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

Karnataka Institute of Medical Sciences

Status and phase

Unknown

Phase 3

Conditions

Chronic Otitis Media

Tubotympanic Disease

Treatments

Procedure: mastoidotympanoplasty and tympanoplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT00271778

M06b/2003-04

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

10 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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