Giovanni Cacciamani

Quality of Life Assessment With Orthotopic Ileal Neobladder Reconstruction After Radical Cystectomy: Results From a Prospective Italian Multicenter Observational Study.

OBJECTIVE To assess health-related quality of life (HRQoL) parameters in patients who received radical cystectomy (RC) with ileal orthotopic neobladder (IONB) reconstruction and to identify clinic-pathologic predictors of HRQoL. PATIENTS AND METHODS From January 2010 to December 2013, a multicenter, retrospective on 174 RC-IONB patients was carried out. All patients completed the following questionnaires: the European Organization for Research and Treatment of Cancer (EORTC) generic (QLQ-C30) and bladder cancer-specific instruments (QLQ-BLM30) and the IONB-Patient Reported Outcome (IONB-PRO). Univariate and multivariate analyses were computed to identify clinic-pathologic predictors of HRQoL. RESULTS Median age was 66 years (range, 31-83), and 91.4% of patients were men. Median follow-up period was 37 months (range, 3-247). The EORTC QLQ-C30 revealed that age >65 years, absence of urinary incontinence, and absence of peripheral vascular disease were independent predictors of deteriorated body image. A follow-up > 36 months and the presence of urinary incontinence were independent predictors of worsened urinary symptoms, whereas the absence of urinary incontinence was an independent predictor of a worsened body image according to EORTC QLQ-BLM30 results. A follow-up >36 months and the absence of urinary incontinence were independent predictors of better functioning in terms of relational life, emotional life, and fatigue as revealed by the IONB-PRO. CONCLUSION Age, presence of urinary incontinence, length of follow-up, and comorbidity status may influence postoperative HRQoL and should all be taken into account when counseling RC-IONB patients.

Development of a questionnaire specifically for patients with Ileal Orthotopic Neobladder (IONB)

BackgroundThe ileal orthotopic neobladder (IONB) is often used in patients undergoing radical cystectomy. The IONB allows to void avoiding the disadvantages of the external urinary diversion.In IONB patients the quality of life (QoL) appears compromised by the need to urinate voluntarily. The patients need to wake up at night interrupting the sleep-wake rhythm with consequences on social and emotional life.At present the QoL in IONB patients is evaluated by generic questionnaires. These are useful when IONB patients are compared with patients with different urinary diversions but they are less effective when only IONB patients are evaluated. To address this problem a specific questionnaire—the IONB-PRO—was developed.MethodsA) Based on a conceptual framework, narrative-based interviews were conducted on 35 IONB patients. A basic pool of 43 items was produced and organized throughout two clinical and four QoL dimensions. An additional 15 IONB patients were interviewed for face validity testing.B) Psychometric testing was conducted on 145 IONB patients. Both classic test strategy and Rasch analysis were applied. Psychometric properties of the resulting scales were comparatively tested against other QoL-validated scales.ResultsThe IONB-PRO questionnaire includes two sections: one on the QoL and a second section on the capability of the patient to manage the IONB. For evaluation of the QoL, three versions were delivered: 1) a basic 23-item QoL version (3 domains 23-items; alpha 0.86÷ 9.69), 2) a short-form 12-item QoL scale (alpha = 0.947), and 3) a short-form 15-item Rasch QoL scale (alpha = 0.967). Correlations of the long version scales with the corresponding dimensions of the EORTC-QLQ C30 and the EORTC-BLM30 were significant. The short forms exhibited significant correlations with the global health dimension of the EORTC-QLQ and with the urinary subscales of the EORTC-BLM30. The effect size was approximately 1.00 between patients at the 1-year follow-up period and those with 3, 5, and > 5-year follow-up periods for all scales. No relevant differences were observed between the 12-item short-form and the Rasch scale.ConclusionsThe IONB-PRO long and short-forms demonstrated a high level of internal consistency and reliability with an excellent discriminanting validity.

High Testosterone Preoperative Plasma Levels Independently Predict Biopsy Gleason Score Upgrading in Men with Prostate Cancer Undergoing Radical Prostatectomy.

