Davide De Marchi

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.

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 ERPs 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.

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.

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.

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.

The preoperative serum ratio of total prostate specific antigen (PSA) to free testosterone (FT), PSA/FT index ratio, and prostate cancer. Results in 220 patients undergoing radical prostatectomy

OBJECTIVES To evaluate associations of preoperative total prostate specific antigen (PSA) to free testosterone (FT), the PSA/FT index ratio, with features of pathology prostate cancer (PCA) and to investigate its prognostic potential in clustering the PCA population. PATIENTS AND METHODS After excluding criteria, the records of 220 patients who underwent radical prostatectomy (RP) were retrospectively reviewed. Serum samples of PSA, total testosterone (TT) and FT were collected at 8.00 A.M., one month after biopsies and before RP. The PSA/FT ratio was computed in the population of patients who were clustered in groups according to ranking intervals of the PSA/FT ratio which identified at least 4 clusters which were coded as A, B, C, and D. The independent associations of the PSA/FT index ratio were assessed by statistical methods and a two-sided P < 0.05 was considered to indicate statistical significance. RESULTS TT correlated to FT which was a significant predictor of PSA in the population of patients who were subsequently clustered, according to increasing interval values of the PSA/FT index ratio, in groups that showed a stronger linear association of FT with PSA. The PSA/FT index ratio significantly associated with pathology features of prostate cancer such as pathology Gleason score (pGS), invasion of the seminal vesicles (pT3b), proportion of positive cores (P+) and proportion of cancer involving the volume of the prostate. In the population of patients, TT, PSA/FT index ratio and P+ independently associated with pGS ≥ 7 and pT3b; moreover, the odds ratio (OR) of the PSA/FT index ratio resulted 9.11 which was stronger than TT (OR = 1.11) and P+ (OR = 8.84). In the PCA population, TT, PSA/FT index ratio and P+ also independently associated with pT3b PCA; interestingly, the OR of PSA/FT index resulted 54.91 which was stronger than TT (OR = 1.31) and P+ (26.43). CONCLUSIONS Preoperative PSA/FT index ratio is an independent strong factor which directly associates with aggressive features of pathology PCA; moreover, it might express prognostic potential for clustering the patient population in risk classes. Confirmatory studies are required.

Prostate-specific antigen associates with extensive lymph node invasion in high-risk prostate cancer

Objective: To evaluate clinical predictors of lymph node invasion (LNI) in patients with high-risk prostate cancer undergoing radical prostatectomy (RP) with extended pelvic lymph node dissection (ePLND). Methods: A contemporary cohort of 116 patients, who underwent ePLND during RP, was retrospectively evaluated. Patients were classified into 3 groups including cases without LNI (group 1), with 1 to 3 positive nodes (group 2; limited LNI), and with more than 3 positive nodes (group 3; extensive LNI). The multinomial logistic regression model (multivariate analysis) evaluated the risk of LNI. Results: Overall, 30 patients (25.9%) had LNI, which was limited in 17 cases (14.7%) and extensive in 13 subjects (11.2%). Median prostate-specific antigen (PSA) was higher in cases with limited (11.4 ng/mL) or extensive (23.5 ng/mL) LNI than cases without (7.3 ng/mL) and the difference was significant (p <.0001). Median proportion of biopsy-positive cores was higher in limited (0.64) or extensive (0.54) LNI than cases without (0.34) and the difference was significant (p < .0001). The distribution of other factors did not show any significant difference among the groups. On multivariate analysis, only higher values of PSA significantly affected the odds of extensive LNI when compared to cases without (odds ratio, 1.054; p = .005); PSA showed a fair discrimination power (area under the curve 0.792). Conclusion: PSA was the only independent predictor of extensive LNI and could be an important preoperative factor for stratifying high-risk patients.

