Prospective quality of life in men choosing open vs. robotic radical prostatectomy: long-term results from a racially diverse multi-institutional database.

PURPOSE: To compare 5-year health-related quality of life (HRQoL) outcomes between prostate cancer (CaP) patients who underwent robotic-assisted laparoscopic radical prostatectomy (RALP) versus open radical retropubic prostatectomy (RRP) and assess for racial disparities between Caucasian American (CA) and African American (AA) men undergoing surgery. METHODS: A prospective cohort study of HRQoL data was conducted on patients diagnosed with CaP from 2007 to 2017 and enrolled in the Center for Prostate Disease Research (CPDR) Multicenter National Database. Using the EPIC and SF-36 instruments, changes in urinary, sexual, bowel, and hormonal domains, as well as physical and mental component summary scores were compared across surgery type (RALP versus RRP) at pre-treatment ("baseline"), and annually for 5 years. We further compared HRQoL outcomes in CA and AA men undergoing surgery. Longitudinal HRQoL patterns were modeled using generalized estimating equations (GEE), adjusting for baseline HRQoL and other characteristics. RESULTS: 448 CaP patients (22% AA) met study inclusion criteria, 66% underwent RALP and 34% underwent RRP. At baseline, HRQoL domains were comparable across treatment group (RALP vs. RRP). In the adjusted low-risk cohort, there were only three time points that met a statistically significant HRQoL difference in EPIC scores between RALP and RRP. Urinary function score during year 4 of follow-up showed a 7.5 (95% CI 3.1-11.9, P = 0.01) points difference in favor of RRP. Bowel bother scores favored RRP in year 1 with a difference of 3.1 (95% CI 0.7-5.4, P = 0.04) points, and in year 5 with a difference of 3.8 (95% CI 1.1-6.4, P = 0.03) points. In the intermediate/high-risk cohort, there were no statistically significant differences in any of the domain scores between RALP and RRP during follow-up. CONCLUSIONS: The robotic and open approach to radical prostatectomy led to comparable HRQoL outcomes at a follow-up length of 60 months. No HRQoL racial disparities were found between AA and CA men during long-term follow-up.

Minimally invasive retroperitoneal lymph node dissection for men with testis cancer: a retrospective cohort study of safety and feasibility.

PURPOSE: To describe the perioperative safety, functional and immediate post-operative oncological outcomes of minimally invasive RPLND (miRPLND) for testis cancer. METHODS: We performed a retrospective multi-centre cohort study on testis cancer patients treated with miRPLND from 16 institutions in eight countries. We measured clinician-reported outcomes stratified by indication. We performed logistic regression to identify predictors for maintained postoperative ejaculatory function. RESULTS: Data for 457 men undergoing miRPLND were studied. miRPLND comprised laparoscopic (n = 56) or robotic (n = 401) miRPLND. Indications included pre-chemotherapy in 305 and post-chemotherapy in 152 men. The median retroperitoneal mass size was 32 mm and operative time 270 min. Intraoperative complications occurred in 20 (4%) and postoperative complications in 26 (6%). In multivariable regression, nerve sparing, and template resection improved ejaculatory function significantly (template vs bilateral resection [odds ratio (OR) 19.4, 95% confidence interval (CI) 6.5-75.6], nerve sparing vs non-nerve sparing [OR 5.9, 95% CI 2.3-16.1]). In 91 men treated with primary RPLND, nerve sparing and template resection, normal postoperative ejaculation was reported in 96%. During a median follow-up of 33 months, relapse was detected in 39 (9%) of which one with port site (< 1%), one with peritoneal recurrence and 10 (2%) with retroperitoneum recurrences. CONCLUSION: The low proportion of complications or peritoneal recurrences and high proportion of men with normal postoperative ejaculatory function supports further miRPLND studies.

Primary robotic RLPND for nonseminomatous germ cell testicular cancer: a two-center analysis of intermediate oncologic and safety outcomes.

