An interventional study of Myringotomy with ventilation tube and Myringotomy alone in Otitis Media With Effusion in Children and Hearing Loss, sponsored by Allama Iqbal Teaching Hospital. Completed at 1 site in Pakistan. Open to participants aged 5 Years to 14 Years. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by Allama Iqbal Teaching Hospital · Not applicable, Interventional, and Treatment
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:
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's enrollment of 60 is above the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Allama Iqbal Teaching Hospital is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
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.
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.
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.
Time frame: Before and Three months post operatively
Hearing Loss (dB)
All patients underwent pure tone audiometry for assessment of hearing loss (dB)
Time frame: Before and Three months post operatively
Degree of Hearing Loss
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).
Time frame: Before and Three months post operatively
Plan to share: No — Individual participant data (IPD) might not be shared because it contains sensitive personal health information. Sharing such data could compromise participant confidentiality and privacy, and may conflict with ethical guidelines, informed consent, and regulatory requirements.
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Sep 2024, 8 months.
Of 196 non-industry interventional studies with no phase under Hearing Loss, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 59. This study's 8 months is below that.
Counting every sponsor, half of 321 studies reached it within 19 months; a quarter within 5 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Allama Iqbal Teaching Hospital