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

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.

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.

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

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 ).

BMC cancer. 2018 Sep 03*** epublish ***

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

Department of Urology, Rijnstate Hospital, Wagnerlaan 55, 6815, AD, Arnhem, The Netherlands. ., Department of Urology, Rijnstate Hospital, Wagnerlaan 55, 6815, AD, Arnhem, The Netherlands., Department of Urology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands., Departments of Operating Rooms and Health Evidence, Radboud university medical center, Geert Grooteplein Noord 21, 6500, HB, Nijmegen, The Netherlands., Department of Urology, Radboud university medical center, Geert Grooteplein Noord 21, 6500, HB, Nijmegen, The Netherlands.

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