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Cost effectiveness of MRI diffusion in cholesteatoma follow-up


- candidate number25284
- NTR NumberNTR6087
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-sep-2016
- Secondary IDsABR/CCMO: NL50862.___.16 ZonMw project: 80-83700-98-16504
- Public TitleCost effectiveness of MRI diffusion in cholesteatoma follow-up
- Scientific TitleCost effectiveness of follow-up with diffusion-weighted MRI versus surgical follow-up after cholesteatoma treatment
- ACRONYMDCD
- hypothesisDiffusion-weighted MRI is a cost-effective follow-up strategy after primary cholesteatoma surgery compared to the usual care, 2nd look surgery with equal quality of care in terms of hearing, cholesteatoma detection rate, complications and quality of life.
- Healt Condition(s) or Problem(s) studiedCholesteatoma, MRI, Cost-effectiveness
- 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
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 or 1,2 and 4 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)
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.)
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-dec-2016
- planned closingdate30-nov-2020
- Target number of participants153
- InterventionsOnly questionnaires will be extra for all patients Half of the patients will undergo the standard care, which is a second look surgery intervention 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)
- Primary outcome1. 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 outcome2. The estimated costs of three years follow-up (especially in Observational CWU follow-up)
3. The outcomes of health related quality of life questionnaires (EQ-5D, OQUA, AIAHD)in each year of follow-up after primary cholesteatoma surgery.
4. The number of additional surgeries with cholesteatoma present (number of residual and recurrent cholesteatoma)
5. The number of additional surgeries without cholesteatoma to improve the hearing
6. The number and nature of the complications
- TimepointsTIME SCHEDULE (months)
0-12 inclusion of participants
6-18 first intervention
30 two year follow-up and 85% of all interventions completed
34-48 start implementation, national and local meetings and guideline group
44-48 completion of the data gathering, analysis and publication
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Paul Merkus
- CONTACT for SCIENTIFIC QUERIESDr. Paul Merkus
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryBACKGROUND
Eradication and follow-up of a cholesteatoma (a keratin 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.

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?

HYPOTHESIS
Diffusion-weighted MRI is a cost-effective follow-up strategy after primary cholesteatoma surgery compared to the usual care, 2nd look surgery with equal quality of care in terms of hearing, cholesteatoma detection rate, complications and quality of life.

STUDY DESIGN
Economic evaluation alongside a prospective multicenter randomized controlled trial with an intention-to-treat analysis plus additional observational study.

STUDY POPULATION(S)/DATASETS
153 patients of 16 years and older after primary or recurrent cholesteatoma surgery treatment with normal to mild conductive hearing loss.

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.

OUTCOME MEASURES
1. The degree of hearing loss after 3 thee years of follow-up
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

SAMPLE SIZE CALCULATION/DATA ANALYSIS
To detect a clinically relevant difference of 8dB conductive hearing loss, the minimal number of participants needed after 3 year follow-up is: 122 (61 in each arm). Because of an expected drop-out of 20%, 153 patients will be included..

COST-EFFECTIVENESS ANALYSIS/ BUDGET IMPACT ANALYSIS
An economic evaluation will be performed from a societal as well as a healthcare perspective
Intervention costs of surgery and MRI will be estimated using a micro-costing approach.
Both a cost-effectiveness analysis in terms of the primary outcome (hearing) and a cost-utility analysis (QALYs) will be performed. Economic evaluations will be performed in accordance with the intention-to-threat principle

TIME SCHEDULE (months)
0-12 inclusion of participants
6-18 first intervention
30 two year follow-up and 85% of all interventions completed
34-48 start implementation, national and local meetings and guideline group
44-48 completion of the data gathering, analysis and publication

KEYWORDS
Cholesteatoma, MRI, Hearing, Cost-effectiveness, Quality of Life, QALY
- Main changes (audit trail)
- RECORD13-sep-2016 - 11-nov-2016


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