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

Phase 3

• Conditions: Chronic Otitis Media; Tubotympanic Disease

• Registration Number: NCT00271778
• Lead Sponsor: Karnataka Institute of Medical Sciences

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:

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 Timeline

• Study Start: 2003-07
• Status Verified: 2005-12
• Study First Submitted: 2006-01-03
• Study First Submitted QC: 2006-01-03
• Last Update Submitted: 2006-01-03
• Study First Posted: 2006-01-04
• Last Update Posted: 2006-01-04
• Study Completion: 2006-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pure tone audiometry
Impedance audiometry
Otoendoscopy
External ear canal dimensions

Trial Locations

Locations (1)

Department of ENT, KIMS; 🇮🇳 Hubli, Karnataka, India