Silvia Secco

Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) Classification of Renal Tumours in Patients who are Candidates for Nephron-Sparing Surgery

BACKGROUND Besides clinical tumour size, other anatomical aspects of the renal tumour are routinely considered when evaluating the feasibility of elective nephron-sparing surgery (NSS). OBJECTIVE To propose an original, standardised classification of renal tumours suitable for NSS based on their anatomical features and size and to evaluate the ability of this classification to predict the risk of overall complications resulting from the surgery. DESIGN, SETTING, AND PARTICIPANTS We enrolled prospectively 164 consecutive patients who underwent NSS for renal tumours at a tertiary academic referral centre from January 2007 to December 2008. INTERVENTION Open partial nephrectomy without vessel clamping. MEASUREMENTS All tumours were classified by integrating size with the following anatomical features: anterior or posterior face, longitudinal, and rim tumour location; tumour relationships with renal sinus or urinary collecting system; and percentage of tumour deepening into the kidney. We generated an algorithm evaluating each anatomical parameter and tumour size (the preoperative aspects and dimensions used for an anatomical [PADUA] score) to predict the risk of complications. RESULTS AND LIMITATIONS Overall rates of complication were significantly correlated to all the evaluated anatomical aspects, excluding clinical size and anterior or posterior location of the tumour. By multivariate analysis, PADUA scores were independent predictors of the occurrence of any grade complications (hazard ratio [HR] for score 8-9 vs 6-7: 14.535; HR for score ≥10 vs 6-7: 30.641). Potential limitations were the limited number of patients with T1b tumours included in the study and the lack of laparoscopically treated patients. Further external validation of the PADUA score is needed. CONCLUSIONS The PADUA score is a simple anatomical system that can be used to predict the risk of surgical and medical perioperative complications in patients undergoing open NSS. The use of an appropriate score can help clinicians stratify patients suitable for NSS into subgroups with different complication risks and can help researchers evaluate the real comparability among patients undergoing NSS with different surgical approaches.

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

CONTEXT Anticholinergic 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. OBJECTIVE To evaluate efficacy and safety of different doses, formulations, and route of administration of the available anticholinergic drugs. EVIDENCE ACQUISITION A 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). EVIDENCE SYNTHESIS Our 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. CONCLUSION Many 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).

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

BACKGROUND Very few studies have evaluated the risk of complications following robotic-assisted laparoscopic radical prostatectomy (RARP), and all were flawed by several methodological biases. OBJECTIVE To evaluate the prevalence of early complications and risk factors following RARP, reporting complications in agreement with the standardised Martin criteria. DESIGN, SETTING, AND PARTICIPANTS All 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. INTERVENTION RARP was performed by two surgeons with the same technique. MEASUREMENTS Complications were collected and reported according to the standardised Martin criteria. RESULTS AND LIMITATIONS One 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. CONCLUSIONS Applying 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.

Predictors of Positive Surgical Margins After Laparoscopic Robot Assisted Radical Prostatectomy

PURPOSE We identified the predictors of positive surgical margins in a series of patients undergoing robot assisted laparoscopic radical prostatectomy. MATERIALS AND METHODS We 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. RESULTS Positive 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). CONCLUSIONS Pathological 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.

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

INTRODUCTION To 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. AIM To 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. METHODS The 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. MAIN OUTCOME MEASURES Twelve-month potency rate after RALP, defined as an International Index of Erectile Function 6 (IIEF-6) score > or =18. RESULTS Data 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). CONCLUSIONS In 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.

Trifecta outcomes after robot-assisted laparoscopic radical prostatectomy.

Study Type – Therapy (outcomes research)
Level of Evidence 2c

Risk stratification and prognostication of renal cell carcinoma.

ObjectivesTo review the most recent data on prognostic factors and describe the characteristics and prognostic accuracy of the most important prognostic systems available to predict the risk of recurrence, progression, and mortality in patients with renal cell carcinoma (RCC).MethodsThe study was based on a non-systematic review of literature.ResultsClinical (performance status, and mode of presentation), anatomical (size and extension of the primary tumor, lymph node involvement, and distant metastasis), and histological factors (histological subtypes, nuclear grade, and tumor necrosis) are the most largely evaluated prognostic factors in RCC. Valuable prognostic accuracy has been shown for several laboratory parameters (erythrocyte sedimentation rate, platelet count, serum calcium, hemoglobin, and lactate dehydrogenase levels) and a few genetical and molecular markers (CAIX, B7-H1, and B7-H4). A few integrating systems have been proposed and validated, integrating both clinical and pathological (UCLA Integrating Staging Systems, Kattan nomogram, and Sorbellini nomogram) or only pathological variables (SSIGN score).ConclusionsSeveral large and methodologically consistent studies have been published. The chance to integrate the data derived from each prognostic factor into prognostic algorithms and scores has allowed improving significantly the stratification of the prognosis of patients with RCC. The currently available prognostic systems can be further improved through the inclusion of molecular and genetic variables. Integrating prognostic systems should be used to design randomized controlled trials (RCTs), which will evaluate the efficacy of the new-targeted therapies in either neoadjuvant, adjuvant, or salvage treatments of patients with RCC.

Impact of surgical and medical castration on serum testosterone level in prostate cancer patients

Introduction: The paper aims at evaluating the role of testosterone levels and their cut-off points in the treatment of prostate cancer with androgen deprivation therapy. Materials and Methods: We performed a non-systematic review of the literature, searching Medline using the following key words: ‘Prostatic neoplasms/therapy’ [MeSH], ‘Buserelin’ [MeSH], ‘Goserelin’ [MeSH], ‘Leuprolide’ [MeSH], ‘Triptorelin’ [MeSH], ‘prostate cancer*’ [tiab], and ‘testoster*’ [tiab]. Results: The most commonly used cut-off point of testosterone to define castration was 50 ng/dl. In this respect, GnRH agonists allowed castration in a very high percentage of patients (87.5–100%). Specifically, triptorelin was reported to yield castration level of testosterone in 98.8%, the classical formulation of leuprolide in 95–98.8% of the cases, and Eligard®, a novel formulation of leuprolide, in 99–100%. With regard to the 20-ng/dl breakpoint, available data suggest that goserelin yields castration level of testosterone in 96%, the classical formulation of leuprolide in 87–92% of the patients, and the novel formulation in 88–97.5%. Conclusions: The clinical significance of different levels of testosterone yielded during androgen deprivation therapy is still unknown. Considering the standard cut-off point of 50 ng/dl, GnRH agonists allowed castration in a very high percentage of patients.

Surgical treatment of recurrent stress urinary incontinence in women: a systematic review and meta-analysis of randomised controlled trials

CONTEXT Recurrent stress urinary incontinence (R-SUI) represents a management dilemma; however, only a limited number of randomised controlled trials (RCTs) have assessed the various surgical procedures used for its treatment. OBJECTIVE To assess the effectiveness and complications of various surgical procedures for the treatment of female R-SUI. EVIDENCE ACQUISITION A prospective peer-reviewed protocol was prepared a priori. A systematic literature review of all published RCTs comparing surgical procedures for treatment of R-SUI was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement. Data were analysed using RevMan 5. EVIDENCE SYNTHESIS We conducted a literature search from 1945 to February 2013. Data were available for a total of 350 women in 10 RCTs with a mean follow-up of 18.1 mo. Meta-analysis was possible for the comparison of retropubic tension-free vaginal tape (RP-TVT) versus transobturator tension-free vaginal tape (TO-TVT) in five RCTs (n = 135). There was no statistically significant difference between RP-TVT and TO-TVT in the patient-reported improvement (odds ratio [OR]: 0.84, 95% confidence interval [CI], 0.41-1.69) or objective cure/improvement (OR: 1.75; 95% CI, 0.86-3.54). One RCT showed a trend towards a higher rate of patient-reported and objective cure/improvement with the inside-out TO-TVT compared with the outside-in; however, it was not statistically significant (OR: 3.00; 95% CI, 0.85-10.57, and OR: 3.32; 95% CI, 0.96-11.41, respectively). There was no significant difference between Burch colposuspension and RP-TVT (one RCT) in patient-reported improvement (OR: 0.33; 95% CI, 0.01-8.57) or objective cure/improvement (OR: 0.52; 95% CI, 0.13-2.05). CONCLUSIONS This meta-analysis shows no evidence of a significant difference in patient-reported and objective cure/improvement rates between RP-TVT and TO-TVT in the surgical treatment of women with R-SUI. However, due to the relatively low number of patients, the analysis might be underpowered. This review highlights the poor level of evidence in this field and the need for well-designed clinical trials to address this important clinical dilemma.