Effect of Robot-Assisted Radical Cystectomy With Intracorporeal Urinary Diversion vs Open Radical Cystectomy on 90-Day Morbidity and Mortality Among Patients With Bladder Cancer: A Randomized Clinical Trial.

Importance: Robot-assisted radical cystectomy is being performed with increasing frequency, but it is unclear whether total intracorporeal surgery improves recovery compared with open radical cystectomy for bladder cancer. Objectives: To compare recovery and morbidity after robot-assisted radical cystectomy with intracorporeal reconstruction vs open radical cystectomy. Design, Setting, and Participants: Randomized clinical trial of patients with nonmetastatic bladder cancer recruited at 9 sites in the UK, from March 2017-March 2020. Follow-up was conducted at 90 days, 6 months, and 12 months, with final follow-up on September 23, 2021. Interventions: Participants were randomized to receive robot-assisted radical cystectomy with intracorporeal reconstruction (n = 169) or open radical cystectomy (n = 169). Main Outcomes and Measures: The primary outcome was the number of days alive and out of the hospital within 90 days of surgery. There were 20 secondary outcomes, including complications, quality of life, disability, stamina, activity levels, and survival. Analyses were adjusted for the type of diversion and center. Results: Among 338 randomized participants, 317 underwent radical cystectomy (mean age, 69 years; 67 women [21%]; 107 [34%] received neoadjuvant chemotherapy; 282 [89%] underwent ileal conduit reconstruction); the primary outcome was analyzed in 305 (96%). The median number of days alive and out of the hospital within 90 days of surgery was 82 (IQR, 76-84) for patients undergoing robotic surgery vs 80 (IQR, 72-83) for open surgery (adjusted difference, 2.2 days [95% CI, 0.50-3.85]; P = .01). Thromboembolic complications (1.9% vs 8.3%; difference, -6.5% [95% CI, -11.4% to -1.4%]) and wound complications (5.6% vs 16.0%; difference, -11.7% [95% CI, -18.6% to -4.6%]) were less common with robotic surgery than open surgery. Participants undergoing open surgery reported worse quality of life vs robotic surgery at 5 weeks (difference in mean European Quality of Life 5-Dimension, 5-Level instrument scores, -0.07 [95% CI, -0.11 to -0.03]; P = .003) and greater disability at 5 weeks (difference in World Health Organization Disability Assessment Schedule 2.0 scores, 0.48 [95% CI, 0.15-0.73]; P = .003) and at 12 weeks (difference in WHODAS 2.0 scores, 0.38 [95% CI, 0.09-0.68]; P = .01); the differences were not significant after 12 weeks. There were no statistically significant differences in cancer recurrence (29/161 [18%] vs 25/156 [16%] after robotic and open surgery, respectively) and overall mortality (23/161 [14.3%] vs 23/156 [14.7%]), respectively) at median follow-up of 18.4 months (IQR, 12.8-21.1). Conclusions and Relevance: Among patients with nonmetastatic bladder cancer undergoing radical cystectomy, treatment with robot-assisted radical cystectomy with intracorporeal urinary diversion vs open radical cystectomy resulted in a statistically significant increase in days alive and out of the hospital over 90 days. However, the clinical importance of these findings remains uncertain. Trial Registration: ISRCTN Identifier: ISRCTN13680280; ClinicalTrials.gov Identifier: NCT03049410.

Morbidity and mortality after robot-assisted radical cystectomy with intracorporeal urinary diversion in octogenarians: results from the European Association of Urology Robotic Urology Section Scientific Working Group.

