Introduction and objective
The role of minimal access surgery using a robotic platform to perform radical cystectomy and intracorporeal diversion is unclear and the potential for gain such as early recovery and reduced complication rates are largely based on observational case series.
Methods
The iROC trial is the first RCT comparing intracorporeal robot-assisted RC (iRARC) vs open RC (ORC). Nine centres in the UK recruited patients into the iROC trial with a 1:1 randomisation. The primary endpoint of the trial was days alive and out of hospital within 90 days following surgery (90DAOH). Secondary outcomes were survival, complications, physical activity, quality of life (QoL) and cancer recurrenceTrial registration: ISRCTN13680280 and NCT03049410.
Results
338 patients were randomised, of which 317 had cystectomy and 21 did not have cystectomy. Of these, 301 (95.0%) received their allocated approach. Most participants were male (78.9%), the average age was 69 years (SD 8.2), 19 (6.0%) were over 80 years old and most were current or ex-smokers (71%). 34% received neoadjuvant chemotherapy. Most patients underwent ileal conduit reconstruction (89%). Patients randomised to iRARC spent more days out of hospital (median 82 days (IQR 76 to 84)) than those receiving Open RC (80 (72 to 83 days (72 to 83) for ORC (p=0.012); adj. p=0.012) within 90 days of surgery. This reflected shorter lengths of stay (iRARC median 7 days (6 to 10) versus ORC 8 (6 to 14)) and fewer readmissions. 6 (1.8%) participants died within 90 days of surgery (including 4 who received ORC). Differences were seen in the rate and type of post-operative complications. WHODAS 2.0 and EORTC QLQ-C30 QoL scores reported improved outcomes from iRARC compared to ORC until 12 weeks post-op, but were similar by 26 weeks. Activity levels measured by fitness trackers were significantly higher in the immediate post-operative period, but not significantly different by 5 weeks post-operatively. No difference in cancer recurrence or overall survival was seen.
Conclusions
In this trial, patients undergoing iRARC spent fewer days in hospital within 90 days of surgery, and may offer quicker recovery than ORC. No difference was detected in overall or cancer specific survival.
Source of funding
Funded by The Urological Foundation and the Champniss Foundation