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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Karnataka Institute of Medical Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Karnataka Institute of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00270660
First received: December 23, 2005
Last updated: November 29, 2006
Last verified: December 2005
History of Changes
  Purpose

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
Cholesteatoma
 Behavioral: biopsy, audiometry, ET function test, ear swab culture, DNE
 Phase 3

Study Type: Observational
Study Design: Additional Descriptors: Convenience Sample
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:

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

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

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
  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270660

Locations
India
Department of ENT, KIMS
"hubli", Karnataka, India, 580021
Sponsors and Collaborators
Karnataka Institute of Medical Sciences
Investigators
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

No publications provided

ClinicalTrials.gov 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:
Cholesteatoma
Otitis
Otitis Media
Keratosis
 Skin Diseases
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013