OBJECTIVES: To evaluate the postoperative complication and mortality rate following laparoscopic radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) in octogenarians. PATIENTS AND METHODS: We conducted a retrospective analysis comparing postoperative complication and mortality rates depending on age in a consecutive series of 1890 patients who underwent RARC with ICUD for bladder cancer between 2004 and 2018 in 10 European centres. Outcomes of patients aged <80 years and those aged ≥80 years were compared with regard to postoperative complications (Clavien-Dindo grading) and mortality rate. Cancer-specific mortality (CSM) and other-cause mortality (OCM) after surgery were calculated using the non-parametric Aalen-Johansen estimator. RESULTS: A total of 1726 patients aged <80 years and 164 aged ≥80 years were included in the analysis. The 30- and 90-day rate for high-grade (Clavien-Dindo grades III-V) complications were 15% and 21% for patients aged <80 years compared to 11% and 13% for patients aged ≥80 years (P = 0.2 and P = 0.03), respectively. In a multivariable logistic regression analysis adjusting for pre- and postoperative variables, age ≥80 years was not an independent predictor of high-grade complications (odds ratio 0.6, 95% confidence interval 0.3-1.1; P = 0.12). The non-cancer-related 90-day mortality was 2.3% for patients aged ≥80 years and 1.8% for those aged <80 years, respectively (P = 0.7). The estimated 12-month CSM and OCM rates for those aged <80 years were 8% and 3%, and for those aged ≥80 years, 15% and 8%, respectively (P = 0.009 and P < 0.001). CONCLUSIONS: The minimally invasive approach to RARC with ICUD for bladder cancer in well-selected elderly patients (aged ≥80 years) achieved a tolerable high-grade complication rate; the 90-day postoperative mortality rate was driven by cancer progression and the non-cancer-related rate was equivalent to that of patients aged <80 years. However, an increased OCM rate in this elderly group after the first year should be taken into account. These results will support clinicians and patients when balancing cancer-related vs treatment-related risks and benefits.

Comparison of 2-Year Oncological Outcome and Early Recurrence Patterns in Patients with Urothelial Bladder Carcinoma Treated with Open or Robot-Assisted Radical Cystectomy with an Extracorporeal Urinary Diversion.

BACKGROUND: Data on oncological follow-up after robotic-assisted radical cystectomy (RARC) have been reported only scarcely and individual studies have reported an increase in early recurrences and atypical recurrences. PATIENTS AND METHODS: Clinical data of 89 patients with RARC were compared to 59 patients with open radical cystectomy (ORC) at a single institution. Two-year cancer-specific (2y-CSS) and 2-year overall survival (2y-OS) related to histopathological tumor stage of RARC patients calculated by Kaplan-Meier method were compared to ORC patients using log-rank test. Early clinical recurrence rate (eCR, progression ≤6 months post-cystectomy) and metastatic pattern of both groups were compared by chi-square test. RESULTS: Median follow-up 32 months (RARC) and 47.5 months (ORC), both groups were balanced in baseline characteristics. For RARC pts, -2y-OS and CSS-free survival rates were 80 and 90%, for ORC pts 65 and 71% (all p > 0.05). Margin status was not significantly different. eCR was observed in 10 out of 89 (11%) RARC pts and in 7 out of 59 (12%) ORC pts (p = 0.9). No difference in atypical metastases was seen between groups. CONCLUSION: Two-year oncological outcomes of RARC patients are comparable to ORC patients without differences regarding ePR or metastatic pattern.

Open radical cystectomy in England: the current standard of care - an analysis of the British Association of Urological Surgeons (BAUS) cystectomy audit and Hospital Episodes Statistics (HES) data.

OBJECTIVE: To establish the current standard for open radical cystectomy (ORC) in England, as data entry by surgeons performing RC to the British Association of Urological Surgeons (BAUS) database was mandated in 2013 and combining this with Hospital Episodes Statistics (HES) data has allowed comprehensive outcome analysis for the first time. PATIENTS AND METHODS: All patients were included in this analysis if they were uploaded to the BAUS data registry and reported to have been performed in the 2 years between 1 January 2014 and 31 December 2015 in England (from mandate onwards) and had been documented as being performed in an open fashion (not laparoscopic, robot assisted or the technique field left blank). The HES data were accessed via the HES website. Office of Population Censuses and Surveys Classification of Surgical Operations and Procedures version 4 (OPCS-4) Code M34 was searched during the same 2-year time frame (not including M34.4 for simple cystectomy or with additional minimal access codes Y75.1-9 documenting a laparoscopic or robotic approach was used) to assess data capture. RESULTS: A total of 2 537 ORCs were recorded in the BAUS registry and 3 043 in the HES data. This indicates a capture rate of 83.4% of all cases. The median operative time was 5 h, harvesting a median of 11-20 lymph nodes, with a median blood loss of 500-1 000 mL, and a transfusion rate of 21.8%. The median length of stay was 11 days, with a 30-day mortality rate of 1.58%. CONCLUSIONS: This is the largest, contemporary cohort of ORCs in England, encompassing >80% of all performed operations. We now know the current standard for ORC in England. This provides the basis for individual surgeons and units to compare their outcomes and a standard with which future techniques and modifications can be compared.

Effects of intraoperative PEEP optimization on postoperative pulmonary complications and the inflammatory response: study protocol for a randomized controlled trial.

BACKGROUND: Patients undergoing general anesthesia and mechanical ventilation during major abdominal surgery commonly develop pulmonary atelectasis and/or hyperdistention of the lungs. Recent studies show benefits of lung-protective mechanical ventilation with the use of low tidal volumes, a moderate level of positive end-expiratory pressure (PEEP) and regular alveolar recruitment maneuvers during general anesthesia, even in patients with healthy lungs. The purpose of this clinical trial is to evaluate the effects of intraoperative lung-protective mechanical ventilation, using individualized PEEP values, on postoperative pulmonary complications and the inflammatory response. METHODS/DESIGN: A total number of 40 patients with bladder cancer undergoing open radical cystectomy and urinary diversion (ileal conduit or orthotopic bladder substitute) will be enrolled and randomized into a study (SG) and a control group (CG). Standard lung-protective ventilation with a PEEP of 6 cmH2O will be applied in the CG and an optimal PEEP value determined during a static pulmonary compliance (Cstat)-directed PEEP titration procedure will be used in the SG. Low tidal volumes (6 mL/Kg ideal bodyweight) and a fraction of inspired oxygen of 0.5 will be applied in both groups. After surgery both groups will receive standard postoperative management. Primary endpoints are postoperative pulmonary complications and serum procalcitonin kinetics during and after surgery until the third postoperative day. Secondary and tertiary endpoints will be: organ dysfunction as monitored by the Sequential Organ Failure Assessment Score, in-hospital stay, 28-day and in-hospital mortality. DISCUSSION: This trial will assess the possible benefits or disadvantages of an individualized lung-protective mechanical ventilation strategy during open radical cystectomy and urinary diversion regarding postoperative pulmonary complications and the inflammatory response. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02931409 . Registered on 5 October 2016.

Mortality following augmentation cystoplasty: A transitional urologist's viewpoint.

INTRODUCTION: Three complications have been hypothesized to increase patient mortality following enterocystoplasty: spontaneous bladder perforation, bladder neoplasia, and chronic renal failure (CRF). The present study examined risk of their occurrence and discussed ways to improve the quality of care. MATERIALS AND METHODS: The present transitional clinic followed 385 patients with a history of bladder augmentation using either ileal, sigmoid, or ascending colon. The median age was 37 years (range 16-71). Median follow-up interval after augmentation was 26 years (range 2-59). DISCUSSION: Spontaneous rupture of the bladder occurred in 3% (13/385), with one associated death (0.25%, 1/385). Spontaneous bladder rupture significantly correlated with substance abuse, non-compliance with catheterization, and mental/physical disabilities that required the use of surrogates to perform and monitor intermittent catheterization (P < 0.01). Of the 203 patients that were followed for ≥10 years, 4% (8/203) developed a bladder tumor. In comparison, 2.5% (5/203) of an age-matched control population, managed by anticholinergics and intermittent catheterization, developed a bladder tumor. Therefore, enterocystoplasty cannot be associated with an increased risk of cancer development (P = 0.397). Chronic renal failure ≥ Stage 3 arose in 15% (58/385), and 1% (4/385) of the patients died as a result of this complication. Obese patients (BMI ≥30) catheterizing per urethra were more likely to be non-compliant with catheterization and develop CRF compared with obese patients with a continent catheterizable stoma (P > 0.001). These findings suggest that compliance with intermittent catheterization and renal preservation are enhanced by the presence of a catheterizable abdominal stoma. CONCLUSION: The individual's intellectual and physical capability to obey medical directives, refrain from high-risk habits, maintain a healthy weight, and comply with long-term follow-up visits were all critical to the enduring success of bladder augmentation.

A prognostic model for survival after palliative urinary diversion for malignant ureteric obstruction: a prospective study of 208 patients.

OBJECTIVE: To identify factors associated with survival after palliative urinary diversion (UD) for patients with malignant ureteric obstruction (MUO) and create a risk-stratification model for treatment decisions. PATIENTS AND METHODS: We prospectively collected clinical and laboratory data for patients who underwent palliative UD by ureteric stenting or percutaneous nephrostomy (PCN) between 1 January 2009 and 1 November 2011 in two tertiary care university hospitals, with a minimum 6-month follow-up. Inclusion criteria were age >18 years and MUO confirmed by computed tomography, ultrasonography or magnetic resonance imaging. Factors related to poor prognosis were identified by Cox univariable and multivariable regression analyses, and a risk stratification model was created by Kaplan-Meier survival estimates at 1, 6 and 12 months, and log-rank tests. RESULTS: The median (range) survival was 144 (0-1084) days for the 208 patients included after UD (58 ureteric stenting, 150 PCN); 164 patients died, 44 (21.2%) during hospitalisation. Overall survival did not differ by UD type (P = 0.216). The number of events related to malignancy (≥4) and Eastern Cooperative Oncology Group (ECOG) index (≥2) were associated with short survival on multivariable analysis. These two risk factors were used to divide patients into three groups by survival type: favourable (no factors), intermediate (one factor) and unfavourable (two factors). The median survival at 1, 6, and 12 months was 94.4%, 57.3% and 44.9% in the favourable group; 78.0%, 36.3%, and 15.5% in the intermediate group; and 46.4%, 14.3%, and 7.1% in the unfavourable group (P < 0.001). CONCLUSIONS: Our stratification model may be useful to determine whether UD is indicated for patients with MUO.

Urinary diversion: tailored solutions for individual patients.

PURPOSE OF REVIEW: Various urinary diversions are at disposition for reconstructive surgery after cystectomy. The chosen diversion has a strong impact on patients' life regarding complications and quality of life. The purpose of this review is to summarize the current tendency to adapt surgical solutions to individual needs of the patient. RECENT FINDINGS: Tailored surgery requires that the surgeon has been trained in the handling of all gut segments. Only in this case can he react to anatomical variants, patient comorbidities and oncological circumstances, as well as to the prognosis and the social circumstances of the patient with a tailored diversion. Changing demography and ageing populations with increasing incidence of muscle invasive bladder cancer request new, less invasive methods of urinary diversions. There is little evidence as to which is the best urinary diversion due to a lack of well designed studies. SUMMARY: The ileum conduit is still the most used urinary diversion worldwide. However, there are multiple techniques available to us, which guarantee the safest solution in combination with the highest quality of life for the construction of tailored urinary diversion.

Impact of the use of bowel for urinary diversion on perioperative complications and 90-day mortality in patients aged 75 years or older.

OBJECTIVE: A potential strategy to decrease the high complication rate of radical cystectomy (RC) in the elderly is to avoid the use of bowel for urinary diversion. The aim of this study was to address this issue in a multicentre study of patients aged ≥ 75 years. PATIENTS AND METHODS: We performed a retrospective, multicentre study of a consecutive series of patients aged ≥ 75 years who underwent RC for muscle-invasive bladder cancer between 2006 and 2010. Medical, surgical and wound complications were graded according to the modified Clavien-Dindo classification. RESULTS: A total of 256 patients (68% men, mean age 79.6 years) were analysed. 204 (80%) patients received a urinary diversion with use of bowel and 52 (20%) a ureterocutaneostomy (UC). Patients with UC were older (82.0 vs. 78.9 years, p < 0.001) and had a higher ASA score (2.6 vs. 2.3, p = 0.007), while the mean Charlson score was lower (4.2 vs. 5.6, p < 0.001). Patients with UC had a shorter operating time (279 vs. 311 min, p = 0.002) and a shorter period in the intensive care unit (0.9 vs. 2.2 days). The overall rate of severe complications graded as Clavien III-V was significantly lower in the UC group (11.5%) as compared to patients receiving bowel for urinary diversion (25.0%) (p = 0.003). Severe (Clavien grade III-V) medical (3.9 vs. 10.3%) and surgical (2.1 vs. 14.1%) complications were all less frequent in the UC group. Inpatient, 30- and 90-day mortality was 5.8, 7.7 and 17.3% in the UC group as compared to 3.9, 5.9 and 6.9% in the bowel cohort, respectively. CONCLUSION: UC following RC is associated with a lower complication rate in geriatric patients. The constantly increasing cohort of geriatric, multimorbid patients requiring cystectomy might justify reconsideration of this form of diversion.

[Treatment of invasive bladder cancer: robot-assisted radical cystectomy and intracorporeal urinary diversion]. / Therapie des invasiven Harnblasenkarzinoms : Roboterassistierte radikale Zystektomie und intrakorporale Harnableitung.

PURPOSE: Robot-assisted radical cystectomy (RARC) and intracorporeal urinary diversion are only performed in a few centers of excellence worldwide. Functional and oncologic outcomes are comparable. We report on our experience with RARC and intracorporeal diversion. PATIENTS AND METHODS: We retrospectively identified 86 RARCs in 72 men and 14 women (mean age 69.7 years). All patients underwent robot-assisted radical cystectomy and pelvic lymphadenectomy followed by intracorporeal urinary diversion using ileal conduit or neobladder. Of the 86 patients, 24 patients (28%) underwent intracorporeal ileal conduit and 62 patients (72%) underwent intracorporeal neobladder formation. A Studer pouch was created in all who underwent intracorporeal neobladder diversion. Cancer specific survival (CSS) and overall survival (OS) are reported. RESULTS: The mean operative time was 418.9 min (range 205-690 min) and blood loss was 380 ml (range 100-1000 ml). The mean hospital stay was 17.5 days (range 5-62 days). All the surgeries were completed with no open conversions. Minor complications (grade I and II) were reported in 23 patients, while major complications (grade III and above) were reported in 21 patients. The mean nodal yield was 20.3 (range 0-46). Positive margins were found in in 8%. The average follow-up was 31.5 months (range 3-52 months). Continence could be achieved in 88% of patients who received an intracorporeal neobladder. The cancer-specific survival (CSS) and overall survival (OS) were 80% and 70%, respectively. CONCLUSION: RARC with intracorporeal diversion seems to be safe and reproducible in tertiary centers with robotic expertise. Operative times are acceptable and complications as well as functional and oncologic outcomes are comparable. Further standardization of RARC with intracorporeal diversion may lead to a wider adoption of the approach.

Incidence and risk factors of 30-day early and 90-day late morbidity and mortality of radical cystectomy during a 13-year follow-up: a comparative propensity-score matched analysis of complications between neobladder and ileal conduit.

OBJECTIVE: We report on the short and late morbidity and mortality of ileal conduit and neobladder after radical cystectomy with their associated risk factors. METHODS: We retrospectively collected data on 308 non-metastatic bladder cancer patients who underwent radical cystectomy with either ileal conduit or neobladder for a curative intent from January 1999 to December 2011. Post-operative morbidity and mortality of 30-day (early) and 90-day (late) complication with their risk factors were examined in association with different types of urinary diversion. A comparative analysis using propensity-score matching was performed with matching variables of age, sex, number of underlying diseases and pathologic T and N stages, lymph node dissection, operative time and time of surgical year for comparison of the early and late morbidities between ileal conduit and neobladder. RESULTS: During the median follow-up of 46.6 months, early and late morbidities were 29.5% (n=91) and 19.8% (n=61), and complication-related mortalities were 2.2 and 6.6%, respectively. The type of urinary diversion significantly affected only the late complications (early: neobladder 57 vs. ileal conduit 47, P=0.096; late: neobladder 67 vs. ileal conduit 37, P<0.001). However, after propensity-score matching, no significant differences in early and late morbidities were observed between neobladder and ileal conduit. For risk factors of morbidity, number of removed lymph node states and hypertension were independently significant for both early and late complications (P<0.05). CONCLUSIONS: The type of urinary diversion affected only late complication, however, results of the matching analysis showed no significant differences in early and late morbidities between neobladder and ileal conduit.

Short-term morbidity and mortality of Indiana pouch, ileal conduit, and neobladder urinary diversion following radical cystectomy.

PURPOSE: Literature surrounding Indiana pouch (IP) urinary diversion suggests a higher incidence of complications and longer operative time compared with ileal conduit (IC) and neobladder (NB). We sought to assess short-term complications of IP diversions compared with other diversions at our institution. MATERIALS AND METHODS: Using institutional National Surgical Quality Improvement Program data, we identified radical cystectomy cases performed for bladder cancer at Indiana University from January 2011 until June 2013. During this time period, the National Surgical Quality Improvement Program randomly evaluated approximately 70% of radical cystectomies performed for urothelial carcinoma at our institution. Multivariable logistic regression was performed to identify factors associated with Clavien grade III-V complications. RESULTS: A total of 233 cases were identified, 139 IC, 39 IP, and 55 NB. Mean (standard deviation) operative times for IC, IP, and NB were 257 (84), 383 (78), and 327 (88) minutes, respectively (P<0.001). Half of the patients required blood transfusion during the hospitalization. The overall rate of complications was significantly lower among NB (P = 0.009). Overall, 12% of patients developed a Clavien grade III-V complication, with no difference observed between groups (P = 0.884). After controlling for preoperative confounders, IP patients were not at increased odds of developing a Clavien III-V complication compared with IC (odds ratio = 1.38, P = 0.599). CONCLUSIONS: At a high-volume center, the incidence of serious complications was similar between diversion types. IP patients were more likely to experience minor complications. Patients should be counseled regarding rates of short-term complications and blood transfusion.

Metabolic syndrome, obesity, and radical cystectomy complications: a clavien classification system-based analysis.

INTRODUCTION/BACKGROUND: The objective of this study was to evaluate the effect of MetS and its components on the early complications observed in patients treated with RC and urinary diversion. PATIENTS AND METHODS: We retrospectively analyzed 346 patients with bladder cancer undergoing RC with standard lymphadenectomy, according to the procedure suggested by the International Consultation on Bladder Cancer, and urinary diversion. All early complications within 90 days of surgery were recorded and collected according to the 10 Martin criteria and classified according to the established 5 grades of the modified Clavien classification system (CCS). MetS was defined according to the National Cholesterol Educational Program's Third Adult Treatment Panel. A binary logistic regression analysis was used to analyze MetS and, separately, its single components, as possible independent risk factors for high-grade complications. RESULTS: A total of 323 complications occurred in 231 of 346 patients (66.8%). The rates for low-grade (CCS I-II) and high-grade complications (CCS III-V), and mortality within 90 days (CCS V), were 80.8% (261 of 323), 19.2% (62 of 323), and 1.7% (6 of 346), respectively. At univariate analysis, MetS patients showed a higher rate of high-grade complications compared with patients without MetS (P < .001). At binary logistic regression analysis, MetS (OR, 1.3; P = .010), waist circumference (OR, 1.9; P = .022) and, only in single model, urinary diversion (OR, 1.3; P = .024) were independent risk factors for high-grade complications. CONCLUSION: RC is a major surgical procedure with a significant early complications rate, nevertheless, most are low-grade complications. MetS and, separately, waist circumference are associated with high-grade complications.

The role of mechanical bowel preparation before ileal urinary diversion: a systematic review and meta-analysis.

BACKGROUND: Although the use of mechanical bowel preparation (MBP) is still widely promoted as the dogma before patients undergo ileal urinary diversion, an increasing number of clinical trials have suggested that there is no benefit. Thus, we performed a meta-analysis to evaluate the efficacy of MBP in ileal urinary diversion surgery. METHODS: A literature search was performed in electronic databases, including PubMed, Embase, Science Citation Index Expanded as well as the Cochrane Library and the Cochrane Clinical Trials Registry, from 1966 to January 1, 2013. Clinical trials comparing outcomes of MBP versus no MBP for ileal urinary diversion surgery were included in the meta-analysis. Pooled odds ratios with 95% confidence intervals were calculated using the fixed- or random-effects models. RESULTS: In total, two randomized controlled trials and five cohort studies were included in this meta-analysis. The primary outcomes, such as bowel leak and bowel obstruction, showed no statistical difference between the two groups. Additionally, the overall mortality rate and death rate related to operation also manifested that MBP does not offer an advantage over the no MBP. CONCLUSION: This meta-analysis suggests that MBP does not reduce the incidence of perioperative complications in urinary diversion compared with no MBP. However, large randomized controlled clinical trials are needed to confirm this finding.

Simple modification in Hautmann neobladder to carry out left ureteroileal anastmosis without mobilization of the ureter.

We describe a simple modification in Hautmann neobladder that involves an elongation of its left chimney to advance it through the pelvic mesocolon in order to reach the left ureter in its original place. This technique was carried out on 27 patients who had Hautmann pouch after radical cystectomy, and we reported the outcome and complications that occurred at the site of urteteroileal anastomosis in the first 3 years after surgery. The modification was applied easily without any perioperative complications that were related to this step in particular. During follow up of these cases, we lost three patients who died before the end of the third postoperative year. At a mean follow up of 41.3 ± 10.2 months, we have not detected any cases of stricture formation or ureteral recurrence at the sites of the ureteroileal anastmosis. There was only one patient who developed acute pyelonephritis (3.7%) as a result of reflux.

Fast track surgery to reduce short-term complications following radical cystectomy and intestinal urinary diversion with Vescica Ileale Padovana neobladder: proposal for a tailored enhanced recovery protocol and preliminary report from a pilot study.

