NCT00271778

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Karnataka Institute of Medical Sciences · Academic / Other
• Sex: All
• Age: 10 Years – 50 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Otitis Media
• Tubotympanic Disease

Interventions

Type	Name	Description
PROCEDURE	mastoidotympanoplasty and tympanoplasty

Timeline

• Start date: 2003-07-01
• Completion: 2006-06-01
• First posted: 2006-01-04
• Last updated: 2006-01-04

Locations

1 site across 1 country: India