This trial is active, not recruiting.

Conditions chronic otitis media, cholesteatoma
Treatment biopsy, audiometry, et function test, ear swab culture, dne
Phase phase 3
Sponsor Karnataka Institute of Medical Sciences
Start date July 2003
End date December 2005
Trial size 192 participants
Trial identifier NCT00270660, M06a/2003-04


The purpose of the study is to study the clinicopathologic behaviour of the 3 dangerous types of chronic otitis media that are prone for complications. In which type are the complications more common? Which type gives rise to more hearing loss? How does the disease process in the 3 types evolve? should the 3 types of otitis media be managed differently?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose screening
Time perspective cross-sectional

Eligibility Criteria

Male or female participants at least 8 years old.

Inclusion Criteria:1. Atticoantral chronic otitis media 2. complicated unsafe otitis media 3. Otitis media with cholesteatoma, polyp, granulation tissue 4. Ear with retraction pockets leading to attic - Exclusion Criteria: 1. tubotympanic otitis media alone 2. otitis media with effusion 3. Acute otitis media -

Additional Information

Official title A Cross Sectional Study of Clinicopathologic Behaviour of Primary, Secondary and Mixed Types of Atticoantral Chronic Otitis Media
Principal investigator Vikram K Bhat, MS, DNB.
Description Design: prospective cross sectional study setting: tertiary referral medical college hospital No of groups: 3 group 1: primary acquired atticoantral disease group 2: secondary acquired atticoantral disease group 3: mixed atticoantral disease Interventions: 1. Diagnostic nasal endoscopy 2. Eustachian tube function tests 3. Pure tone audiometry 4. biopsy of middle ear mucosa 5. culture and sensitivity of ear discharge
Trial information was received from ClinicalTrials.gov and was last updated in November 2006.
Information provided to ClinicalTrials.gov by Karnataka Institute of Medical Sciences.