Non-inferiority, randomised, open-label clinical trial on the effectiveness of transurethral microwave thermotherapy compared to prostatic artery embolisation in reducing severe lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for the TUMT-PAE-1 trial.

BACKGROUND: One-fourth of men older than 70 years have lower urinary tract symptoms (LUTS) that impair their quality of life. Transurethral resection of the prostate (TURP) is considered the gold standard for surgical treatment of LUTS caused by benign prostatic hyperplasia (BPH) that cannot be managed conservatively or pharmacologically. However, TURP is only an option for patients fit for surgery and can result in complications. Transurethral microwave thermotherapy (TUMT) and prostatic artery embolisation (PAE) are alternative minimally invasive surgical therapies (MISTs) performed in an outpatient setting. Both treatments have shown to reduce LUTS with a similar post-procedure outcome in mean International Prostate Symptom Score (IPSS). It is however still unknown if TUMT and PAE perform equally well as they have never been directly compared in a randomised clinical trial. The objective of this clinical trial is to assess if PAE is non-inferior to TUMT in reducing LUTS secondary to BPH. METHODS: This study is designed as a multicentre, non-inferiority, open-label randomised clinical trial. Patients will be randomised with a 1:1 allocation ratio between treatments. The primary outcome is the IPSS of the two arms after 6 months. The primary outcome will be evaluated using a 95% confidence interval against the predefined non-inferiority margin of + 3 points in IPSS. Secondary objectives include the comparison of patient-reported and functional outcomes at short- and long-term follow-up. We will follow the patients for 5 years to track long-term effect. Assuming a difference in mean IPSS after treatment of 1 point with an SD of 5 and a non-inferiority margin set at the threshold for a clinically non-meaningful difference of + 3 points, the calculated sample size was 100 patients per arm. To compensate for 10% dropout, the study will include 223 patients. DISCUSSION: In this first randomised clinical trial to compare two MISTs, we expect non-inferiority of PAE to TUMT. The most prominent problems with MIST BPH treatments are the unknown long-term effect and the lack of proper selection of candidates for a specific procedure. With analysis of the secondary outcomes, we aspire to contribute to a better understanding of durability and provide knowledge to guide treatment decisions. TRIAL REGISTRATION: ClinicalTrials.gov NCT05686525. Registered on January 17, 2023, https://clinicaltrials.gov/study/NCT05686525 .

Early experience with targeted and combination biopsies in prostate cancer work-up in Denmark from 2012 to 2016.

PURPOSE: To investigate the early implementation of combined systematic and targeted (cBx) primary biopsy in prostate cancer diagnosis and define the concordance in Gleason grading (GG) of different biopsy techniques with radical prostatectomy (RP) pathology. METHODS: This population-based analysis includes data on all men in Denmark who underwent primary cBx or standalone systematic (sBx) prostate biopsy between 2012 and 2016. Biopsy results were compared to RP pathology if performed within a year. Concordance measurement was estimated using Cohen's Kappa, and the cumulative incidence of cancer-specific death was estimated at 6 years with the Aalen-Johansen estimator. RESULTS: Concordance between biopsy and RP pathology was 0.53 (95CI: 0.43-0.63), 0.38 (95CI: 0.29-0.48), and 0.16 (95CI: 0.11-0.21) for cBx, targeted biopsy (tBx), and sBx, respectively. For standalone sBx and RP, concordance was 0.29 (95CI: 0.27-0.32). Interrelated GG concordance between tBx and sBx was 0.67 (95CI: 0.62-0.71) in cBx. The proportion of correctly assessed GG based on RP pathology was 54% in both cBx and standalone sBx. Incidence of prostate cancer-specific death was 0% regardless of biopsy technique in GG 1, and 22% (95CI: 11-32), 30% (95CI: 15-44), and 19% (95CI: 7.0-30) in GG 5 for cBx, tBx, or sBx, respectively. CONCLUSION: Overall, the cBx strategy demonstrates higher concordance to RP pathology than the standalone sBx. However, cBx exhibits more overgrading of the GG of RP pathology compared to sBx. Ultimately, the classic grading system does not take change in the diagnostic pathway into account, and grading should be altered accordingly to ensure appropriate treatment.

