Ropen Radical Cystectomy Versus Robot-Assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Early Outcomes of 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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Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial

Supportive Care in Cancer ◽

10.1007/s00520-021-06002-5 ◽

2021 ◽

Author(s):

Ruth E. Ashton ◽

Jonathan J. Aning ◽

Garry A. Tew ◽

Wendy A Robson ◽

John M Saxton

Keyword(s):

Randomised Controlled Trial ◽

Radical Prostatectomy ◽

Muscular Strength ◽

Controlled Trial ◽

Control Group ◽

Robot Assisted ◽

Resistance Exercise Training ◽

Home Based ◽

Aerobic Exercise Capacity ◽

Randomised Controlled

Abstract Purpose To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP). Methods This study was a single-site, two-arm randomised controlled trial, with 40 participants randomised to either the intervention or control group over a 10-month period. In addition to receiving usual care, the intervention group completed three weekly RET sessions using resistance bands for 6 months. Participants performed 3 sets of 12–15 repetitions for each exercise, targeting each major muscle group. The control group received usual care only. Brachial artery flow-mediated dilatation (FMD) was the primary outcome and assessed at baseline, 3 and 6 months. Secondary outcomes included body weight, body fat, aerobic fitness, strength and blood-borne biomarkers associated with cardiometabolic risk. Results There was no significant difference between the groups in FMD at 3 or 6 months. However, there were improvements in aerobic exercise capacity (P < 0.01) and upper- (P < 0.01) and lower-limb (P = 0.01) strength in favour of the RET group at 6 months, accompanied by greater weight loss (P = 0.04) and a reduction in body fat (P = 0.02). Improvements in HRQoL were evident in the RET group at 3 and 6 months via the PCa-specific component of the FACT-P questionnaire (both P < 0.01). Five adverse events and one serious adverse event were reported throughout the trial duration. Conclusion This study demonstrates that home-based RET is an effective and safe mode of exercise that elicits beneficial effects on aerobic exercise capacity, muscular strength and HR-QoL in men who have undergone RARP. Trial registration ISRCTN10490647.

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