OBJECTIVE: To evaluate the intermediate-term oncologic outcomes and safety profile of the largest case series of primary robotic retroperitoneal lymphadenectomy for low-clinical-stage non-seminomatous germ cell testicular cancer. METHODS: This was a two-center retrospective analysis of robotic RPLND cases for low-clinical-stage (stage I-IIB) non-seminomatous germ cell testicular cancer in the primary setting. Demographic, perioperative, operative and oncologic variables were collected between March 2008 and May 2019. Descriptive analyses were performed and presented as medians with interquartile ranges for continuous variables and frequency and proportions for categorical variables. A survival analysis of time to recurrence was performed using Cox proportional hazards model. Using logistic regression, risk factors for complications were analyzed. Both univariate and multivariate analyses were performed. RESULTS: A total of 58 patients (CS 1 = 56, CS IIA = 2, CS IIB = 0) were identified. The median follow-up was 47 months and the 2-year recurrence-free survival rate was 91%. The five recurrences were all out of the performed dissection template (pelvis = 1 and lung = 4). Only five patients (29%) with occult metastasis underwent adjuvant chemotherapy. The median operative time was 319 min [interquartile range (IQR) 276-355 min], estimated blood loss was 100 ml (IQR 75-200 ml), node count was 26 (IQR 20-31), and length of stay 2 d (IQR 1-3 days). There were 2 (3.3%) intraoperative complications, 19 (32.7%) 30-day postoperative complications to include 14 (24.1%) Clavien grade I, 4 (6.9%) Clavien grade II, 1 (1.7%) Clavien grade III and 0 Clavien grade IV complications. No statistical significance was found on multivariate or univariate analysis for survival analysis of time to recurrence and risk factors for complications. CONCLUSIONS: This study represents the largest case series of primary R-RPLND for the treatment of low-stage non-seminomatous germ cell tumors (NSGCT). With 47 months of follow-up and a low rate of adjuvant chemotherapy, intermediate oncologic efficacy appears to be comparable to the gold standard open approach.

Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial.

Importance: Guidelines endorsing vegetable-enriched diets to improve outcomes for prostate cancer survivors are based on expert opinion, preclinical studies, and observational data. Objective: To determine the effect of a behavioral intervention that increased vegetable intake on cancer progression in men with early-stage prostate cancer. Design, Setting, and Participants: The Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) was a randomized clinical trial conducted at 91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group = 1 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level less than 10 ng/mL. Enrollment occurred from January 2011 to August 2015; 24-month follow-up occurred from January 2013 to August 2017. Interventions: Patients were randomized to a counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n = 237) or a control group, which received written information about diet and prostate cancer (n = 241). Main Outcomes and Measures: The primary outcome was time to progression; progression was defined as PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade) on follow-up prostate biopsy. Results: Among 478 patients randomized (mean [SD] age, 64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis. There were 245 progression events (intervention: 124; control: 121). There were no significant differences in time to progression (unadjusted hazards ratio, 0.96 [95% CI, 0.75 to 1.24]; adjusted hazard ratio, 0.97 [95% CI, 0.76 to 1.25]). The 24-month Kaplan-Meier progression-free percentages were 43.5% [95% CI, 36.5% to 50.6%] and 41.4% [95% CI, 34.3% to 48.7%] for the intervention and control groups, respectively (difference, 2.1% [95% CI, -8.1% to 12.2%]). Conclusions and Relevance: Among men with early-stage prostate cancer managed with active surveillance, a behavioral intervention that increased vegetable consumption did not significantly reduce the risk of prostate cancer progression. The findings do not support use of this intervention to decrease prostate cancer progression in this population, although the study may have been underpowered to identify a clinically important difference. Trial Registration: ClinicalTrials.gov Identifier: NCT01238172.

Radical prostatectomy and the effect of close surgical margins: results from the Shared Equal Access Regional Cancer Hospital (SEARCH) database.

OBJECTIVE: To evaluate biochemical recurrence (BCR) patterns amongst men undergoing radical prostatectomy (RP) with specimens having negative (NSM), positive (PSM), and close surgical margins (CSM) from the Shared Equal Access Regional Cancer Hospital (SEARCH) cohort, as PSM after RP are a significant predictor of biochemical failure and possible disease progression, with CSM representing a diagnostic challenge for surgeons. PATIENTS AND METHODS: Men undergoing RP between 1988 and 2015 with known final pathological margin status were evaluated. The cohort was divided into three groups based on margin status; NSM, PSM, and CSM. CSM were defined by distance of tumour ≤1 mm from the surgical margin. BCR was defined as a prostate-specific antigen (PSA) level of >0.2 ng/mL, two values at 0.2 ng/mL, or secondary treatment for an elevated PSA level. Predictors of BCR, metastases, and mortality were analysed using Cox proportional hazard models. RESULTS: Of 5515 men in the SEARCH database, 4337 (79%) men met criteria for inclusion in the analysis. Of these, 2063 (48%) had NSM, 1902 (44%) had PSM, and 372 (8%) had CSM. On multivariable analysis, relative to NSM, men with CSM had a higher risk of BCR (hazard ratio [HR] 1.51, 95% confidence interval [CI] 1.25-1.82; P < 0.001) but a decreased risk of BCR when compared to those men with PSM (HR 2.09, 95% CI 1.86-2.36; P < 0.001). Metastases, prostate cancer-specific mortality and all-cause mortality did not differ based on margin status alone. CONCLUSIONS: Management of men with CSM is a diagnostic challenge, with a disease course that is not entirely benign. The evaluation of other known risk factors probably provides greater prognostic value for these men and may ultimately better select those who may benefit from adjuvant therapy.

