PD42-02 RESULTS OF THE INTRACORPOREAL ROBOTIC VS OPEN CYSTECTOMY (IROC) MULTI-CENTRE RANDOMISED TRIAL

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You have accessJournal of UrologyCME1 May 2022PD42-02 RESULTS OF THE INTRACORPOREAL ROBOTIC VS OPEN CYSTECTOMY (IROC) MULTI-CENTRE RANDOMISED TRIAL Pramit Khetrapal, James Catto, Gareth Ambler, Frederico Ricciardi, Shamim Khan, Andrew Feber, Simon Dixon, Norman Williams, Imran Ahmed, Philip Charlesworth, Marcus Cumberbatch, Syed Hussain, Aidan Noon, Sanjeev Kotwal, Edward Rowe, Anthony Koupparis, John McGrath, Nikhil Vasdev, Chris Brew-Graves, Daryl Hagan, John Kelly, and iROC Trial Study Group Pramit KhetrapalPramit Khetrapal More articles by this author , James CattoJames Catto More articles by this author , Gareth AmblerGareth Ambler More articles by this author , Frederico RicciardiFrederico Ricciardi More articles by this author , Shamim KhanShamim Khan More articles by this author , Andrew FeberAndrew Feber More articles by this author , Simon DixonSimon Dixon More articles by this author , Norman WilliamsNorman Williams More articles by this author , Imran AhmedImran Ahmed More articles by this author , Philip CharlesworthPhilip Charlesworth More articles by this author , Marcus CumberbatchMarcus Cumberbatch More articles by this author , Syed HussainSyed Hussain More articles by this author , Aidan NoonAidan Noon More articles by this author , Sanjeev KotwalSanjeev Kotwal More articles by this author , Edward RoweEdward Rowe More articles by this author , Anthony KoupparisAnthony Koupparis More articles by this author , John McGrathJohn McGrath More articles by this author , Nikhil VasdevNikhil Vasdev More articles by this author , Chris Brew-GravesChris Brew-Graves More articles by this author , Daryl HaganDaryl Hagan More articles by this author , John KellyJohn Kelly More articles by this author , and iROC Trial Study Group More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002603.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract 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 recu