Clinical Trials Logo
  1. Home
  2. Chronic Otitis Media
  3. NCT00271778
  4. Details
NCT00271778 Clinical Trial

A Comparative Study of the Outcomes of 2 Surgical Procedures for Safe Type of Chronic Otitis Media

Chronic Otitis Media Clinical Trial

Official title:
A Randomized Control Study of the Outcomes of Mastoidotympanoplasty Versus Tympanoplasty in Quiescent Tubotympanic Otitis Media

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00271778
Other study ID # M06b/2003-04
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received January 3, 2006
Last updated January 3, 2006
Start date July 2003
Est. completion date June 2006

Study information
Verified date December 2005
Source Karnataka Institute of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority India: Ministry of Health
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• mastoidotympanoplasty and tympanoplasty

Locations
Country Name City State
India Department of ENT, KIMS Hubli Karnataka

Sponsors (1)
Lead Sponsor Collaborator
Karnataka Institute of Medical Sciences

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pure tone audiometry
Primary Impedance audiometry
Primary Otoendoscopy
Primary External ear canal dimensions
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03294421 - Combined Access Closed Tympanomastoidectomy: Microsurgery Allied to Endoscopy N/A
Completed NCT01855425 - Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose N/A
Not yet recruiting NCT01157910 - Bacterial Assessment of Middle Ear Fluid in Children Undergoing Ventilation Tube Placement Surgery N/A
Completed NCT02226718 - Validation of a Questionnaire for Measuring Quality of Life in Patients With Chronic Inflammation of the Middle Ear
Not yet recruiting NCT06398899 - Sugammadex v.s. Neostigmine/Glycopyrrolate N/A
Completed NCT02495038 - Optimal Dose of Combination of Rocuronium and Cisatracurium N/A
Completed NCT01251432 - Risk Factors and Potential Causes of Eustachian Tube Dysfunction in Adults N/A
Withdrawn NCT04423952 - Validity of the French Version of the Quality of Life Questionnaire COMQ12-FR
Active, not recruiting NCT00270660 - A Study of the Clinicopathologic Behaviour of the Different Types of Unsafe Chronic Otitis Media Phase 3
Completed NCT01188551 - Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement Phase 2/Phase 3
Completed NCT04374266 - Tegmen Defect Management During Mastoidectomy
Completed NCT00189098 - Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media N/A
Completed NCT04864912 - Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery
Active, not recruiting NCT04396145 - The Effects of Chronic Otitis Surgery on SVV
Completed NCT02716376 - Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy N/A
Completed NCT00941993 - Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus N/A