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NCT Number: NCT06909084

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

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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Key information

Conditions

Otitis Media With Effusion in Children Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otitis Otitis Media Otitis Media with Effusion Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allama Iqbal Teaching Hospital Dera Ghazi Khan

Dera Ghazi Khan, Punjab Province, 32200, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myringotomy with ventilation tube

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

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.

Primary outcomes

  1. Improvement in hearing

    Time frame: Before and Three months post operatively

    The degree of hearing loss (dB) on pure tone audiometry was done before and after surgical procedure. Improvement in hearing level was labelled if there was decrease in hearing loss of 25% from baseline.

Secondary outcomes

  1. Hearing Loss (dB)

    Time frame: Before and Three months post operatively

    All patients underwent pure tone audiometry for assessment of hearing loss (dB)

  2. Degree of Hearing Loss

    Time frame: Before and Three months post operatively

    The degree of hearing loss (dB) on pure tone audiometry was done before and after surgical procedure. Degree of hearing loss was labelled as mild (20-40 dB), moderate (40-60 dB) and severe (60-80 dB).

Sponsors and collaborators

Lead sponsor

Allama Iqbal Teaching Hospital

Other Gov

Registry information

Official study title

Comparison of Outcome of Myringotomy With or Without Ventilation Tube in Children With Glue Ears

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2025
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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