ERAS for Ambulatory TURBT: Enhancing Bladder Cancer Care (EMBRACE) randomised controlled trial protocol.

INTRODUCTION: Transurethral resection of bladder tumour (TURBT) is one of the more common procedures performed by urologists. It is often described as an 'incision-free' and 'well-tolerated' operation. However, many patients experience distress and discomfort with the procedure. Substantial opportunity exists to improve the TURBT experience. An enhanced recovery after surgery (ERAS) protocol designed by patients with bladder cancer and their providers has been developed. METHODS AND ANALYSIS: This is a single-centre, randomised controlled trial to investigate the effectiveness of an ERAS protocol compared with usual care in patients with bladder cancer undergoing ambulatory TURBT. The ERAS protocol is composed of preoperative, intraoperative and postoperative components designed to optimise each phase of perioperative care. 100 patients with suspected or known bladder cancer aged ≥18 years undergoing initial or repeat ambulatory TURBT will be enrolled. The change in Quality of Recovery 15 score, a measure of the quality of recovery, between the day of surgery and postoperative day 1 will be compared between the ERAS and control groups. ETHICS AND DISSEMINATION: The trial has been approved by the Johns Hopkins Institutional Review Board #00392063. Participants will provide informed consent to participate before taking part in the study. Results will be reported in a separate publication. TRIAL REGISTRATION NUMBER: NCT05905276.

Survival outcomes and molecular drivers of testicular cancer in hispanic men.

OBJECTIVE: To examine survival outcomes and molecular drivers in testis cancer among Hispanic men using a large national sample and molecular database. METHODS: We reviewed the SEER registry for testicular cancer from 2000 to 2020. Cox proportional hazards models were used to examine the relationship between race/ethnicity and cancer-specific survival (CSS) by tumor type (seminoma vs. nonseminomatous germ cell tumors [NSGCT]). All models were adjusted for demographic, socioeconomic, and treatment variables. We accessed somatic mutations for testicular cancers through AACR Project GENIE v13.1 and compared mutational frequencies by ethnicity. RESULTS: Our cohort consisted of 43,709 patients (23.3% Hispanic) with median follow-up 106 months (interquartile range: 45-172). Compared to Non-Hispanic Whites (NWH), Hispanics presented at a younger age but with more advanced disease. Hispanics experienced worse CSS for NSGCT (HR 1.7, 95% CI: 1.5-2.0, P < 0.01) but not seminoma. Somatic mutation data was available for 699 patients. KIT and KRAS mutations occurred in 24.2% and 16.9% of seminoma patients (n = 178), respectively. TP53 and KRAS mutations occurred in 12.1% and 7.9% of NSGCT patients (n = 521), respectively. No differences in mutational frequencies were observed between ethnic groups. There was significant heterogeneity in primary ancestral group for Hispanic patients with available data (n = 53); 14 (26.4%) patients had primary Native American ancestry and 30 (56.6%) had primary European ancestry. CONCLUSIONS: Cancer-specific survival is worse for Hispanic men with non-seminoma of the testicle. Somatic mutation analysis suggests no differences by ethnicity, though genetic ancestry is heterogeneous among patients identifying as Hispanic.

Prognostic significance of pT3a staging subclassifications in renal cell carcinoma: Not all pT3a are equal.

OBJECTIVE: To examine the prognostic significance of perinephric fat, renal sinus fat, and renal vein invasion in patients with pT3a renal cell carcinoma (RCC) by histologic type. METHODS: A population-based retrospective cohort study of patients with pT3aN0M0 RCC was performed using Surveillance, Epidemiology, and End Results (SEER) data for the years 2010 through 2019. Cox proportional hazards models were used to examine the relationship between pT3a subclassification groups and cancer-specific survival (CSS) by histological subtype (clear cell, papillary, chromophobe, and other). RESULTS: The cohort consisted of 10,170 patients with pT3a RCC, including 8,446 (83.0%) with clear cell RCC and 1,724 (17.0%) with nonclear cell RCC (nccRCC). Median follow up was 36 months. Differences in CSS by pT3a subclassification groups were observed in all histological subtypes but were most pronounced in nccRCC, specifically papillary RCC. Compared to perinephric fat (PF) invasion only, renal vein (RV) invasion (HR = 4.9, 95%CI: 2.5-9.3, P < 0.01), renal sinus fat invasion (HR = 3.0, 95%CI: 1.4-6.2), RV and PF invasion (HR = 7.5, 95%CI: 3.5-16.0), and combination of all three characteristics (HR = 4.4, 95%CI: 1.2-15.5) were associated with worse CSS in patients with papillary RCC. CONCLUSION: We examined the prognostic role of pT3a staging subclassifications in RCC by histologic subtype and observed survival differences, particularly in papillary RCC. Our findings highlight the need to refine pT3a staging criteria to help guide individualized, multimodal treatment strategies for locally advanced RCC.

