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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00271778

Enrollment

Registered

2006-01-04

Start date

2003-07-31

Completion date

2006-06-30

Last updated

2006-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Otitis Media, Tubotympanic Disease

Keywords

Otitis media suppurative, surgery ear

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

Interventions

PROCEDUREmastoidotympanoplasty and tympanoplasty

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

10 Years to 50 Years

Healthy volunteers

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 \-

Design outcomes

Primary

Measure	Time frame
Pure tone audiometry	—
Impedance audiometry	—
Otoendoscopy	—
External ear canal dimensions	—

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026