An Update of the American Urological Association White Paper on the Prevention and Treatment of the More Common Complications Related to Prostate Biopsy.

PURPOSE: In this white paper update we identify and discuss the prevalence and prevention of common complications of prostate needle biopsy. MATERIALS AND METHODS: A literature review was performed on prostate biopsy complications via queries of PubMed and EMBASE® databases for prostate biopsy complications from January 1, 2010 until June 1, 2015. We focused on infection, bleeding, urinary retention, needle tract seeding and erectile dysfunction. A total of 346 articles were identified for full text review and 119 are included in the final data synthesis. RESULTS: Infection is the most common complication of prostate biopsy with fluoroquinolone resistant Escherichia coli having a prominent role. Reported rates of infectious complications range from 0.1% to 7.0%, and sepsis rates range from 0.3% to 3.1% depending on antibiotic prophylaxis regimens. Mild, self-limiting and transient bleeding is also a common complication. Other complications are extremely rare. CONCLUSIONS: This white paper provides a concise reference document for the more common prostate biopsy complications and prevention strategies. Risk assessment should be performed for all patients to identify known risk factors for harboring fluoroquinolone resistance. If infection incidence increases check the local antibiogram, current equipment and cleaning practices, and consider alternate approaches to antibiotic prevention such as needle cleaning, risk basked augmentation, rectal culture with targeted prophylaxis and transperineal biopsy. If infection occurs, actively re-situate the patient and start empiric intravenous treatment with carbapenems, amikacin or second and third generation cephalosporins.

Biopsy Detected Gleason Pattern 5 is Associated with Recurrence, Metastasis and Mortality in a Cohort of Men with High Risk Prostate Cancer.

PURPOSE: We evaluated the relative risk of biochemical recurrence, metastasis and death from prostate cancer contributed by biopsy Gleason pattern 5 among men at high risk with Gleason 8-10 disease in the SEARCH (Shared Equal Access Regional Cancer Hospital) cohort. MATERIALS AND METHODS: Men with biopsy Gleason sum 8-10 prostate cancer treated with radical prostatectomy were evaluated. The cohort was divided into men with Gleason 4 + 4 vs those with any pattern 5 (ie Gleason 3 + 5, 5 + 3, 4 + 5, 5 + 4 or 5 + 5). Predictors of biochemical recurrence, metastases, and prostate cancer specific and overall survival were analyzed using Kaplan-Meier, log rank test and Cox proportional hazards models. RESULTS: We identified 634 men at high risk in the SEARCH database, of whom 394 (62%) had Gleason 4 + 4 and 240 (38%) had Gleason pattern 5 on biopsy. Baseline characteristics did not significantly differ between the groups. On multivariable analysis relative to Gleason 4 + 4 men at high risk with Gleason pattern 5 showed no difference in the risk of biochemical recurrence (HR 1.26, 95% CI 0.99-1.61, p = 0.065). However, they were at significantly greater risk for metastasis (HR 2.55, 95% CI 1.50-4.35, p = 0.001), prostate cancer specific mortality (HR 2.67, 95% CI 0.1.26-5.66, p = 0.010) and overall mortality (HR 1.60, 95% CI 1.09-2.34, p = 0.016). CONCLUSIONS: Preoperative subclassification of high risk prostate cancer by biopsy Gleason grade (4 + 4 vs any Gleason pattern 5) identified men at highest risk for progression. Any Gleason 5 on biopsy is associated with a greater risk of metastasis, and prostate cancer specific and overall mortality. Grouping all Gleason 8-10 tumors together as high risk lesions may fail to fully stratify men at highest risk for poor outcomes.

Comparison of retroperitoneal and transperitoneal robotic partial nephrectomy for Pentafecta perioperative and renal functional outcomes.

BACKGROUND: We compared quality outcomes between transperitoneal (TRPN) and retroperitoneal robotic partial nephrectomy (RRPN). METHODS: Two-center retrospective analysis of TRPN and RRPN from 10/2009 to 10/2015. Perioperative/renal function outcomes were analyzed. Primary endpoint was Pentafecta, a composite measure of quality [negative margin, no 30-day complication, ischemia time ≤25 min, return of glomerular filtration rate (eGFR) to >90% from baseline at last follow-up, and no chronic kidney disease upstaging]. Multivariable analysis (MVA) for factors associated with lack of optimal outcome was performed. RESULTS: 404 patients (TRPN 263, RRPN 141) were analyzed. Comparing TRPN vs. RRPN, mean tumor size (3.1 vs. 2.9 cm, p = 0.122) and RENAL score (7.4 vs. 7.2, p = 0.503) were similar. Most TRPN were anterior (65.0%) and most RRPN posterior (65.3%, p < 0.001). Operative time (p = 0.001) was less for RRPN. No significant differences between TRPN vs. RRPN were noted for ischemia time (23.1 vs. 22.8 min, p = 0.313), blood loss (p = 0.772), positive margins (p = 0.590), complications (p = 0.537), length of stay (p = 0.296), ΔeGFR (p = 0.246), eGFR recovery to >90% (55.9 vs. 57.4%, p = 0.833), and lack of CKD upstaging (84.0 vs. 87.2%, p = 0.464). Pentafecta rates were not significantly different (TRPN 33.9 vs. RRPN 43.3%, p = 0.526). MVA revealed increasing RENAL score (OR 1.5, p < 0.001) and decreasing baseline eGFR (OR 2.4, p = 0.017) as predictive for lack of Pentafecta. CONCLUSIONS: TRPN and RRPN have similar quality outcomes, though RRPN may offer modest benefit for operative time and have utility in posterior tumors. Association of increasing RENAL score and decreased baseline eGFR with lack of Pentafecta suggests dominant role of non-modifiable factors.

Determinants of renal functional decline after open partial nephrectomy: a comparison of warm, cold, and non-ischemic modalities.

INTRODUCTION: Renal functional decline after partial nephrectomy (PN) may be related to a variety of nonmodifiable and modifiable factors, including ischemia time (IT) and modality. We sought to determine the impact of these factors on renal functional degeneration after PN. MATERIALS AND METHODS: Multicenter retrospective analysis (n = 347) was performed, identifying patients who underwent open PN using warm, cold, and non-ischemic techniques. Primary outcome was development of de novo chronic kidney disease (CKD), (estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2), at 1 year follow up. Univariate and multivariable analysis (MVA) were performed examining factors associated with ischemia technique and the development of de novo CKD. RESULTS: Median follow up 34.7 months. Two hundred and forty-one patients underwent warm ischemic, 31 cold ischemic, and 75 clampless PN. Patient characteristics were similar between groups. Clampless group had lower mean RENAL scores (6.4) than cold (7.9, p = 0.005) and warm (7, p = 0.037) ischemia groups. Cold ischemia cohort had longer median IT than the warm cohort (50min versus 25 min, p = 0.001). There were no significant differences in proportion of patients developing de novo CKD (warm 14.9%, cold 15%, clampless 8.7%, p = 0.422). MVA demonstrated that neither ischemic modality nor IT ≥ 30 minutes was associated with development of de novo CKD, while RENAL scores of increasing complexity (RENAL score 7-9 OR 4.32, p = 0.003; RENAL score ≥ 10 OR 15.42, p < 0.001) were independently associated with de novo CKD. CONCLUSIONS: Increasing tumor complexity, as indicated by the RENAL score, was an overriding determinant of post PN renal functional outcome. Prospective investigation is requisite to elucidate risk and protective factors for renal functional degeneration after PN.

Trends in the surgical management of localized renal masses: thermal ablation, partial and radical nephrectomy in the USA, 1998-2008.

OBJECTIVE: To evaluate the diffusion of nephron-sparing modalities (NSM) for the treatment of renal neoplasms in the USA over the last decade and to identify the factors associated with renal procedure selection. PATIENTS AND METHODS: The Nationwide Inpatient Sample was utlized to identify patients undergoing cryo/radiofrequency ablation (C/RFA), radical nephrectomy (RN) and partial nephrectomy (PN) from 1998 to 2008. Annual trends in procedure prevalence were determined. Multivariate analyses were performed to query the influence of age, race, sex and comorbid disease on surgery selection. RESULTS: We identified 443,853 procedures performed during the study period: 25,599 C/RFA, 79,568 PN and 338,687 RN. The prevalence per 100,000 hospital admissions in 1998 was 3.7 for C/RFA, nine for PN and 87.1 for RN. All procedures increased over the study period, by 1.05, 3.1 and 2.2/100,000 admissions per year, respectively (all P < 0.001). Diabetes, urban, teaching and large capacity hospitals were associated with NSM (either C/RFA or PN) compared to RN (all P ≤ 0.011). Age ≥70 years, female, hypertension, diabetes, chronic kidney disease (CKD) and region outside the Northeast favoured C/RFA over PN (all P ≤ 0.026). Compared to those without CKD, patients with CKD had an almost twofold higher probability of undergoing RN than NSM (odds ratio, 1.88; 95% confidence interval, 1.7-2.1). Despite increasing NSM utilization over the study period, most patients with CKD still received RN. CONCLUSIONS: Although the prevalence of NSM is increasing, RN is more common. The low utilization of NSM in patients with pre-existing CKD warrants further investigation.

Impact of tumour morphology on renal function decline after partial nephrectomy.