Oncologic Outcomes in Patients with Residual Upper Tract Urothelial Carcinoma Following Neoadjuvant Chemotherapy.

BACKGROUND AND OBJECTIVE: Growing evidence supports the use of neoadjuvant chemotherapy (NAC) for upper tract urothelial carcinoma (UTUC). However, the implications of residual UTUC at radical nephroureterectomy (RNU) after NAC are not well characterized. Our objective was to compare oncologic outcomes for pathologic risk-matched patients who underwent RNU for UTUC who either received NAC or were chemotherapy-naïve. METHODS: We retrospectively identified 1993 patients (including 112 NAC recipients) who underwent RNU for nonmetastatic, high-grade UTUC between 1985 and 2022 in a large, international, multicenter cohort. We divided the cohort into low-risk and high-risk groups defined according to pathologic findings of muscle invasion and lymph node involvement at RNU. Recurrence-free survival (RFS), overall survival (OS), and cancer-specific survival (CSS) estimates were calculated using the Kaplan-Meier method. Multivariable analyses were performed to determine clinical and demographic factors associated with these outcomes. KEY FINDINGS AND LIMITATIONS: Among patients with low-risk pathology at RNU, RFS, OS, and CSS were similar between the NAC and chemotherapy-naïve groups. Among patients with high-risk pathology at RNU, the NAC group had poorer RFS (hazard ratio [HR] 3.07, 95% confidence interval [CI] 2.10-4.48), OS (HR 2.06, 95% CI 1.33-3.20), and CSS (subdistribution HR 2.54, 95% CI 1.37-4.69) in comparison to the pathologic risk-matched, chemotherapy-naïve group. Limitations include the lack of centralized pathologic review. CONCLUSIONS AND CLINICAL IMPLICATIONS: Patients with residual invasive disease at RNU after NAC represent a uniquely high-risk population with respect to oncologic outcomes. There is a critical need to determine an optimal adjuvant approach for these patients. PATIENT SUMMARY: We studied a large, international group of patients with cancer of the upper urinary tract who underwent surgery either with or without receiving chemotherapy beforehand. We identified a high-risk subgroup of patients with residual aggressive cancer after chemotherapy and surgery who should be prioritized for clinical trials and drug development.

Transperineal Versus Transrectal Magnetic Resonance Imaging-targeted and Systematic Prostate Biopsy to Prevent Infectious Complications: The PREVENT Randomized Trial.

BACKGROUND AND OBJECTIVE: The transrectal biopsy approach is traditionally used to detect prostate cancer. An alternative transperineal approach is historically performed under general anesthesia, but recent advances enable transperineal biopsy to be performed under local anesthesia. We sought to compare infectious complications of transperineal biopsy without antibiotic prophylaxis versus transrectal biopsy with targeted prophylaxis. METHODS: We assigned biopsy-naïve participants to undergo transperineal biopsy without antibiotic prophylaxis versus transrectal biopsy with targeted prophylaxis (rectal culture screening for fluoroquinolone-resistant bacteria and antibiotic targeting to culture and sensitivity results) through a multicenter, randomized trial. The primary outcome was post-biopsy infection captured by a prospective medical review and patient report on a 7-d survey. The secondary outcomes included cancer detection, noninfectious complications, and a numerical rating scale (0-10) for biopsy-related pain and discomfort during and 7-d after biopsy. KEY FINDINGS AND LIMITATIONS: A total of 658 participants were randomized, with zero transperineal versus four (1.4%) transrectal biopsy infections (difference -1.4%; 95% confidence interval [CI] -3.2%, 0.3%; p = 0.059). The rates of other complications were very low and similar. Importantly, detection of clinically significant cancer was similar (53% transperineal vs 50% transrectal, adjusted difference 2.0%; 95% CI -6.0, 10). Participants in the transperineal arm experienced worse periprocedural pain (0.6 adjusted difference [0-10 scale], 95% CI 0.2, 0.9), but the effect was small and resolved by 7-d. CONCLUSIONS AND CLINICAL IMPLICATIONS: Office-based transperineal biopsy is tolerable, does not compromise cancer detection, and did not result in infectious complications. Transrectal biopsy with targeted prophylaxis achieved similar infection rates, but requires rectal cultures and careful attention to antibiotic selection and administration. Consideration of these factors and antibiotic stewardship should guide clinical decision-making. PATIENT SUMMARY: In this multicenter randomized trial, we compare prostate biopsy infectious complications for the transperineal versus transrectal approach. The absence of infectious complications with transperineal biopsy without the use of preventative antibiotics is noteworthy, but not significantly different from transrectal biopsy with targeted antibiotic prophylaxis.

