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

NCT06909084 | Completed

• 1 other identifier: U1111-1317-1361
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 1.Have their hearing evaluated before surgery
2. 2.Undergo either myringotomy with ventilation tube insertion or myringotomy alone
3. 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

Keywords

Otitis Media with Effusion; Hearing Loss; Children; Middle ear Ventilation

Outcome Measures

Primary Outcomes (1)

• Improvement in hearing

  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.

  Before and Three months post operatively

Secondary Outcomes (2)

• Hearing Loss (dB)

  Before and Three months post operatively

• Degree of Hearing Loss

  Before and Three months post operatively

Study Arms (2)

Myringotomy with Ventilation tube

EXPERIMENTAL

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)

Procedure: Myringotomy with ventilation tube

Myringotomy alone

ACTIVE COMPARATOR

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)

Procedure: Myringotomy alone

Interventions

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 with Ventilation tube

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.

Myringotomy alone

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children having recurrent otitis media
• Discharging ears
• History of bleeding disorder

Sponsors & Collaborators

• Allama Iqbal Teaching Hospital: lead

Study Sites (1)

Allama Iqbal Teaching Hospital Dera Ghazi Khan

Dera Ghazi Khan, Punjab Province, 32200, Pakistan

Location

MeSH Terms

Conditions

Hearing Loss; Otitis Media with Effusion

Interventions

Middle Ear Ventilation

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Otitis Media; Otitis

Intervention Hierarchy (Ancestors)

Ostomy; Surgical Procedures, Operative; Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures

Study Officials

• Dr. Sharbaz Hussain Khosa, FCPS

  Allama Iqbal Teaching Hospital Dera Ghazi Khan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: January 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)