Purpose: The study aims to investigate the potential associations between preoperative plasma levels of total testosterone (TT) and biopsy Gleason score (bGS) upgrading in prostate cancer (PCA) patients undergoing radical prostatectomy (RP). Materials and Methods: Exclusion criteria were treatment with 5α-reductase inhibitors, LH-releasing hormone analogues or testosterone replacement. Criteria of bGS upgrading were as follows: (i) bGS 6 to pathological Gleason score (pGS) >6, (ii) bGS 7 with pattern 3 + 4 to pGS 7 with pattern 4 + 3 or to pGS >7, (iii) bGS 7 with pattern 4 + 3 to pGS >7. Patients who showed bGS >7 were excluded from the cohort. Results: The study included 209 patients. Tumor upgrading was assessed in 76 (36.4%) cases of the entire cohort, in 51 out of 130 cases (39.2%) of the bGS 6 group and 25 out of 79 patients (31.6%) in the bGS 7 cluster. Logistic regression models showed that independent clinical covariates predicting the risk of bGS upgrading included TT (OR 1.058; p = 0.027) and prostate-specific antigen (PSA) density (OR 23.3; p = 0.008) as well as TT (OR 1.057; p = 0.029) with PSA (OR 1.061; p = 0.023). The model suggests that 1 unit increase in TT plasma levels increases the odds of bGS upgrading by 5.8 or 5.7%. Conclusions: In summary, we have determined that high TT preoperative plasma levels independently predict bGS upgrading in men with PCA undergoing RP. Preoperative plasma levels of TT might be included as a potential marker for assessing the risk bGS upgrading.

Chronic Inflammation in Prostate Biopsy Cores is an Independent Factor that Lowers the Risk of Prostate Cancer Detection and is Inversely Associated with the Number of Positive Cores in Patients Elected to a First Biopsy

Objectives: To investigate associations of chronic inflammatory infiltrate (CII) with prostate cancer (PCa) risk and the number of positive cores in patients elected to a first set of biopsies. Materials and Methods: Excluding criteria were as follows: active surveillance, prostate specific antigen (PSA) ≥ 30 ng/l, re-biopsies, incidental PCa, less than 14 cores, metastases, or 5-alpha reductase inhibitors. The cohort study was classified as negative (control group) and positive cores between 1 and 2 or > 2. Results: The cohort included 421 cases who did not meet the exclusion criteria. PCa was detected in 192 cases (45.6%) of which the number of positive cores was between 1 and 2 in 77 (40.1%) cases. The median PSA was 6.05 ng/ml (range 0.3-29 ng/ml). Linear regression models showed that CII was an independent predictor inversely associated with the risk of PCa. Multinomial logistic regression models showed that CII was an independent factor that was inversely associated with PCa risk in cases with positive cores between 1 and 2 (OR = 0.338; p = 0.004) or more than 2 (OR = 0.076; p < 0.0001) when compared to the control group. Conclusion: In a cohort of men undergoing the first biopsy set after prostate assessment, the presence of CII in the biopsy core was an independent factor inversely associated with PCa risk as well as with the number of positive biopsy cores (tumor extension). Clinically, the detection of CII in negative biopsy cores might reduce the risk of PCa in repeat biopsies as well as the probability of detecting multiple positive cores.

Prostate Volume Index Associates with a Decreased Risk of Prostate Cancer: Results of a Large Cohort of Patients Elected to a First Biopsy Set.

Background/Aims/Objectives: In patients elected to the first prostate biopsy set, the risk of prostate cancer (PCA) may be predicted by clinical factors. The aim of this study was to investigate on prostate volume index (PVI), defined as the ratio of volume of the transitional zone to the volume of the peripheral zone, and PCA risk. Methods: The study retrospectively evaluated 1,327 patients and included only the first biopsy set with 14 cores. PCA risk was assessed by using the multivariate logistic regression model. Results: The analysis evaluated 596 patients. The detection rate of PCA was 49%. Age, prostate specific antigen, PVI and digital rectal exam were independent factors of PCA risk, which was decreased by PVI (OR 0.224; 95% CI 0.157-0.380). The goodness of fit statistics assessed model efficacy. Conclusions: In a large cohort undergoing the first biopsy set, PVI associated with a decreased risk of PCA. Confirmatory studies are required.

