MedTrace Logo

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

NCT06909084 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Allama Iqbal Teaching Hospital

    lead OTHER_GOV

Principal Investigators

  • Dr. Sharbaz Hussain Khosa, FCPS · Allama Iqbal Teaching Hospital Dera Ghazi Khan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06909084 on ClinicalTrials.gov