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

November 29, 2006 updated by: Karnataka Institute of Medical Sciences

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

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?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • "hubli", Karnataka, India, 580021
        • Department of ENT, KIMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

December 23, 2005

First Submitted That Met QC Criteria

December 23, 2005

First Posted (Estimate)

December 28, 2005

Study Record Updates

Last Update Posted (Estimate)

November 30, 2006

Last Update Submitted That Met QC Criteria

November 29, 2006

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M06a/2003-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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