Likelihood of sampling prostate cancer at systematic biopsy as a function of gland volume and number of cores.

BACKGROUND: Pre-biopsy multiparametric magnetic resonance imaging (mpMRI) of the prostate is used to conduct targeted prostate biopsy (TB), guided by ultrasound and registered (fused) to the MRI. Systematic biopsy (SB) continues to be used together with TB or in mpMRI-negative patients. There is insufficient evidence on how to use SB to inform clinical decision-making in the mpMRI era. The purpose of this study was to estimate the effect of prostate volume and number of SB cores on sampling clinically significant prostate cancer (csPCa) using a simulation method based on clinical data. METHODS: SBs were simulated using data from 42 patients enrolled in a transrectal ultrasound robot-assisted biopsy trial. Linear mixed models were used to examine the relationship between the number of SB cores and prostate volume on 1) clinically significant cancer detection probability (csCDP) and 2) percent of mpMRI depicted regions of interest (ROIs) sampled with the SB. RESULTS: Median values and interquartile range (IQR) were 47.16 cm3 (35.61-65.57) for prostate volume, 0.57 cm3 (0.39-0.83) for ROI volume, and 4.0 (2-4) for PI-RADS v2.1 scores on MRI. csCDP increased with the increasing number of simulated SB cores and decreased substantially with larger prostate volume. Similarly, the percent of ROIs sampled increased with the increasing number of simulated SB cores and was lower for prostate volumes ≥60 cm3 compared to glands <60 cm3. CONCLUSIONS: The effect of the number of SBs performed on detecting csPCa varies largely with gland volume. The common 12-core SB can achieve adequate cancer detection and sampling of ROIs in smaller glands, but not in larger glands. In addition to TB or in mpMRI-negative patients, the number of SB cores can be adjusted to prostate volume. Performing 12-core SB alone in ≥60 cm3 glands results in inadequate sampling and potential PCa underdiagnosis.

Risk of Biochemical Recurrence in Patients With Grade Group 1 Prostate Cancer With Extraprostatic Extension Treated With Radical Prostatectomy.

PURPOSE: We sought to examine the association of extraprostatic extension (EPE) with biochemical recurrence (BCR) separately in men with Grade Group (GG) 1 and GG2 prostate cancer (PCa) treated with radical prostatectomy. MATERIALS AND METHODS: We reviewed our institutional database of patients who underwent radical prostatectomy for PCa between 2005 and 2022 and identified patients with GG1 and GG2 disease on final pathology. Fine-Gray competing risk models with an interaction between EPE (yes vs no) and GG (GG1 vs GG2) were used to examine the relationship between disease group and BCR-free survival. RESULTS: The cohort consisted of 6309 men, of whom 169/2740 (6.2%) with GG1 disease had EPE while 1013/3569 (28.4%) with GG2 disease had EPE. Median follow-up was 4 years. BCR occurred in 400/6309 (6.3%) patients. For men with GG1, there was no statistically significant difference in BCR-free survival for men with vs without EPE (subdistribution HR = 0.88; 95% CI: 0.37-2.09). However, for GG2 patients BCR-free survival was significantly worse for those with vs without EPE (subdistribution HR = 1.97, 95% CI: 1.54-2.52). CONCLUSIONS: Although there is a subset of GG1 PCas capable of invading through the prostatic capsule, patients with GG1 PCa and EPE at prostatectomy experience similar biochemical recurrence and survival outcomes compared to GG1 patients without EPE. However, among men with GG2, EPE connotes a worse prognosis.