OBJECTIVE: To examine the association of renal morphology with renal function after partial nephrectomy (PN). PATIENTS AND METHODS: We conducted a multi-institutional retrospective analysis of 322 PNs performed between 2003 and 2011. The RENAL nephrometry score for each lesion was determined and the estimated glomerular filtration rate (eGFR) was calculated preoperatively and at last follow-up. We divided patients into two RENAL nephrometry score groups, low (<8) and high (≥8), and analysed and compared the outcomes of each group. The primary outcome was median change in eGFR between preoperative and last follow-up (ΔeGFR). The secondary outcome was eGFR <60 mL/min/1.73 m(2) at last follow-up. Multivariable analysis was conducted to evaluate the risk factors for eGFR <60 mL/min/1.73 m(2) at last follow-up. RESULTS: The median (interquartile range) follow-up was 25.2 (13.5-39.3) months. Low (n = 165) and high (n = 157) RENAL score groups were well-matched for baseline eGFR. The median tumour size (4.2 vs 2.4 cm, P < 0.001) was greater for the high group. In all, 64% of the low and 88.2% of the high RENAL score group (P < 0.001) had decreased eGFR at last follow-up. Median eGFR was -7 for the low vs -13.8 mL/min/1.73 m(2) for the high group (P = 0.001); eGFR <60 mL/min/1.73 m(2) at last follow-up was 27.3% for the low vs 37.6% for the high group (P = 0.057). Linear regression analysis showed that for each 1-point increase in RENAL score, there was 2.5% decrease in eGFR (P = 0.002); for each 1-cm increase in tumour size, there was 1.8% decrease in eGFR (P = 0.013). Area under curve analyses showed no significant difference between RENAL score and tumour size for prediction of de novo eGFR <60 mL/min/1.73 m(2) (P = 0.920) and ΔeGFR ≥50% (P = 0.85). Multivariable analysis showed that increasing RENAL score (odds ratio [OR] 1.24, P = 0.046) and decreasing preoperative eGFR (OR 1.10, P < 0.001) were risk factors for eGFR <60 mL/min/1.73 m(2) at last follow-up. CONCLUSIONS: Increasing RENAL nephrometry score is an independent risk factor for eGFR <60 mL/min/1.73 m(2) after PN. RENAL nephrometry score may serve as an additional measure for risk stratification before PN, but further investigation is required.

Outcomes and complications of pelvic lymph node dissection during robotic-assisted radical prostatectomy.

PURPOSE: Describe the outcomes and complications of patients who underwent standard pelvic lymphadenectomy (SPLND) and extended PLND (EPLND), or who did not undergo PLND (non-PLND) at the time of robotic-assisted laparoscopic radical prostatectomy (RALP). METHODS: Retrospective analysis of prospectively collected longitudinal data of 492 RALPs performed by a single surgeon (Kane) over a 5-year period. Patients are subdivided into three treatment groups: 54 EPLND; 231 SPLND; and 207 non-PLND. Indications for EPLND include Gleason score ≥ 8, PSA ≥ 10 ng/mL, and higher D'Amico risk group. Patient demographics, perioperative complications, and short-term oncologic outcomes are compared. RESULTS: Patients who underwent EPLND had higher-risk prostate cancer as evidenced by higher mean PSA (8.5 ng/mL), biopsy Gleason sum (≥ 8) (57.7 %), and D'Amico risk group (75.9 %), compared to SPLND and/or non-PLND groups (p ≤ 0.001). The EPLND total lymph node yield was similar compared to SPLND (20 vs. 18; p = 0.070). When the EPLND (n = 41) and SPLND (n = 57) were examined among only high-risk patients, the lymph node (IQR) yields [20 (14-29) vs. 17 (12-23)] and the proportion of positive nodes [29.3 % (12/41) vs. 12.3 % (7/57)] differed significantly (p = 0.048 and p = 0.042, respectively). Complication rates for all groups were similar and lymphocele formation was 5 %; 2.5 % were clinically significant. CONCLUSIONS: Robotic PLND can be performed with nodal yield comparable to open or laparoscopic PLND. Robotic EPLND improves nodal yield and the proportion of high-risk patients with nodal metastases recognized. Robotic PLND is associated with an approximately 5 % lymphocele rate. There is no difference in complications between EPLND and SPLND.

Telementoring in robotic surgery.

PURPOSE OF REVIEW: To provide an overview of the current concepts regarding telementoring with robotic surgery highlighting recent advances with respect to urological minimally invasive surgery (MIS). RECENT FINDINGS: As robotic surgery continues to evolve, telementoring will become a viable alternative to traditional on-site surgical proctoring. SUMMARY: MIS represents one of the most important breakthroughs in medicine over the past few decades. Newcomers to MIS need the guidance of more experienced, 'high volume' mentors to achieve the superior outcomes promised by MIS over conventional techniques.Telementoring, a subset of telemedicine, allows a surgeon at a remote site to offer intraoperative guidance via telecommunication networks. MIS lends itself well to telementoring techniques for several reasons; the primary surgeon performing MIS is working off of video images of the surgical field or images sent to a console. As such, the mentor is seeing the exact same images as the primary surgeon. In this review, we highlight many of the latest technologies in telemedicine, which are applicable to MIS and provide an overview of the pitfalls, which need to be overcome to make telementoring (and eventually telesurgery) a standard tool in the MIS arsenal.

Patient safety and the diffusion of surgical innovations: a national analysis of laparoscopic partial nephrectomy.

BACKGROUND: There are scant data on patient safety and the national diffusion of surgical innovations. Laparoscopic partial nephrectomy (LPN) provides an apt model for population-based analyses of patient safety and the propagation of complex surgical innovations. METHODS: In the nationwide inpatient sample, we identified patients undergoing partial nephrectomy for renal tumors from 1998 to 2009 and utilized patient safety indicators (PSI) to measure preventable adverse outcomes. RESULTS: Of the cases, 68,713 (87 %) were OPN and 9,842 (13 %) were LPN. The prevalence of LPN increased more than threefold from 2006 to 2009. Compared to open partial nephrectomy (OPN), LPN patients were more likely to be younger (p = 0.022), have lower Charlson comorbidity scores (p = 0.002), and undergo surgery at urban (p < 0.001) and teaching (p = 0.02) hospitals. On multivariate analysis, LPN was associated with a 28 % decreased probability of any PSI (adjusted odds ratio [ORadj] 0.72, 95 % confidence interval [CI] 0.55-0.96, p = 0.025), although this benefit did not attain significance when comparing robot-assisted LPN to OPN (ORadj 0.72, 95 % CI 0.44-1.16, p = 0.173). Overall mortality decreased from 0.9 % in 1998 to 0.1 % in 2009 (p < 0.001). There were no differences in adjusted mortality between LPN and OPN (p = 0.75). CONCLUSIONS: During its initial national diffusion, LPN resulted in enhanced perioperative patient safety compared to OPN. Mortality for both LPN and OPN decreased over time. Further study is needed to elucidate and promote factors contributing to the safe diffusion of complex surgical innovations.

Are repeat prostate biopsies safe? A cohort analysis from the SEARCH database.

PURPOSE: Patients question whether multiple biopsy sessions cause worse prostate cancer outcomes. Therefore, we investigated whether there is an association between the number of prior biopsy sessions and biochemical recurrence after radical prostatectomy. MATERIALS AND METHODS: Men in the SEARCH (Shared Equal Access Regional Cancer Hospital) database who underwent radical prostatectomy between 1988 and 2010 after a known number of prior biopsies were included in the analysis. Number of biopsy sessions (range 1 to 8) was examined as a continuous and categorical (1, 2 and 3 to 8) variable. Biochemical recurrence was defined as a prostate specific antigen greater than 0.2 ng/ml, 2 values at 0.2 ng/ml or secondary treatment for an increased prostate specific antigen. The association between number of prior biopsy sessions and biochemical recurrence was analyzed using the Cox proportional hazards model. Kaplan-Meier estimates of freedom from biochemical recurrence were compared among the groups. RESULTS: Of the 2,739 men in the SEARCH database who met the inclusion criteria 2,251 (82%) had only 1 biopsy, 365(13%) had 2 biopsies and 123 (5%) had 3 or more biopsies. More biopsy sessions were associated with higher prostate specific antigen (p<0.001), greater prostate weight (p<0.001), lower biopsy Gleason sum (p=0.01) and more organ confined (pT2) disease (p=0.017). The Cox proportional hazards model demonstrated no association between number of biopsy sessions as a continuous or categorical variable and biochemical recurrence. Kaplan-Meier estimates of freedom from biochemical recurrence were similar across biopsy groups (log rank p=0.211). CONCLUSIONS: Multiple biopsy sessions are not associated with an increased risk of biochemical recurrence in men undergoing radical prostatectomy. Multiple biopsy sessions appear to select for a low risk cohort.

Trends in adverse events of benign prostatic hyperplasia (BPH) in the USA, 1998 to 2008.

OBJECTIVE: To determine if the adverse events (AEs) of benign prostatic hyperplasia (BPH) have declined in tandem with increased use of oral therapy. MATERIALS AND METHODS: We used the Nationwide Inpatient Sample, a 20% sample of USA community hospitals, weighted to estimate national numbers to characterize the prevalence of AEs of BPH from 1998 to 2008. We calculated the age-adjusted prevalence of BPH and associated conditions and analyzed prevalence trends with regression modelling. RESULTS: Of 134 million estimated eligible discharges during the study period, 7,464,730 (5.6%) had either a primary or secondary diagnosis of BPH. The age-adjusted prevalence of BPH among all hospitalizations, irrespective of primary diagnosis, increased from 4.3% to 8% (P < 0.001) during the study period. The age-adjusted prevalence of BPH as a primary diagnosis decreased from 0.88% to 0.48% (P < 0.001). Discharges for BPH surgery decreased 51% (odds ratio [OR] 0.49, 95% confidence interval [CI] 0.45-0.54, P-trend <0.001) over time. Discharges for primary BPH with acute renal failure increased >400% (OR 4.28, 95% CI 3.22-5.71, P-trend <0.001). There were no significant changes in discharges for primary BPH with urinary retention (P-trend = 0.636), bladder stones (P-trend = 0.117), or urinary infection (P-trend = 0.101) over time. CONCLUSIONS: Increased hospitalizations for BPH with acute renal failure and stable hospitalizations for other AEs of BPH indicate that severe AEs of BPH persist despite widespread use of oral therapies in the USA. Further studies are needed to explain these trends.

Inpatient safety trends in laparoscopic and open nephrectomy for renal tumours.

UNLABELLED: Study Type--Cohort study Level of Evidence 2b. What's known on the subject? and What does the study add? Laparoscopic radical nephrectomy for renal cancer provides equivalent long-term cancer control with shorter hospital stays, less postoperative pain, and faster resumption of normal activities, but it has diffused slowly into clinical practice, perhaps as a result of perceptions about safety. Patient safety outcomes for laparoscopic and open radical nephrectomy using validated measures remain incompletely characterized. This is the first study to investigate peri-operative outcomes of radical nephrectomy using validated patient safety measures. We found a 32% decreased probability of adverse patient safety events occurring in laparoscopic compared with open radical nephrectomy. The safety benefits of laparoscopy were attained only after 10% of cases were completed laparoscopically--a proportion some have proposed as the 'tipping point' for the adoption of surgical innovations. This observation could have implications for patient safety in the setting of diffusion of new surgical techniques. OBJECTIVE: • To compare peri-operative adverse patient safety events occurring in laparoscopic radical nephrectomy (LRN) with those occurring in open radical nephrectomy (ORN). METHODS: • We used the US Nationwide Inpatient Sample to identify patients undergoing kidney surgery for renal tumours from 1998 to 2008. • We used patient safety indicators (PSIs), which are validated measures of preventable adverse outcomes, and multivariate regression to analyse associations of surgery type with patient safety. RESULTS: • Open radical nephrectomy accounted for 235,098 (89%) cases while 28,609 (11%) cases were LRN. • Compared with ORN, LRN patients were more likely to be male (P= 0.048), have lower Charlson comorbidity scores (P < 0.001), and to undergo surgery at urban (P < 0.001) and teaching (P < 0.001) hospitals. • PSIs occurred in 18,714 (8%) of ORN and 1434 (5%) of LRN cases (P < 0.001). • On multivariate analysis, LRN was associated with a 32% decreased probability of any PSI (adjusted odds ratio 0.68, 95% confidence interval: 0.6 to 0.77, P < 0.001). Stratification by year showed that this difference was initially manifested in 2003, when the proportion of LRN cases first exceeded 10%. CONCLUSIONS: • We found that LRN was associated with substantially superior peri-operative patient safety outcomes compared with ORN, but only after the national prevalence of LRN exceeded 10%. • Further study is needed to explain these patterns and promote the safe diffusion of novel surgical therapies into broad practice.

Percutaneous stone surgery using a tubeless technique with fibrin sealant: report of our first 107 cases.

UNLABELLED: Study Type--Therapy (case series) Level of Evidence 4. What's known on the subject? and What does the study add? Small case series support the safety and efficacy of tubeless PCNL with fibrin sealant. However, there is a paucity of data from larger case series supporting this approach. To our knowledge, this is among the largest tubeless PCNL series. We found the use of fibrin sealant for tubeless PCNL was associated with excellent stone-free rates (approaching 90%), short hospitalisation, and low complication rates. Tubeless PCNL with nephrostomy tract fibrin sealant appears to be viable option for appropriately select patients. OBJECTIVE: • To report on our first 107 cases of tubeless percutaneous nephrolithotomy (PCNL) using fibrin sealant as a haemostatic agent within the access tract. PCNL is the preferred treatment for patients with large renal stones, and the tubeless technique with the use of fibrin sealant has recently gained popularity. PATIENTS AND METHODS: • We performed a retrospective review of single-access, PCNL cases performed without a nephrostomy tube from January 2002 to July 2008. • Nephrostomy tracts were sealed at the conclusion of each procedure with fibrin-containing haemostatic agents. • We evaluated demographic variables, tracked complications, and compared pre- and postoperative haemoglobin, haematocrit and creatinine levels. • On postoperative day 1 computed tomography was used to determine stone-free rates. • Student's t-test calculations were used to determine statistical significance at P ≤ 0.05. RESULTS: • In all, 59 men and 48 women with a mean age of 43 years were included in the analysis of 107 cases. The mean stone size was 2.9 cm(2) and the average hospital stay was 1.07 days. • Pre- and postoperative changes in serum haemoglobin and serum creatinine were not statistically different. Postoperative haematocrit declined by a mean of 4.5% (P ≤ 0.05), but no patients required a transfusion. • Stone-free rates were 72% overall, and 90% when excluding patients with residual fragments of <4 mm. • Complications included seven asymptomatic subcapsular haematomas, one pseudoaneurysm requiring selective embolization, one urine leak, and five return visits to the emergency room for pain. CONCLUSIONS: • The use of fibrin sealant in this large tubeless PCNL series was associated with favourable stone-free rates, short hospital stays, and low complication rates with no significant bleeding. • Tubeless PCNL with nephrostomy tract fibrin sealant appears to be a viable option for appropriately selected patients, but future randomised trials are warranted.

