy with ventilation tube

Myringotomy alone

Active Comparator group

Description:

Incision in the eardrum (myringotomy) will be made. Middle ear canal will be cleaned after draining the fluid and the canal will be packed with bismuth iodoform paraffin paste (BIPP)

Treatment:

Procedure: Myringotomy alone