Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00271778
Status:
UNKNOWN
Last Update Posted:
2006-01-04
First Post:
2006-01-03
Brief Title:
A Comparative Study of the Outcomes of 2 Surgical Procedures for Safe Type of Chronic Otitis Media
Sponsor:
Karnataka Institute of Medical Sciences
Organization:
Karnataka Institute of Medical Sciences
Study Overview
Official Title:
A Randomized Control Study of the Outcomes of Mastoidotympanoplasty Versus Tympanoplasty in Quiescent Tubotympanic Otitis Media
Status:
UNKNOWN
Status Verified Date:
2005-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None