OBJECTIVE(S)/RESEARCH QUESTION(S) 1. Are the hearing levels after three years of follow-up with annual diffusion-weighted MRI comparable to those after follow-up with second look surgery?2. Is a diffusion-weighted MRI follow-up strategy cost-…
ID
Source
Brief title
Condition
- Middle ear disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
OUTCOME MEASURES
1. The degree of hearing loss after 3 thee years of follow-up
Secondary outcome
2. The costs of three years follow-up
3. The number of 2nd look surgeries without cholesteatoma present (unnecessary
surgical procedures)and the number of residual and recurrent cholesteatoma,
health related quality of life and number of complications
Background summary
BACKGROUND
Eradication and follow-up of a cholesteatoma (a keratine mass in the ear) is
mandatory because it is a slow growing but destructive disease with the risk of
hearing loss, imbalance or facial nerve paralysis. Follow-up must be done
because in about 20% there is a residual cholesteatoma.
Study objective
OBJECTIVE(S)/RESEARCH QUESTION(S)
1. Are the hearing levels after three years of follow-up with annual
diffusion-weighted MRI comparable to those after follow-up with second look
surgery?
2. Is a diffusion-weighted MRI follow-up strategy cost-effective compared to
second look surgery?
3.Are other outcome measures (residual and recurrent cholesteatoma, quality of
life and adverse events) comparable between both follow-up strategies?
Study design
STUDY DESIGN
Economic evaluation alongside a prospective multicenter randomized controlled
trial with an intention-to-treat analysis plus additional observational study.
Intervention
INTERVENTION
Annual diffusion-weighted MRI during 3 consecutive years, starting 1 year after
primary surgery.
STANDARD INTERVENTION TO BE COMPARED TO
Second look surgery 1 year after primary surgery and follow-up during 3
consecutive years.
Study burden and risks
Only questionnaires will be extra for all patients
Half of the patients will undergo the standard care, which is a tympanoplasty/
second look surgery including one day hospitalization.
The other half will undergo each year a MRI scan of around 40 minutes
There are NO additional interventions which are part of the research, they are
all part of the normal follow-up (like audiogram, otoscopy)
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
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.)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50862.029.16 |
| Other | NTR application pending |