OBJECTIVE: Different fast track programs for patients undergoing radical cystectomy (RC) can be found in the current literature. The aim of this work was to develop a new enhanced recovery protocol (ERP). PATIENTS AND METHODS: The ERP was designed after a structured literature review focusing on reduced bowel preparation, standardized feeding, postoperative nausea, vomiting and pain control. In order to test the ERP, a pilot observational prospective cohort study was planned, enrolling all patients consecutively undergoing RC and Vescica Ileale Padovana (VIP) neobladder. These patients were compared with a matched group of subjects who had undergone RC and VIP neobladder before implementation of the ERP. To achieve good comparability, a propensity score-matching was performed. The primary aim was to assess the ERP's feasibility; the secondary outcome measures were early morbidity and mortality. RESULTS AND LIMITATIONS: After an exhaustive literature search and a multidisciplinary consultation, an ERP was designed. Nine consecutive patients participated in the pilot study and were compared to 13 patients treated before implementation of the ERP. We did not find any statistically significant difference in terms of mortality rate (none died peri- or postoperatively in both groups). The complication rate, according to the modified Clavien classification, was significantly lower in the ERP group (22.22 vs. 84.61%, p < 0.004). The major limitations are the low number of patients enrolled to test the protocol and the lack of randomization for the comparative evaluations. CONCLUSION: The introduction of our ERP was proven to be feasible in the management of patients undergoing RC and intestinal urinary diversion with VIP neobladder. The postoperative course was enhanced by a significant reduction in both nasogastric tube insertion and parenteral nutrition support, with early postoperative feeding. All these findings were associated with no deleterious effect on morbidity or mortality, indeed there was a reduced occurrence of postoperative complication rates.

Standardized assessment of complications in a contemporary series of European patients undergoing radical cystectomy.

OBJECTIVES: To examine postoperative complications in a contemporary series of patients after radical cystectomy using a standardized reporting system, and to identify readily available preoperative risk factors. METHODS: Using the modified Clavien-Dindo classification, we assessed the 90-day postoperative clinical course of 535 bladder cancer patients who underwent radical cystectomy and urinary diversion (ileal conduit n = 349, ileal neobladder n = 186) between June 2003 and February 2012 at a single institution. All Martin criteria for standardized reporting of complications were met. Uni- and multivariable analyses for prediction of complications were carried out; covariates included body mass index, Charlson Comorbidity Index, age, sex, American Society of Anesthesiologists Score, neoadjuvant chemotherapy, prior abdominal or pelvic surgery, localized tumor and urinary diversion type. RESULTS: The 90-day rates for overall (Clavien-Dindo classification I-V) and high-grade complications (Clavien-Dindo classification III-V), as well as mortality (Clavien-Dindo classification V), were 56.4, 18.7 and 3.9%, respectively. Infections (16.4%), bleeding (14.2%) and gastrointestinal complications (10.7%) were the most common adverse outcomes. Independent risk factors for overall complications were body mass index (odds ratio 1.08) and Charlson Comorbidity Index ≥3 (odds ratio 1.93). Risk factors for high-grade complications were Charlson Comorbidity Index ≥3 (odds ratio 1.86), American Society of Anesthesiologists Score ≥3 (odds ratio 1.92) and body mass index (odds ratio 1.07, all P < 0.03). CONCLUSIONS: Radical cystectomy is associated with significant morbidity; nevertheless, the majority of complications are minor. Charlson Comorbidity Index, American Society of Anesthesiologists Score and body mass index might help to identify patients at risk for high-grade complications after radical cystectomy.

Estudio comparativo de morbimortalidad entre conducto ileal y ureterosigmoidostomía tras cistectomía radical por neoplasia vesical / Comparative Study of Morbidity and Mortality Between Ileal Conduit and Ureterosigmoidostomy After Radical Cystectomy for Bladder Neoplasm

Objetivos: Pese a la tendencia creciente a la elaboración de neovejigas ortotópicas, en muchos casos no es posible su realización, manteniendo su vigencia otras técnicas. Planteamos un análisis comparativo entre pacientes con cistectomía radical por neoplasia vesical y reconstrucción mediante conducto ileal (CI) o ureterosigmoidostomía (USG). Pacientes y método: Estudio retrospectivo observacional sobre 255 pacientes con cistectomía radical entre 1985 y 2009, seleccionando las derivaciones mediante CI o USG. Análisis de características demográficas y prequirúrgicas, complicaciones periquirúrgicas, anatomía patológica y complicaciones a medio y largo plazo. Comparación entre grupos mediante «t» de Student, U Mann-Whitney y chi cuadrado, considerando significación estadística si p < 0,05. Elaboración de tablas de supervivencia según Kaplan-Meier, estableciendo comparaciones mediante el test log rank. Resultados: Cuarenta y un CI y 55 USG, con edad media aproximada de 61 años. USG realizada en un mayor número de mujeres que el CI. Sin diferencias en la necesidad de transfusión, con resultados similares a otras series. Mayor tendencia hacia la aparición de fístulas intestinales y mayor morbimortalidad en el postoperatorio en la USG, aunque no significativa. A largo plazo, mayor presencia de eventraciones en CI y pielonefritis, y necesidad de toma de alcalinizantes en USG. Aparición de hernias periestomales en CI menor que en series previas. Con seguimiento medio superior a 50 meses, supervivencia global del 40% a 5 años, sin diferencias según derivación urinaria. Conclusiones: CI y USG son 2 derivaciones urinarias aplicables en caso de no poder realizar neovejiga ortotópica, con un perfil de complicaciones y supervivencia a largo plazo similares en nuestra serie, aunque con una mayor morbilidad en las complicaciones postoperatorias de la USG (AU)

