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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00271778
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
January 3, 2006
January 4, 2006
January 4, 2006
July 2003
Not Provided
  • Pure tone audiometry
  • Impedance audiometry
  • Otoendoscopy
  • External ear canal dimensions
Same as current
No Changes Posted
Not Provided
Not Provided
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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
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.

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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
  • Chronic Otitis Media
  • Tubotympanic Disease
Procedure: mastoidotympanoplasty and tympanoplasty
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
June 2006
Not Provided

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

Sexes Eligible for Study: All
10 Years to 50 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT00271778
M06b/2003-04
Not Provided
Not Provided
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Karnataka Institute of Medical Sciences
Not Provided
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
Karnataka Institute of Medical Sciences
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP