Incidence of Preoperative Antibiotic Use and Its Association with Postoperative Infectious Complications after Radical Cystectomy.

OBJECTIVE: To determine exposure rates to antibiotics prior to radical cystectomy and determine if there is correlation with post-operative infections. METHODS AND MATERIALS: 2248 patients were identified in the 2016 SEER-Medicare linkage who underwent radical cystectomy between 2008 and 2014 with complete prescription information. An outpatient prescription for an antibiotic within 30 days prior to cystectomy was considered exposure. Antibiotic class and combinations were recorded. Postoperative infectious diagnoses and readmissions were tabulated within 30 days of cystectomy. RESULTS: Fifty one percent of patients (n = 1149) were prescribed an outpatient antibiotic prior to cystectomy. Patients receiving antibiotics were more likely to be female (31% vs 25%, P < .01) and had been diagnosed with an infection (17% vs 11%, P < .01). Antibiotic bowel prophylaxis was prescribed to 42% of patients receiving antibiotics. Postoperatively, the exposure group had higher rates of any infection, (56% vs 51% P < .01) and UTI (36% vs 31% P < .01). All-cause readmission within 30 days was higher in the exposure cohort (26% vs 22%, P = .02) Multivariable logistic regression showed outpatient preoperative antibiotics were an independent risk factor for any infection (HR 1.19, P < .05) and readmission (hazards ratio 1.24, P = .03) in the 30 days after radical cystectomy. CONCLUSION: Outpatient antibiotic use prior to radical cystectomy is common and may be associated with increased risk of postoperative infection and readmission. Antibiotic use prior to radical cystectomy should be examined as a modifiable factor to decrease post-operative morbidity.

Comparison of Robot-Assisted and Open Radical Cystectomy in Recovery of Patient-Reported and Performance-Related Measures of Independence: A Secondary Analysis of a Randomized Clinical Trial.

Importance: No data exist on time to recovery of patient-reported and performance-related measures of functional independence after radical cystectomy (open or robotic). Objective: To determine recovery of functional independence after radical cystectomy and whether robot-assisted radical cystectomy (RARC) is associated with any advantage over open procedures. Design, Setting, and Participants: Data for this secondary analysis from the RAZOR (Randomized Open vs Robotic Cystectomy) trial were used. RAZOR was a phase 3 multicenter noninferiority trial across 15 academic medical centers in the US from July 1, 2011, to November 18, 2014, with a median follow-up of 2 years. Participants included the per-protocol population (n = 302). Data were analyzed from February 1, 2017, to May 1, 2021. Interventions: Robot-assisted radical cystectomy or open radical cystectomy (ORC). Main Outcomes and Measures: Patient-reported (activities of daily living [ADL] and independent ADL [iADL]) and performance-related (hand grip strength [HGS] and Timed Up & Go walking test [TUGWT]) measures of independence were assessed. Patterns of postoperative recovery for the entire cohort and comparisons between RARC and ORC were performed. Exploratory analyses to assess measures of independence across diversion type and to determine whether baseline impairments were associated with 90-day complications or 1-year mortality were performed. Findings: Of the 302 patients included in the analysis (254 men [84.1%]; mean [SD] age at consent, 68.0 [9.7] years), 150 underwent RARC and 152 underwent ORC. Baseline characteristics were similar in both groups. For the entire cohort, ADL, iADL, and TUGWT recovered to baseline by 3 postoperative months, whereas HGS recovered by 6 months. There was no difference between RARC and ORC for ADL, iADL, TUGWT, or HGS scores at any time. Activities of daily living recovered 1 month after RARC (mean estimated score, 7.7 [95% CI, 7.3-8.0]) vs 3 months after ORC (mean estimated score, 7.5 [95% CI, 7.2-7.8]). Hand grip strength recovered by 3 months after RARC (mean estimated HGS, 29.0 [95% CI, 26.3-31.7] kg) vs 6 months after ORC (mean estimated HGS, 31.2 [95% CI, 28.8-34.2] kg). In the RARC group, 32 of 90 patients (35.6%) showed a recovery in HGS at 3 months vs 32 of 88 (36.4%) in the ORC group (P = .91), indicating a rejection of the primary study hypothesis for HGS. Independent ADL and TUGWT recovered in 3 months for both approaches. Hand grip strength showed earlier recovery in patients undergoing continent urinary diversion (mean HGS at 3 months, 31.3 [95% CI, 27.7-34.8] vs 33.9 [95% CI, 30.5-37.3] at baseline; P = .09) than noncontinent urinary diversion (mean HGS at 6 months, 27.4 [95% CI, 24.9-30.0] vs 29.5 [95% CI, 27.2-31.9] kg at baseline; P = .02), with no differences in other parameters. Baseline impairments in any parameter were not associated with 90-day complications or 1-year mortality. Conclusions and Relevance: The results of this secondary analysis suggest that patients require 3 to 6 months to recover baseline levels after radical cystectomy irrespective of surgical approach. These data will be invaluable in patient counseling and preparation. Hand grip strength and ADL tended to recover to baseline earlier after RARC; however, there was no difference in the percentage of patients recovering when compared with ORC. Further study is needed to assess the clinical significance of these findings. Trial Registration: ClinicalTrials.gov Identifier: NCT01157676.

