Stefano Cavalleri

A systematic review and meta-analysis of randomized controlled trials with antimuscarinic drugs for overactive bladder

CONTEXTnAnticholinergic drugs are commonly used in patients with overactive bladder (OAB) who do not achieve symptom relief and quality of life improvement with conservative management. Several drugs, with different doses, formulations, and routes of administration are currently available, making the choice quite difficult.nnnOBJECTIVEnTo evaluate efficacy and safety of different doses, formulations, and route of administration of the available anticholinergic drugs.nnnEVIDENCE ACQUISITIONnA systematic review of the literature was performed in August 2007 using Medline, Embase, and Web of Science. Efficacy (micturitions per 24h, volume voided per micturition, urgency urinary incontinence episodes per 24h, incontinence episodes per 24h) and safety (mainly, adverse events and withdrawal rates) end points were evaluated in the randomized control trials (RCTs) assessing the role of anticholinergic drugs in non-neurogenic OAB. Meta-analysis of RCTs was conducted using the Review Manager software 4.2 (Cochrane Collaboration).nnnEVIDENCE SYNTHESISnOur systematic search identified 50 RCTs and three pooled analyses. Tolterodine immediate release (IR) had a more favorable profile of adverse events than oxybutynin IR. Regarding different dosages of IR formulations, dose escalation might yield some limited improvements in the efficacy but at the cost of significant increase in the rate of adverse events. In the comparisons between IR and extended-release (ER) formulations, the latter showed some advantages, both in terms of efficacy and safety. With regard to the route of administration, use if a transdermal route of administration does not provide significant advantage over an oral one.nnnCONCLUSIONnMany of the available RCTs have good methodological quality. ER formulations should be preferred to the IR ones. With regard to IR formulations, dose escalation might yield some improvements in the efficacy with significant increase in the AE. More clinical studies are needed to indicate which of the drugs should be used as first-, second-, or third-line treatment.

A prospective, non―randomized trial comparing robot―assisted laparoscopic and retropubic radical prostatectomy in one European institution

To compare the functional results of two contemporary series of patients with clinically localized prostate cancer treated by robot‐assisted laparoscopic prostatectomy (RALP) or retropubic radical prostatectomy (RRP).

Complications and Mortality After Radical Cystectomy for Bladder Transitional Cell Cancer

PURPOSEnWe evaluated early postoperative complications and 3-month mortality after radical cystectomy using a standardized method to report complications.nnnMATERIALS AND METHODSnWe retrospectively collected data on all 358 consecutive patients who underwent radical cystectomy for nonmetastatic bladder transitional cell carcinoma at a tertiary academic referral center from January 2002 to December 2006. The Martin criteria were used to report complications, which were graded according to a 5-grade modification of the Clavien system.nnnRESULTSnA total of 231 complications occurred in 174 patients (49%), of which 13% were grades 3 to 5. The 3-month mortality rate was 3%. After evaluating the whole patient cohort American Society of Anesthesiologists score was the only covariate significantly associated with grade 3 to 5 complications on univariate analysis. Subgroup analysis limited to patients with an orthotopic ileal neobladder showed that female gender (HR 0.204, p = 0.017) and American Society of Anesthesiologists score (HR 2.851, p = 0.013) were independent predictors of grade 3 to 5 complications on multivariate analysis.nnnCONCLUSIONSnWhen applying a standardized methodology to report early morbidity, about 50% of patients undergoing radical cystectomy had complications within 3 months of surgery. Although most complications were minor, about 13% of patients experienced grade 3 to 5 events, resulting in a 3-month mortality rate of 3%. American Society of Anesthesiologists score was significantly associated with major complications, while on subgroup analysis in patients who received an orthotopic ileal neobladder female gender was also an independent predictor of major complications.

Prospective Evaluation With Standardised Criteria for Postoperative Complications After Robotic-Assisted Laparoscopic Radical Prostatectomy