Management of pediatric renal trauma - Results from the American Association for Surgery and Trauma Multi-Institutional Pediatric Acute Renal Trauma Study (Mi-PARTS).

BACKGROUND: Pediatric renal trauma is rare and lacks sufficient population-specific data to generate evidence-based management guidelines. A non-operative approach is preferred and has been shown to be safe. However, bleeding risk assessment and management of collecting system injury is not well understood. We introduce the Multi-institutional Pediatric Acute Renal Trauma Study (Mi-PARTS), a retrospective cohort study designed to address these questions. This manuscript describes the demographics and contemporary management of pediatric renal trauma at Level I trauma centers in the United States. METHODS: Retrospective data were collected at 13 participating Level I trauma centers on pediatric patients presenting with renal trauma between 2010-2019. Data were gathered on demographics, injury characteristics, management, and short-term outcomes. Descriptive statistics were used to report on demographics, acute management and outcomes. RESULTS: In total 1216 cases were included in this study. 67.2% were male, and 93.8% had a blunt injury mechanism. 29.3% had isolated renal injuries. 65.6% were high-grade (AAST Grade III-V) injuries. The mean Injury Severity Score (ISS) was 20.5. Most patients were managed non-operatively (86.4%) 3.9% had an open surgical intervention, including 2.7% having nephrectomy. Angioembolization was performed in 0.9%. Collecting system intervention was performed in 7.9%. Overall mortality was 3.3% and was only observed in polytrauma. The rate of avoidable transfer was 28.2%. CONCLUSION: The management and outcomes of pediatric renal trauma lacks data to inform evidence-based guidelines. Non-operative management of bleeding following renal injury is a well-established practice. Intervention for renal trauma is rare. Our findings reinforce differences from the adult population, and highlights opportunities for further investigation. With data made available through Mi-PARTS we aim to answer pediatric specific questions, including a pediatric-specific bleeding risk nomogram, and better understanding indications for interventions for collecting system injuries. LEVEL OF EVIDENCE: IV, Epidemiological (prognostic/epidemiological, therapeutic/care management, diagnostic test/criteria, economic/value-based evaluations, and Systematic Review and Meta-Analysis).

Effect of Transperineal Versus Transrectal Prostate Biopsy on the Quality of Hydrogel Spacer Placement in Men Prior to Radiation Therapy for Prostate Cancer.

OBJECTIVE: To determine whether prostate biopsy type affects spacer placement quality using a large sample of patients treated in the ambulatory setting. METHODS: A retrospective cohort study was conducted on patients diagnosed with prostate cancer who underwent hydrogel spacer placement before primary radiation treatment between 2018 and 2023 after transperineal (TP) or transrectal (TR) prostate biopsy. Study outcomes were Spacer Quality Score (SQS) (0-2, with greater values indicating better placement), Rectal Wall Infiltration (RWI) (0-3, with lower values indicating lack of RWI), and the occurrence of other hydrogel complications. RESULTS: A total of 395 patients were included. A pre-hydrogel TR biopsy was performed in 273 patients (69.1%), while TP biopsy was performed in 122 (30.9%). A SQS ≥1 occurred in 308 (77.9%) patients. A greater proportion of TP patients had a favorable SQS (≥1) compared to those who underwent TR (87.7 vs 73.5%, P <.002). An RWI score ≥2 was found in 180 (45.6%) patients. The proportion of patients with an unfavorable RWI score (≥2) did not differ significantly by type of biopsy performed. Patients who had an interval of >70 days between biopsy and hydrogel placement had significantly decreased odds of an RWI score ≥2 (odds ratio = 0.42, 95% confidence interval: 0.21-0.83). Only one infection was found after hydrogel placement. CONCLUSION: The quality of hydrogel placement was significantly better in men who had undergone TP biopsy. Rectal wall infiltration was more common than previously reported but did not differ between TP and TR biopsies.

Socioeconomic determinants of racial disparities in survival outcomes among patients with renal cell carcinoma.