The association of salvage intravesical therapy following BCG with pathologic outcomes and survival after radical cystectomy for patients with high-grade non-muscle invasive bladder cancer: A multi-institution analysis.

INTRODUCTION: While numerous current clinical trials are testing novel salvage therapies (ST) for patients with recurrent nonmuscle invasive bladder cancer (NMIBC) after bacillus Calmette-Guérin (BCG), the natural history of this disease state has been poorly defined to date. Herein, we evaluated oncologic outcomes in patients previously treated with BCG and ST who subsequently underwent radical cystectomy (RC). METHODS: We identified 378 patients with high-grade NMIBC who received at least one complete induction course of BCG (n = 378) with (n = 62) or without (n = 316) additional ST and who then underwent RC between 2000 and 2018. Oncologic outcomes were compared using the Kaplan-Meier method and Cox proportional hazards models. Sensitivity analyses were conducted stratifying by presenting tumor stage, matched 1:3 for receipt vs. no receipt of ST. RESULTS: Patients receiving ST were more likely to initially present with CIS (26% vs. 17%) and less likely with T1 disease (34% vs. 50%, P = 0.06) compared to patients not treated with ST. Receipt of ST was not associated with increased risk of adverse pathology (≥pT2 or pN+) at RC (31% vs. 41%, P = 0.14). Likewise, 5-year cancer-specific survival did not significantly differ between groups on univariable Kaplan-Meier analysis (73% for ST and 74% for no ST, P = 0.7). Moreover, on multivariable analysis, receipt of ST was not significantly associated the risk of death from bladder cancer (HR 1.12; 95% CI 0.60-2.09, P = 0.7). Results were unchanged on sensitivity analysis. CONCLUSIONS: These data suggest that, in carefully selected patients, ST following BCG for high grade NMIBC does not compromise oncologic outcomes for patients who ultimately undergo RC.

Health Related Quality of Life of Patients with Bladder Cancer in the RAZOR Trial: A Multi-Institutional Randomized Trial Comparing Robot versus Open Radical Cystectomy.

PURPOSE: We evaluated health related quality of life following robotic and open radical cystectomy as a treatment for bladder cancer. MATERIALS AND METHODS: Using the Randomized Open versus Robotic Cystectomy (RAZOR) trial population we assessed health related quality of life by using the Functional Assessment of Cancer Therapy (FACT)-Vanderbilt Cystectomy Index and the Short Form 8 Health Survey (SF-8) at baseline, 3 and 6 months postoperatively. The primary objective was to assess the impact of surgical approach on health related quality of life. As an exploratory analysis we assessed the impact of urinary diversion type on health related quality of life. RESULTS: Analyses were performed in subsets of the per-protocol population of 302 patients. There was no statistically significant difference between the mean scores by surgical approach at any time point for any FACT-Vanderbilt Cystectomy Index subscale or composite score (p >0.05). The emotional well-being score increased over time in both surgical arms. Patients in the open arm showed significantly better SF-8 sores in the physical and mental summary scores at 6 months compared to baseline (p <0.05). Continent diversion (versus noncontinent) was associated with worse FACT-bladder-cystectomy score at 3 (p <0.01) but not at 6 months, and the SF-8 physical component was better in continent-diversion patients at 6 months (p=0.019). CONCLUSIONS: Our data suggests lack of significant differences in the health related quality of life in robotic and open cystectomies. As robotic procedures become more widespread it is important to discuss this finding during counseling.

The Impact of Lymphovascular Invasion on Risk of Upstaging and Lymph Node Metastasis at the Time of Radical Cystectomy.

