Open vs robot-assisted radical cystectomy with totally intracorporeal urinary diversion: perioperative outcomes from a single center randomised controlled trial

IntroductionBladder 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 analysisiROC 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.Ethics and disseminationThe 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.Trial registration numbersISRCTN13680280andNCT03049410.

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Pentafecta achievement comparison between open and robot-assisted radical cystectomy with totally intracorporeal urinary diversion: Results from a randomized controlled trial

European Urology ◽

10.1016/s0302-2838(21)01190-8 ◽

2021 ◽

Vol 79 ◽

pp. S1129-S1130

Author(s):

R. Mastroianni ◽

G. Tuderti ◽

U. Anceschi ◽

A.M. Bove ◽

A. Brassetti ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Radical Cystectomy ◽

Urinary Diversion ◽

Controlled Trial ◽

Robot Assisted ◽

Randomized Controlled ◽

Intracorporeal Urinary Diversion

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The perioperative outcomes of robot-assisted radical cystectomy with intracorporeal urinary diversion compared with laparoscopic radical cystectomy with extracorporeal urinary diversion at a single institution.

10.21203/rs.3.rs-821069/v1 ◽

2021 ◽

Author(s):

Atsuto Suzuki ◽

Kentaro Muraoka ◽

Tomoyuki Tatenuma ◽

Kimito Osaka ◽

Yumiko Yokomizo ◽

...

Keyword(s):

Radical Cystectomy ◽

Urinary Diversion ◽

Ileal Conduit ◽

Oral Intake ◽

Length Of Hospital Stay ◽

Operation Time ◽

Median Number ◽

Perioperative Outcomes ◽

Robot Assisted ◽

Intracorporeal Urinary Diversion

Abstract Background The number of facilities adapting intracorporeal urinary diversion (ICUD) using robots instead of extracorporeal urinary diversion (ECUD) is increasing, but the clinical evidence is limited. Methods We retrospectively analyzed 26 consecutive patients who underwent ICUD with an ileal conduit following robot-assisted radical cystectomy (RARC) between 2018 and 2020 (RARC + ICUD group), and compared them with 26 consecutive patients who underwent ECUD with an ileal conduit following laparoscopic radical cystectomy (LRC) between 2012 and 2019 (LRC + ECUD group) at Yokohama City University. Results In both groups, the patient background was similar except for age and neoadjuvant chemotherapy. In the RARC + ICUD group vs. the LRC + ECUD group, the median total operation time was 516 min vs. 532.5 min (p = 0.217), the time to cystectomy was 163 min vs. 194.5 min (p = 0.007), and the time of urinary diversion with an ileal conduit was 161 min vs. 201.5 min (p < 0.001). The postoperative maximum value of C-reactive protein was 6.98 mg/L vs. 12.46 mg/L (p = 0.001). The median number of days to oral intake was 3 days vs. 5 days (p = 0.003). The median length of hospital stay was 17 days vs. 32 days (p < 0.001). The postoperative complication rate (within 90 days) was 23.1% vs. 42.3% (p = 0.237). Clavien-Dindo classification ≥ 3 was noted in 1 vs. 4 patients (p = 0.350). The median number of dissected lymph nodes was 20 vs. 15 (p = 0.008). Conclusions RARC + ICUD was superior to LRC + ECUD in terms of time to cystectomy and ileal conduit urinary diversion, invasiveness, and lymph node dissection. We consider ICUD with an ileal conduit following RARC to be the more advantageous procedure.

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