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

• Sponsor: Karnataka Institute of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00271778
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 35
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Otitis Media; Tubotympanic Disease	Procedure: mastoidotympanoplasty and tympanoplasty	Phase 3

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: A Randomized Control Study of the Outcomes of Mastoidotympanoplasty Versus Tympanoplasty in Quiescent Tubotympanic Otitis Media
• Study Start Date: Jul 1, 2003
• Study Completion Date: Jun 1, 2006

Outcome Measures

Primary Outcome Measures

1. Pure tone audiometry []

2. Impedance audiometry []

3. Otoendoscopy []

4. External ear canal dimensions []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00271778
• Other Study ID Numbers: M06b/2003-04
• First Posted: Jan 4, 2006
• Last Update Posted: Jan 4, 2006
• Last Verified: Dec 1, 2005

• Keywords provided by , ,: Otitis media suppurative; surgery ear
• Additional relevant MeSH terms: Otitis; Otitis Media

Study Results

No Results Posted as of Jan 4, 2006