Cost effectiveness of MRI diffusion in cholesteatoma follow-up
- Conditions
- ENG: Cholesteatoma, MRI, Hearing, Cost-effectiveness, Quality of Life, QALYDUTCH: Cholesteatoom, MRI, Gehoor, Kosteneffectiviteit, Kwaliteit van Leven, QALY
- Registration Number
- NL-OMON26889
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 153
Inclusion Criteria
•16 years of age or older.
•patients who underwent a surgical procedure (canal wall up tympanoplasty) for eradication of primary acquired or recurrent cholesteatoma
Exclusion Criteria
•patients who underwent a canal wall down tympanoplasty procedure as last ear surgical procedure (patients with a canal wall down procedure in the last 10 months will be requested to participate in the cholesteatoma observational study)
•patients with a moderate to severe average air-bone gap of more than (>) 20 dB (patients eligible for a chain reconstruction will be requested to participate in the cholesteatoma observational study)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.The degree of hearing loss (in average air-bone gap (dB))and high and low Fletcher index in each year of follow-up after primary cholesteatoma surgery
- Secondary Outcome Measures
Name Time Method 2.The estimated costs of three years follow-up (especially in Observational CWU follow-up)<br /><br>3.The outcomes of health related quality of life questionnaires (EQ-5D, OQUA, AIAHD)in each year of follow-up after primary cholesteatoma surgery.<br /><br>4.The number of additional surgeries with cholesteatoma present (number of residual and recurrent cholesteatoma)<br /><br>5.The number of additional surgeries without cholesteatoma to improve the hearing<br /><br>6.The number and nature of the complications