BACKGROUNDnVery few studies have evaluated the risk of complications following robotic-assisted laparoscopic radical prostatectomy (RARP), and all were flawed by several methodological biases.nnnOBJECTIVEnTo evaluate the prevalence of early complications and risk factors following RARP, reporting complications in agreement with the standardised Martin criteria.nnnDESIGN, SETTING, AND PARTICIPANTSnAll 415 patients who underwent surgery for clinically localised prostate cancer from April 2005 to April 2009 at a single tertiary academic centre were prospectively studied.nnnINTERVENTIONnRARP was performed by two surgeons with the same technique.nnnMEASUREMENTSnComplications were collected and reported according to the standardised Martin criteria.nnnRESULTS AND LIMITATIONSnOne hundred and two complications were observed in 90 patients (21.6%), with bleeding (5.3%), lymphorrhoea (4.3%), and pelvic haematoma (2.4%) the most common ones. According to the modified Clavien system, 41 patients (10%) had grade 1, 37 (9%) had grade 2, 11 (3%) had grade 3, and 1 (0.2%) had grade 4 complications. On multivariable analysis, prostate volume (odds ratio: 0.985; p<0.001) and the number of cases performed (p<0.001) were independent predictors of the occurrence of any grade complications. Considering grade 3 to 4 complications, only the number of cases performed by the surgeons was significantly associated with major complications in a univariable analysis (p<0.001). The major limitation of the study is represented by the relatively small number of patients and events included in the analysis, resulting in the study being underpowered to identify some factors predicting any or high-grade complications.nnnCONCLUSIONSnApplying standardised criteria to collect and report complications, we identified early complications in about 22% of our patients undergoing RARP. Although most of the patients experienced minor complications, 3% of them did experience grade 3 or 4 complications. Prostate volume and number of RARP performed by the surgeons were independent predictors of the occurrence of complications.

Evaluating Urinary Continence and Preoperative Predictors of Urinary Continence After Robot Assisted Laparoscopic Radical Prostatectomy

PURPOSEnWe evaluated urinary continence using a validated questionnaire in a series of consecutive patients who underwent robot assisted laparoscopic radical prostatectomy, and identified the preoperative predictors of the return to urinary continence.nnnMATERIALS AND METHODSnThe clinical records of 308 consecutive patients who underwent robot assisted laparoscopic radical prostatectomy for clinically localized prostate cancer at a tertiary academic center were prospectively collected. All patients were continent before surgery. Urinary continence was evaluated using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form instrument. All of the patients reporting no leak in response to the question, How often do you leak urine? were defined as continent.nnnRESULTSnA total of 273 patients (90%) were continent 12 months after robot assisted laparoscopic radical prostatectomy. Continent patients were significantly younger (61.4 +/- 6.4 vs 64.1 +/- 6.1 years, p = 0.02) than those who were incontinent. On univariable regression analysis patient age at surgery (OR 1.075, p = 0.024) and Charlson comorbidity index (OR 1.671, p = 0.007) were significantly associated with 12-month continence status. On multivariable analysis age (OR 1.076, p = 0.027) and Charlson comorbidity index (OR 1.635, p = 0.009) were independent predictors of continence rates.nnnCONCLUSIONSnUsing the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form 90% of patients undergoing robot assisted laparoscopic radical prostatectomy reported no urine leak 12 months after surgery. Patient age at surgery and Charlson comorbidity index were independent predictors of the return to urinary continence, whereas notably no variable related to prostate cancer was significantly correlated with urinary continence.

Learning curve and preliminary experience with da Vinci-assisted laparoscopic radical prostatectomy.

Objective: To report our initial experience in the treatment of prostate cancer with robotic-assisted laparoscopic radical prostatectomy (RALP), evaluating our results in terms of learning curve, postoperative outcomes and positive surgical margins. Material and Methods: From April 2005 to February 2006, a single surgeon performed 41 RALP using the da Vinci robot (Intuitive Surgical, Inc., Sunnyvale, Calif., USA). Clinical and pathological data were collected prospectively and analyzed by a researcher from outside our clinic. The main perioperative parameters assessed were the following: operative time, blood loss, transfusion rate, conversion rate, intra- and postoperative complications, hospitalization time, catheterization time, and positive surgical margin rate. To evaluate the learning curve, patients were stratified into three groups: from case 1 to 10 (group 1), from case 11 to 20 (group 2), and from case 21 to 41 (group C). Results: Median operative time was 210 min. Mean blood loss was 400 ml, with 9.8% of the patients receiving blood transfusions. Conversion to open surgery occurred in 2 cases (4.9%), while 4 postoperative complications (9.7%) were reported. Median times of hospitalization and catheterization were 7 days. Positive surgical margins were detected in 26.8% of the cases (6.9% among pT2 patients). Operative time (p < 0.001), blood loss (p = 0.02), transfusion rate (p = 0.006), and postoperative complication rates (p = 0.03) reduced along the learning curve. Conclusion: RALP is a feasible and reproducible technique, with a short learning curve and low perioperative complication rate. Even during the initial phase of the learning curve, good results were obtained with regard to postoperative complications and oncological outcome.

