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 because the information has not been verified recently.
Verified December 2005 by Karnataka Institute of Medical Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Karnataka Institute of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00271778
First received: January 3, 2006
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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.

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
  Eligibility

Ages Eligible for Study:   10 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271778

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

No publications provided

ClinicalTrials.gov Identifier: NCT00271778     History of Changes
Other Study ID Numbers: M06b/2003-04
Study First Received: January 3, 2006
Last Updated: January 3, 2006
Health Authority: India: Ministry of Health

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

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014