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Chronic otitis media is a long-term ear infection that may cause a hole in the eardrum, leading to repeated ear discharge and hearing loss. When such perforations do not heal on their own, surgery called tympanoplasty is performed to repair the eardrum and improve hearing.
There are different surgical techniques for tympanoplasty. In the underlay technique, the graft (a small piece of tissue used to repair the hole) is placed beneath the layers of the eardrum. This approach is simpler and commonly used, but it carries risks such as displacement of the graft. In the interlay technique, the graft is positioned between specific layers of the eardrum, which may allow more natural healing and better hearing results, but it is technically more demanding.
This clinical study will compare the postoperative outcomes of these two techniques-interlay and underlay-among adults with large central perforations of the eardrum caused by chronic otitis media. The main outcomes assessed will include hearing improvement (measured by closure of the air-bone gap on hearing tests).
We hypothesize that the placement of the graft significantly influences surgical success and hearing recovery. By comparing interlay versus underlay techniques, the study aims to identify which method provides better results for patients. The findings may help refine surgical approaches and improve the overall quality of life for individuals undergoing tympanoplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Underlay Technique) | Experimental | Patients will undergo tympanoplasty using the underlay graft technique. Under endoscopic guidance, the tympanomeatal flap will be elevated, and the temporalis fascia graft will be placed beneath the remaining tympanic membrane layers along the annulus. The flap will then be repositioned, and the external auditory canal will be packed. |
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| Group B (Interlay Technique) | Experimental | Patients will undergo tympanoplasty using the interlay graft technique. Under endoscopic guidance, the tympanomeatal flap will be elevated circumferentially. The temporalis fascia graft will be inserted between the fibrous and mucosal layers of the tympanic membrane, particularly beneath the handle of the malleus, before repositioning the flap. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Underlay Tympanoplasty | Procedure | Tympanoplasty performed using the underlay graft technique, where the graft is positioned beneath all three layers of the tympanic membrane remnant. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Hearing Gain (Closure in Air-Bone Gap) | The average improvement in hearing thresholds, measured by pure-tone audiometry at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz. The outcome will be assessed by calculating the difference between the preoperative and postoperative air-bone gap (ABG) values in decibels (dB). This measure evaluates the effectiveness of tympanoplasty in restoring conductive hearing loss. | 3 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaikh Zayed Medical college/hospital, Lahore | Lahore | Punjab Province | 54000 | Pakistan |
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| ID | Term |
|---|---|
| D018058 | Tympanic Membrane Perforation |
| D006314 | Hearing Loss, Conductive |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014947 | Wounds and Injuries |
| D034381 | Hearing Loss |
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| Interlay Tympanoplasty | Procedure | Tympanoplasty performed using the interlay graft technique, where the graft is positioned between the mucosal and fibrous layers of the tympanic membrane. |
|
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| D006311 |
| Hearing Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |