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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.

Purpose: We designed a prospective randomized, controlled pilot trial to investigate the effects of an enriched oral nutrition supplement on body composition and clinical outcomes following radical cystectomy., Materials and Methods: A total of 61 patients were randomized to an oral nutrition supplement or a multivitamin multimineral supplement twice daily during an 8-week perioperative period. Body composition was determined by analyzing abdominal computerized tomography images at the L3 vertebra. Sarcopenia was defined as a skeletal muscle index of less than 55 cm/m in males and less than 39 cm/m in females. The primary outcome was the difference in 30-day hospital free days. Secondary outcomes included hospital length of stay, complications, readmissions and mortality., Results: The oral nutrition supplement group lost less weight (-5 vs -6.5 kg, p = 0.04) compared to the multivitamin multimineral supplement group. The proportion of patients with sarcopenia did not change in the oral nutrition supplement group but increased 20% in the multivitamin multimineral supplement group (p = 0.01). Mean length of stay and 30-day hospital free days were similar in the groups. The oral nutrition supplement group had a lower rate of overall and major (Clavien grade 3 or greater) complications (48% vs 67% and 19% vs 25%, respectively) and a lower readmission rate (7% vs 17%) but the differences did not reach statistical significance., Conclusions: Patients who undergo radical cystectomy after consuming an oral nutrition supplement perioperatively have a reduced prevalence of sarcopenia and may also experience fewer and less severe complications and readmissions. A larger blinded, randomized, controlled trial is necessary to determine whether oral nutrition supplement interventions can improve outcomes following radical cystectomy.

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%; p non-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., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Purpose: We investigated oncologic and urinary outcomes after anterior exenteration for urothelial cell carcinoma in females, identifying tumor characteristics associated with female pelvic organ involvement. We hypothesized that a lack of trigonal or bladder floor tumor, intraoperative palpable posterior mass and clinical lymphadenopathy is associated with a lack of female pelvic organ involvement., Materials and Methods: We retrospectively reviewed the charts of female patients who underwent radical cystectomy at our institution from 1999 to 2014. Patient and operative characteristics were extracted from the electronic medical record, and performance of hysterectomy was tested for association with disease recurrence. Categorical and continuous variables were analyzed with the chi-square and Student t-test, and Kaplan-Meier analysis was performed to determine recurrence-free survival according to hysterectomy performance. Women who had neobladder creation were additionally evaluated for an association between hysterectomy status, and nighttime wetting and catheter use., Results: Of 322 eligible patients 160 with urothelial cancer did not have a hysterectomy before cystectomy. Mean followup was 2.2 years (SD 2.8). There were 22 patients (13.8%) who had recurrence during followup. No patient or surgical factor other than use of adjuvant chemotherapy or radiation (p <0.01) was associated with recurrence. Of 139 women 32 (23.0%) who underwent exenteration had female pelvic organ involvement. At least 1 of the 3 characteristics of interest were present in 28 of 99 (28.3%) women with any genitourinary organ involvement compared to only 4 of 40 (10.0%) of those who did not (p=0.01). Nighttime continence ranged between 21.9% and 48% but there was no significant association with continence and hysterectomy status., Conclusions: Lack of trigonal/bladder floor tumor, palpable posterior mass and clinical lymphadenopathy is associated with the absence of pelvic organ involvement. Individualized risk assessment using these factors along with patient preferences should be used to guide surgical planning., (Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Introduction: The diagnosis and subsequent management of bladder cancer often involves transurethral resection of bladder tumor (TURBT). Risks of TURBT include perioperative complications such as bleeding, pain and perforation. We aimed to determine TURBT complication rates and risk factors in a contemporary series., Materials and Methods: From 2002 to 2011, 505 patients underwent TURBT either for suspected bladder cancer or during follow up at a single institution. Baseline patient characteristics and complications within 2 weeks of surgery were extracted from the electronic medical record for all TURBTs. Patient and tumor characteristics were evaluated for associations with complication using univariate analysis. A multivariable logistic regression was fit to further examine associations between TURBT related characteristics and complication., Results: A total of 910 TURBTs were performed on 505 patients. Overall complication rate was 8.1%. The most common complications were pain or spasm (3.0%), retention (2.8%), and infection (2.1%), and 0.5% of TURBTs had perforation. Over 85% of complications were Clavien-Dindo grade I or II. Forty-three patients had a complication after their first TURBT, while 25 had complications after subsequent TURBTs. Prior complication and single tumor, but not other patient or tumor-related characteristics, were associated with complication. Only prior complication (p < 0.01) was associated with subsequent complication after TURBT on multivariable analysis., Conclusions: Complication rate after TURBT is 8.1% and complications are generally not severe in nature. Prior short term complication is likely associated with subsequent complication. Further studies are needed to validate these results and determine patient groups most at risk for intraoperative and post TURBT complications.

Health literacy is the ability to obtain, comprehend, and act on medical information and is an independent predictor of health outcomes in patients with chronic health conditions. However, little has been reported regarding the potential association of health literacy and surgical outcomes. We hypothesized that patient complications after radical cystectomy would be associated with health literacy. In a sample of 368 patients, we found that higher health literacy scores (as determined by the Brief Health Literacy Screen) were associated with decreased odds of developing minor complications (odds ratio = 0.90, 95% confidence interval [0.83, 0.97]). Health literacy should be considered when caring for patients undergoing radical cystectomy and should serve as a potential indicator of the need for additional resources to improve postoperative outcomes.

