A Study of the Clinicopathologic Behaviour of the Different Types of Unsafe Chronic Otitis Media

NCT ID: NCT00270660

Last Updated: 2006-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-07-31

Study Completion Date

2005-12-31

Brief Summary

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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?

Detailed Description

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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

Conditions

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Chronic Otitis Media Cholesteatoma

Keywords

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retraction pockets ear unsafe otitis media otitis media complications

Study Design

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Study Time Perspective

OTHER

Interventions

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biopsy, audiometry, ET function test, ear swab culture, DNE

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

1. tubotympanic otitis media alone
2. otitis media with effusion
3. Acute otitis media -
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karnataka Institute of Medical Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Vikram K Bhat, MS, DNB.

Role: PRINCIPAL_INVESTIGATOR

Karnataka Institute of Medical Sciences, Hubli, India

Khaja Naseeruddin, MS, DLO.

Role: STUDY_DIRECTOR

Vijayanagar Institute of Medical Sciences, Bellary, India

Locations

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Department of ENT, KIMS

Hubli, Karnataka, India

Site Status

Countries

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India

Other Identifiers

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M06a/2003-04

Identifier Type: -

Identifier Source: org_study_id