ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00270660
Recruitment Status : Unknown
Verified December 2005 by Karnataka Institute of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : December 28, 2005
Last Update Posted : November 30, 2006
Sponsor:
Information provided by:
Karnataka Institute of Medical Sciences

Brief 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?

Condition or disease Intervention/treatment
Chronic Otitis Media Cholesteatoma Behavioral: biopsy, audiometry, ET function test, ear swab culture, DNE

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

Study Type : Observational
Enrollment : 192 participants
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
Study Start Date : July 2003
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

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





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00270660     History of Changes
Other Study ID Numbers: M06a/2003-04
First Posted: December 28, 2005    Key Record Dates
Last Update Posted: November 30, 2006
Last Verified: December 2005

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

Additional relevant MeSH terms:
Otitis
Otitis Media
Cholesteatoma
Ear Diseases
Otorhinolaryngologic Diseases
Keratosis
Skin Diseases