Purpose: We determined the extent to which complications as well as number of hospital-free days within 30 and 90 days of surgery predicted health related quality of life 1 year after radical cystectomy., Materials and Methods: We used data from a prospective health related quality of life study using a validated instrument, the Vanderbilt Cystectomy Index-15. Complications were graded by the Clavien system, and hospital length of stay and length of stay during readmissions were used to calculate 30 and 90-day hospital-free days, respectively. We compared the number of hospital-free days among patients with varying levels of complications. Multivariate analysis was performed to determine predictors of Vanderbilt Cystectomy Index-15 score 1 year after surgery adjusting for demographic (age, gender, comorbidities) and clinical variables (stage and diversion type)., Results: A total of 100 patients with complete baseline and 1-year followup health related quality of life data were included in the analysis. Median (IQR) 30 and 90-day hospital-free days were 24 (22-25) and 84 (82-85), respectively. Patients who experienced any complications had significantly fewer 30-day hospital-free days (22 vs 24 days, p <0.01) and 90-day hospital-free days (81 vs 84 days, p <0.01), and patients with higher grade complications had fewer hospital-free days than those with lower grade or no complications (p <0.01). On multivariate analysis female gender and baseline Vanderbilt Cystectomy Index-15 score independently predicted higher 1-year health related quality of life scores., Conclusions: Patients who experience complications after radical cystectomy have fewer 30 and 90-day hospital-free days. However, neither predicts health related quality of life at 1 year. Instead, long-term health related quality of life appears to be driven largely by baseline health related quality of life and gender., (Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Objectives: Radical cystectomy (RC) is associated with significant blood loss and transfusion requirement. We performed a prospective, randomized trial to compare blood loss, operative time, and cost using 2 different and commonly employed approaches to tissue ligation and division during RC: mechanical (stapler device) and electrosurgical (heat-sealing device)., Methods and Materials: Eighty patients undergoing RC for urothelial bladder carcinoma were randomized to use of either an Endo GIA Stapler or Impact LigaSure device for tissue ligation and division. Primary outcomes were blood loss, operative time, and device costs. Data were analyzed with Wilcoxon rank sum test and Welch 2-sample t test., Results: There were no significant demographic or preoperative differences between the cohorts. Mean estimated blood loss was similar between the electrosurgical (687 ml) and stapler (708 ml) arms (P = 0.850). There were no significant differences between cohorts when comparing operative times or transfusion requirement. There was a significant increase in the mean number of adjunctive suture ligatures used in the stapling device arm (3.0 vs. 1.5, P = 0.047). Total device costs were significantly lower with the LigaSure compared with the GIA Stapler ($625.00 vs. $1490.10, P<0.001). There were no complications attributable to either device., Conclusions: This prospective, randomized study demonstrates no significant difference in blood loss, transfusion requirement, or safety between mechanical vs. electrosurgical control of the vascular pedicles. The LigaSure device, however, is significantly less costly than the GIA Stapler and required fewer additional measures for hemostasis., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objectives: The relationship between perioperative blood transfusion (PBT) and oncologic outcomes is controversial. In patients undergoing surgery for colon cancer and several other solid malignancies, PBT has been associated with an increased risk of mortality. Yet, the urologic literature has a paucity of data addressing this topic. We sought to evaluate whether PBT affects overall survival following radical cystectomy (RC) for patients with bladder cancer., Methods: The medical records of 777 consecutive patients undergoing RC for urothelial carcinoma of the bladder were reviewed. PBT was defined as transfusion of red blood cells during RC or within the postoperative hospitalization. The primary outcome was overall survival. Clinical and pathologic variables were compared using χ(2) tests, and Cox multivariate survival analyses were performed., Results: A total of 323 patients (41.6%) underwent PBT. In the univariate analysis, PBT was associated with increased overall mortality (HR 1.40, 95% CI 1.11-1.78). Additionally, an independent association was demonstrated in a non-transformed Cox regression model (HR, 95% CI 1.01-1.36) but not in a model utilizing restricted cubic splines (HR 1.03, 95% CI 0.77-1.38). The c-index was 0.78 for the first model and 0.79 for the second., Conclusions: In a traditional multivariate model, mirroring those that have been applied to this question in the general surgery literature, we demonstrated an association between PBT and overall mortality after RC. However, this relationship is not observed in a second statistical model. Given the complex nature of adequately controlling for confounding factors in studies of PBT, a prospective study will be necessary to fully elucidate the independent risks associated with PBT., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Purpose: Robot-assisted laparoscopic radical cystectomy has been increasingly used to decrease the morbidity of radical cystectomy. However, whether it truly lowers the complication rate compared to open radical cystectomy is not well established. We examined the benign ureteroenteric anastomotic stricture rates of open and robot-assisted laparoscopic radical cystectomy., Materials and Methods: In the 478 consecutive patients who underwent radical cystectomy at our institution from December 2007 to December 2011 we examined the proportion diagnosed with benign ureteroenteric anastomotic stricture. Clinicopathological variables were compared by treatment group. Cox multivariable analysis was performed to determine which patient or disease specific factors were independently associated with stricture diagnosis., Results: A total of 375 patients (78.5%) underwent open radical cystectomy and 103 (21.5%) underwent robot-assisted laparoscopic radical cystectomy. Of the patients 45 (9.4%) were diagnosed with ureteroenteric anastomotic stricture a median of 5.3 months postoperatively. There was no difference in the stricture rate between the open and robot-assisted groups (8.5% vs 12.6%, p = 0.21). On adjusted Cox proportional hazards analysis no patient variable was independently associated with stricture diagnosis, including operative approach., Conclusions: Of the patients 9.4% were diagnosed with benign ureteroenteric anastomotic stricture after radical cystectomy with no significant difference in the risk of diagnosis by surgical approach. No patient or disease specific factor was independently associated with an increased risk of stricture diagnosis. Ureteroenteric anastomotic stricture is likely related to surgical technique. Continued efforts are needed to refine the technique of open and robot-assisted laparoscopic radical cystectomy to minimize the occurrence of this critical complication., (Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Hospital volume and surgeon volume are each associated with outcomes after complex oncological surgery. However, the interplay between hospital and surgeon volume, and their impact on these outcomes has not been well characterized. We studied the relationship between surgeon and hospital volume, and overall mortality after radical cystectomy., Materials and Methods: The SEER (Surveillance, Epidemiology and End Results)-Medicare linked database was used to identify 7,127 patients with urothelial carcinoma of the bladder who underwent radical cystectomy from 1992 to 2006. Hospital volume and surgeon volume were expressed by tertile. The primary outcome measure was overall survival. Covariates included age, Charlson comorbidity index, stage, grade, node count, node density, number of positive nodes, urinary diversion and year of surgery. Multivariate analyses using generalized linear multilevel models were used to determine the independent association between hospital and surgeon volume and survival., Results: When hospital volume or surgeon volume was included in the multivariate model, a significant volume-survival relationship was observed for each. However, when both were in the model, hospital volume attenuated the impact of surgeon volume on mortality while the significant hospital volume-mortality relationship persisted (HR 1.18, 95% CI 1.08-1.30, p <0.01). In addition, the adjusted 3-year probability of survival was significantly correlated with hospital volume in each distinct surgeon volume stratum while survival was not correlated with surgeon volume in each hospital volume stratum., Conclusions: After adjustment for patient and disease characteristics, the relationship between surgeon volume and survival after radical cystectomy is accounted for by hospital volume. In contrast, hospital volume remained an independent predictor of survival, suggesting that structure and process characteristics of high volume hospitals drive long-term outcomes after radical cystectomy., (Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Objective: To better define the relationship between lymph node count and survival in patients undergoing radical cystectomy for bladder cancer by identifying and controlling for key confounding variables in a large population-based cohort. Considerable controversy remains regarding the correlation between node count and survival, and most prior analyses have not accounted for both patient and provider factors., Methods: The Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database was used to identify patients with urothelial bladder carcinoma who underwent radical cystectomy from 1992 to 2006. Patients were divided into 2 cohorts based on the presence or absence of nodal metastases, and we performed Cox regression analyses to evaluate the association between node count and survival. Covariates included age, Charlson comorbidity index, stage, grade, lymph node density, number of positive nodes, urinary diversion, chemotherapy, year of surgery, transfusion, and surgeon volume., Results: The cohort consisted of 2391 node-negative and 779 node-positive patients. In node-negative patients, individuals with low node counts had significantly worse overall survival (OS) and disease-specific survival (DSS) compared to the highest node count tertile. In node-positive patients, node count was not an independent predictor of OS or DSS., Conclusion: Lymph node count at radical cystectomy is associated with both OS and DSS in patients without nodal metastases. However, in patients with node-positive disease, node count is not an independent predictor of survival suggesting that it is likely a proxy for other patient and provider factors in these individuals., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Purpose: Despite the increased morbidity and mortality of radical cystectomy in elderly individuals with bladder cancer numerous studies show that surgery can provide a survival benefit. We sought to better identify patients at substantial risk for postoperative mortality., Materials and Methods: We evaluated 220 consecutive patients 75 years old or older treated with radical cystectomy for bladder cancer at a single institution from 2000 to 2008. The analytical cohort comprised 169 patients with complete preoperative data available. A Cox proportional hazards model was used to determine the value of precystectomy clinical information to predict 90-day survival after radical cystectomy. Results were used to create a nomogram predicting the probability of 90-day survival after radical cystectomy. The model was then subjected to 200 bootstrap resamples for internal validation., Results: Of the 220 patients 28 (12.7%) died within 90 days of surgery. Older age (HR 2.30, 95% CI 1.22-4.32) and lower preoperative albumin (HR 2.50, 95% CI 1.40-4.45) were significant predictors of 90-day mortality. We developed a nomogram based on patient age, clinical stage, Charlson comorbidity index and albumin to predict the likelihood of 90-day mortality with 75% accuracy. Internal validation showed a bootstrap adjusted concordance index of 71%., Conclusions: We developed a nomogram that provides individualized risk estimations to predict the probability of 90-day mortality, potentially enhancing preoperative counseling and providing clinicians with an added tool to individualize treatment decisions in this challenging patient population. These data suggest that albumin is a strong predictor of postoperative mortality and show the importance of assessing this variable before surgery., (Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Poor preoperative nutritional status is a risk factor for adverse outcomes after major surgery. We evaluated the effect of preoperative nutritional deficiency on perioperative mortality and overall survival in patients undergoing radical cystectomy for bladder cancer., Materials and Methods: A total of 538 patients underwent radical cystectomy for urothelial carcinoma between January 2000 and June 2008, and had nutritional parameters documented. Patients with preoperative albumin less than 3.5 gm/dl, body mass index less than 18.5 kg/m(2) or preoperative weight loss greater than 5% of body weight were considered to have nutritional deficiency. Primary outcomes were 90-day mortality and overall survival. Survival was estimated using Kaplan-Meier analysis and compared using the log rank test. Cox proportional hazards models were used for multivariate survival analysis., Results: Of 538 patients 103 (19%) met the criteria for nutritional deficiency. The 90-day mortality rate was 7.3% overall (39 deaths), with 16.5% in patients with nutritional deficiency and 5.1% in the others (p < 0.01). Nutritional deficiency was a strong predictor of death within 90 days on multivariate analysis (HR 2.91; 95% CI 1.36, 6.23; p < 0.01). Overall survival at 3 years was 44.5% (33.5, 54.9) for nutritionally deficient patients and 67.6% (62.4, 72.2) for those who were nutritionally normal (p < 0.01). On multivariate analysis nutritional deficiency cases had a significantly higher risk of all cause mortality (HR 1.82; 95% CI 1.25, 2.65; p < 0.01)., Conclusions: Nutritional deficiency, as measured by preoperative weight loss, body mass index and serum albumin, is a strong predictor of 90-day mortality and poor overall survival. Prospective studies are needed to demonstrate the best indices of preoperative nutritional status and whether nutritional intervention can alter the poor prognosis for patients treated with radical cystectomy who have nutritional deficiencies., (Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: We describe hospital discharge status in patients after radical cystectomy for bladder cancer. We determined factors affecting discharge status., Materials and Methods: The 445 patients underwent radical cystectomy for urothelial carcinoma from January 2004 to December 2007. Patients were grouped by hospital discharge status into 1 of 4 groups, including home under self-care without services, home with home health services, subacute, rehabilitation or skilled nursing facility, or hospice/in-hospital mortality. We compared clinical, perioperative and pathological variables in these groups. We also examined the association of discharge status with the hospital readmission rate and 90-day mortality., Results: Of the 440 patients 250 (56.8%), 145 (32.9%), 39 (8.9%) and 6 (1.4%) were in the home without services, home with services, facility and mortality groups, respectively. On multivariate analysis older age, lower preoperative albumin, unmarried status and higher Charlson comorbidity index were predictors of discharge home with services while older age, poor preoperative exercise tolerance and longer hospital stay predicted discharge to a facility. Patients in the facility group were more likely to die within 90 days of surgery than those who returned home independently or with services. There was no difference in the likelihood of rehospitalization., Conclusions: Sociodemographic factors, preoperative performance status, and comorbidities and perioperative factors contribute to the discharge decision after radical cystectomy. Some subgroups can be predicted to have increased postoperative care needs and may be appropriate targets for disposition planning preoperatively., (Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Radical cystectomy remains associated with significant morbidity. Most series report outcomes with relatively short-term followup that may underestimate the true magnitude of the procedure and many report length of hospital stay but ignore readmission rates. We analyzed the predictors of early (30 days or less), late (31 to 90 days) and cumulative 90-day hospital readmissions, as well as morbidity and mortality rates., Materials and Methods: We reviewed our prospectively collected database of 753 patients who underwent radical cystectomy for urothelial cancer between January 2001 and December 2007. We examined the relationship between clinical variables and readmission rates during the early, late and 90-day postoperative period, and reviewed mortality and perioperative morbidity rates., Results: There were 200 (26.6%) patients readmitted in the first 90 days following radical cystectomy. Of these patients 148 (19.7%) were readmitted early, 81 (10.8%) were readmitted late, and 29 (3.9%) had an early and late readmission. Logistical regression revealed gender (OR 1.50, 95% CI 1.00-2.27, p = 0.05), age adjusted Charlson comorbidity index (OR 1.19, 95% CI 1.06-1.34, p = 0.003) and any postoperative complications before discharge home (OR 1.84, 95% CI 1.19-2.83, p = 0.006) as independent predictors of 90-day readmission. The 30 and 90-day mortality rates were 2.1% (16) and 6.9% (52), respectively., Conclusions: Readmission rates after radical cystectomy are significant, approaching 27% within the first 90 days. Gender and age adjusted Charlson comorbidity index were independent predictors providing preoperative information identifying patients more likely to require readmission or possibly to benefit from a longer initial hospital stay., (Copyright © 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Preoperative hydronephrosis may be associated with a worse outcome in patients who undergo radical cystectomy for invasive bladder cancer. We characterized the prognostic significance of hydronephrosis, and its relationship to cancer stage and outcome. We also evaluated concordance between the side of identifiable hydronephrosis and concomitant pelvic lymph node metastasis., Materials and Methods: We analyzed information from our prospectively collected database of patients who underwent radical cystectomy for bladder cancer from January 2001 to December 2007. We examined the relationship between hydronephrosis and clinical variables as well as survival outcome. Hydronephrosis was diagnosed intraoperatively or by radiographic imaging within 3 months of radical cystectomy., Results: Of 753 patients 244 (32%) were diagnosed with hydronephrosis. Logistic regression modeling revealed that hydronephrosis was an independent predictor of extravesical disease (OR 2.01, 95% CI 1.37 to 2.96, p <0.001) and node positive disease (OR 1.94, 95% CI 1.29 to 2.91, p = 0.001). Of patients with hydronephrosis 88 (36.1%) had concomitant node positive disease and 74 (30.3%) had node positive disease on the same side as hydronephrosis. Thus, hydronephrosis predicted the side of nodal involvement in 74 of 88 patients (84%) with identifiable hydronephrosis and node positive disease., Conclusions: Hydronephrosis is an independent predictor of advanced bladder cancer stage, and it predicts extravesical disease and node positive disease. Thus, it could prove useful to select patients for neoadjuvant chemotherapy before surgery. The strong correlation between hydronephrosis side and nodal metastasis may have implications for surgical staging and approach., (2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: We analyzed patient characteristics and practice patterns at our institution with time, and identified current patterns and factors contributing to the choice of urinary diversion., Materials and Methods: We reviewed the records of 553 consecutive radical cystectomy and urinary diversions performed from January 2000 to July 2005. Multivariate analysis was done to determine significant differences in diversion choice., Results: We analyzed the records of 539 patients, including 338 with an ileal conduit and 201 with a neobladder. Patients with a neobladder were younger (mean age 62 vs 71 years) and had fewer comorbidities (American Society of Anesthesiologists class greater than 2 in 31% vs 69%) than those with an ileal conduit. Mean age and the percent of American Society of Anesthesiologists class 3 or 4 cases increased during the study. Neobladder represented 47% of urinary diversions in 2000 and 21% in 2005. On multivariate analysis age (p <0.001), gender (p = 0.004), surgery year (p = 0.002), American Society of Anesthesiologists class greater than 2 (p = 0.004), organ confined disease (p = 0.01) and surgeon (p <0.001) independently predicted diversion choice. Patients were dichotomized into young (younger than 65 years) and old (65 years old or older) groups. Overall 59% of younger and 26% of older patients received a neobladder (p <0.001)., Conclusions: There was a significant trend toward the more liberal use of ileal conduit urinary diversion. Patients with female gender, advanced age, significant medical comorbidity or locally advanced disease were less likely to undergo neobladder urinary diversion. This trend is partly explained by surgeon preference combined with an aging, more comorbid patient population. Neobladder continues to be the most commonly performed urinary diversion in patients younger than 65 years.

Objective: To examine the risk factors for urothelial carcinoma (UC) involvement of the prostate in patients undergoing radical cystoprostatectomy (RCP) for bladder cancer, as such involvement has both prognostic and therapeutic implications., Patients and Methods: We examined 308 consecutive men from 1998 to 2005 who had RCP for UC of the bladder, with whole-mount processing of their prostate. Prostatic involvement was categorized by site of origin (the bladder or the prostatic urethra) and, in the case of prostatic urethral origin, by depth of invasion, i.e. dysplasia/carcinoma in situ (CIS), involving the prostatic urethra, prostatic ductal invasion or prostatic stromal invasion. The impact of pathological characteristics was evaluated., Results: In all, 121 (39.3%) patients had some form of urothelial involvement of the prostate, of whom 59 (48.8%) had dysplasia/CIS of the prostatic urethra, 20 (16.5%) had ductal involvement and 32 (26.4%) had stromal involvement. Multivariate analysis showed that bladder CIS (odds ratio 2.0, 95% confidence interval, 1.2-3.6, P = 0.012) and trigonal involvement of bladder tumours (2.0, 1.1-3.7, P = 0.028) were independent risk factors for urothelial involvement of the prostate., Conclusion: There was prostatic involvement with UC in nearly 40% of patients undergoing RCP. In this study CIS and trigonal involvement were independent predictors of risk, but were not adequate enough to accurately identify most patients who have UC within their prostate; further prospective studies are needed to more accurately predict risk factors and depth of invasion.

Objective: To evaluate the impact of prostatic urothelial carcinoma (PUC) on survival of patients with bladder cancer undergoing radical cystoprostatectomy (RCP)., Patients and Methods: From 1998 to 2005, 463 consecutive RCPs were performed for UC of the bladder. Patients with PUC at final pathology were grouped by route of prostatic invasion (bladder origin or prostatic urethral origin) and by depth of invasion (carcinoma in situ, ductal invasion, and stromal invasion). Univariate and multivariate survival analyses were performed., Results: In all, 35% (162/463) of patients had PUC. The 3-year overall survival (OS) was 58.2% for patients who did not have PUC, 59.2%, 51.7%, and 16.8% in order of increasing depth of prostatic invasion for patients with PUC of urethral origin, and 6.7% for patients with bladder-origin PUC. Survival differed significantly between stromal and non-stromal PUC (P < 0.001). Patients with PUC of bladder origin had a higher rate of positive lymph nodes (LNs) than patients with stromal PUC of prostate origin (74.3% vs 27.8%, P < 0.001), but survival was similar (P = 0.619). On multivariate analysis, age (P = 0.035), increasing bladder stage (P = 0.003), stromal invasion (P = 0.002) and positive LNs (P < 0.001) were predictors of poor OS., Conclusion: Depth of prostatic invasion correlates with outcome. While prostatic involvement originating in the bladder is associated with higher rates of positive LNs, survival is similar to patients with stromal involvement of urethral origin. Age, bladder tumour stage, prostatic stromal involvement and positive LNs predict adverse outcome. Our data support separate staging of the prostate in RCP specimens.

Background: The radical cystectomy experience at Vanderbilt University Medical Center was scrutinized to determine whether there was a difference in survival between patients with lymph node-negative pathologic T3a versus pathologic T3b urothelial carcinoma of the bladder., Methods: Pathologic and clinical data were reviewed on patients who underwent radical cystectomy for urothelial carcinoma between 1995 and 2005. We excluded patients with nontransitional cell cancer, lymph node disease, or with unknown lymph node status. Of the 790 reviewed patients, 75 patients (9.4%) were diagnosed with pathologic T3 urothelial cancer of the bladder. The impact of pathologic substaging (pT3a vs pT3b) was examined to determine the effect on overall, disease-specific, and recurrence-free survival., Results: The mean age was 68.6 years (36 years to 83 years). Median overall follow-up was 25.3 months (1.13 months to 130.17 months). Median follow-up for patients alive at last follow-up was 55.9 months (25.3 months to 130.2 months). Actuarial overall survival at 5 years was 29.5% for pT3a and 29.3% for pT3b (P = .79). Actuarial disease-specific survival at 5 years was 54.1% for pT3a and 42.4% for pT3b (P = .21). Actuarial recurrence-free survival at 5 years was 68.1% for pT3a and 71.9% for pT3b (P = .53)., Conclusions: There were no significant differences in overall, disease-specific, or recurrence-free survival when comparing lymph node-negative pT3a versus pT3b urothelial cancer of the bladder following radical cystectomy. Simplification of pathologic staging for urothelial carcinoma of the bladder should be considered at future revisions of the American Joint Committee on Cancer staging system., ((c) 2009 American Cancer Society.)

Purpose: The feasibility of laparoscopic or robotic assisted radical cystectomy has been demonstrated in several small series, but the specific advantages are uncertain and require comparisons to more recent results that incorporate refinements in open technique and perioperative management. We reviewed our contemporary radical cystectomy series to evaluate perioperative outcome measures which could be affected by surgical approach for the purpose of establishing contemporary benchmarks for future comparisons., Materials and Methods: The medical records of 553 consecutive patients undergoing radical cystectomy from January 2000 through June of 2005 were reviewed. Perioperative and demographic data, type of urinary diversion, hospital stay, complications and perioperative mortality were examined., Results: Median patient age was 69 years (range 22 to 94) and average American Society of Anesthesiologists classification was 2.7. Median operative time was 258 minutes (range 89 to 801). Mean operative time for ileal conduit diversion was 271 vs 312 minutes for neobladder diversion. Median blood loss was 600 ml (range 200 to 4,200). A total of 210 patients (38%) received a blood transfusion either intraoperatively or within the first 30 days of their procedure. Median length of hospital stay was 6 days (range 4 to 79). Minor and major complications occurred in 209 (38%) and 41 (7.4%) patients, respectively. Perioperative mortality was 1.7%., Conclusions: These results demonstrate that contemporary radical cystectomy can be accomplished through an open operative approach consistently with acceptable morbidity/mortality and with a median length of stay of less than 1 week. Efforts to further reduce morbidity and improve outcomes should continue.

Objective: To assess the frequency, presentation, treatment, and outcomes of bladder neck contractures (BNCs) among patients who had an orthotopic urinary diversion after radical cystectomy., Patients and Methods: We retrospectively examined our single-institution database of 788 patients who had a radical cystectomy from 1 January 1996 to 4 January 2006 for BNC; variables evaluated included presentation, degree of stricture/contracture, clinical management, and outcomes after management., Results: Of the 374 patients who had an orthotopic urinary diversion, 11 (2.9%) men developed BNC; four BNCs were between 17 F and 22 F, six were <17 F, and one was pinhole-sized. Nine of the 11 patients presented with voiding difficulties, one in complete retention after complicated urinary tract infection, and one with new-onset nocturnal urinary incontinence. The treatment of BNC included cystoscopic dilatation in the clinic in six and under anaesthesia in three, and transurethral incision with a Collins knife or holmium laser in seven. After treatment, all patients were instructed to use continuous intermittent catheterization (CIC). Ten patients had follow-up data available after the intervention, with a mean (range) follow-up of 40.6 (10.6-98.0) months. Six patients were stricture-free for a mean period of 35.4 (10.6-98.0) months, while four patients had a recurrence within a mean of 7.4 (1.3-17.1) months. At the last follow-up, nine of the 10 patients were using CIC. No patient had significant daytime or night-time incontinence after treatment., Conclusion: BNC develops in a small proportion of patients undergoing orthotopic urinary diversion, with most patients presenting with voiding difficulty. Most will require transurethral incision rather than an office-based dilatation. After endoscopic incision to correct BNC, we recommend CIC to ensure complete emptying and to maintain the patency of the anastomotic stricture.

Purpose: Studies of national databases yield important information about expected outcomes after radical cystectomy and factors that influence patient morbidity and mortality. We examined the hospital characteristics associated with outcomes after radical cystectomy in a cohort study using results from a single, high volume academic institution as well as a nationwide data set of academic institutions., Materials and Methods: We obtained data from the University HealthSystem Consortium Clinical Database on 6,728 patients nationwide who underwent radical cystectomy for bladder cancer between 2002 and 2005 as well as on 421 who underwent cystectomy at our institution during this period. Outcomes were compared by hospital characteristics (geographic location, total hospital discharges and procedure volume). The outcome measures analyzed were length of hospital stay, the complication rate and in hospital mortality., Results: The overall complication rate at our institution was 32.07% with an in hospital mortality rate of 0.95% and an average length of stay of 7.05 days. The overall complication rate in the University HealthSystem Consortium data set was 37.16% with an in hospital mortality rate of 1.47% and an average length of stay of 10.98 days. Institutions with higher cystectomy volumes had significantly better outcomes than institutions with lower procedure volumes. The mortality rate at institutions with greater than 50 cystectomies per year was 0.54% compared to 2.70% at institutions with 10 or fewer per year (p <0.0005). Outcomes varied only minimally with total hospital discharges or geographic region., Conclusions: Even among academic medical centers hospitals with a higher volume of cystectomies in 2002 to 2005 were associated with improved outcomes, including decreased mortality, shorter length of stay and lower rehospitalization rates. These data may provide a framework for self-assessment and help establish criteria for performance evaluation.

Purpose: We characterized initial relapse patterns in patients who underwent cystectomy for transitional cell carcinoma of the bladder at our institution., Materials and Methods: Between June 1995 and December 2001 a total of 417 patients underwent radical cystectomy for transitional cell carcinoma. Of the 399 patients treated with orthotopic diversion or incontinent cutaneous diversion, recurrent TCC developed in 86 (21.6%). We retrospectively examined this population to determine if any perioperative variables influenced the first site of disease recurrence., Results: Of the 86 patients in whom metastatic disease developed after cystectomy, the mean followup was 22.1 months. Mean time to disease recurrence was 15.1 months. Recurrence was most commonly initially in the pelvis (30.2%). Other common sites of first recurrence included the viscera (26.7%), the retroperitoneum (16.3%) and the skeletal system (16.3%). The site of first recurrence did not correlate significantly with gender, age, diversion type, pathological stage, nodal status, prostatic involvement or the presence of a positive surgical margin. Lymphovascular invasion was more prevalent in the pelvic recurrence group (62%) than in the retroperitoneal (36%), visceral (22%) or skeletal metastases (29%) groups (p = 0.03)., Conclusions: While the pelvis is the most common site of disease recurrence following radical cystectomy, TCC of the bladder recurs in an unpredictable pattern and aggressive surveillance is indicated. Patients with local pelvic recurrence had a higher percentage of lymphovascular invasion on cystectomy than the other recurrence site groups.

Purpose: We present our experience with urethral recurrence of transitional cell carcinoma following cystectomy and orthotopic urinary diversion in a contemporary series., Materials and Methods: Between June 1995 and December 2001, 415 patients underwent radical cystectomy for transitional cell carcinoma. Of those patients 196 (47.2%) received an orthotopic urinary diversion. Demographics, clinical characteristics, pathological stage and patient outcomes were reviewed., Results: Mean followup was 34.1 months (range 0.3 to 97.3). Of the 196 patients who underwent orthotopic diversion 59 (30.1%) had T3 or greater disease on final pathological evaluation. Thirteen patients (6.6%) were found to have prostatic urethral involvement while 83 (42.3%) had elements of carcinoma in situ. No patient with prostatic urethral involvement had subsequent urethral recurrence. Overall only 1 patient (0.5%) had urethral recurrence of transitional cell carcinoma following orthotopic urinary diversion. The urethral recurrence rate in patients with orthotopic diversion was less than in patients with ileal conduit creation during the same period (2.1%). The overall disease recurrence rate following orthotopic diversion was 31.6% (62 of 196)., Conclusions: Urethral recurrence following orthotopic neobladder was rare in this series despite using selection criteria that were less stringent than those of other comparable series. Overall disease recurrence was relatively high in patients with high risk pathological features but urethral recurrence in this group with orthotopic urinary diversion remained low.

