Study Title: A phase III multicentre randomised controlled trial to compare the efficacy of Robotically Assisted Radical Cystectomy (RARC) and intracorporeal urinary diversion with Open Radical Cystectomy (ORC) in patients with bladder cancer.
Short Title: iROC
iROC is a prospective multicentre randomised controlled trial comparing the outcomes from Intracorporeal RARC (iRARC) with open radical cystectomy (ORC) in patients with bladder cancer. The study will recruit patients with non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancer (MIBC) who have selected radical cystectomy (RC) for the treatment of BC. The time of interest for measurement of the primary outcomes will be 90 days post-surgery. Eligible patients will include those receiving neo-adjuvant chemotherapy (typically gemcitabine and cisplatin) and those having either an ileal conduit or a neo-bladder reconstruction.
Patients who have selected RC after appropriate counselling and following a specialist multi-disciplinary team (SMDT) recommendation, will be approached and asked to consent for this study.
Consenting participants will be randomised 1:1 to either iRARC or ORC. Patients will be followed for a minimum of 90 days post-surgery.
Trial assessments will be conducted at baseline (before RC), whilst participants are on admission and then 5, 12, 24weeks and 1 year post surgery.
Sponsor: University College London
Supported by: The Urology Foundation and The Champniss Foundation
ClinicalTrials.gov Identifier: NCT03049410