This trial is active, not recruiting.

Conditions chronic otitis media, tubotympanic disease
Treatment mastoidotympanoplasty and tympanoplasty
Phase phase 3
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Pure tone audiometry
time frame:
Impedance audiometry
time frame:
time frame:
External ear canal dimensions
time frame:

Eligibility Criteria

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 -

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in January 2006.
Information provided to ClinicalTrials.gov by Karnataka Institute of Medical Sciences.