Urinary diversion among patients receiving prior radiation is common. Herein, we present our experience with ileal conduit (IC) diversion in patients with a history of prior abdominal and/or pelvic radiation therapy. We analyzed the charts of 177 patients who underwent IC urinary diversion between 1/1994 and 6/2000, and 36 patients were identified who had previously undergone radiation therapy. Decisions to proceed were based on surgeon preference as determined by intraoperative appearance and viability of the selected bowel segment. Chart review included serum studies, upper tract imaging studies, and complications related to diversion. Durability of diversion was determined by examining the interval between urinary diversion and the need for additional procedures. A total of 30 patients with at least 3 months follow-up were identified. Renal function remained stable in 86% (26/30) with a median follow-up of 21.5 months (range 3-63 months). Hydronephrosis was noted preoperatively in 4 patients (13%) who demonstrated stable upper tracts and serum creatinine in the post-operative period. Three patients (10%) developed unilateral hydronephrosis related to tumor recurrence, with one patient demonstrating a rise in baseline serum creatinine. Hydronephrosis was noted in 5 patients (16%) secondary to development of ureteroenteric stricture. Serum creatinine remained stable in 2 patients without intervention with 2 years follow-up. Intervention for obstruction was necessary in 3 patients at 22, 31, and 61 months following diversion. In one patient, an intraoperative decision to use the colon for urinary diversion was made secondary to appearance of small bowel. Minor complications were noted in 9 patients (30%), while 3 patients (10%) experienced major complications in the immediate post-operative period. Five patients (17%) experienced complications potentially related to the use of ileum for urinary diversion. The use of ileum for urinary diversion among patients with a history of radiation appears technically feasible and a viable treatment alternative. Our data support the use of ileum in the majority of patients as evidence by a low complication rate and a high rate of upper tract preservation. In addition, these data imply that a prior history of abdominal and/or pelvic radiation should not serve as the sole determining factor in the selection of bowel segment utilized during urinary diversion.

Purpose: Pathological stage influences patient outcome after radical cystectomy. We present our experience with patients who have only transitional cell carcinoma in situ of the bladder (pCIS-only) on final pathological examination after radical cystectomy., Materials and Methods: Between August 1995 and June 2003, 576 patients underwent radical cystectomy at our institution. Of these patients 54 were pathological stage CIS-only on final cystectomy specimen. Four patients simultaneously had invasive transitional cell carcinoma of the ureter or renal pelvis and were excluded from evaluation. Variables examined included demographic characteristics, preoperative pathological stage, high risk features and followup parameters., Results: Of the 50 patients with pCIS-only 44 (88%) were disease-free at last followup. Mean followup was 37.2 months (range 3.6 to 93.5). Of the 50 patients 21 had focal CIS while 29 had multifocal disease. There was no difference in disease recurrence between these 2 groups (9.5% vs 13.7%, p = 0.8). There were 9 patients with proximal urethral CIS involvement, of whom metastatic disease developed in 3. Only 1 of the 8 patients (12.5%) with ureteral orifice involvement had recurrence. Of the 50 patients 22 had muscle invasive disease on initial transurethral resection without residual invasive disease at cystectomy. This subset fared significantly worse after radical cystectomy than the 28 patients with less than stage T2 disease on transurethral bladder tumor resection (22.7% vs 3.6% metastasis, p < or = 0.05)., Conclusions: The outcome of patients who have pCIS-only after radical cystectomy is not uniform. Patients may be at higher risk for recurrence if disease extends to the proximal urethra. In addition, patients demonstrating invasion on clinical staging (stage T2 or greater) but subsequent pCIS-only disease have a worse prognosis compared to those with superficial clinical staging. Patients with CIS-only on clinical and pathological staging have an excellent disease-free survival with radical cystectomy even with the presence of multifocal disease.

Although recent series have demonstrated that radical cystectomy can be safely performed in elderly patients, few if any, have examined the long-term success of this procedure. We sought to determine the long-term benefit and survival outcomes after radical cystectomy in the elderly, high operative risk patient. We reviewed the records of all patients undergoing radical cystectomy between July 1994 and January 2000. Of these 382 patients, we identified 38 patients with transitional cell carcinoma who met our predetermined selection criteria of elderly, high peri-operative risk patients [age > or = 75 years and American Society of Anesthesiologists (ASA) classification > or = 3]. We analyzed patient characteristics, presenting symptoms, pathology, outcomes, and survival. Median age was 79 years (75-87 years). All but a single patient underwent surgery for symptomatic disease. No patient died in the early perioperative period. At a mean follow-up of 22 months (3-90 months), 11/38 (29%) patients are alive. Of the patients with < or = pT2B pathology, 9/27 (33%) are alive and are disease-free. There are 2/11 patients (18%) with > or = pT3 pathology still alive with 1 of those patients (pT4a) alive with disease 34 months after his radical cystectomy. Kaplan-Meier survival curves demonstrate that patients with organ confined disease (< or = pT2B) had a significantly longer mean overall survival than patients with nonorgan confined disease (> or = pT3): 31 months vs. 18 months, P = 0.046. Cause of death was known in 17 patients, with the majority (14/17) because of bladder cancer. However, there were no local recurrences, and palliative goals were achieved in all patients. Our results validate radical cystectomy as a safe and effective treatment choice in the elderly patient with significant co-morbidities. These patients, most of whom are symptomatic, can achieve palliation of their symptoms, local control, and long term survival, especially if their bladder cancer is organ confined. Reluctance to offer timely, aggressive local therapy may compromise ultimate survival, even amongst high operative risk, elderly patients., (Copyright 2004 Elsevier Inc.)

Purpose: Historically obesity has been thought to impact negatively patients undergoing surgery. We evaluated the impact of body mass index (BMI), an objective measure of obesity, on operative and perioperative outcomes in patients undergoing radical cystectomy., Material and Methods: We reviewed the records of 304 consecutive patients who underwent radical cystectomy and urinary diversion between October 1995 and July 2000. Factors analyzed included BMI, clinical demographic characteristics, comorbidities, operative variables (eg estimated blood loss [EBL], transfusion requirement and operative time), length of stay and postoperative complications. Results were analyzed using the nonpaired heteroscedastic Student t test assuming unequal variances to determine statistical significance., Results: Of the patients 61% were overweight or obese (BMI 25 or greater). BMI did not correlate with type of urinary diversion, gender or race. On univariate analysis the preoperative variables age, American Society of Anesthesiologists score and BMI correlated with EBL. However, on multivariate analysis BMI was the only preoperative or operative variable that significantly correlated with EBL (p = 0.01). Mean EBL in patients with a normal BMI (less than 25) was 595 ml compared to the mean EBL for overweight and obese patients (25 or greater of 811 ml (p <0.001). However, BMI did not correlate with the complication rate or hospital stay., Conclusions: On multivariate analysis considering preoperative and operative variables BMI was the only preoperative variable that predicted increased blood loss. Despite this finding overweight or obese patients in this series did not have a higher complication rate or longer hospital stay.

