Open vs robot-assisted radical cystectomy (BORARC): a double-blinded, randomised feasibility study.

OBJECTIVE: To examine surgical outcomes and feasibility of blinding patients and care providers to the surgical technique of radical cystectomy (RC). PATIENTS AND METHODS: Single-centre, parallel-group, double-blinded, randomised feasibility study of open RC (ORC) vs robot-assisted RC with intracorporeal urinary diversion (iRARC) in an 'Enhanced Recovery After Surgery' setup. A total of 50 patients aged ≥18 years with bladder cancer planned for RC with an ileal conduit were included. Patients with previous major abdominal/pelvic surgery, pelvic radiation or anaesthesiological contraindications were excluded. Primary outcomes were proportion of unblinded patients and success of blinding using Bang's Blinding Index. Secondary outcomes included length of stay (LOS), complication rates, blood loss, pain, and opioid consumption. RESULTS: A total of 26% of the patients were unblinded before discharge. We demonstrated that patients and doctors remained blinded for the allocated treatment, but nurses did not. Blood loss was greater in the ORC group as was operative time in the iRARC group. We found no difference in complication rate, LOS, or use of analgesics. CONCLUSIONS: The present study demonstrates that blinding of surgical technique in RC is possible. The results of secondary outcomes are consistent with the findings of previous unblinded randomised controlled trials. Our study highlights that it is possible to perform a blinded phase III study to explore the optimal surgical technique in RC.

Morbidity and Days Alive and Out of Hospital Within 90 Days Following Radical Cystectomy for Bladder Cancer.

BACKGROUND: Morbidity after radical cystectomy (RC) is usually quantified in terms of rates of complications, mortality, reoperations, and readmissions, and length of stay (LOS). The overall burden following RC within the first 90 d following RC may be better described using days alive and out of hospital (DAOH), which is a validated, patient-centred proxy for both morbidity and mortality. OBJECTIVE: To report short-term morbidity, LOS, and DAOH within 90 d after RC and risk factors associated with these parameters. DESIGN SETTING AND PARTICIPANTS: The study included 729 patients undergoing RC for bladder cancer at a single academic centre from 2009 to 2019. Data were retrieved from national electronic medical charts. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Multivariate analysis was used to investigate variables associated with a major complication, LOS >7 d, and DAOH <80 d. RESULTS AND LIMITATIONS: The 90-d complication rate was 80%, including major complications in 37% of cases. Median LOS was 7 d (interquartile range (IQR) 6-9) and median DAOH was 80 d (IQR 71-83) days. Body mass index and the Charlson comorbidity index (CCI) predicted major complications. CCI predicted LOS >7 d and DAOH <80 d. CONCLUSIONS: RC was associated with significant short-term morbidity and DAOH was a good marker for cumulative morbidity after RC. We propose that DAOH should be a standard supplement for reporting surgical outcomes following RC for bladder cancer, which may facilitate better comparison of outcomes across treating institutions. PATIENT SUMMARY: We studied complications after surgical removal of the bladder for bladder cancer. We assessed a novel patient-centred tool that more accurately describes the total burden of complications after surgery than traditional models. We found that patients with a high body mass index and coexisting chronic diseases had a higher risk of a complicated surgical course.