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

Chronic Otitis Media Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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:

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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00271778
Study type Interventional
Source Karnataka Institute of Medical Sciences
Contact
Status Active, not recruiting
Phase Phase 3
Start date July 2003
Completion date June 2006
View Details
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