NCT06909084

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Allama Iqbal Teaching Hospital · Other Government
• Sex: All
• Age: 5 Years – 14 Years
• Healthy volunteers: Not accepted

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

Conditions

• Otitis Media With Effusion in Children
• Hearing Loss

Interventions

Type	Name	Description
PROCEDURE	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.
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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-09-30
• Completion: 2024-12-31
• First posted: 2025-04-03
• Last updated: 2025-04-03

Locations

1 site across 1 country: Pakistan