Cost effectiveness of follow-up with diffusion-weighted MRI versus surgical follow-up after cholesteatoma treatment.

Recruiting

Conditions: cholesteatoma
middle ear sac of skin
10027584

Registration Number: NL-OMON47835

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 153

Inclusion Criteria

Inclusion criteria RCT
* 18 years of age or older.
* patients who underwent a surgical procedure (canal wall up tympanoplasty) for eradication of primary or recurrent acquired cholesteatoma
* primary surgery at a maximum of 11 months prior to the start of the study.
* patients with normal to mild conductive hearing loss, defined as:
mean air-bone gap of less than or equal to (*) 20dB on pure tone audiometry at frequencies of 0.5, 1 and 2 kHz .
* capable and willing to participate in a follow-up study of three years

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, which is an anonymous follow-up study of usual care in post-cholesteatoma surgery patients without randomization);* 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);* patients not capable to undergo a MRI (claustrophobic, metal parts or implants in the body etc.)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>OUTCOME MEASURES<br /><br>1. The degree of hearing loss after 3 thee years of follow-up</p><br>

Secondary Outcome Measures

Name	Time	Method
<p><br /><br>2. The costs of three years follow-up<br /><br>3. The number of 2nd look surgeries without cholesteatoma present (unnecessary<br /><br>surgical procedures)and the number of residual and recurrent cholesteatoma,<br /><br>health related quality of life and number of complications</p><br>