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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:
Tools for measurement of outcomes [before and after surgery]:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mastoidotympanoplasty and tympanoplasty | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Pure tone audiometry | ||
| Impedance audiometry | ||
| Otoendoscopy | ||
| External ear canal dimensions |
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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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| Name | Affiliation | Role |
|---|---|---|
| Vikram K Bhat, MS, DNB. | Karnataka Institute of Medical Sciences, Hubli, India | Principal Investigator |
| Khaja Naseeruddin, MS, DLO. | Vijayanagar Institute of Medical Sciences, Bellary, India | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of ENT, KIMS | Hubli | Karnataka | 580021 | India |
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| ID | Term |
|---|---|
| D010035 | Otitis Media, Suppurative |
| ID | Term |
|---|---|
| D013492 | Suppuration |
| D007239 | Infections |
| D010033 | Otitis Media |
| D010031 | Otitis |
| D004427 |
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| ID | Term |
|---|---|
| D014433 | Tympanoplasty |
| ID | Term |
|---|---|
| D013506 | Otologic Surgical Procedures |
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |