To compare the postoperative hearing outcomes in patients with chronic otitis media after Ossiculoplasty
- Conditions
- Chronic tubotympanic suppurative otitis media,
- Registration Number
- CTRI/2025/06/089833
- Lead Sponsor
- Government Institute of Medical Sciences Greater Noida
- Brief Summary
Aim: To compare the hearing outcomes in patients of chronic otitis media using autologous cartilage and synthetic prosthesis after ossiculoplasty. Objectives 1. To evaluate the hearing outcomes in terms of air bone gap closure in each group after ossiculoplasty. 2. To compare the accuracy of prognostic indices with hearing outcomes after ossiculoplasty. Operational Definitions Chronic Suppurative Otitis Media (CSOM): A chronic inflammation of the middle ear and mastoid cavity is characterized by persistent or recurrent ear discharge through a perforated tympanic membrane, lasting more than 6–12 weeks. Ossiculoplasty: A surgical procedure to reconstruct the ossicular chain in the middle ear to restore sound transmission often performed in CSOM patients with ossicular erosion or discontinuity. Autologous Cartilage: Cartilage tissue harvested from the patient’s own body, used as a biological material to reconstruct the ossicular chain. Synthetic Prosthesis: Man-made materials such as teflon are used as prosthesis for ossicular chain reconstruction. Active (mucosal) Chronic otitis Media : Permanent defect of the pars tensa where there is an inflamed middle ear mucosa which produces mucopus. Active (squamosal) Chronic otitis Media: Retraction of the pars flaccida or tensa that has retained squamous epithelial debris and is 8 associated with cholesteatoma formation. Inactive (squamosal) Chronic otitis media : Retraction of the pars flaccida or pars tensa (usually poster superior) which is self cleansing. Good Cochlear Reserve: A good cochlear reserve means that the inner ear (cochlea) remains capable of adequately perceiving sound once sound conduction is restored. Clinically, it is indicated by near-normal bone conduction thresholds on pure tone audiometry. Post-operative Hearing Outcome: The change in auditory function is measured by pure tone audiometry (PTA), specifically assessed by air-bone gap (ABG) closure and improvement from preoperative values. Air-Bone Gap (ABG): It is the difference (in decibels) between air conduction and bone conduction thresholds on PTA. It is used to quantify conductive hearing loss.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 56
- 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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pure Tone Average Pre- and postoperative PTA (usually average of 0.5, 1, 2, 3 kHz) | in Decibels.
- Secondary Outcome Measures
Name Time Method -Speech Discrimination Score (SDS): Improvement or stability postoperatively -Graft Integration / Extrusion Rate: Incidence of graft failure or extrusion
Trial Locations
- Locations (1)
Government Institute of Medical Sciences (GIMS)
🇮🇳Nagar, UTTAR PRADESH, India
Government Institute of Medical Sciences (GIMS)🇮🇳Nagar, UTTAR PRADESH, IndiaDr Monika PatelPrincipal investigator9028738326drmpatel85@gmail.com