Prostate chronic inflammation type IV and prostate cancer risk in patients undergoing first biopsy set: Results of a large cohort study

Objective In prostate specimens, chronic inflammatory infiltrate (CII) type IV has been detected, but its association with prostate cancer (PCa) is controversial. The aim of the present study is to investigate on associations of CII with PCa detection in patients undergoing prostate first biopsy set. Methods Ultrasound transrectal-guided biopsies by the transperineal approach were retrospectively evaluated in 441 consecutive patients. The study excluded patients who were in active surveillance, prostate specific antigen (PSA) ≥30 ng/mL, re-biopsies, incidental PCa after transurethral resection of the prostate (TURP), less than 14 cores or metastatic. Analysis of population and subpopulations (with or without PCa) was performed by statistical methods which included Mann–Whitney (U test), Kruskal–Wallis test, Chi-squared statistic, logistic regression. Multivariate logistic regression models predicting mean probability of PCa detection were established. Results PCa detection rate was 46.03%. Age, PSA, prostate volume (PV), prostate intraepithelial neoplasia (PIN) and CII were the significant independent predictors of PCa detection. PV (OR = 0.934) and CII (OR = 0.192) were both negative independent predictors. CII was a significant negative independent predictor in multivariate logistic regression models predicting the mean probability of PCa detection by age, PSA and PV. The inverse association of CII with PCa does not necessary mean protection because of PSA confounding. Conclusion In a population of patients undergoing prostate first biopsy set, CII was a strong negative independent predictor of PCa detection. CII type IV should be considered as an adjunctive parameter in re-biopsy or active surveillance protocols.

Clinical Factors of Disease Reclassification or Progression in a Contemporary Cohort of Prostate Cancer Patients Elected to Active Surveillance

Objectives: To evaluate clinical predictors of disease reclassification or progression (DR/P) in prostate cancer patients elected to active surveillance (AS). Material and Methods: Patients were assessed on the basis of DR/P criteria. Predictors of DR/P were evaluated by multivariate logistic regression and Cox proportional hazards. Results: The median DR/P free time was 16.5 months. DR/P was detected in 30 out of 84 cases (35.7%). In DR/P cases, the median prostate volume (PV) was significantly lower (34.7 vs. 42.7 ml) and the percentage of cases with 2 or 3 vs. 1 initial biopsy positive cores (BPC) was significantly higher (36.7 vs. 7.4%). The multivariate logistic regression model showed that PV (OR 0.9; p = 0.021) and initial n >1 BPC (OR 9.8; p = 0.001) were independent predictors of DR/P. By Cox multivariate proportional hazards, only n >1 BPC predicted early DR/P (hazard ratio 3.1; p = 0.003). Conclusions: In a contemporary cohort of patients elected to AS, independent factors stratifying the risk of DR/P were PV and initial BPC, which also predicted early DR/P. In patients elected to AS, the identification of risk factors of DR/P require early re-biopsy. Confirmatory studies are required.

A new training model for robot-assisted urethrovesical anastomosis and posterior muscle-fascial reconstruction: the Verona training technique.

A training model is usually needed to teach robotic surgical technique successfully. In this way, an ideal training model should mimic as much as possible the “in vivo” procedure and allow several consecutive surgical simulations. The goal of this study was to create a “wet lab” model suitable for RARP training programs, providing the simulation of the posterior fascial reconstruction. The second aim was to compare the original “Venezuelan” chicken model described by Sotelo to our training model. Our training model consists of performing an anastomosis, reproducing the surgical procedure in “vivo” as in RARP, between proventriculus and the proximal portion of the esophagus. A posterior fascial reconstruction simulating Rocco’s stitch is performed between the tissues located under the posterior surface of the esophagus and the tissue represented by the serosa of the proventriculus. From 2014 to 2015, during 6 different full-immersion training courses, thirty-four surgeons performed the urethrovesical anastomosis using our model and the Sotelo’s one. After the training period, each surgeon was asked to fill out a non-validated questionnaire to perform an evaluation of the differences between the two training models. Our model was judged the best model, in terms of similarity with urethral tissue and similarity with the anatomic unit urethra-pelvic wall. Our training model as reported by all trainees is easily reproducible and anatomically comparable with the urethrovesical anastomosis as performed during radical prostatectomy in humans. It is suitable for performing posterior fascial reconstruction reported by Rocco. In this context, our surgical training model could be routinely proposed in all robotic training courses to develop specific expertise in urethrovesical anastomosis with the reproducibility of the Rocco stitch.

