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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2006-06-30

Brief Summary

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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

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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:

1. Improvement of hearing
2. Closure of tympanic perforation
3. Recurrence of disease
4. external ear canal stenosis

Tools for measurement of outcomes \[before and after surgery\]:

1. Pure tone audiometry
2. Impedance audiometry
3. Otoendoscopy
4. External ear canal dimensions

Conditions

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Chronic Otitis Media Tubotympanic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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mastoidotympanoplasty and tympanoplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

\-

Minimum Eligible Age

10 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Vikram K Bhat, MS, DNB.

Role: PRINCIPAL_INVESTIGATOR

Karnataka Institute of Medical Sciences, Hubli, India

Khaja Naseeruddin, MS, DLO.

Role: STUDY_DIRECTOR

Vijayanagar Institute of Medical Sciences, Bellary, India

Locations

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Department of ENT, KIMS

Hubli, Karnataka, India

Site Status

Countries

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India

Other Identifiers

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M06b/2003-04

Identifier Type: -

Identifier Source: org_study_id