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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Otitis Media With Effusion in Children Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Myringotomy with Ventilation tube

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)

Group Type EXPERIMENTAL

Myringotomy with ventilation tube

Intervention Type PROCEDURE

Under microscope tympanic membrane was visualized after cleaning the external auditory canal and myringotomy incision was given with the help of myringotome in anteroinferior quadrant of tympanic membrane. Secretions from middle ear were drained by suction. A tympanostomy tube (Shepard tube) of appropriate size was placed in the incision and canal was packed with bismuth iodoform paraffin paste which was removed after 24 hours.

Myringotomy alone

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)

Group Type ACTIVE_COMPARATOR

Myringotomy alone

Intervention Type PROCEDURE

Under microscope tympanic membrane was visualized after cleaning the external auditory canal and myringotomy incision was given with the help of myringotome in anteroinferior quadrant of tympanic membrane. Secretions from middle ear were drained by suction. NO FURTHER PROCEDURE WAS DONE and canal was packed with bismuth iodoform paraffin paste which was removed after 24 hours.

Interventions

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Myringotomy with ventilation tube

Under microscope tympanic membrane was visualized after cleaning the external auditory canal and myringotomy incision was given with the help of myringotome in anteroinferior quadrant of tympanic membrane. Secretions from middle ear were drained by suction. A tympanostomy tube (Shepard tube) of appropriate size was placed in the incision and canal was packed with bismuth iodoform paraffin paste which was removed after 24 hours.

Intervention Type PROCEDURE

Myringotomy alone

Under microscope tympanic membrane was visualized after cleaning the external auditory canal and myringotomy incision was given with the help of myringotome in anteroinferior quadrant of tympanic membrane. Secretions from middle ear were drained by suction. NO FURTHER PROCEDURE WAS DONE and canal was packed with bismuth iodoform paraffin paste which was removed after 24 hours.

Intervention Type PROCEDURE

Eligibility Criteria

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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