A Comparative Study of the Outcomes of 2 Surgical Procedures for Safe Type of Chronic Otitis Media
This trial is active, not recruiting.
|Conditions||chronic otitis media, tubotympanic disease|
|Treatment||mastoidotympanoplasty and tympanoplasty|
|Sponsor||Karnataka Institute of Medical Sciences|
|Start date||July 2003|
|End date||June 2006|
|Trial size||60 participants|
|Trial identifier||NCT00271778, M06b/2003-04|
Mastoidotympanoplasty is a recognised surgery that is performed for chronic otitis media. But whether mastoidectomy in addition to tympanoplasty is really necessary in each and every case of quiescent chronic otitis media still remains controversial. Hence this study has been undertaken to study the differences in the outcomes of the 2 surgical procedures performed for chronic otitis media in a randomized control design.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Pure tone audiometry
External ear canal dimensions
Male or female participants from 10 years up to 50 years old.
Inclusion Criteria:Chronic tubotympanic otitis media in quiescent phase with intact ossicular chain - Exclusion Criteria:1. atticoantral otitis media 2. Specific otitis media 3. Sensorineural hearing loss 4. Fixed/Dislocated ossicular chain 5. Uncorrectable disease focus in nose/throat 6. Chronic otitis media in active phase 7. Chronic otitis media with complications 8. Extensive unresectable tympanosclerosis -
|Official title||A Randomized Control Study of the Outcomes of Mastoidotympanoplasty Versus Tympanoplasty in Quiescent Tubotympanic Otitis Media|
|Principal investigator||Vikram K Bhat, MS, DNB.|
|Description||Design: single blinded randomized control study. Setting: Tertiary referral medical college hospital. Sample size: 60. No of groups: 2 [30 cases in each group]. Group 1: Patients undergoing mastoidotympanoplasty. Group 2: Patients undergoing tympanoplasty only. No of strata: 3. Outcomes: 1. Improvement of hearing 2. Closure of tympanic perforation 3. Recurrence of disease 4. external ear canal stenosis Tools for measurement of outcomes [before and after surgery]: 1. Pure tone audiometry 2. Impedance audiometry 3. Otoendoscopy 4. External ear canal dimensions|
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