Genitourinary abnormalities in an asymptomatic screening population: findings on virtual colonoscopy.

INTRODUCTION: The true incidences of genitourinary conditions in the modern era are not completely known. We sought to determine the incidence of genitourinary abnormalities in a group of asymptomatic adult patients undergoing axial imaging with virtual colonoscopy. METHODS: We performed a post-hoc analysis of imaging results from a prospective, IRB-approved study that randomized patients to screening "virtual" CT colonography (CTC) followed by standard endoscopic colonoscopy. CTC scans were reviewed separately by an independent radiologist and a urologist for genitourinary abnormalities. Genitourinary abnormalities were characterized as of minor, moderate, or major clinical significance. Identified nephroliths were categorized by location, laterality, size, and number. Student's t-tests and Fisher's exact-tests were used for continuous and categorical variables as appropriate. RESULTS: Of 490 patients undergoing CTC and eligible for analysis, no genitourinary abnormalities were found in 294 (60%), minor genitourinary abnormalities were found in 100 (20.4%), moderate genitourinary abnormalities were found in 86 (17.6%), and major genitourinary abnormalities were found in 10 (2%). Renal cysts (n = 60, 12%) were the most common minor urologic findings. Moderate and major genitourinary findings of nephrolithiasis, adrenal adenomas, and renal masses were noted in 13.9%, 3%, and 2% of the population, respectively. The largest stone was 1.2 cm, and the smallest was 1 mm; while 59% had stones < 3mm, 20% between 3 mm and 5 mm, 18% between 5 mm and 10 mm, and 3% > 10 mm in size. Unilateral stones were found in 85%, while bilateral were found in 15%, and the average number of stones was 2, (range 1 - 16). Age and male sex were significantly associated with moderate or major genitourinary findings p = 0.04 and p = 0.05, respectively. CONCLUSIONS: CT colonography in an asymptomatic screening population helped to identify nephrolithiasis in 13.9%. Moderate and major urologic abnormalities were found in 20% of the cohort. Risk factors included male sex and older age.

Race-specific prostate cancer outcomes in a cohort of military health care beneficiaries undergoing surgery: 1990-2017.

BACKGROUND: There is substantial variability in prostate cancer (PCa) mortality rates across Caucasian American (CA), African American (AA), Asian, and Hispanic men; however, these estimates are unable to disentangle race or ethnicity from confounding factors. The current study explores survival differences in long-term PCa outcomes between self-reported AA and CA men, and examines clinicopathologic features across self-reported CA, AA, Asian, and Hispanic men. METHODS: This retrospective cohort study utilized the Center for Prostate Disease Research (CPDR) Multi-center National Database from 1990 to 2017. Subjects were consented at military treatment facilities nationwide. AA, CA, Asian, or Hispanic men who underwent radical prostatectomy (RP) for localized PCa within the first year of diagnosis were included in the analyses. Time from RP to biochemical recurrence (BCR), BCR to metastasis, and metastasis to overall death were evaluated using Kaplan-Meier unadjusted estimation curves and adjusted Cox proportional hazards regression. RESULTS: This study included 7067 men, of whom 5155 (73%) were CA, 1468 (21%) were AA, 237 (3%) were Asian, and 207 (3%) were Hispanic. AA men had a significantly decreased time from RP to BCR compared to CA men (HR = 1.25, 95% CI = 1.06-1.48, p = 0.01); however, no difference was observed between AA and CA men for a time from BCR to metastasis (HR = 0.73, 95% CI = 0.39-1.33, p = 0.302) and time from metastasis to overall death (HR = 0.67, 95% CI = 0.36-1.26, p = 0.213). CONCLUSIONS: In an equal access health care setting, AA men had a shorter survival time from RP to BCR, but comparable survival time from BCR to metastasis and metastasis to overall death.