Automated performance metrics and surgical gestures: two methods for assessment of technical skills in robotic surgery.

The objective of this study is to compare automated performance metrics (APM) and surgical gestures for technical skills assessment during simulated robot-assisted radical prostatectomy (RARP). Ten novices and six experienced RARP surgeons performed simulated RARPs on the RobotiX Mentor (Surgical Science, Sweden). Simulator APM were automatically recorded, and surgical videos were manually annotated with five types of surgical gestures. The consequences of the pass/fail levels, which were based on contrasting groups' methods, were compared for APM and surgical gestures. Intra-class correlation coefficient (ICC) analysis and a Bland-Altman plot were used to explore the correlation between APM and surgical gestures. Pass/fail levels for both APM and surgical gesture could fully distinguish between the skill levels of the surgeons with a specificity and sensitivity of 100%. The overall ICC (one-way, random) was 0.70 (95% CI: 0.34-0.88), showing moderate agreement between the methods. The Bland-Altman plot showed a high agreement between the two methods for assessing experienced surgeons but disagreed on the novice surgeons' skill level. APM and surgical gestures could both fully distinguish between novices and experienced surgeons in a simulated setting. Both methods of analyzing technical skills have their advantages and disadvantages and, as of now, those are only to a limited extent available in the clinical setting. The development of assessment methods in a simulated setting enables testing before implementing it in a clinical setting.

Management and Oncologic Outcomes of Incidental Prostate Cancer After Transurethral Resection of the Prostate in Denmark.

PURPOSE: Approximately 1 in 10 patients without prior prostate biopsy undergoing surgery for lower urinary tract symptoms harbors incidental prostate cancer; however, practice guidelines do not provide recommendations for its management. We aimed at describing the oncologic outcomes of patients with Grade Group (GG) 1 and GG2 prostate cancer diagnosed at transurethral resection of the prostate (TURP). MATERIALS AND METHODS: This was a nationwide, population-based, observational study of patients undergoing TURP in Denmark from 2006 to 2022 using the Danish Prostate Registry. We estimated the cumulative incidence of further biopsies and MRI, curative treatment, endocrine treatment, and cause-specific mortality with competing risk analyses. RESULTS: Among 24,494 patients who underwent TURP, there were 1016 men with GG1 and 381 with GG2 prostate cancer. The 5-year cumulative incidence of further MRIs or biopsies was 36% (95% CI 33%-39%) for GG1 and 30% (95% CI 25%-34%) for GG2 disease. Fifteen-year prostate cancer mortality was 8.4% (95% CI 5.3%-11%) for GG1 and 14% (7.5%-21%) for GG2. A total of 270 men with GG1 disease underwent a biopsy after the TURP, and 162 (60%) had no cancer; in this group, prostate cancer mortality after 15 years was 0.6% (95% CI 0%-1.8%). Men with post-TURP biopsy ≥ GG2 had a prostate cancer mortality of 30% (95% CI 9%-50%) 15 years post TURP. The major limitation was the heterogeneous follow-up, which could lead to an overestimation of prostate cancer mortality compared to a more standardized follow-up. CONCLUSIONS: We observed high prostate cancer mortality after TURP with GG1 or GG2, likely due to unsampled high-grade cancer in the peripheral zone. Patients with incidental prostate cancer should be further investigated to rule out high-grade cancer. For patients with GG1 on TURP, once a subsequent biopsy does not show cancer, follow-up should be lessened similar to that of patients with an initial nonmalignant biopsy.

Injection of luteinizing hormone or human chorionic gonadotropin increases calcium excretion and serum PTH in males.

