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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2005 by Karnataka Institute of Medical Sciences.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: January 4, 2006
Last Update Posted: January 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Karnataka Institute of Medical Sciences
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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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.


  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

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 50 Years   (Child, Adult)
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271778

Department of ENT, KIMS
Hubli, Karnataka, India, 580021
Sponsors and Collaborators
Karnataka Institute of Medical Sciences
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

ClinicalTrials.gov Identifier: NCT00271778     History of Changes
Other Study ID Numbers: M06b/2003-04
First Submitted: January 3, 2006
First Posted: January 4, 2006
Last Update Posted: January 4, 2006
Last Verified: December 2005

Keywords provided by Karnataka Institute of Medical Sciences:
Otitis media suppurative
surgery ear

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases