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Objectives: To assess and compare peri-operative outcomes of patients undergoing robot-assisted partial nephrectomy (RAPN) for imperative vs elective indications., Patient and Methods: We retrospectively reviewed a multinational database of 3802 adults who underwent RAPN for elective and imperative indications. Laparoscopic or open partial nephrectomy (PN) were excluded. Baseline data for age, gender, body mass index, American Society of Anaesthesiologists score and PADUA score were examined. Patients undergoing RAPN for an imperative indication were matched to those having surgery for an elective indication using propensity scores in a 1:3 ratio. Primary outcomes included organ ischaemic time, operating time, estimated blood loss (EBL), rate of blood transfusions, Clavien-Dindo complications, conversion to radical nephrectomy (RN) and positive surgical margin (PSM) status., Results: After propensity-score matching for baseline variables, a total of 304 patients (76 imperative vs 228 elective indications) were included in the final analysis. No significant differences were found between groups for ischaemia time (19.9 vs 19.8 min; P = 0.94), operating time (186 vs 180 min; P = 0.55), EBL (217 vs 190 mL; P = 0.43), rate of blood transfusions (2.7% vs 3.7%; P = 0.51), or Clavien-Dindo complications (P = 0.31). A 38.6% (SD 47.9) decrease in Day-1 postoperative estimated glomerular filtration rate was observed in the imperative indication group and an 11.3% (SD 45.1) decrease was observed in the elective indication group (P < 0.005). There were no recorded cases of permanent or temporary dialysis. There were no conversions to RN in the imperative group, and seven conversions (5.6%) in the elective group (P = 0.69). PSMs were seen in 1.4% (1/76) of the imperative group and in 3.3% of the elective group (7/228; P = 0.69)., Conclusion: We conclude that RAPN is feasible and safe for imperative indications and demonstrates similar outcomes to those achieved for elective indications., (© 2021 The Authors BJU International © 2021 BJU International Published by John Wiley & Sons Ltd.)

Objective: To predict intra-operative (IOEs) and postoperative events (POEs) consequential to the derailment of the ideal clinical course of patient recovery., Materials and Methods: The Vattikuti Collective Quality Initiative is a multi-institutional dataset of patients who underwent robot-assisted partial nephectomy for kidney tumours. Machine-learning (ML) models were constructed to predict IOEs and POEs using logistic regression, random forest and neural networks. The models to predict IOEs used patient demographics and preoperative data. In addition to these, intra-operative data were used to predict POEs. Performance on the test dataset was assessed using area under the receiver-operating characteristic curve (AUC-ROC) and area under the precision-recall curve (PR-AUC)., Results: The rates of IOEs and POEs were 5.62% and 20.98%, respectively. Models for predicting IOEs were constructed using data from 1690 patients and 38 variables; the best model had an AUC-ROC of 0.858 (95% confidence interval [CI] 0.762, 0.936) and a PR-AUC of 0.590 (95% CI 0.400, 0.759). Models for predicting POEs were trained using data from 1406 patients and 59 variables; the best model had an AUC-ROC of 0.875 (95% CI 0.834, 0.913) and a PR-AUC 0.706 (95% CI, 0.610, 0.790)., Conclusions: The performance of the ML models in the present study was encouraging. Further validation in a multi-institutional clinical setting with larger datasets would be necessary to establish their clinical value. ML models can be used to predict significant events during and after surgery with good accuracy, paving the way for application in clinical practice to predict and intervene at an opportune time to avert complications and improve patient outcomes., (© 2020 The Authors BJU International © 2020 BJU International Published by John Wiley & Sons Ltd.)

Objective: To compare survival outcome between chemoradiation therapy (CRT) and radical cystectomy (RC) for muscle-invasive bladder cancer (MIBC)., Patients and Methods: We conducted a retrospective analysis of patients with MIBC (≥cT2, N0, M0) in the National Cancer Database (2004-2013). CRT was defined as a radiation dose of ≥40 Gy and chemotherapy within 90 days of radiation. Descriptive statistics were used to compare groups. RC and CRT patients were propensity matched. Kaplan-Meier analysis was used to compare overall survival (OS). Multivariable Cox regression was used to determine predictors of survival., Results: In all, 8 379 (6 606 RC and 1 773 CRT) patients met the inclusion criteria and 1 683 patients in each group were propensity matched. On multivariable extended Cox analysis, significant predictors of decreased OS were age, Charlson-Deyo Comorbidity score of 1, Charlson-Deyo Comorbidity score of 2, stage cT3-4, and urothelial histology. CRT was associated with decreased mortality at year 1 (hazard ratio [HR] 0.84, 95% confidence interval [CI] 0.74-0.96; P = 0.01), but at 2 years (HR 1.4, 95% CI 1.2-1.6; P < 0.001) and 3 years onward (HR 1.5, 95% CI 1.2-1.8; P < 0.001) CRT was associated with increased mortality. The 5-year OS was greater for RC than for CRT (38% vs 30%, P = 0.004)., Conclusions: Initially after treatment for MIBC the risk of mortality is lower with CRT compared to RC. However, at ≥2 years after treatment the mortality risk favours RC. Patients who are suitable surgical candidates, with a low risk of morbidity, may be better served by RC., (© 2018 The Authors BJU International © 2018 BJU International Published by John Wiley & Sons Ltd.)

Objective: To determine whether there is a survival difference for African-American men (AAM) versus Caucasian American men (CM) with penile squamous cell carcinoma (pSCC), particularly in locally advanced and metastatic cases where disease mortality is highest., Patients and Methods: Using the Florida Cancer Data System, we identified men with pSCC from 2005 to 2013. We compared age, follow-up, stage, race, and treatment type between AAM and CM. We performed Kaplan-Meier analysis for overall survival (OS) between AAM and CM for all stages, and for those with locally advanced and metastatic disease. A multivariable model was developed to determine significant predictors of OS., Results: In all, 653 men (94 AAM and 559 CM) had pSCC and 198 (30%) had locally advanced and/or metastatic disease. A higher proportion of AAM had locally advanced and/or metastatic disease compared to CM (38 [40%] vs 160 [29%], P = 0.03). The median (interquartile range) follow-up for the entire cohort was 12.6 (5.4-32.0) months. For all stages, AAM had a significantly lower median OS compared to CM (26 vs 36 months, P = 0.03). For locally advanced and metastatic disease, there was a consistent trend toward disparity in median OS between AAM and CM (17 vs 22 months, P = 0.06). After adjusting for age, stage, grade, and treatment type, AAM with pSCC had a greater likelihood of death compared to CM (hazard ratio 1.64, P = 0.014)., Conclusions: AAM have worse OS compared to CM with pSCC and this may partly be due to advanced stage at presentation. Treatment disparity may also contribute to lessened survival in AAM, but we were unable to demonstrate a significant difference in treatment utilisation between the groups., (© 2018 The Authors BJU International © 2018 BJU International Published by John Wiley & Sons Ltd.)

Objective: To assess the 1-year renal functional changes in patients undergoing partial nephrectomy with intra-operative renal biopsies., Patients and Methods: A total of 40 patients with a single renal mass deemed fit for a partial nephrectomy were recruited prospectively between January 2009 and October 2010. We performed renal biopsies of normal renal parenchyma and collected serum markers before, during and after surgically induced renal clamp ischaemia during the partial nephrectomy. We then followed patients clinically with interval serum creatinine and physical examination., Results: Peri-operative data from 40 patients showed a transient increase in creatinine levels which did not correlate with ischaemia time. Renal ultrastructural changes were generally mild and included mitochondrial swelling, which resolved at the post-perfusion biopsy. A total of 37 patients had 1-year follow-up data. Creatinine at 1 year increased by 0.121 mg/dL, which represents a 12.99% decrease in renal function from baseline (preoperative creatinine 0.823 mg/dL, estimated glomerular filtration rate = 93.9 mL/min/1.73 m(2) ). The only factors predicting creatinine change on multivariate analysis were patient age, race and ischaemia type, with cold ischaemia being associated with higher creatinine level. Importantly, the duration of ischaemia did not show any significant correlation with renal function change, either as a continuous variable (P = 0.452) or as a categorical variable (P = 0.792)., Conclusions: Our data suggest that limited ischaemia is generally well tolerated in the setting of partial nephrectomy and does not directly correspond to long-term renal functional decline. For surgeons performing partial nephrectomy, the kidney can be safely clamped to ensure optimum oncological outcomes., Competing Interests: Conflicts of Interest: None declared., (© 2015 The Authors BJU International © 2015 BJU International Published by John Wiley & Sons Ltd.)