BACKGROUND: Lymphovascular invasion (LVI) in muscle-invasive bladder cancer is associated with a poor prognosis when identified from radical cystectomy (RC) specimens. However, LVI is not clearly emphasized in any risk models to guide clinical decision-making. The impact of LVI on the risk of lymph node (LN) metastasis after a transurethral resection of bladder tumor (TURBT) specimen is less understood. OBJECTIVE: The goal was to describe the impact of LVI and the risk of LN metastasis at each clinical stage of urothelial carcinoma of the bladder (UC). DESIGN, SETTING, AND PARTICIPANTS: The National Cancer Database was queried for patients with bladder cancer who underwent RC with LN dissection from 2004 to 2014. Patients with non-bladder primary, non-UC histology, clinical metastatic disease, and having received chemotherapy/radiation were excluded. Pathologic LN positive rates at RC were determined. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was pathologic upstaging at RC and pathologic node positivity. Secondary outcomes included determining overall survival (OS). All hypotheses testing were two-sided and a p value of <0.05 was considered statistically significant. All statistical analyses were performed using Stata version 13.1. RESULTS AND LIMITATIONS: A total of 3007 patients with UC underwent RC with pelvic LN dissection. In patients with LVI, the risk of LN metastasis was significantly higher at each clinical stage as was the rate of pathologic upstaging. Patients with LVI on TURBT had worse OS stage for stage in pure UC (p<0.001). Limitations include that there was no central pathologic review and the number of TURBTs per patient was not known. CONCLUSIONS: Patients with UC with LVI had worse OS and are at higher risk for LN-positive disease and pathologic upstaging at surgery than patients without LVI. PATIENT SUMMARY: In this report we examined the impact of lymphovascular invasion (LVI) at transurethral resection of bladder tumor on pathologic upstaging and lymph node metastasis at radical cystectomy using the National Cancer Database. We identified LVI as being prognostic at each stage of urothelial carcinoma.

Predictors of Recurrence, and Progression-Free and Overall Survival following Open versus Robotic Radical Cystectomy: Analysis from the RAZOR Trial with a 3-Year Followup.

PURPOSE: The RAZOR (Randomized Open versus Robotic Cystectomy) trial revealed noninferior 2-year progression-free survival for robotic radical cystectomy. This update was performed with extended followup for 3 years to determine potential differences between the approaches. We also report 3-year overall survival and sought to identify factors predicting recurrence, and progression-free and overall survival. MATERIALS AND METHODS: We analyzed the per protocol population of 302 patients from the RAZOR study. Cumulative recurrence was estimated using nonbladder cancer death as the competing risk event and the Gray test was applied to assess significance in differences. Progression-free survival and overall survival were estimated by the Kaplan-Meier method and compared with the log rank test. Predictors of outcomes were determined by Cox proportional hazard analysis. RESULTS: Estimated progression-free survival at 36 months was 68.4% (95% CI 60.1-75.3) and 65.4% (95% CI 56.8-72.7) in the robotic and open groups, respectively (p=0.600). At 36 months overall survival was 73.9% (95% CI 65.5-80.5) and 68.5% (95% CI 59.8-75.7) in the robotic and open groups, respectively (p=0.334). There was no significant difference in the cumulative incidence rates of recurrence (p=0.802). Patient age greater than 70 years, poor performance status and major complications were significant predictors of 36-month progression-free survival. Stage and positive margins were significant predictors of recurrence, and progression-free and overall survival. Surgical approach was not a significant predictor of any outcome. CONCLUSIONS: This analysis showed no difference in recurrence, 3-year progression-free survival or 3-year overall survival for robotic vs open radical cystectomy. It provides important prospective data on the oncologic efficacy of robotic radical cystectomy and high level data for patient counseling.

Safety and Efficacy of Hypofractionated Radiotherapy With Capecitabine in Elderly Patients With Urothelial Carcinoma.

