A Comparative Study of the Outcomes of 2 Surgical Procedures for Safe Type of Chronic Otitis Media - Full Text View

Sponsored by:	Karnataka Institute of Medical Sciences
Information provided by:	Karnataka Institute of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00271778

Purpose

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.

Condition	Intervention	Phase
Chronic Otitis Media Tubotympanic Disease	Procedure: mastoidotympanoplasty and tympanoplasty	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Control Study of the Outcomes of Mastoidotympanoplasty Versus Tympanoplasty in Quiescent Tubotympanic Otitis Media

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections Surgery

U.S. FDA Resources

Further study details as provided by Karnataka Institute of Medical Sciences:

Primary Outcome Measures:

Pure tone audiometry
Impedance audiometry
Otoendoscopy
External ear canal dimensions

Estimated Enrollment:	60
Study Start Date:	July 2003
Estimated Study Completion Date:	June 2006

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:

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

Eligibility

Ages Eligible for Study:	10 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271778

Locations

India, Karnataka
Department of ENT, KIMS
HUBLI, Karnataka, India, 580021

Sponsors and Collaborators

Karnataka Institute of Medical Sciences

Investigators

Principal Investigator:	Vikram K Bhat, MS, DNB.	Karnataka Institute of Medical Sciences, Hubli, India
Study Director:	Khaja Naseeruddin, MS, DLO.	Vijayanagar Institute of Medical Sciences, Bellary, India

More Information

No publications provided

Study ID Numbers:	M06b/2003-04
Study First Received:	January 3, 2006
Last Updated:	January 3, 2006
ClinicalTrials.gov Identifier:	NCT00271778 History of Changes
Health Authority:	India: Ministry of Health

Keywords provided by Karnataka Institute of Medical Sciences:

Otitis media suppurative
surgery ear

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Otitis
Otitis Media

Suppuration
Otitis Media, Suppurative
Ear Diseases

Additional relevant MeSH terms:

Otorhinolaryngologic Diseases
Otitis
Otitis Media
Ear Diseases

ClinicalTrials.gov processed this record on July 02, 2009