Objective: To evaluate the outcomes of robot-assisted partial nephrectomy (RAPN) in cystic tumours, analysing a large, multi-institutional, retrospective series of RAPN, as limited data are available about the outcome of RAPN in cystic tumours., Patients and Methods: We evaluated 465 patients who received RAPN for either cystic or solid tumours from 2010 to 2013 and included in the multi-institutional, retrospective Vattikuti Global Quality Initiative in Robotic Urologic Surgery (GQI-RUS) database. Univariable and multivariable linear and logistic regression models addressed the association of cystic tumours with perioperative outcomes., Results: In all, 54 (12%) tumours were cystic. Cystic tumours were associated with significantly lower operative time (t -3.9; P < 0.001), once adjusted for the effect of covariates, whereas blood loss and warm ischaemia time were similar. Postoperative any grade complications were recorded in 66 solid (16%) and nine cystic (17%) tumours (P = 0.08). In multivariable analysis, cystic tumours were not associated with a significantly lower risk of any grade postoperative complications [odds ratio (OR) 0.9; P = 0.8]. Similarly, presence of tumours with cystic features was not associated with a significantly different risk of high-grade postoperative complications (OR 2.2; P = 0.1). Prevalence of cancer histology and positive surgical margin rates were similar in cystic and solid tumours. Cystic tumours were not associated with significantly different postoperative estimated glomerular filtration rate (t 0.4; P = 0.7), once adjusted for the effect of covariates., Conclusions: RAPN can be performed in cystic renal tumours with perioperative, pathological, and functional outcomes similar to those achievable in solid tumours., (© 2015 The Authors BJU International © 2015 BJU International Published by John Wiley & Sons Ltd.)

The purpose of the RAZOR (randomized open vs robotic cystectomy) study is to compare open radical cystectomy (ORC) vs robot-assisted RC (RARC), pelvic lymph node dissection (PLND) and urinary diversion for oncological outcomes, complications and health-related quality of life (HRQL) measures with a primary endpoint of 2-year progression-free survival (PFS). RAZOR is a multi-institutional, randomized, non-inferior, phase III trial that will enrol at least 320 patients with T1-T4, N0-N1, M0 bladder cancer with ≈160 patients in both the RARC and ORC arms at 15 participating institutions. Data will be collected prospectively at each institution for cancer outcomes, complications of surgery and HRQL measures, and then submitted to trial data management services Cancer Research and Biostatistics (CRAB) for final analyses. To date, 306 patients have been randomized and accrual to the RAZOR trial is expected to conclude in 2014. In this study, we report the RAZOR trial experimental design, objectives, data safety, and monitoring, and accrual update. The RAZOR trial is a landmark study in urological oncology, randomizing T1-T4, N0-N1, M0 patients with bladder cancer to ORC vs RARC, PLND and urinary diversion. RAZOR is a multi-institutional, non-inferiority trial evaluating cancer outcomes, surgical complications and HRQL measures of ORC vs RARC with a primary endpoint of 2-year PFS. Full data from the RAZOR trial are not expected until 2016-2017., (© 2014 The Authors. BJU International © 2014 BJU International.)

Objective: To compare health-related quality-of-life (HRQoL) outcomes for robot-assisted laparoscopic radical cystectomy (RARC) with those of traditional open radical cystectomy (ORC) in a prospective randomised fashion., Patients and Methods: This was a prospective randomised clinical trial evaluating the HRQoL for ORC vs RARC in consecutive patients from July 2009 to June 2011. We administered the Functional Assessment of Cancer Therapy-Vanderbilt Cystectomy Index questionnaire, validated to assess HRQoL, preoperatively and then at 3, 6, 9 and 12 months postoperatively. Scores for each domain and total scores were compared in terms of deviation from preoperative values for both the RARC and the ORC cohorts. Multivariate linear regression was used to assess the association between the type of radical cystectomy and HRQoL., Results: At the time of the study, 47 patients had met the inclusion criteria, with 40 patients being randomised for analysis. The cohorts consisted of 20 patients undergoing ORC and 20 undergoing RARC, who were balanced with respect to baseline demographic and clinical features. Univariate analysis showed a return to baseline scores at 3 months postoperatively in all measured domains with no statistically significant difference among the various domains between the RARC and the ORC cohorts. Multivariate analysis showed no difference in HRQoL between the two approaches in any of the various domains, with the exception of a slightly higher physical well-being score in the RARC group at 6 months., Conclusions: There were no significant differences in the HRQoL outcomes between ORC and RARC, with a return of quality of life scores to baseline scores 3 months after radical cystectomy in both cohorts., (© 2014 The Authors. BJU International © 2014 BJU International.)