Adherence to the European Association of Urology Guidelines: A National Survey among Italian Urologists

Objective: The study aimed to explore adherence to the European Urological Association (EAU) Guidelines (GLs) grade A recommendation among Italian urologists. Materials and Methods: A 13-item multiple-choice questionnaire covering oncological and non-oncological urological diseases was e-mailed to all Italian Urologist Society (Società Italiana di Urologia or SIU) members. We asked members to provide an explanation for their answer choice where needed. The quantitative data were tested using the Pearson’s chi-square test. For all statistical comparisons, significance was considered as p < 0.05. Results: Of the 2011 invited SIU members, 210 (10.4%) completed the survey. The sample was composed of 22 (10.5%) Academic Urologists (AcUs), 110 (52.4%) Attending Urologists (AtUs), 32 (15.2%) Private Practice Urologists (PPUs), and 41 (19.5%) Residents in Urology (RUs). The mean adherence to the EAU Oncologic GLs ranged from 54.5 to 97.1%, while the adherence to the non-oncologic GLs ranged from 45 to 87.6%. We found that adherence differed across the working categories assessed. Conclusion: Our survey showed that professional role, updates, and local facilities seem to be the drivers that influence the non-adherence to the GLs. Urologists who work in university hospital would be more inclined to adopt the GLs compared to those who practice in non-academic centers.

Impact of Surgical Factors on Robotic Partial Nephrectomy Outcomes: Comprehensive Systematic Review and Meta-analysis

Purpose: Utilization of robotic partial nephrectomy has increased significantly. We report a literature wide systematic review and cumulative meta‐analysis to critically evaluate the impact of surgical factors on the operative, perioperative, functional, oncologic and survival outcomes in patients undergoing robotic partial nephrectomy. Materials and Methods: All English language publications on robotic partial nephrectomy comparing various surgical approaches were evaluated. We followed the PRISMA (Preferred Reporting Items for Systematic Review and Meta‐Analyses) statement and AHRQ (Agency for Healthcare Research and Quality) guidelines to evaluate PubMed®, Scopus® and Web of Science™ databases (January 1, 2000 to October 31, 2016, updated June 2017). Weighted mean difference and odds ratio were used to compare continuous and dichotomous variables, respectively. Sensitivity analyses were performed as needed. To condense the sheer volume of analyses, for the first time data are presented using novel summary forest plots. The study was registered at PROSPERO (https://www.crd.york.ac.uk/prospero/, ID CRD42017062712). Results: Our meta‐analysis included 20,282 patients. When open partial nephrectomy was compared to robotic partial nephrectomy, the latter was superior for blood loss (weighted mean difference 85.01, p <0.00001), transfusions (OR 1.81, p <0.001), complications (OR 1.87, p <0.00001), hospital stay (weighted mean difference 2.26, p = 0.001), readmissions (OR 2.58, p = 0.005), percentage reduction of latest estimated glomerular filtration rate (weighted mean difference 0.37, p = 0.04), overall mortality (OR 4.45, p <0.0001) and recurrence rate (OR 5.14, p <0.00001). Sensitivity analyses adjusting for baseline disparities revealed similar findings. When robotic partial nephrectomy was compared to laparoscopic partial nephrectomy, the former was superior for ischemia time (weighted mean difference 4.21, p <0.0001), conversion rate (OR 2.61, p = 0.002), intraoperative (OR 2.05, p >0.0001) and postoperative complications (OR 1.27, p = 0.0003), positive margins (OR 2.01, p <0.0001), percentage decrease of latest estimated glomerular filtration rate (weighted mean difference ‐1.97, p = 0.02) and overall mortality (OR 2.98, p = 0.04). Hilar control techniques, selective and unclamped, are effective alternatives to clamped robotic partial nephrectomy. An important limitation is the overall suboptimal level of evidence of publications in the field of robotic partial nephrectomy. No level I prospective randomized data are available. Oxford level of evidence was level II, III and IV in 5%, 74% and 21% of publications, respectively. No study has indexed functional outcomes against volume of parenchyma preserved. Conclusions: Based on the contemporary literature, our comprehensive meta‐analysis indicates that robotic partial nephrectomy delivers mostly superior, and at a minimum equivalent, outcomes compared to open and laparoscopic partial nephrectomy. Robotics has now matured into an excellent approach for performing partial nephrectomy for renal masses.