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

This study is ongoing, but not recruiting participants.
Information provided by:
Karnataka Institute of Medical Sciences Identifier:
First received: December 23, 2005
Last updated: November 29, 2006
Last verified: December 2005
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?

Condition Intervention Phase
Chronic Otitis Media
Behavioral: biopsy, audiometry, ET function test, ear swab culture, DNE
Phase 3

Study Type: Observational
Study Design: Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: A Cross Sectional Study of Clinicopathologic Behaviour of Primary, Secondary and Mixed Types of Atticoantral Chronic Otitis Media

Resource links provided by NLM:

Further study details as provided by Karnataka Institute of Medical Sciences:

Estimated Enrollment: 192
Study Start Date: July 2003
Estimated Study Completion Date: December 2005
Detailed 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


  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

Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 -
  Contacts and Locations
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Please refer to this study by its identifier: NCT00270660

Department of ENT, KIMS
"hubli", Karnataka, India, 580021
Sponsors and Collaborators
Karnataka Institute of Medical Sciences
Principal Investigator: Vikram K Bhat, MS, DNB. Karnataka Institute of Medical Sciences, Hubli, India
Study Director: Khaja Naseeruddin, MS, DLO. Vijayanagar Institute of Medical Sciences, Bellary, India
  More Information Identifier: NCT00270660     History of Changes
Other Study ID Numbers: M06a/2003-04 
Study First Received: December 23, 2005
Last Updated: November 29, 2006
Health Authority: India: Institutional Review Board

Keywords provided by Karnataka Institute of Medical Sciences:
retraction pockets ear
unsafe otitis media
otitis media complications

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Skin Diseases processed this record on January 17, 2017