Objectives: Despite the growing trend in the development of orthotopic neobladders, the procedure cannot be performed in many cases, thereby retaining the validity of other techniques. We propose a comparative analysis between patients with radical cystectomy for bladder neoplasm and reconstruction using the ileal conduit (IC) or ureterosigmoidostomy (USG). Patients and method: Observational retrospective study on 255 patients with radical cystectomy between 1985 and 2009, selecting group assignments by the use of IC and USG. Analysis of the demographic and preoperative characteristics, perioperative complications, pathology and medium to long-term complications. Comparison of groups using T-Student, U-Mann–Whitney and chi square tests, with p < 0.05 indicating statistical significance. Preparation of survival tables according to Kaplan–Meier, establishing comparisons using the log-rank test. Results: There were 41 cases of IC and 55 cases of USG, with a mean patient age of approximately 61 years. USGs were performed on a greater number of females than ICs. There were no differences in the need for transfusion, with similar results as other series. There was a greater trend toward the appearance of intestinal fistulae and greater morbidity and mortality in the postoperative period in USG, although it was not significant. There was a greater long-term presence of eventrations in IC, and of pyelonephritis and the need for taking alkalinizing agents in USG. The appearance of peristomal hernias in IC was less than in previous series. With a mean follow-up greater than 50 months, the overall survival was 40% at 5 years, with no differences according to urinary diversion. Conclusions: IC and USG are two applicable urinary diversions in the event that orthotopic neobladder surgery cannot be performed. They have a similar long-term complication and survival profile in our series, although with a higher morbidity in postoperative complications for USG (AU)

Oncologic, functional, and complications outcomes of robot-assisted radical cystectomy with totally intracorporeal neobladder diversion.

BACKGROUND: Robot-assisted radical cystectomy (RARC) with totally intracorporeal neobladder diversion is a complex procedure that has been reported with good outcomes in small series. OBJECTIVE: To present complications and oncologic and functional outcomes of this procedure. DESIGN, SETTING, AND PARTICIPANTS: Between 2003 and 2012 in a tertiary referral center, 70 patients were operated on by two experienced robotic surgeons. Data were collected prospectively and reviewed retrospectively. INTERVENTION: RARC with totally intracorporeal modified Studer ileal neobladder formation. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The overall outcome of RARC with a totally intracorporeal neobladder was presented by assessing (1) surgical margins, (2) recurrence or cancer-specific death at 24 mo, (3) 30-d and 90-d complications graded according to the modified Clavien-Dindo system, (4) daytime and nighttime continence (no or one pad per day) at 6 and 12 mo, and (5) satisfactory sexual activity or potency at 6 mo and 12 mo. Survival rates were estimated by Kaplan-Meier plots. RESULTS AND LIMITATIONS: Median follow-up of the cohort was 30.3 mo (interquartile range: 12.7-35.6). We recorded negative margins in 69 of 70 patients (98.6%). Clavien 3-5 complications occurred in 22 of 70 patients (31.4%) at 30 d and 13 of 70 (18.6%) at >30 d. At 90 d, the overall complication rate was 58.5%. Clavien <3 and Clavien ≥3 complications were recorded in 15 of 70 patients (21.4%) and 26 of 70 (37.1%), respectively. Kaplan-Meier estimates for recurrence-free, cancer-specific, and overall survival at 24 mo were 80.7%, 88.9%, and 88.9%, respectively. Daytime continence and satisfactory sexual function or potency at 12 mo ranged between 70% and 90% in both men and women. Limitations of this study include its retrospective design, selection bias due to the learning curve phase, and missing data. CONCLUSIONS: In this expert center for RARC, outcomes after RARC with totally intracorporeal neobladder diversion appear satisfactory and in line with contemporary open series.