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A Comparative Study of the Outcomes of 2 Surgical Procedures for Safe Type of Chronic Otitis Media

Primary Purpose

Chronic Otitis Media, Tubotympanic Disease

Status

Unknown status

Phase

Phase 3

Locations

India

Study Type

Interventional

Intervention

mastoidotympanoplasty and tympanoplasty

About this trial

This is an interventional treatment trial for Chronic Otitis Media focused on measuring Otitis media suppurative, surgery ear

Eligibility Criteria

10 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Chronic tubotympanic otitis media in quiescent phase with intact ossicular chain - Exclusion Criteria:1. atticoantral otitis media 2. Specific otitis media 3. Sensorineural hearing loss 4. Fixed/Dislocated ossicular chain 5. Uncorrectable disease focus in nose/throat 6. Chronic otitis media in active phase 7. Chronic otitis media with complications 8. Extensive unresectable tympanosclerosis -

Sites / Locations

Department of ENT, KIMS

Outcomes

Primary Outcome Measures

Pure tone audiometry

Impedance audiometry

Otoendoscopy

External ear canal dimensions

Secondary Outcome Measures

Full Information

NCT ID

NCT00271778

First Posted

January 3, 2006

Last Updated

January 3, 2006

Sponsor

Karnataka Institute of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00271778

Brief Title

A Comparative Study of the Outcomes of 2 Surgical Procedures for Safe Type of Chronic Otitis Media

Official Title

A Randomized Control Study of the Outcomes of Mastoidotympanoplasty Versus Tympanoplasty in Quiescent Tubotympanic Otitis Media

Study Type

Interventional

2. Study Status

Record Verification Date

December 2005

Overall Recruitment Status

Unknown status

Study Start Date

July 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Karnataka Institute of Medical Sciences

4. Oversight

5. Study Description

Brief Summary

Mastoidotympanoplasty is a recognised surgery that is performed for chronic otitis media. But whether mastoidectomy in addition to tympanoplasty is really necessary in each and every case of quiescent chronic otitis media still remains controversial. Hence this study has been undertaken to study the differences in the outcomes of the 2 surgical procedures performed for chronic otitis media in a randomized control design.

Detailed Description

Design: single blinded randomized control study. Setting: Tertiary referral medical college hospital. Sample size: 60. No of groups: 2 [30 cases in each group]. Group 1: Patients undergoing mastoidotympanoplasty. Group 2: Patients undergoing tympanoplasty only. No of strata: 3. Outcomes: Improvement of hearing Closure of tympanic perforation Recurrence of disease external ear canal stenosis Tools for measurement of outcomes [before and after surgery]: Pure tone audiometry Impedance audiometry Otoendoscopy External ear canal dimensions

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Otitis Media, Tubotympanic Disease

Keywords

Otitis media suppurative, surgery ear

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

mastoidotympanoplasty and tympanoplasty

Primary Outcome Measure Information:

Title

Pure tone audiometry

Title

Impedance audiometry

Title

Otoendoscopy

Title

External ear canal dimensions

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vikram K Bhat, MS, DNB.

Organizational Affiliation

Karnataka Institute of Medical Sciences, Hubli, India

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Khaja Naseeruddin, MS, DLO.

Organizational Affiliation

Vijayanagar Institute of Medical Sciences, Bellary, India

Official's Role

Study Director

Facility Information:

Facility Name

Department of ENT, KIMS

City

Hubli

State/Province

Karnataka

ZIP/Postal Code

580021

Country

India

12. IPD Sharing Statement

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A Comparative Study of the Outcomes of 2 Surgical Procedures for Safe Type of Chronic Otitis Media

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