Unlabelled: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: No cost-effectiveness studies exist in patients after radical cystectomy for the routine use of alvimopan for the prevention of postoperative ileus. The present study provides a reasonable estimate of the cost-effectiveness of alvimopan for the prevention of postoperative ileus in the patient after radical cystectomy., Objective: To determine if the cost of administering alvimopan, to help restore bowel function after abdominal surgery, to all patients undergoing radical cystectomy (RC) is cost prohibitive., Patients and Methods: A cost-effective analysis was conducted from a healthcare payer perspective using a decision-tree model that incorporated direct healthcare costs and probabilities associated with the possible events and outcomes. Sensitivity analyses were conducted on the influence of the cost and effectiveness of the drug, the probability of POI in RC patients, and the extended length of stay (LOS) as a result of POI. Precision in estimates was determined using probabilistic sensitivity analyses with 5000 Monte-Carlo simulations., Results: Under the base case assumption, the additional cost of a patient's LOS related to POI was $10 246 per person. Under the assumption that 15.6% of patients will have POI, the mean cost associated with POI in a cohort of patients not treated with alvimopan was $1597 (90% confidence interval [CI] $1335-1875) per patient. Conversely, the routine use of alvimopan for all patients undergoing RC was associated with a mean POI-associated cost of $1495(90% CI $1312-1696) per person, which represents the cost of alvimopan ($700 per hospitalisation) and a 50% reduction in the rate of POI. Sensitivity analyses revealed that there is a cost savings with the routine use of alvimopan under the following conditions: the POI results in extending LOS by ≥3.5 days, POI occurs in ≥14% of patients undergoing RC, or the drug results in a relative risk reduction of ≥44%., Conclusions: Routine use of perioperative alvimopan may not be cost prohibitive because of its influence on POI rate and associated costs. The cost-effectiveness of alvimopan is influenced by the POI incidence and the degree to which the drug can decrease the LOS., (© 2012 BJU International.)

Objective: To prospectively evaluate p53 overexpression as a predictor of survival in patients with a first diagnosis of T1 transitional cell carcinoma (TCC) of the bladder, as several reports implicate p53 as an important prognostic marker for progression and survival, but all previous studies were retrospective, giving conflicting and irreproducible results, rendering inappropriate any attempt at integrating p53 into clinical decision-making., Patients and Methods: Patients with a first diagnosis of T1 TCC of the bladder were enrolled; p53 overexpression was assessed by immunohistochemistry (IHC) using both monoclonal antibody 1801 and DO7. The pathological stage and IHC score were assigned by one pathologist, and the markers were scored categorically., Results: Of the 89 patients who were evaluable, 53 had p53-positive tumours. The median follow-up for the survivors was 52 months. Eighty-two patients had high-grade tumours, using the World Health Organisation/International Society of Urological Pathology 1998 grading system. Fifty-eight patients had unifocal tumours and 34 had associated carcinoma in situ. The 3 year and 5 year overall survival rates were 81% (95% Cl: 73%, 90%) and 68% (95% Cl: 56%, 80%) respectively. The 3 year and 5 year disease specific survival rates were 87% (95% Cl: 79%, 94%) and 79% (95% Cl: 70%, 89%) respectively. There was no difference in disease-specific survival between patients with and without p53 over expression (p=0.56) [corrected], Conclusions: p53 tissue typing by IHC in a prospective cohort of patients with T1 bladder cancer was not clinically useful as a prognostic marker in a contemporary series of T1 tumours.