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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hearing Loss (dB) | All patients underwent pure tone audiometry for assessment of hearing loss (dB) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Sharbaz Hussain Khosa, FCPS | Allama Iqbal Teaching Hospital Dera Ghazi Khan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allama Iqbal Teaching Hospital Dera Ghazi Khan | Dera Ghazi Khan | Punjab Province | 32200 | Pakistan |
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.
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|
| 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. |
|
| Before and Three months post operatively |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D010034 | Otitis Media with Effusion |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010033 | Otitis Media |
| D010031 | Otitis |
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| ID | Term |
|---|---|
| D008876 | Middle Ear Ventilation |
| ID | Term |
|---|---|
| D010030 | Ostomy |
| D013514 | Surgical Procedures, Operative |
| D013506 | Otologic Surgical Procedures |
| D013517 | Otorhinolaryngologic Surgical Procedures |
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