EAU 2019: The iROC trial: An RCT Comparing Intracorporeal Robot-Assisted vs Open Radical Cystectomy for Bladder Cancer

Barcelona, Spain (UroToday.com) It is rare to see a surgical clinical trial, but these studies are important to continue to advance the field forward – and to question techniques that have been used indefinitely based on experience but without much evidence.

Robotic surgery has had an increasing role in the field of urologic oncology, first taking over robotic prostatectomy and then robotic kidney surgery. More recently, the emphasis has been on robotic cystectomy. While many have adopted the robotic cystectomy, the use of the robotic for the diversion platform had required a more significant learning curve and the adoption has been much slower.

To date, 5 RCTs have been published comparing open radical cystectomy (ORC) and Robotic Radical Cystectomy (RARC). However, all trials have used the extracorporeal approach (eRARC) for urinary diversion (and found no difference in 3 month morbidity/mortality), but no RCT has been undertaken to compare intracorporeal RARC (iRARC) to eRARC. Per the authors, iRARC offers theoretical benefits of a completely MIS approach when compared to eRARC, and therefore, they felt that an RCT in this setting would be informative of the potential benefits.

Study Design:
Prospective randomized controlled trial – randomizing patients in multiple high-volume centers in the UK in a 1:1 fashion to either open radical cystectomy (ORC) or intracorporeal Robotic Radical Cystectomy (iRARC). This was planned over a 3 year period.

Inclusion/Exclusion:
Surgeons recruiting into the trial must have performed >30 RCs using the technique they would be operating for the trial and have 90-day mortality of <5%. All surgical centers operating as part of the iROC trial agreed to withdraw robot-assisted RC from the standard of care and only offered it through the trial.

Of note, only centers performing > 35 RCs/year and who had enhanced recovery programs in place were allowed to join

Outcomes:
The primary outcome of the iROC trial is days alive and out of the hospital at 90 days.

Secondary outcome: to assess recovery and complications in patients undergoing iRARC vs. eRARC.

  • Patients issued a fitness tracker to wear at 4 different time points: baseline, POD #5, 1 month and 3 months post-op
Expected and actual enrollment:
The expected sample size was 340 patients.

To date: 155 patients recruited, exceeding initial enrollment expectations – but still under the 212 expected at this time. They are expected to meet sample size before 3 years. This is likely due to the withdrawal of RARC from routine care in these centers.

8 sites are recruiting currently.

Preliminary Results:
Preliminary fitness tracker data is shown below:
EAU 2019 iroc copy

This is not separated out by treatment type – but indicates the data collected and the trends in the post-operative period. Patients don’t appear to reach their pre-op baseline until 6 months.

Presented by: Pramit Khetrapal, MD, Department of Urology, the University College of London, London, United Kingdom

Written by: Thenappan Chandrasekar, MD (Clinical Instructor, Thomas Jefferson University) (twitter: @tchandra_uromd, @JEFFUrology) at the 34th European Association of Urology (EAU 2019) #EAU19 conference in Barcelona, Spain, March 15-19, 2019.
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