Animal and human studies have suggested that sex steroids have calciotropic actions, and it has been proposed that follicle-stimulating hormone (FSH) may exert direct effects on bone. Here, we demonstrate the expression of the receptor for Luteinizing hormone (LH) and human choriogonadotropin (hCG), LHCGR, in human kidney tissue, suggesting a potential influence on calcium homeostasis. To investigate the role of LHCGR agonist on calcium homeostasis in vivo, we conducted studies in male mice and human subjects. Male mice were treated with luteinizing hormone (LH), and human extrapolation was achieved by injecting 5000 IU hCG once to healthy men or men with hypergonadotropic or hypogonadotropic hypogonadism. In mice, LH treatment significantly increased urinary calcium excretion and induced a secondary increase in serum parathyroid hormone (PTH). Similarly, hCG treatment in healthy men led to a significant increase in urinary calcium excretion, serum PTH levels, and 1,25 (OH)2D3, while calcitonin, and albumin levels were reduced, possibly to avoid development of persistent hypocalcemia. Still, the rapid initial decline in ionized calcium coincided with a significant prolongation of the cardiac QTc-interval that normalized over time. The observed effects may be attributed to LH/hCG-receptor (LHCGR) activation, considering the presence of LHCGR expression in human kidney tissue, and the increase in sex steroids occurred several hours after the changes in calcium homeostasis. Our translational study shed light on the intricate relationship between gonadotropins, sex hormones and calcium, suggesting that LHCGR may be influencing calcium homeostasis directly or indirectly.

Surgical Complications Following Renal Transplantation in a Large Institutional Cohort.

Background: Successful renal transplantation (RTx) relies on immunosuppression and an optimal surgical course with few surgical complications. Studies reporting the postoperative complications after RTx are heterogeneous and often lack systematic reporting of complications. This study aims to describe and identify postoperative short-term and long-term complications after RTx in a large institutional cohort and identify risk factors for a complicated surgical course. Methods: The study is a retrospective single-center cohort of 571 recipients who underwent living or deceased donor open RTx between 2014 and 2021. Data were collected on background information and perioperative and postoperative data. Complications were defined as short-term (<30 d) or long-term (>30 d) after transplantation and graded according to the Clavien-Dindo classification. Multivariable logistic regression was performed to evaluate risk factors for serious short-term complications and multivariable time-dependent Cox regression to evaluate risk factors for long-term complications. Results: A total of 351 patients received a graft from a deceased donor, and 144 of these grafts were on perfusion machine before transplantation. One or more short-term complications occurred in 345 (60%) patients. Previous RTx was associated with short-term Clavien-Dindo >2 complications in recipients (odds ratio = 2.08; 95% confidence interval [CI], 1.18-3.69; P = 0.01). Being underweight (body mass index <18.5) in combination with increasing age increased the odds of short-term Clavien-Dindo >2 and vascular complications. Increasing blood loss per 100 mL was associated with increased odds of short-term Clavien-Dindo >2 (odds ratio = 1.11; 95% CI, 1.01-1.21; P = 0.032). No associations were found for long-term complications after RTx. The 5-y cumulative incidence of graft loss was 12.6% (95% CI, 8.9-16.3). Conclusions: Short-term complications are common after RTx, and risk factors for severe short-term complications include previous RTx, increasing age, and low body mass index. No risk factors were identified for severe long-term complications. Further studies should explore whether new surgical techniques can reduce surgical complications in RTx.

Oncological and Functional Outcomes of Whole-Gland HIFU as the Primary Treatment for Localized Prostate Cancer: A Systematic Review.

INTRODUCTION: High-intensity focused ultrasound (HIFU) is regarded as a promising alternative treatment option for localized prostate cancer (PCa) as it has been proposed to offer similar oncologic control to the standard of care, but with significantly reduced treatment-related side effects. This systematic literature review assesses the available evidence of whole-gland HIFU as primary treatment for localized PCa. METHODS: MEDLINE (PubMed) was searched for studies investigating oncological and functional outcomes following whole-gland HIFU as primary treatment for localized PCa. Our primary outcomes for the review were biochemical disease-free survival rates (BDFS), overall and PCa-specific survival rates as well as negative biopsy rates. Our secondary outcomes were functional results and complications of the treatment. RESULTS: A total of 375 articles were identified, of which 35 were included in the present review. All 35 articles were prospective or retrospective case series. Mean/median duration of follow-up across studies was 10.9 to 94 months, and 6618 patients were included in the review. The BDFS rate varied greatly across studies from 21.7% to 89.2% during follow-up. The 10-year PCa-specific survival rate following HIFU was 90%, 99%, and 100% in 3 studies. Negative biopsy rates post-HIFU ranged from 20% to 92.7% across studies. Common side effects to HIFU included urinary incontinence (grade 1: 0%-22.7%), erectile dysfunction (11.6%-77.1%), urinary tract infections (1.5%-47.9%), and bladder outlet obstruction mainly as urethral strictures (7%-41.2%). CONCLUSION: Great variation in oncological and functional outcomes was seen across studies. More prospective trials are needed before whole-gland HIFU can be considered as a treatment option for localized PCa.

