Clinical Trial: A Comparative Study of the Outcomes of 2 Surgical Procedures for Safe Type of Chronic Otitis Media
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Randomized Control Study of the Outcomes of Mastoidotympanoplasty Versus Tympanoplasty in Quiescent Tubotympanic Otitis Media
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 Summary:
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
Sponsor: Karnataka Institute of Medical Sciences
Current Primary Outcome:
- Pure tone audiometry
- Impedance audiometry
- Otoendoscopy
- External ear canal dimensions
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Karnataka Institute of Medical Sciences
Dates:
Date Received: January 3, 2006
Date Started: July 2003
Date Completion: June 2006
Last Updated: January 3, 2006
Last Verified: December 2005