BACKGROUND: Bladder cancer is commonly diagnosed in patients ineligible for radical cystectomy or chemoradiotherapy (chemo-RT) with cisplatin or fluorouracil with mitomycin. We assessed tolerability, efficacy, and toxicity of hypofractionated radiotherapy with capecitabine in this challenging population. PATIENTS AND METHODS: Patients with high-grade urothelial bladder cancer ineligible for radical cystectomy or high-intensity chemo-RT underwent maximal transurethral resection of bladder tumor followed by capecitabine (median, 825 mg/m2 per day 2 times a day) and radiation (median, 55 Gy in 2.2 Gy per fraction). Patients underwent surveillance cystoscopy and imaging, and were evaluated for toxicity, freedom from local failure and freedom from distant metastasis, progression-free survival, and overall survival. RESULTS: Eleven patients (median age, 80 years) with localized disease (n = 7), locally advanced disease (n = 3), or local-only recurrence after cystectomy (n = 1) were treated. Four patients (35%) had an Eastern Cooperative Oncology Group performance status of 2; median Charlson comorbidity index was 5. There was 1 acute grade 3 genitourinary event (9%), 6 acute grade 3 hematologic events (55%) of lymphopenia, and no acute grade 4 or higher events or hospitalizations. Ten patients (91%) completed radiotherapy, while 4 patients (36%) temporarily discontinued capecitabine. The complete response rate in the bladder was 64%. Two patients (18%) experienced late grade 1/2 genitourinary toxicities, and 1 (9%) experienced a transient late grade 4 genitourinary toxicity. With a median follow-up of 16.6 months, overall survival, progression-free survival, freedom from local failure, and freedom from distant metastasis at 1 year were 82%, 55%, 100%, and 55%, respectively, and at 2 years were 61%, 41%, 80%, and 55%, respectively. CONCLUSION: Hypofractionated chemo-RT was well tolerated and was associated with a high rate of local control in this comorbid population, thus providing a treatment option for select bladder cancer patients.

The impact of surgical duration on complications after transurethral resection of the prostate: an analysis of NSQIP data.

BACKGROUND: Transurethral resection of the prostate is the most commonly performed procedure for the management of benign prostatic obstruction. However, little is known about the effect surgical duration has on complications. We assess the relationship between operative time and TURP complications using a modern national surgical registry. METHODS: We queried the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) from 2006 to 2016 for patients undergoing TURP. Patients were separated into five groups based on operative time: 0-30 min, 30.1-60 min, 60.1-90 min, 90.1-120 min, and greater than 120 min. Standard statistical analysis, including multivariate regression, was performed to determine factors associated with complications. RESULTS: 31,813 patients who underwent TURP were included. The overall complication rate was 9.0% and increased significantly with longer surgical duration (p < 0.001). Longer operative time was associated with a greater risk of postoperative sepsis or shock, transfusion, reoperation, and deep vein thrombus or pulmonary embolism. Longer surgical duration was associated with increased odds of any complication and, specifically, blood transfusion after controlling for age, race, comorbidities, American Society of Anesthesia (ASA) class, type of anesthesia administered, and trainee involvement. The adjusted risk of each of the above complications remained significantly increased for surgeries lasting longer than 120 min. CONCLUSIONS: As surgical duration increases, there is a significant increase in the rate of complications after TURP. These data demonstrate that this procedure is safest when performed in under 90 min.

The role of inguinal lymph node dissection in men with urethral squamous cell carcinoma.

INTRODUCTION: Urethral squamous cell cancer is a rare disease with limited clinical recommendations regarding management of the inguinal lymph nodes. Despite the similarities to penile cancer in terms of squamous cell carcinoma (SCC) histology and lymphatic drainage, there is not enough evidence to recommend for or against a prophylactic inguinal lymph node dissection (ILND) in patients with clinically negative groins and a primary tumor stage of T1b or higher. The objective of the study was to identify the rate of prophylactic inguinal lymph node dissection, node positive rate, and overall survival in patients with clinical T1 to T4 stage. The patients were separated into clinical N stage and the rates of node positivity were compared. We hypothesize that the node positivity rate would be similar to that observed in penile cancer of similar clinical T and N stage and provide evidence for prophylactic inguinal lymph node dissection in urethral squamous cancer. We also sought to determine the value of ILND in clinically node positive (cN+) and clinically node negative (cN-) patients. METHODS: The National Cancer Database was queried for all cases of primary urethral cancer in men from 2004 to 2014. Patients with other cancer diagnoses, metastasis, nonsquamous histology, female patients, and patients with a history of radiation therapy were excluded. Male patients with urethral squamous cell cancer of the anterior urethra with T1 or higher T stage were included in this study. All-cause mortality was compared using multivariable Cox regression controlling for covariates. RESULTS: The study included 725 men with urethral SCC with T1 or higher clinical T stage. The median age was 63 years (33-83 interquartile range). Of the 725 men, 536 men did not receive an ILND and 189 (26%) underwent ILND. Patients who received LND had significantly higher clinical T and clinical N stage. There was no difference in age, sex, or histology between those with ILND versus no ILND. In patients with T1 to T4 and clinical N0, the ILND rate was 21.8% (89/396). The lymph node positive rate in patients with N0 and T1 to T4 primary tumor was 9%. In patients with clinically node positive disease (N1/N2), the overall ILND rate was 76%. The lymph node positive rate for patients with clinical nodal disease was 84%. On multivariable analysis cox regression, lymph node positivity was associated with worse overall survival when controlling for T stage, clinical N stage, and age (HR 1.56, 95% 1.3-1.9, P = 0.000). On multivariable analysis after controlling for T stage, sex, and age, having an ILND was associated with improved OS in patients with clinical N1 or N2 disease (HR 0.46, 95% 0.28-0.78 P = 0.002). CONCLUSION: The node positivity rate in patients with T1 to T4 and N0 is 9%, much lower than reported in penile cancer with a high-risk primary tumor but clinically negative groins. This argues against routine prophylactic inguinal ILND in patients with urethral SCC who are clinically N0, perhaps suggesting different biological behavior of urethral SCC compared to penile SCC. Performing a lymph node dissection in patients with clinically N1 or N2 disease is associated with improved OS.

Robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR): an open-label, randomised, phase 3, non-inferiority trial.

BACKGROUND: Radical cystectomy is the surgical standard for invasive bladder cancer. Robot-assisted cystectomy has been proposed to provide similar oncological outcomes with lower morbidity. We aimed to compare progression-free survival in patients with bladder cancer treated with open cystectomy and robot-assisted cystectomy. METHODS: The RAZOR study is a randomised, open-label, non-inferiority, phase 3 trial done in 15 medical centres in the USA. Eligible participants (aged ≥18 years) had biopsy-proven clinical stage T1-T4, N0-N1, M0 bladder cancer or refractory carcinoma in situ. Individuals who had previously had open abdominal or pelvic surgery, or who had any pre-existing health conditions that would preclude safe initiation or maintenance of pneumoperitoneum were excluded. Patients were centrally assigned (1:1) via a web-based system, with block randomisation by institution, stratified by type of urinary diversion, clinical T stage, and Eastern Cooperative Oncology Group performance status, to receive robot-assisted radical cystectomy or open radical cystectomy with extracorporeal urinary diversion. Treatment allocation was only masked from pathologists. The primary endpoint was 2-year progression-free survival, with non-inferiority established if the lower bound of the one-sided 97·5% CI for the treatment difference (robotic cystectomy minus open cystectomy) was greater than -15 percentage points. The primary analysis was done in the per-protocol population. Safety was assessed in the same population. This trial is registered with ClinicalTrials.gov, number NCT01157676. FINDINGS: Between July 1, 2011, and Nov 18, 2014, 350 participants were randomly assigned to treatment. The intended treatment was robotic cystectomy in 176 patients and open cystectomy in 174 patients. 17 (10%) of 176 patients in the robotic cystectomy group did not have surgery and nine (5%) patients had a different surgery to that they were assigned. 21 (12%) of 174 patients in the open cystectomy group did not have surgery and one (1%) patient had robotic cystectomy instead of open cystectomy. Thus, 302 patients (150 in the robotic cystectomy group and 152 in the open cystectomy group) were included in the per-protocol analysis set. 2-year progression-free survival was 72·3% (95% CI 64·3 to 78·8) in the robotic cystectomy group and 71·6% (95% CI 63·6 to 78·2) in the open cystectomy group (difference 0·7%, 95% CI -9·6% to 10·9%; pnon-inferiority=0·001), indicating non-inferiority of robotic cystectomy. Adverse events occurred in 101 (67%) of 150 patients in the robotic cystectomy group and 105 (69%) of 152 patients in the open cystectomy group. The most common adverse events were urinary tract infection (53 [35%] in the robotic cystectomy group vs 39 [26%] in the open cystectomy group) and postoperative ileus (33 [22%] in the robotic cystectomy group vs 31 [20%] in the open cystectomy group). INTERPRETATION: In patients with bladder cancer, robotic cystectomy was non-inferior to open cystectomy for 2-year progression-free survival. Increased adoption of robotic surgery in clinical practice should lead to future randomised trials to assess the true value of this surgical approach in patients with other cancer types. FUNDING: National Institutes of Health National Cancer Institute.

Prospective, randomized clinical trial comparing use of intraoperative transesophageal echocardiography to standard care during radical cystectomy.

