Status:
COMPLETED
Comparison of Postoperative Outcomes of Interlay vs Underlay Graft in Tympanoplasty
Lead Sponsor:
Shaikh Zayed Hospital, Lahore
Conditions:
Chronic Otitis Media
Tympanic Membrane Perforation
Eligibility:
All Genders
16-60 years
Phase:
NA
Brief Summary
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 cal...
Eligibility Criteria
Inclusion
- Patients aged l6-60 years, of any gender.
- individuals with chronic otitis media characterized by inactive mucosal disease (absence of discharge) accompanied by a large central perforation persisting for at least 6 weeks and exhibiting pure conductive hearing loss as established through pure-tone audiometry.
Exclusion
- Presence of active otitis media manifesting acute infection or discharge.
- Patients diagnosed with tympanosclerosis or ossicular necrosis, adversely affecting ossicular chain mobility, as identified in preoperative assessments.
- History of ear surgeries, excluding myringotomy, that could potentially impact tympanoplasty outcomes, such as ossiculoplasty or mastoidectomy.
- Individuals with sensorineural or mixed hearing loss, as determined by pure-tone audiometry, indicating a possible alternate or additional source of hearing impairment.
- Conditions potentially hindering wound healing or compliance with postoperative care, including but not limited to uncontrolled diabetes mellitus or immunodeficiency disorders.
- Patients exhibiting eustachian tube dysfunction, as confirmed through clinical evaluation or medical records.
- Patients with an active focus of infection in the throat, nose, paranasal sinuses, or oral cavity, as determined by medical records.
Key Trial Info
Start Date :
January 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07149480
Start Date
January 9 2025
End Date
July 9 2025
Last Update
September 2 2025
Active Locations (1)
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1
Shaikh Zayed Medical college/hospital, Lahore
Lahore, Punjab Province, Pakistan, 54000