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To compare the postoperative hearing outcomes in patients with chronic otitis media after Ossiculoplasty

To Compare The Postoperative Hearing Outcomes In Patients With Chronic Otitis Media After Ossiculoplasty Using Autologous Cartilage And Synthetic Prosthesis - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089833
Enrollment
56
Registered
2025-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H661- Chronic tubotympanic suppurative otitis media

Interventions

Intervention1: Autograft: From baseline to end of study at 7th day, 15th day, 90th day and 180 day Control Intervention1: synthetic prosthesis: From Baseline to end of the study at the time point 7th

Sponsors

Government Institute of Medical Sciences Greater Noida
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Age 18-50 years. -Inactive mucosal chronic otitis media -Air bone gap of more than 25 dB and ossicular chain necrosis. -Good cochlear reserve. -Normal eustachian tube function. -Patients willing to participate and who provide informed written consent for participation in the study.

Exclusion criteria

Exclusion criteria: -Active mucosal chronic otitis media -Active squamosal chronic otitis media -Inactive squamosal chronic otitis media -Patients with sensorineural hearing loss -Patients with complications of CSOM -Revision surgery -Otosclerosis /Fixed stapes footplate -Patients with only functioning ear -Patients with Chronic Tonsillitis and Adenoid Hypertrophy.

Design outcomes

Primary

MeasureTime frame
Pure Tone AverageTimepoint: Pre- and postoperative PTA (usually average of 0.5, 1, 2, 3 kHz) in Decibels.

Secondary

MeasureTime frame
-Speech Discrimination Score (SDS): Improvement or stability postoperatively -Graft Integration / Extrusion Rate: Incidence of graft failure or extrusion -Revision Surgery Requirement: Need for revision ossiculoplasty or tympanoplasty -Middle Ear Status (on follow-up): Middle ear mucosa, eustachian tube function.Timepoint: from baseline to end of treatment

Countries

India

Contacts

Public ContactDr Versha Singh

Government Institute of Medical Sciences

singhversha246@gmail.com9027248035

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026