PURPOSE: Our prospective, randomized clinical study aims to evaluate the utility of intraoperative transesophageal echocardiography (TEE) in patients undergoing radical cystectomy. MATERIALS AND METHODS: Eighty patients were randomized to a standard of care group or the intervention group that received continuous intraoperative TEE. Data are presented as means ± standard deviations, median (25th percentile, 75th percentile), or numbers and percentages. Characteristics were compared between groups using independent sample t-tests, Wilcoxon-Mann-Whitney tests or Chi-square tests, as appropriate. All tests were two-sided and P < 0.05 was considered to indicate statistical significance. RESULTS: Both groups had similar preoperative demographic characteristics. There was a significant difference between central line insertion with all insertions in the control group (15%, 6 vs. 0%, 0; P < 0.003). Of all the perioperative complications, 80% occurred in the control group versus 20% in the TEE group, with 21% of controls experiencing a cardiac or pulmonary complication compared to 5% in the TEE group (8 vs. 2, P < 0.04). The control group patients were more likely to have adverse cardiac complications than the TEE group (15%, 6 vs. 3%, 1; P < 0.040). Postoperative cardiac arrhythmia was observed only in the control group (13%, 5 vs. 0%, 0; P <.007). Prolonged intubation was only observed in the control group (10%, 4 vs. 0%, 0; P < 0.017). CONCLUSION: TEE can be a useful monitoring tool in patients undergoing radical cystectomy, limiting the use of central line insertion and potentially translating into earlier extubation and decreased postoperative cardiac morbidities.

Rates and Predictors of Conversion to Open Surgery During Minimally Invasive Radical Cystectomy.

OBJECTIVE: To assess the frequency of minimally invasive radical cystectomy (MIRC) conversion to open surgery, what factors influence conversion, whether or not the benefits of MIRC vs open radical cystectomy (ORC) persist after conversion, and compare ORC and MIRC outcomes. MATERIALS AND METHODS: We performed a retrospective cohort study from the National Cancer Data Base (2010 to 2013) analyzing patients who underwent completed MIRC (n = 5750), converted MIRC (n = 245), and ORC (n = 12,053) without prior radiotherapy. Multivariable logistic and linear regression analyses were used to assess the association between covariates, open conversion as well as surgical approach, and secondary outcomes such as positive surgical margins (PSMs), use of lymphadenectomy, lymph node yield, hospital length of stay (LOS), and 30-day readmission. RESULTS: Rates of conversion were independent of patient factors such as race, sex, use of neoadjuvant chemotherapy, and clinical stage. Conversion occurred in 245 of 5750 MIRCs (4.3%) and declined over time (5.8% in 2010 vs 3.2% in 2013, odds ratio [OR] 0.50, 95% confidence interval [CI] 0.34-0.75, p = 0.001). MIRC was associated with fewer positive margins, higher lymph node yield, shorter LOS, and fewer readmissions compared with ORC, however, patients requiring open conversion had longer median hospital stays (8 days vs 7 days, p = 0.013), lower median lymph node yields (14 vs 17, p = 0.007), more PSMs (17% vs 11%, p = 0.006), and more 30-day readmissions (14% vs 9%, p = 0.008) compared to nonconverted. Converted MIRC had similar hospital LOS and 30-day readmission rates compared to ORC. CONCLUSION: Open conversion during MIRC is uncommon and has decreased in recent years despite the rising use of MIRC. MIRC had better short-term outcomes compared with ORC. These benefits were negated with open conversion; however, outcomes were similar compared to planned ORC.

Perioperative and long-term outcomes after radical cystectomy in hemodialysis patients.

PURPOSE: Patients on hemodialysis have an increased risk of developing advanced stage bladder cancer. They also have a significant risk of noncancer-related mortality. Radical cystectomy (RC) is the standard of care for nonmetastatic muscle-invasive bladder cancer, however little is known regarding outcomes in this population. MATERIALS AND METHODS: The United States Renal Disease System database was used to identify all patients on hemodialysis who underwent RC for bladder cancer in the United States between 1984 and 2013. A total of 985 patients were identified for analysis. Perioperative outcomes were evaluated. Competing risks analysis was used to estimate overall and cancer-specific mortality along with factors associated with death. RESULTS: Median hospital length of stay was 10 days and 43.1% of patients experienced a complication. Mortality within 30 days was 9.3%. Overall mortality at 1, 3, and 5 years was 51.7%, 77.3%, and 87.9%, respectively. Cancer-specific mortality at 1, 3, and 5 years was 12.3%, 18.4%, and 19.7%, respectively. Age, diabetes, and cerebrovascular disease were independently associated with overall mortality, while performance of urinary diversion was associated with a protective effect. Active smoking was the sole risk factor for cancer-specific mortality. CONCLUSIONS: RC in dialysis patients is associated with significant morbidity and mortality, with less than 15% overall survival at 5 years. Older patients, and those with a history of diabetes or cerebrovascular disease, are at an increased risk of mortality.