Robotic bladder diverticulectomy: step-by-step extravesical posterior approach – technique and outcomes

Abstract Objective: The aim of this study was to evaluate the feasibility of robotic extravesical posterior surgical bladder diverticulectomy for treatment of symptomatic bladder diverticula (BD). Materials and methods: Data from patients with posterior BD who consecutively underwent robotic bladder diverticulectomy (RBD) from 2013 to 2016 in Azienda Ospedaliera Universitaria Integrata, Verona, were retrospectively reviewed. Baseline characteristics, perioperative outcomes including operative time (OT), estimated blood loss (EBL), postoperative transfusion rate and length of hospital stay (LOS), and early (30 days) and late (90 days) postoperative complications were recorded and analysed. Results: Six patients underwent RBD. Storage, voiding and postvoiding lower urinary tract symptoms (LUTS) were reported by 33.3%, 100% and 33.3% of patients, respectively. The median [interquartile range (IQR)] BD diameter was 7.1 (5.5–9.5) cm; median (IQR) preoperative postvoiding residual volume (PVR) was 300 (90–395) ml. The median (IQR) OT was 112.5 (83.7–133.7) min and median (IQR) EBL was 25.8 (0–50) ml. The median (IQR) LOS was 7 (4.7–9.0) days. One patient (16.7%) reported early minor postoperative complication. No patient showed early or late major postoperative complications. At 2 month follow-up, all patients underwent a lower abdomen ultrasound and minimal or no postoperative PVR was found. At 6 month follow-up no LUTS were reported. Conclusions: RBD appears to be a safe treatment for posterior BD with excellent perioperative and functional outcomes. The three-dimensional visualization, greater magnification and wristed instrumentation with seven degrees of freedom allow precise dissection of BD and reconstruction of the bladder wall.

Quality of life following urinary diversion: Orthotopic ileal neobladder versus ileal conduit. A multicentre study among long-term, female bladder cancer survivors

INTRODUCTION Women undergoing radical cystectomy (RC) followed by urinary diversion (UD) for bladder cancer experience a substantial reduction in health-related quality of life (HRQOL). At present, studies comparing long-term QOL outcomes for different UD methods, needed to inform evidence-based choices of bladder reconstruction for female patients, are sparse. Our objective was to compare two common UD methods in terms of their HRQOL outcomes in women. MATERIALS AND METHODS We retrospectively analysed HRQOL in 73 consecutive female bladder cancer patients having undergone orthotopic ileal neobladder (IONB, N = 24) or ileal conduit (IC, N = 49) following RC between 2007 and 2013 in six Italian academic urological centres. Patients had no evidence of tumour recurrence and were actively followed up. Validated Italian versions of the European Organisation for Research and Treatment of Cancer (EORTC) generic (QLQ-C30) and bladder-cancer-specific (QLQ-BLM30) questionnaires were used to evaluate HRQOL. RESULTS Patients in the IONB group were significantly younger than those in the IC group (median age: 67 and 73 years, respectively, p = 0.02). Barring that, the two groups did not present statistically significant differences in median length of follow-up (43 vs 54 months), pathological stage, grading of the neoplasm, or adjuvant chemo - or radiotherapy. No significant differences in QOL were found between the groups, with the exception of financial difficulties, affecting IONB patients significantly more than IC patients (mean score on a scale of 0-100: 33.3 ± 29.5 vs 18.4 ± 19.3, respectively; p = 0.05). CONCLUSION Financial difficulties was the only HRQOL item to differ between the two UD groups.

Clinical Factors Predicting Tumour Upgrading in Patients Under Active Surveillance and Elected to Active Treatment after Disease Reclassification or Progression

Objectives: To evaluate clinical factors associated with tumour upgrading (UPG) in low-intermediate risk patients who progressed while under active surveillance (AS) and underwent delayed radical prostatectomy. Material and Methods: The evaluated factors included prostate specific antigen (PSA), prostate volume, PSA density and number of biopsy positive cores (BPC). Multivariate logistic regression by the forward step Wald procedure was used. Results: The study evaluated 24 patients who had UPG in 13 cases (54.2%). Independent factors associated with tumour UPG included PSA (OR 2.1; p = 0.047) and BPC (OR 2; p = 0.042). Conclusions: Clinical factors associated with UPG were identified in patients who were under AS for with low-intermediate risk disease. Preoperative PSA levels and number of BPC were independent factors associated with UPG in a contemporary cohort of patients who progressed under AS and underwent delayed active treatment.