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Article History

Received: 22 May 2018

Accepted: 23 August 2018

First Online: 3 September 2018

Ethics approval and consent to participate

: The study protocol, amendments, informed consent form and patient information brochure have been reviewed and approved by the sponsor (ZonMw, The Netherlands Organization for Health Research and Development) and the accredited medical ethics committee (Commission for Research in Human Subjects, in Dutch: Commissie Mensgebonden Onderzoek (CMO), region Arnhem – Nijmegen, the Netherlands). Since the enforcement of the Centrale Commissie Mensgebonden Onderzoek (CCMO) External Review Directive in 2012, local medical ethical committees of local participating centers are no longer involved in reviewing the study protocol of multicenter research in the Netherlands and ethical approval obtained, covers all participating centers. The Medical Research Ethics Committee (MREC) “CMO Regio Arnhem-Nijmegen” determined that the RACE study does not fall under the scope of the Medical Research Involving Human Subjects Act (WMO). There will be no extra burden for the patients participating in this study, as the study does not include additional actions compared to regular care except for the questionnaires.

: Not applicable.

: Carl Wijburg is a freelance proctor (cystectomy and prostatectomy) with a per day fee from Intuitive Surgical.Charlotte Michels has no competing interests.Jorg Oddens has no competing interests.Janneke Grutters has no competing interests.Fred Witjes has no competing interests.Maroeska Rovers has no competing interests.

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