Fistulous Complications following Radical Cystectomy for Bladder Cancer: Analysis of a Large Modern Cohort.

PURPOSE: Fistula formation is a rare and poorly described complication following radical cystectomy with urinary diversion. We sought to identify patients who experienced any type of fistulous complication and we analyzed risk factors for formation as well as management outcomes. MATERIALS AND METHODS: We retrospectively reviewed the records of patients who underwent radical cystectomy for bladder cancer at our institution. Patients who experienced any fistula were identified. Risk factors, management strategies and outcomes were analyzed. Patients underwent initial conservative treatment and those in whom this treatment failed underwent surgical repair. Univariable and multivariable analyses were performed to identify predictors of fistula formation as well as the need for surgical repair. RESULTS: Of the 1,041 patients 31 (3.0%) experienced fistula formation. Median time to fistula presentation was 31 days. Enterodiversion was the most common fistula type, noted in 54.8% of patients, followed by enterocutaneous and diversion cutaneous treatment in 29.0% and 12.9%, respectively. On multivariable analyses a history of radiation therapy (OR 3.1, p = 0.03) and an orthotopic neobladder (OR 3.1, p = 0.04) were predictors of fistula formation. Conservative management was successful in 41.9% of cases. There were no predictors of failed conservative management. Of patients who required surgical repair success was achieved in 94.4% at a single operation. CONCLUSIONS: Fistulas are rare after radical cystectomy and they are most common between the urinary diversion and the small bowel. A history of radiation therapy and a orthotopic neobladder are risk factors for formation. When required, surgical repair is generally successful at a single operation.

National Surgical Quality Improvement Program surgical risk calculator poorly predicts complications in patients undergoing radical cystectomy with urinary diversion.

PURPOSE: To evaluate the accuracy of the American College of Surgeons National Surgical Quality Improvement Programs (ACS-NSQIP) surgical risk calculator in patients undergoing radical cystectomy (RC) with urinary diversion. MATERIALS AND METHODS: Preoperative characteristics of patients who underwent RC with ileal conduit or orthotropic neobladder (ONB) between 2007 and 2016 were entered into the proprietary online ACS-NSQIP calculator to generate 30-day predicted risk profiles. Predicted and observed outcomes were compared by measuring Brier score (BS) and area under the receiver operating characteristic curve (AUC). RESULTS: Of 954 patients undergoing RC, 609 (64%) received ileal conduit and 345 (36%) received ONB. The calculator underestimated most risks by 10%-81%. The BSs exceeded the acceptable threshold of 0.01 and AUC were less than 0.8 for all outcomes in the overall cohort. The mean (standard deviation) predicted vs. observed length of stay was 9 (1.5) vs. 10.6 (7.4) days (Pearson's r = 0.09). Among patients who received ONB, adequate BS (<0.01) was observed for pneumonia, cardiac complications, and death. The receiver operating characteristic curve analysis revealed moderate accuracy of calculator for cardiac complications (AUC = 0.69) and discharge to rehab center (AUC = 0.75) among patients who underwent RC with ONB. CONCLUSIONS: The universal ACS-NSQIP calculator poorly predicts most postoperative complications among patients undergoing RC with urinary diversion. A procedure-specific risk calculator is required to better counsel patients in the preoperative setting and generate realistic quality measures.

Temporal trends in perioperative morbidity for radical cystectomy using the National Surgical Quality Improvement Program database.