PURPOSE: Racially driven outcomes in cancer are challenging to study. Studies evaluating the impact of race in renal cell carcinoma (RCC) outcomes are inconsistent and unable to disentangle socioeconomic disparities from inherent biological differences. We therefore seek to investigate socioeconomic determinants of racial disparities with respect to overall survival (OS) when comparing Black and White patients with RCC. METHODS: We queried the National Cancer Database (NCDB) for patients diagnosed with RCC between 2004 and 2017 with complete clinicodemographic data. Patients were examined across various stages (all, cT1aN0M0, and cM1) and subtypes (all, clear cell, or papillary). We performed Cox proportional hazards regression with adjustment for socioeconomic and disease factors. RESULTS: There were 386,589 patients with RCC, of whom 46,507 (12.0%) were Black. Black patients were generally younger, had more comorbid conditions, less likely to be insured, in a lower income quartile, had lower rates of high school completion, were more likely to have papillary RCC histology, and more likely to be diagnosed at a lower stage of RCC than their white counterparts. By stage, Black patients demonstrated a 16% (any stage), 22.5% (small renal mass [SRM]), and 15% (metastatic) higher risk of mortality than White patients. Survival differences were also evident in histology-specific subanalyses. Socioeconomic factors played a larger role in predicting OS among patients with SRMs than in patients with metastasis. CONCLUSIONS: Black patients with RCC demonstrate worse survival outcomes compared to White patients across all stages. Socioeconomic disparities between races play a significant role in influencing survival in RCC.

A multicenter investigation examining timing of penile prosthesis infection management and responsible organisms.

The purpose of this investigation was to examine the timing of penile prosthesis infection management by different responsible organisms. A retrospective cohort study was performed of patients who underwent penile prosthesis salvage or explant procedures due to a suspected infection between 2001 and 2018. The cohort consisted of 216 patients from 33 different facilities and six countries. The most common primary organisms responsible for device infections included, Gram-positives (31.5%), no growth cultures (30.6%), Gram-negatives (22.2%), fungal (11.6%), and anaerobic organisms (4.2%). Overall, median time to infection was 1.8 (interquartile range [IQR]: 1.0-3.0) months for all patients. Median time to infection management was similar between responsible organisms: 1.0 (IQR: 1.0-2.3) months for Gram-negatives and 2 months for Gram-positives (IQR: 1.0-1.4), fungal (IQR: 1.0-5.0), anaerobes (IQR: 1.0-2.5), and no growth cultures (IQR: 1.0-3.0, p = 0.56). Median time to infection management was significantly shorter among patients who received aminoglycoside/vancomycin prophylaxis (1.5 months, IQR: 1.0-2.5, p < 0.01) compared to other antibiotic groups. Median time to infection management was significantly longer for patients managed with a three-piece inflatable implant salvage procedure (2.8 months, IQR: 1.0-5.0, p = 0.02) compared to other salvage procedures. Conventional wisdom surrounding early versus late penile prosthesis infections should largely be abandoned. More than half of penile prosthesis infections are surgically managed within 2 months of initial device placement.

Ileal Conduit Versus Continent Urinary Diversion in Radical Cystectomy: A Retrospective Cohort Study of 30-day Complications, Readmissions, and Mortality.

OBJECTIVE: To quantify the short-term burden associated with continent diversion relative to ileal conduit creation. METHODS: Bladder cancer patients who underwent radical cystectomy in 2019 and 2020 were identified in the American College of Surgeons National Surgical Improvement Program database using current procedural terminology codes and pathology reports. Patients were grouped by urinary diversion performed: ileal conduit versus continent diversion (neobladder or cutaneous reservoir). Multiple logistic regression was used to examine the association between type of urinary diversion and 30-day outcomes, including postoperative complications, all-cause readmissions, and mortality, adjusting for baseline differences. RESULTS: Of 4,755 patients who underwent radical cystectomy, 677 underwent continent diversion (14.2%). These patients were significantly younger (median 62 vs 71 years, P <.01) and less likely to have diabetes (13.6% vs 20.1%, P <.01), COPD (3.7% vs 7.1%, P<0.01), and prior pelvic radiation (5.5% vs 13.1%, P <.01). A greater proportion of continent diversion patients experienced a postoperative complication (56.0% vs 48.9%, P <.01) and all-cause readmission (30.3% vs 20.4%, P <.0). After adjustment, continent diversion patients had 1.4 (95% CI: 1.1-1.7) and 1.7 (95% CI: 1.4-2.1) times the odds of experiencing a postoperative complication or all-cause readmission, respectively. There was no statistically significant difference in mortality (OR 1.2, 95% CI: 0.5-2.9). CONCLUSION: Compared to ileal conduit creation, continent urinary diversion is associated with increased odds of postoperative complications and readmission to the hospital within 30 days of surgery. Bladder cancer patients undergoing cystectomy and seeking continent diversion should be counseled on the increased short-term morbidity associated with this specific type of diversion.