Purpose: Prostatic carcinoma (Pca) at cystoprostatectomy is usually an incidental finding with the majority thought to be clinically insignificant. Most studies have not specifically addressed the location of Pca or the incidence and location of in situ or invasive urothelial carcinoma (Uca) in prostates of cystoprostatectomy specimens. The frequency of involvement of the apex with these processes has clinical implications. Specifically urinary continence following orthotopic diversion may be enhanced by prostate apical sparing. In this study the pathological features of Pca and Uca, and the frequency of apical involvement were investigated in prostates from cystoprostatectomy specimens., Materials and Methods: Whole mounted prostates from 121 consecutive cystoprostatectomy specimens were analyzed. Pca location, tumor volume, grade, stage, surgical margin and pelvic lymph node status of Pcas were assessed. Clinically insignificant Pcas had a volume of less than 0.5 cc without Gleason pattern 4, extracapsular extension, seminal vesicle invasion, lymph node involvement or positive surgical margins. Prostate involvement by Uca or urothelial carcinoma in situ (CIS)/severe dysplasia and its location were assessed., Results: Of 121 prostates 50 (41%) had unsuspected Pca, of which 24 (48%) were clinically significant. Of Pcas 30 of 50 (60%) involved the apex, including 19 of 24 (79%) that were significant and 11 of 26 (42%) that were insignificant. Of 121 prostates 58 (48%) had Uca involving the prostatic stroma, noninvasive Uca or urothelial CIS/severe dysplasia in the prostatic urethra or periurethral ducts, of which 19 (33%) had apical involvement. Overall only 32 of 121 patients (26%) had no Pca or prostate Uca/CIS and only 45 (37%) had no clinically significant Pca or Uca/CIS in the prostate. However, 74 of the 121 patients (61%) had no prostatic apical involvement by Pca or Uca/CIS and 85 (70%) had no apical involvement by clinically significant Pca or Uca/CIS. Patients with prostatic apical involvement by invasive or in situ Uca uniformly had involvement of more proximal (toward the base) portions of the prostate., Conclusions: The majority of prostates from cystoprostatectomies had no involvement of the prostatic apex by Uca or clinically significant Pca. Hence, most patients may be candidates for prostate apical sparing. However, involvement of the apex by Uca in any patient raises concern about procedures that leave portions of the prostate urethra after cystectomy in an effort to improve continence. In candidates for orthotopic neobladder reconstruction removing all of the prostatic urethra and sparing the remainder of the prostatic apex may allow improved preservation of urinary continence with an acceptable low risk of clinical Pca progression. Whether future strategies for preoperative exclusion of apical Pca and intraoperative assessment of more proximal prostate to help exclude apical urothelial disease may identify patients suitable for prostatic apical sparing remains to be determined. The impact on functional outcomes and cancer control also require additional study.

Purpose: The impact of treatment on the health related quality of life (HRQOL) of patients is being recognized with increasing importance, particularly in those with urological malignancies. However, a validated disease and treatment specific instrument to assess HRQOL following radical cystectomy (RC) and urinary diversion (UD) is currently lacking. We report the results of a new questionnaire designed specifically to measure HRQOL in these patients., Materials and Methods: A 45-item questionnaire consisting of the Functional Assessment of Cancer Therapy (FACT)-General and 17 additional items designed to measure disease and treatment specific health outcomes were combined to form the Vanderbilt Cystectomy Index (FACT-VCI). FACT-VCI and the generic RAND 36-Item Health Survey (SF-36) were administered to 50 patients from our institution RC data base who were more than 1 year from the time of surgery. Each patient was asked to complete the survey at 1 and 4 weeks. The results of the SF-36 and FACT-VCI were correlated along with the first and second administration of the FACT-VCI., Results: Overall FACT-VCI was found to have adequate internal consistency (Cronbach's alpha >0.70). Furthermore, intraclass correlation for the first and second administration of the VCI was 0.79. In addition, there was good correlation between the validated SF-36 and FACT-VCI (r = 0.81). The result was initial validation of a questionnaire for the assessment of HRQOL in patients following RC and UD., Conclusions: Instruments designed to measure accurately HRQOL following RC and UD are in early development. We have now constructed and validated a disease and treatment specific questionnaire that can objectively assess HRQOL following RC and UD. A prospective longitudinal study of FACT-VCI is currently ongoing.

Purpose: While radical cystectomy remains the treatment of choice for invasive transitional cell carcinoma, the importance of its timing has been increasingly scrutinized. We determined whether the interval between diagnosis of muscle invasion and definitive radical cystectomy influenced pathological staging outcome., Materials and Methods: Of the 303 patients who underwent radical cystectomy from January 1998 to December 2001, 153 were diagnosed with muscle invasive transitional cell carcinoma at transurethral resection. Charts were reviewed for pathological stage, demographics and time between diagnosis of muscle invasion and radical cystectomy., Results: Mean patient age was 67.2 years (range 35 to 88) with the majority (121 of 153, 79%) being male. At the time of cystectomy, 68 of 153 (44%) patients had organ confined disease (pT2B or lower), while node positive disease was found in 58 of 153 patients (38%). Mean time from transurethral resection diagnosis of muscle invasive disease until cystectomy was 63 days (range 8 to 473). A statistically significant correlation existed between time of diagnosis and cystectomy, and final pathological stage. Specifically, those patients with an interval greater than 90 days were more likely to have pT3 or higher, nonorgan confined disease compared to those patients undergoing cystectomy before 90 days (81% versus 52%, p = 0.01). Furthermore, those patients with organ confined disease had a significantly shorter mean time between diagnosis and cystectomy of 47.5 days versus 75.1 days for nonorgan confined disease (t test p = 0.02)., Conclusions: In patients with muscle invasion at diagnosis, a delay in surgery is associated with more advanced pathological stage, especially when the delay is longer than 90 days. While appropriate time should be given for consideration of options and pretreatment evaluation, undue delay may compromise cancer control.

Purpose: Radical cystectomy has been associated with significant blood loss and the need for heterologous transfusion. We investigated the potential decrease in blood loss and/or in transfusion requirement using a new stapling device compared with the traditional suture ligation technique., Materials and Methods: We prospectively examined 70 patients with urothelial carcinoma who were scheduled for radical cystectomy. Each patient was randomized to traditional suture ligation or the Compact Flex Articulating Linear Cutter (Ethicon Endo-Surgery, Cincinnati, Ohio) stapling device. The 2 groups were prospectively compared with respect to estimated blood loss, transfusion requirement, operative time and complications., Results: The groups were equivalent in terms of demographic and clinical variables, indicating that randomization produced 2 comparable groups. The stapler group had significantly lower estimated blood loss during cystectomy (p = 0.007) and during the whole procedure (p = 0.02). This group also required fewer transfusions (p = 0.006) and fewer mean units transfused (p = 0.003). The overall transfusion rate was 20% (14 of 70 cases). All patients in the stapler group had lower estimated blood loss and transfusion requirements. There was no statistical difference in time needed for bladder removal (p = 0.91) or total operative time (p = 0.17). No complications were attributable to the stapler device., Conclusions: In this prospective randomized study the stapling device significantly decreased blood loss and the transfusion requirement during radical cystectomy. These significant advantages combined with its relative safety make it an attractive surgical option and argue in favor of continued strategic attempts to decrease blood loss during radical cystectomy.

