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

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

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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 12months. 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.
Original languageEnglish
Article number861
JournalBMC Cancer
Volume18
Issue number1
DOIs
Publication statusPublished - 2018

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