Is robotically assisted laparoscopic radical prostatectomy less invasive than retropubic radical prostatectomy? Results from a prospective, unrandomized, comparative study

To evaluate whether robotically assisted laparoscopic prostatectomy (RALP) is less invasive than radical retropubic prostatectomy (RRP), as experimental studies suggest that the acute phase reaction is proportional to surgery‐induced tissue damage.

Predictors of Positive Surgical Margins After Laparoscopic Robot Assisted Radical Prostatectomy

PURPOSEnWe identified the predictors of positive surgical margins in a series of patients undergoing robot assisted laparoscopic radical prostatectomy.nnnMATERIALS AND METHODSnWe prospectively collected data from 322 patients who underwent robot assisted laparoscopic radical prostatectomy for clinically localized prostate cancer between April 2005 and October 2008, and who had not received any prior hormonal therapy.nnnRESULTSnPositive surgical margins were observed in 95 cases (29.5%). Specifically positive surgical margins were at the apex in 22 cases (6.8%), anterior in 5 (1.6%) and posterolateral in 68 (21%). Among the preoperative variables prostate volume on transrectal ultrasound (HR 0.420, p = 0.002) and cT stage (HR 2.217, p = 0.008) were independent predictors of the presence of any positive surgical margin in the cohort while cT stage (HR 2.070, p = 0.025) and biopsy Gleason score (p = 0.019) were predictors of posterolateral positive surgical margins. Considering pathological variables only extraprostatic extension of the primary tumor was an independent predictor of any positive surgical margin (HR 11.852, p <0.001) and posterolateral positive surgical margins (HR 7.484, p <0.001) in the series. Of those patients with organ confined disease positive surgical margins were present in 21 (10.6%). Only perineural invasion was an independent predictor of any positive surgical margin (HR 4.096, p = 0.028) while a not statistically significant trend was identified with regard to posterolateral positive surgical margins (HR 6.938, p = 0.067).nnnCONCLUSIONSnPathological extension of the primary tumor was the most relevant predictor of positive surgical margins. In patients with organ confined disease the presence of perineural invasion was significantly associated with positive surgical margins.

The 'Stage, Size, Grade and Necrosis' score is more accurate than the University of California Los Angeles Integrated Staging System for predicting cancer-specific survival in patients with clear cell renal cell carcinoma

To compare the prognostic accuracy of the two most used integrated staging systems to predict the outcome of patients with clear cell renal cell carcinoma (RCC).

Preoperative Criteria to Select Patients for Bilateral Nerve-sparing Robotic-assisted Radical Prostatectomy

INTRODUCTIONnTo date, no study has analyzed the predictors of potency recovery in a robot-assisted laparoscopic radical prostatectomy (RALP) series. A novel risk stratification for erectile function recovery after retropubic radical prostatectomy (RRP) has been proposed recently by Briganti et al. from the University Vita-Salute San Raffaele in Milan, Italy.nnnAIMnTo evaluate the potency rate in a series of consecutive patients who underwent bilateral nerve-sparing RALP, to identify the preoperative predictors of erectile function recovery, and to validate the risk-group stratification of Briganti et al.nnnMETHODSnThe clinical records of all patients who underwent RALP for clinically localized prostate cancer between April 2005 and April 2009 were prospectively collected in the Prostate Cancer Padua Database. For the present study, we extracted all consecutive cases receiving a bilateral nerve-sparing technique with a minimum follow-up > or =12 months.nnnMAIN OUTCOME MEASURESnTwelve-month potency rate after RALP, defined as an International Index of Erectile Function 6 (IIEF-6) score > or =18.nnnRESULTSnData showed that 129 out of 208 enrolled patients (62%) were potent 12 months after surgery. Age (hazard ratio [HR]: 2.8; P < 0.001), Charlson score (HR: 2.9; P = 0.007), and baseline IIEF-6 score (HR: 0.8; P < 0.001) were independent predictors of potency recovery at multivariate analysis. According to Briganti et al.s risk-group stratification, the 12-month potency rate following RALP was 81.9% in the low-risk group, 56.7% in the intermediate-risk group, and 28.6% in the high-risk group (P < 0.001).nnnCONCLUSIONSnIn the era of robotic surgery, the key point for the success of the nerve-sparing technique remains the accurate selection of patients. Age < or =65 years, absence of associated comorbidities, and good preoperative erectile function are the most important preoperative factors to select those patients for whom bilateral nerve-sparing RALP can achieve the best results.