Purpose: Radical cystectomy is gold standard treatment for muscle invasive bladder cancer and is an option for many patients with nonmuscle invasive disease at high risk for disease progression. We assessed the early complications of radical cystectomy among patients with nonmuscle invasive compared to those with muscle invasive disease., Materials and Methods: We reviewed the records of 304 consecutive patients who underwent radical cystectomy from December 1995 to July 2000. We evaluated complications that occurred within 30 days of the procedure. Cases were stratified into nonmuscle invasive (PO, Pa, P1 and PIS, N0) or muscle invasive (P2-4, N0-3) tumors based on final specimen pathology. The 2 groups were then compared with respect to age, gender, race, American Society of Anesthesiologists score, type of urinary diversion, estimated blood loss, operative time and length of stay, and major and minor complications., Results: Of the 293 available patients 105 (36.8%) had nonmuscle invasive specimen pathology. Overall major and minor complications occurred in 4.9% and 30.4% of cases, respectively. Independent t test revealed no significant difference between groups in terms of age (p = 0.85), gender (p = 0.77), race (p = 1.0), American Society of Anesthesiologists (p = 0.32), type of urinary diversion (p = 0.33), estimated blood loss (p = 0.31), operative time (p = 0.41), length of stay (p = 0.75), or presence of major (p = 0.78) or minor (p = 0.79) complications., Conclusions: The early morbidity associated with radical cystectomy for nonmuscle invasive disease is similar to but not less than that associated with muscle invasive tumors. These acceptable risks as well as the potential benefits should be discussed with patients with nonmuscle invasive bladder cancer at high risk for disease progression.

Purpose: A significant number of patients requiring radical cystectomy for bladder cancer have substantial co-morbidity. Nonetheless, these patients often prefer orthotopic neobladder reconstruction to avoid an abdominal stoma. We performed a retrospective study to determine perioperative morbidity in this group of patients., Materials and Methods: We used the American Society of Anesthesiologists physical status classification to assign perioperative risk. Of 250 patients undergoing orthotopic neobladder reconstruction after radical cystectomy during a 5-year period we identified 84 with an American Society of Anesthesiologists score of 3 or greater. Charts were available for review for all patients and none was lost to followup., Results: Median operative time (calculated from anesthesia ready time to completion of surgery and application of a dressing) was 256 minutes. In 14 patients (16.6%) transfusion of a median of 2 units of allogeneic blood was required. A total of 79 patients (94%) were transferred directly from the recovery room to the general urology floor without a need for postoperative cardiac monitoring. Median hospital stay was 7 days. One patient (1.1%) died on postopera-tive day 9 of a presumed pulmonary embolus after having been discharged home on postoperative day 6. Minor complications occurred in 16 patients (19%). Only 1 patient required a return to the operating room for endoscopic removal of a retained stent fragment., Conclusions: In experienced hands radical cystectomy and orthotopic neobladder can be offered to patients with co-morbid conditions. Expeditious performance of the surgical procedure, minimization of blood loss, restricting the surgical incision to an infraumbilical location, and avoidance of intraoperative complications all contribute to decreasing morbidity and mortality. Although orthotopic reconstruction is more complex than performance of an ileal conduit, there is no apparent increase in perioperative morbidity or mortality. Therefore, orthotopic reconstruction can be offered to patients who want to avoid an abdominal stoma even in the face of significant co-morbid conditions.

The purpose of this retrospective study was to examine a radical cystectomy population to determine the most common postoperative causes for increased length of stay and to identify patient risk factors that may predict a prolonged hospitalization. These data demonstrate minor and major complications, increased estimated blood loss, and transfusion requirement correlate with delayed discharge. The most common cause for prolonged hospitalization in this series was postoperative paralytic ileus. The use of a collaborative pathway for radical cystectomy that includes a plan of care, structured preoperative and postoperative patient/family teaching, and proactive discharge planning may be a factor in decreasing length of stay in this patient population.

Purpose: Orthotopic urinary reconstruction has been shown to be a viable option in women undergoing radical cystectomy. However, due to anatomical differences and technical considerations orthotopic diversion has been performed in a relatively small number of patients. We examined our technique of vaginal wall preservation during female radical cystectomy and orthotopic neobladder construction., Materials and Methods: We reviewed the records of all patients who underwent radical cystectomy between January 1994 and December 2001. Of these 542 patients we identified 94 females, of whom 25 (27%) underwent orthotopic neobladder substitution. We reviewed perioperative major and minor complications, postoperative care, followup and pathological results., Results: Overall 21 of the 25 patients (84%) underwent anterior vaginal wall sparing. Five patients (24%) had minor complications, there were no major perioperative complications and no patients required transfusion. Median estimated blood loss in this group was 575 ml. (range 200 to 1,250). A single neobladder-vaginal fistula developed in a patient early in our series in whom the anterior vaginal wall was incised and repaired during dissection. Of the 21 patients 15 (72%) were continent. Pathological specimens revealed a negative posterior bladder wall and urethral margins in all cases. At a median followup of 12 months 1 patient had local recurrence., Conclusions: Anterior vaginal wall preservation in female radical cystectomy with orthotopic neobladder substitution is technically feasible, maintains vaginal length and support, has an acceptable complication rate and can achieve negative margins. Prospective evaluation is needed to assess the long-term impact on functional outcomes and cancer control.

Purpose: Health related quality of life after urinary diversion has been increasingly recognized as an important outcome measure. However, few studies have directly compared patients with an ileal conduit with those with a continent orthotopic neobladder and even fewer have used validated quality of life instruments. Therefore, we compared health related quality of life in patients who underwent neobladder versus ileal conduit creation using validated questionnaires., Materials and Methods: We mailed 2 validated questionnaires that are measures of health related quality of life, namely the RAND 36-Item Health Survey (SF-36) and Functional Assessment of Cancer Therapy-General (FACT-G), to patients who underwent radical cystectomy for urothelial carcinoma between January 1995 and December 1999. Statistical analysis was performed, including univariate and multivariate analysis., Results: A total of 112 patients were available for assessment. A total of 72 (64%) questionnaires were returned, including 23 (32%) and 49 (68%) from patients with an ileal conduit and neobladder, respectively. On the SF-36 questionnaire there were significant univariable relationships between treatment and age (p <0.001 and 0.01, respectively). Younger patients and those with a neobladder had higher health related quality of life scores, including significant differences in 5 of the 9 SF-36 domains (general health, physical functioning, physical health, social functioning and energy/fatigue). There was no relationship between health related quality of life and the final pathological stage (p = 0.25). On multivariate analysis adjusting for age led to a suggestive but nonsignificant difference in health related quality of life scores favoring neobladders (p = 0.09). On the FACT-G there were no significant differences in health related quality of life due to treatment (p = 0.28), pathological stage (p = 0.5), age (p = 0.72) or current disease status (p = 0.27). On the FACT-G 2 of the 4 domains (emotional and functional well-being) were significantly in favor of neobladders. Overall satisfaction was high in the 2 groups with 96% and 85% of patients with a neobladder and ileal conduit, respectively, reporting that they would make the same choice of diversion., Conclusions: Based on validated health related quality of life instruments these findings suggest that patients with an orthotopic neobladder have marginal quality of life advantages over those with an ileal conduit. However, differences in health related quality of life in the 2 types of urinary diversion are confounded by age since patients who underwent orthotopic diversion were younger and as a result of age would be expected to have a higher health related quality of life score. A prospective longitudinal study of health related quality of life after adjusting for differences in age among patients undergoing urinary diversion is currently underway to extend further these observations.