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

Chronic Otitis Media Clinical Trial

Official title:

A Cross Sectional Study of Clinicopathologic Behaviour of Primary, Secondary and Mixed Types of Atticoantral Chronic Otitis Media

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00270660
• Other study ID #: M06a/2003-04
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 23, 2005
• Last updated: November 29, 2006
• Start date: July 2003
• Est. completion date: December 2005

Study information

• Verified date: December 2005
• Source: Karnataka Institute of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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?

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 192
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years and older

Eligibility

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 -

Study Design

Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cholesteatoma
• Chronic Otitis Media
• Otitis
• Otitis Media

Intervention

Behavioral:
• biopsy, audiometry, ET function test, ear swab culture, DNE

Locations

Country	Name	City	State
India	Department of ENT, KIMS	"hubli"	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Karnataka Institute of Medical Sciences

Country where clinical trial is conducted

India,