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Setup of a national multi center RCT to evaluate the cost effectiveness of follow-up with diffusion-weighted MRI versus 2nd look surgery after primary cholesteatoma treatment

Presenting Author: Robert Jan Pauw

Published online by Cambridge University Press:  03 June 2016

Robert Jan Pauw  and
Paul Merkus
Robert Jan Pauw
Affiliation:
Erasmus MC
Paul Merkus
Affiliation:
VU University Medical Center Amsterdam
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Abstract

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Learning Objectives: To inform on the setup of a national multi center RCT in The Netherlands that aims to evaluate the cost effectiveness of follow-up with diffusion-weighted MRI versus 2nd look surgery after primary cholesteatoma treatment.

In The Netherlands we have set up a prospective multicenter randomized controlled trial to evaluate the cost effectiveness of follow-up with diffusion-weighted MRI versus 2nd look surgery after primary cholesteatoma treatment. The planned start of the trial is in the 2nd half of 2016. The aims and objectives of the trial as well as the methodology will be discussed.

Research questions:

  1. 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. 2. Is a diffusion-weighted MRI follow-up strategy cost-effective compared to second look surgery?

  3. 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.

Patients and methods: An economic evaluation alongside a prospective multicenter randomized controlled trial with an intention-to-treat analysis plus additional observational study will be performed. 132 patients of 16 years and older after primary cholesteatoma surgery treatment with normal to mild conductive hearing loss will be included and randomized in either.

‘Annual diffusion-weighted MRI during 3 consecutive years, starting 1 year after primary surgery’ or ‘Second look surgery 1 year after primary surgery and follow-up during 3 consecutive years’.

Outcome measures

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

  2. 2. The costs of three years follow-up.

  3. 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.