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Open Access 01-12-2018 | Study protocol

Robot assisted radical cystectomy versus open radical cystectomy in bladder cancer (RACE): study protocol of a non-randomized comparative effectiveness study

Authors: C. J. Wijburg, C. T. J. Michels, J. R. Oddens, J. P. C. Grutters, J. A. Witjes, M. M. Rovers

Published in: BMC Cancer | Issue 1/2018

Abstract

Background

Despite the fact that the cost-effectiveness of robot-assisted radical cystectomy (RARC) is not yet proven, and open radical (ORC) cystectomy is recommended as the standard of care in patients with high-risk non-muscle-invasive and muscle-invasive bladder cancer, the use of RARC is still increasing. The objective of the current ongoing comparative effectiveness trial therefore is to study the (cost-)effectiveness of RARC compared to ORC, both in terms of objective (complication rates, oncological outcomes) and patient-reported (health-related quality of life) outcome measures.

Methods

This study is designed as a non-randomized, multicentre comparative effectiveness trial.

Centres with an annual caseload of > 20 radical cystectomies can include patients after informed consent has been given. Centres that perform RARC must have passed the (initial) learning curve of 40 cases. A total of 338 (2 × 169) patients will be enrolled from 23 participating centres (12 ORC, 10 RARC and 1 LRC). Follow-up visits will be scheduled at 1, 3, 6 and 12 months. During each follow-up visit, clinical data and health-related quality of life questionnaires will be administered. Costs will be studied using a monthly resource usage questionnaire. Impact on complications and quality of life will be calculated as the average difference between the groups with 95% confidence intervals, adjusted for potential baseline differences by means of propensity score matching.

Discussion

This study aims to contribute to the development of evidence-based guidelines regarding the most cost-effective surgical technique for radical cystectomy.

Trial registration

Nederlands Trial Register/Dutch Trial Registry, trial identifying number: NTR5362. Registered on 14 August 2015. (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5362).

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Title: Robot assisted radical cystectomy versus open radical cystectomy in bladder cancer (RACE): study protocol of a non-randomized comparative effectiveness study
Authors: C. J. Wijburg
C. T. J. Michels
J. R. Oddens
J. P. C. Grutters
J. A. Witjes
M. M. Rovers
Publication date: 01-12-2018
Publisher: BioMed Central
Published in: BMC Cancer / Issue 1/2018
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/s12885-018-4779-6

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Abstract

Background

Methods

Discussion

Trial registration

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