Massimo Valerio

Guidelines for perioperative care after radical cystectomy for bladder cancer: Enhanced Recovery After Surgery (ERAS®) society recommendations

PURPOSE Enhanced recovery after surgery (ERAS) pathways have significantly reduced complications and length of hospital stay after colorectal procedures. This multimodal concept could probably be partially applied to major urological surgery. OBJECTIVES The primary objective was to systematically assess the evidence of ERAS single items and protocols applied to cystectomy patients. The secondary objective was to address a grade of recommendation to each item, based on the evidence and, if lacking, on consensus opinion from our ERAS Society working group. EVIDENCE ACQUISITION A systematic literature review was performed on ERAS for cystectomy by searching EMBASE and Medline. Relevant articles were selected and quality-assessed by two independent reviewers using the GRADE approach. If no study specific to cystectomy was available for any of the 22 given items, the authors evaluated whether colorectal guidelines could be extrapolated. EVIDENCE SYNTHESIS Overall, 804 articles were retrieved from electronic databases. Fifteen articles were included in the present systematic review and 7 of 22 ERAS items were studied. Bowel preparation did not improve outcomes. Early nasogastric tube removal reduced morbidity, bowel recovery time and length of hospital stay. Doppler-guided fluid administration allowed for reduced morbidity. A quicker bowel recovery was observed with a multimodal prevention of ileus, including gum chewing, prevention of PONV and minimally invasive surgery. CONCLUSIONS ERAS has not yet been widely implemented in urology and evidence for individual interventions is limited or unavailable. The experience in other surgical disciplines encourages the development of an ERAS protocol for cystectomy.

Enhanced Recovery After Surgery: Are We Ready, and Can We Afford Not to Implement These Pathways for Patients Undergoing Radical Cystectomy?

Enhanced recovery after surgery (ERAS) for radical cystectomy seems logical, but our study has shown a paucity in the level of clinical evidence. As part of the ERAS Society, we welcome global collaboration to collect evidence that will improve patient outcomes.

Role of multiparametric magnetic resonance imaging in early detection of prostate cancer

Most prostate cancers (PC) are currently found on the basis of an elevated PSA, although this biomarker has only moderate accuracy. Histological confirmation is traditionally obtained by random transrectal ultrasound guided biopsy, but this approach may underestimate PC. It is generally accepted that a clinically significant PC requires treatment, but in case of an non-significant PC, deferment of treatment and inclusion in an active surveillance program is a valid option. The implementation of multiparametric magnetic resonance imaging (mpMRI) into a screening program may reduce the risk of overdetection of non-significant PC and improve the early detection of clinically significant PC. A mpMRI consists of T2-weighted images supplemented with diffusion-weighted imaging, dynamic contrast enhanced imaging, and/or magnetic resonance spectroscopic imaging and is preferably performed and reported according to the uniform quality standards of the Prostate Imaging Reporting and Data System (PIRADS). International guidelines currently recommend mpMRI in patients with persistently rising PSA and previous negative biopsies, but mpMRI may also be used before first biopsy to improve the biopsy yield by targeting suspicious lesions or to assist in the selection of low-risk patients in whom consideration could be given for surveillance.Teaching Points• MpMRI may be used to detect or exclude significant prostate cancer.• MpMRI can guide targeted rebiopsy in patients with previous negative biopsies.• In patients with negative mpMRI consideration could be given for surveillance.• MpMRI may add valuable information for the optimal treatment selection.

Can 3T multiparametric magnetic resonance imaging accurately detect prostate cancer extracapsular extension

BACKGROUND Accurate staging is essential to determine the correct management of patients diagnosed with prostate cancer. We assess the accuracy of 3T multiparametric magnetic resonance imaging (MRI) with endorectal coil (3TemMRI) in detecting prostate cancer local extension. METHODS We retrospectively reviewed charts from January 2008 to July 2012 from all patients undergoing radical prostatectomy. Patients were only included if 3TemMRI and radical prostatectomy were performed at our institution. Based on the presence of extracapsular extension (ECE) at 3TemMRI, prostate cancer was dichotomized into locally advanced or organ-confined disease. The accuracy of 3TemMRI local staging was then evaluated using definitive pathology as a reference. RESULTS Overall, 177 radical prostatectomies were performed within the timeframe. After applying exclusion criteria, 60 patients were included in the final analysis. The mean patient age was 67 ± 7 (standard deviation) years. Mean prostate-specific antigen value was 12.7 ± 12.7 ng/L. Based on preoperative characteristics, we considered 38 of the 60 patients (63%) patients high risk. 3TemMRI identified an organ-confined tumour in 46 patients and locally advanced disease in 14 patients. When correlated to final pathology, 3TemMRI specificity, sensitivity, negative and positive predictive values, and accuracy in detecting locally advanced prostate cancer were 90%, 35%, 57%, 79% and 62%, respectively. INTERPRETATION This study shows that the use of preoperative 3TemMRI can be used to identify organ-confined prostate cancer when locally advanced disease is suspected.

Are Patients at Nutritional Risk More Prone to Complications after Major Urological Surgery

PURPOSE The nutritional risk score is a recommended screening tool for malnutrition. While a nutritional risk score of 3 or greater predicts adverse outcomes after digestive surgery, to our knowledge its predictive value for morbidity after urological interventions is unknown. We determined whether urological patients at nutritional risk are at higher risk for complications after major surgery than patients not at nutritional risk. MATERIALS AND METHODS We performed a prospective observational study in consecutive patients undergoing major surgery. A priori sample calculation resulted in a study cohort of 220 patients. Interim analysis was planned after 110 patients. The nutritional risk score was assessed preoperatively by a specialized study nurse. Nutritional care was standardized in all patients. Postoperative complications were defined previously using the standardized Dindo-Clavien classification. The primary end point was 30-day morbidity. Univariate and multivariate analysis was performed to identify predictors of complications. RESULTS The study was discontinued due to significant results after interim analysis. A total of 125 patients were included in analysis from June 2011 to June 2012 and 15 were excluded because of incomplete data. Of 51 patients at nutritional risk 38 (74%) presented with at least 1 complication compared to 28 of 59 controls (47%). Patients at nutritional risk were at threefold risk for complications on univariate and multivariate analysis (OR 3.3, 95% CI 1.3-8.0). Cystectomy was the only other predictor of morbidity (OR 10, 95% CI 2-48). CONCLUSIONS Patients at nutritional risk are more prone to complications after major urological procedures. Whether this increased morbidity can be reversed by perioperative nutritional support should be studied.

Experimental evaluation of an electromechanical artificial urinary sphincter in an animal model

The AMS 800 urinary control system is the gold standard for the treatment of urinary incontinence due to sphincter insufficiency. Despite excellent functional outcome and latest technological improvements, the revision rate remains significant. To overcome the shortcomings of the current device, we developed a modern electromechanical artificial urinary sphincter. The results demonstrated that this new sphincter is effective and well tolerated up to 3 months. This preliminary study represents a first step in the clinical application of novel technologies and an alternative compression mechanism to the urethra.

Comorbidity and nutritional indices as predictors of morbidity after transurethral procedures: A prospective cohort study

INTRODUCTION Preoperative scores are widely used predictors of complications after major surgery. These scores, however, are not widely used in transurethral procedures. The aim of this study was to assess the value of the Charlson Comorbidity Index (CCI), the age-adjusted CCI, the American Society of Anesthesiologist score (ASA) and the Nutritional Risk Score (NRS) in predicting early morbidity after transurethral urological procedures. METHODS Consecutive patients undergoing transurethral resection of the bladder or the prostate were prospectively enrolled. The scores were calculated preoperatively; 30-day complications were prospectively recorded according to the Dindo-Clavien classification. Univariate logistic regression was performed to investigate the value of each score and of other factors (i.e., age, sex, body mass index, anemia, smoking habit, type of operation and anaesthesia) as predictors of complications. A multivariate model was then calculated using these predictors. RESULTS Overall, 197 patients were included. The mean age was 72 (standard deviation ± 10). In total, 26.9% patients had at least 1 complication. Using univariate analysis, we found that each score significantly predicted complications. In multivariate analysis, only the ASA (odds ration [OR] 2.11; 95% confidence interval [CI] 1.01-4.43) and the NRS (OR 2.42; 95% CI 1.56-3.74) remained independent predictors. The best model incorporated ASA, NRS and gender, and predicted morbidity with an area under the curve of 76%. Our studys main limitations are population heterogeneity and limited sample size. CONCLUSION The ASA and the NRS are important and independent determinants of early morbidity after transurethral procedures. The use of these indices may assist clinicians in the decision-making process to balance the possible benefits of transurethral procedures with the potential risks.

Percutaneous drainage and sclerotherapy as definitive treatment of renal lymphangiomatosis

We report the technique and outcome of percutaneous drainage and sclerotherapy as primary treatment of renal lymphangiomatosis. Between January and May 2009, two patients presenting with symptomatic renal lymphangiomatosis were treated in our department by a minimally invasive modality combining percutaneous drainage with repeated sclerotherapy. We retrospectively analysed recurrence, complications and patient satisfaction. In this limited case series, percutaneous drainage and repeated sclerotherapy proved to be safe and effective for treating renal lymphangiomatosis. This procedure provides a minimally invasive option for selected patients, potentially avoiding a surgical procedure and any risk of complications.

Intravesical Bacillus Calmette Guerin combined with a cancer-vaccine increases local T-cell responses in non-muscle-invasive bladder cancer patients.

Purpose: Treatments with cancer vaccines may be delivered as combination therapies for better efficacy. Addition of intravesical immunostimulation with bacteria promotes vaccine-specific T cells in the bladder and tumor-regression in murine bladder cancer models. Here, we determined whether an adjuvanted cancer vaccine can be safely administered with concomitant standard intravesical Bacillus-Calmette-Guérin (BCG) therapy and how vaccine-specific immune responses may be modulated in patients with non-muscle–invasive bladder cancer (NMIBC). Experimental Design: In a nonrandomized phase I open-label exploratory study, 24 NMIBC patients, apportioned in three groups, received 5 injections of a subunit cancer vaccine (recMAGE-A3 protein+AS15) alone or in two combinations of intravesical BCG-instillations. Safety profiles were compared between the three treatment groups, considering single vaccine injections or BCG instillations and concomitant interventions. Immune responses in blood and urine were compared between treatment groups and upon BCG instillations. Results: The mild adverse events (AE) experienced by all the patients were similar to AE previously reported for this vaccine and standard BCG treatment. AEs were not increased by the double interventions, suggesting that BCG did not exacerbate the AE caused by the MAGE-A3 vaccine and vice-versa. All patients seroconverted after MAGE-A3 vaccination. In half of the patients, vaccine-specific T cells were induced in blood, irrespective of BCG treatment. Interestingly, such T cells were only detected in urine upon BCG-induced T-cell infiltration. Conclusions: Cancer vaccines, including strong adjuvants, can be safely combined with intravesical BCG therapy. The increase of vaccine-specific T cells in the bladder upon BCG provides proof-of-principle evidence that cancer vaccines with local immunostimulation may be beneficial. Clin Cancer Res; 23(3); 717–25. ©2016 AACR.

Practice Patterns Compared with Evidence-based Strategies for the Management of Androgen Deprivation Therapy–Induced Side Effects in Prostate Cancer Patients: Results of a European Web-based Survey

BACKGROUND Evidence-based recommendations are available for the management of androgen deprivation therapy (ADT)-induced side effects; however, there are no data on the implementation of the recommendations into daily practice patterns. OBJECTIVE To compare practice patterns in the management of ADT-induced side effects with evidence-based strategies. DESIGN, SETTING, AND PARTICIPANTS A European Web-based survey was conducted from January 16, 2015, to June 24, 2015. The 25-item questionnaire was designed with the aid of expert opinion and covered general respondent information, ADT preference per disease stage, patient communication on ADT-induced side effects, and strategies to mitigate side effects. All questions referred to patients with long-term ADT use. Reported practice patterns were compared with available evidence-based strategies. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Following data collection, descriptive statistics were used for analysis. Frequency distributions were compiled and compared using a generalised chi-square test. RESULTS AND LIMITATIONS In total, 489 eligible respondents completed the survey. Luteinising hormone-releasing hormone-agonist with or without an antiandrogen was the preferred method of ADT in different settings. Patients were well informed about loss of libido (90%), hot flushes (85%), fatigue (67%), and osteoporosis (63%). An osteoporotic and metabolic risk assessment prior to commencing ADT was done by one-quarter of physicians. The majority (85%) took preventive measures and applied at least one evidence-based strategy. Exercise was recommended by three-quarters of physicians who advocate its positive effects; however, only 25% of physicians had access to exercise programmes. Although the minimum sample size was set at 400 participants, the current survey remains susceptible to volunteer and nonresponder bias. CONCLUSIONS Patients were well informed about several ADT-induced complications but uncommonly underwent an osteoporotic and metabolic risk assessment. Nevertheless, physicians partially provided evidence-based strategies for the management of the complications. Physicians often advised exercise to reduce ADT-induced side effects, but programmes were not widely available. PATIENT SUMMARY Implementation of evidence-based strategies for androgen deprivation therapy-induced side effects in real-life practice patterns should be improved.