INTRODUCTION: Radical cystectomy (RC) is the standard of care for invasive nonmetastatic bladder cancer. Unfortunately, it is a complex procedure and more than half of patients experience a complication. A number of efforts to reduce perioperative morbidity have been made, including alterations in pain management, antibiotics, diet advancement, and anticoagulation. Many of these changes in management have been studied with favorable results; however, it is not clear whether complication rates following RC have improved in recent years. With this in mind we sought to evaluate current temporal trends in postoperative complication rates following RC using a large national dataset. MATERIALS AND METHODS: Using the National Surgical Quality Improvement Program participant use files from 2010 to 2015, we identified patients undergoing RC using current procedural terminology codes. Demographic information as well as 30-day complications, length of stay (LOS), readmission and death were compared according to year of operation using univariable and multivariable analysis. RESULTS: Over the 6 year period analyzed, 6,510 patients were identified for analysis. Age and comorbidity were similar across the study period. A robotic approach was used in 5.8% of the entire cohort which did not differ among years. A total of 15.9% of patients underwent a continent urinary diversion, with a trend toward decreased use in recent years, 31.5% of patients experienced a complication and this did not differ significantly among years, and 40.7% of patients required a blood transfusion overall with a trend toward decreased use. LOS decreased over time from 10.6 days in 2010 to 9.2 days in 2015 (P<0.01) whereas readmissions increased slightly over the time period to 21.4% in 2015 (P<0.01). CONCLUSIONS: RC remains a procedure associated with high morbidity. In the recent era of enhanced recovery protocols, complication rates have not changed significantly, however, there has been a consistent decline in LOS and use of blood transfusion.

Utilization and Outcomes of Nephroureterectomy for Upper Tract Urothelial Carcinoma by Surgical Approach.

OBJECTIVES: To compare outcomes and survival of open-, robotic-, and laparoscopic nephroureterectomy (ONU, RNU, LNU) using population-based data. METHODS: Using the National Cancer Database, we identified patients who underwent nephroureterectomy for localized upper tract urothelial carcinoma between 2010 and 2013. Demographic and clinicopathologic characteristics were compared among the three operative approaches. Multivariate regression analyses were used to determine the impact of approach on performance of lymphadenectomy (LND), positive surgical margins (PSM), and overall survival (OS). RESULTS: In total, there were 9401 cases identified for analysis, including 3199 ONU (34%), 2098 RNU (22%), and 4104 LNU (44%). From 2010 to 2013, utilization of RNU increased from 14% to 30%. On multivariate analysis, LND was more likely in RNU (odds ratio [OR] 1.52; p < 0.01) and less likely in LNU (OR 0.77; p < 0.01) compared with ONU. RNU was associated with decreased PSM compared with ONU (OR = 0.73; p = 0.04). After adjusting for other factors, OS was not significantly associated with surgical approach. CONCLUSIONS: RNU utilization doubled over the study period. While RNU was associated with greater likelihood of LND performance as well as lower PSM rates when compared with ONU and LNU, surgical approach did not independently affect OS.

Extended Duration Enoxaparin Decreases the Rate of Venous Thromboembolic Events after Radical Cystectomy Compared to Inpatient Only Subcutaneous Heparin.

PURPOSE: Venous thromboembolic events are a significant source of morbidity after radical cystectomy. At our institution subcutaneous heparin was historically given to patients undergoing radical cystectomy immediately before incision and throughout the inpatient stay. In an effort to decrease the overall rate of venous thromboembolism and post-discharge venous thromboembolism, a regimen including extended duration enoxaparin was initiated for patients undergoing radical cystectomy. MATERIALS AND METHODS: In January 2013 thromboprophylaxis was modified for patients undergoing radical cystectomy by replacing a regimen of subcutaneous heparin before induction and then every 8 hours until discharge home with enoxaparin daily for postoperative prophylaxis continued until 28 days after discharge. Data from our institutional radical cystectomy database for patients undergoing surgery from January 2011 to May 2014 were reviewed. The primary outcome was clinically symptomatic postoperative venous thromboembolism. Secondary outcomes included timing of venous thromboembolism and blood transfusions. Multivariate logistic regression was used to control for differences between cohorts. RESULTS: Of the 402 patients 234 underwent radical cystectomy before the change and 168 after. The enoxaparin regimen decreased the rate of venous thromboembolism (12% vs 5%, p=0.024) with the main benefit on post-discharge venous thromboembolism (6% vs 2%, p=0.039). Overall 17 of 37 (46%) venous thromboembolisms occurred after discharge home. Multivariate analysis confirmed that the enoxaparin regimen was independently associated with reduced odds of venous thromboembolism (OR 0.33, 95% CI 0.14-0.76, p=0.009). Intraoperative and postoperative transfusion rates were similar between cohorts. CONCLUSIONS: Thromboprophylaxis with extended duration enoxaparin decreased the rate of venous thromboembolism after radical cystectomy compared to inpatient only subcutaneous heparin with no increased risk of bleeding.