Current Findings Regarding Perioperative Complications in Benign Scrotal Surgery.

OBJECTIVES: To characterize patients at the greatest risk of morbidity and mortality after benign scrotal surgery. METHODS: A secondary data analysis was conducted of adults undergoing elective scrotal surgery for benign conditions using 2015-2020 American College of Surgeons National Surgical Quality Improvement data. Patients who experienced a postoperative complication, an unplanned procedure, or who died within 30-days of surgery were identified using the composite outcome "postoperative event". Multiple logistic regression was used to examine the association between patient characteristics and the odds of experiencing a postoperative event. RESULTS: The study consisted of 12,917 patients, of which 4.1% experienced a postoperative event. After adjustment, malnourishment (OR 4.1, 95% CI: 1.2 - 14.5) decreased functional status (OR 3.8, 95% CI: 2.0 - 7.1), bleeding disorders (OR 3.4, 95% CI: 2.2 - 5.4), age ≥ 40 years (OR 1.6, 95% CI: 1.2 - 2.0), chronic obstructive pulmonary disease, (COPD, OR 1.8, 95% CI: 1.2 - 2.6), smoking (OR 1.4, 95% CI: 1.2 - 1.8), diabetes (OR 1.3, 95% CI: 1.1 - 1.7) and increased body mass index (BMI, OR 1.1, 95% CI: 1.1-1.1) were identified as risk factors for a postoperative event. The risk of a postoperative event was 2.7%, 4.5%, and 11.2% for patients with none, 1 to 2, and > 2 risk factors, respectively. CONCLUSION: Complications after benign scrotal surgery are not infrequent. Risk factors include malnourishment, decreased functional status, bleeding disorders, age, COPD, smoking, diabetes, and increased BMI. Our results can be used to counsel patients on their risk of negative outcomes following these procedures.

Prophylactic Parastomal Mesh Sublay at the Time of Ileal Conduit: Surgical Technique.

OBJECTIVE: To demonstrate the surgical technique for prophylactic mesh placement in the sublay position during ileal conduit creation because literature suggests that prophylactic mesh placement at the time of cystectomy may reduce the risk of parastomal hernias with low risk of mesh-related complications. Parastomal hernias are one of the most common complications following ileal conduit construction and occur in 17-65% of patients undergoing cystectomy with urinary diversion. Review of our institutions data demonstrated a high incidence of hernias associated with ileal conduits, which have substantial burden to patients, surgeons, and the healthcare system. METHODS: This is a retrospective chart review of data from a single surgeon who performed cystectomy with ileal conduit for 12 patients with bladder cancer between January, 2021-March, 2022 at our institution. These dates were chosen based on the timing of availability of literature suggesting a benefit from prophylactic mesh placement. Preliminary data was analyzed determine the incidence of parastomal hernia and mesh-related complications. RESULTS: A total of 12 patients underwent cystectomy with ileal conduit between January, 2021-March, 2022 at our institution. Eleven patients (92%) had prophylactic mesh placed during their procedure. Median follow up was 5.4 months (0.8-8 months). Two patients (17%) developed a parastomal hernia which was detected clinically and/or radiographically. The hernias occurred in patients with mesh and within 6 months of cystectomy. One patient had stomal stenosis eventually requiring surgical revision. There were no mesh infections or mesh removals. CONCLUSION: Parastomal hernias are a common and morbid complication of ileal conduit urinary diversion. Our early experience demonstrates that the procedure is straightforward, adds little time to the surgical procedure, and is associated with a low complication rate. Our experience is too small and follow up too short to confirm that the results of the randomized trial can be matched at our center.