Robot-assisted radical cystectomy with intracorporeal urinary diversion versus open radical cystectomy (iROC): protocol for a randomised controlled trial with internal feasibility study

Bladder cancer (BC) is a common malignancy and one of the most expensive to manage. Radical cystectomy (RC) with pelvic lymphadenectomy is a gold standard treatment for high-risk BC. Reductions in morbidity and mortality from RC may be achieved through robot-assisted RC (RARC). Prospective comparisons between open RC (ORC) and RARC have been limited by sample size, use of extracorporeal reconstruction and use of outcomes important for ORC. Conversely, while RARC is gaining in popularity, there is little evidence to suggest it is superior to ORC. We are undertaking a prospective randomised controlled trial (RCT) to compare RARC with intracorporeal reconstruction (iRARC) and ORC using multimodal outcomes to explore qualitative and quantitative recovery after surgery. METHODS AND ANALYSIS: iROC is a multicentre prospective RCT in English National Health Service (NHS) cancer centres. We will randomise 320 patients undergoing RC to either iRARC or ORC. Treatment allocation will occur after trial entry and consent. The primary outcome is days alive and out of hospital within the first 90 days from surgery. Secondary outcomes will measure functional recovery (activity trackers, chair-to-stand tests and health related quality of life (HRQOL) questionnaires), morbidity (complications and readmissions), cost-effectiveness (using EuroQol-5 Domain-5 levels (EQ-5D-5L) and unit costs) and surgeon fatigue. Patients will be analysed according to intention to treat. The primary outcome will be transformed and analysed using regression. All statistical assumptions will be investigated. Secondary outcomes will be analysed using appropriate regression methods. An internal feasibility study of the first 30 patients will evaluate recruitment rates, acceptance of randomised treatment choice, compliance outcome collection and to revise our sample size.

The study has ethical approval (REC reference 16/NE/0418). Findings will be made available to patients, clinicians, funders and the NHS through peer-reviewed publications, social media and patient support groups.

ISRCTN13680280 and NCT03049410.

BMJ open. 2018 Aug 08*** epublish ***

James W F Catto, Pramit Khetrapal, Gareth Ambler, Rachael Sarpong, Muhammad Shamim Khan, Melanie Tan, Andrew Feber, Simon Dixon, Louise Goodwin, Norman R Williams, John McGrath, Edward Rowe, Anthony Koupparis, Chris Brew-Graves, John D Kelly

Academic Urology Unit, University of Sheffield, Sheffield, UK., Division of Surgery and Interventional Science, University College London, London, UK., Department of Statistical Science, University College London, London, UK., Surgical and Interventional Trials Unit (SITU), Division of Surgery and Interventional Science, University College London, London, UK., Department of Urology, Guy's and St Thomas' Hospital, London, UK., Health Economics and Decision Science, NIHR Research Design Service Yorkshire and the Humber, University of Sheffield, Sheffield, UK., Department of Urology, Royal Devon and Exeter NHS Trust, Exeter, UK., Department of Urology, North Bristol NHS Trust, Bristol, UK.