The Prognostic Impact of the Surgical Margin in Renal Cell Carcinoma Treated with Partial Nephrectomy: A Multi-Center Study.

Background: Partial nephrectomy (PN) is the preferred treatment for small, localized kidney tumors. Incomplete resection resulting in positive surgical margins (PSM) can occur after PN. The impact of PSM on the risk of recurrence and survival outcomes is not fully understood. We aimed to explore the relationship between PSM, the risk of recurrence and impact on survival after PN in a large multicenter cohort from Denmark. Methods: This was a retrospective cohort study including patients who underwent PN for renal cell carcinoma (RCC) at three departments in Denmark between 2010 and 2016. Data including pathological features, surgical techniques, and patient follow-up was retrieved from electronic medical health records and national databases. We used a combination of descriptive statistics, comparative analysis (comparisons were carried out by Mann-Whitney Test, independent Student's t-test, or Pearson's chi-Square Test), univariate and multivariate logistic regression analyses, and survival analysis methods. Results: A total of 523 patients were included, of which 48 (9.1%) had a PSM. Recurrence was observed in 55 patients (10.5%). Median follow-up time was 75 months. We found a lower incidence of PSM with robot-assisted PN (p = 0.01) compared to open or laparoscopic PN. PSM was associated with a higher risk of recurrence compared to negative margins in univariate analysis, but not multivariate analysis. However, the study was underpowered to describe this association with other risk factors. Overall survival did not differ between patients with PSM and negative margins. Conclusions: Our study presents further evidence on the negative impact of PSM on recurrence after PN for RCC, highlighting the importance of achieving NSM, thus potentially improving clinical outcomes. A surgical approach was found to be the only predictive factor influencing the risk of PSMs, with a reduced risk observed with robot-assisted laparoscopy.

How experienced robotic nurses adapt to the Hugo™ RAS system.

No studies have reported on the impact at team level of the Medtronic Hugo™ RAS system. We described the work patterns and learning curves of an experienced robotic nurse team adapting to the new robotic system. We prospectively recorded the robotic nurse team's preoperative, perioperative, and postoperative tasks on the first 30 robotic procedures performed. The data were descriptively analyzed, and Gantt Charts were created for a timeline overview of the work patterns. We compared the operative times between the Medtronic Hugo™ RAS and the Davinci® system. The preoperative phase seemed to improve with a median time of 94 min (IQR 81-107). After 20 surgeries, the work pattern became more consistent where the scrub and circulating nurses worked simultaneously. There was no noticeable improvement for the perioperative and postoperative phases with a stable median time of 170 min (IQR 135-189) and 26 min (IQR 22-31). We found that the work pattern seemed to stabilize after 20 surgeries but with a continued decrease in preoperative time without a learning curve plateau. The robotic nurse team suffered from few breaks and long working hours because only a few nurses at our facility were trained in the Hugo™ system.

Systemic interrogation of immune-oncology-related proteins in patients with locally advanced prostate cancer undergoing androgen deprivation and intensity-modulated radiotherapy.

PURPOSE: The primary objective was to establish whether blood-based leucine-rich alpha-2-glycoprotein (LRG1) can predict outcomes in patients with locally advanced prostate cancer undergoing androgen-deprivation therapy (ADT) and radiotherapy (RT) and to determine how it may relate to 92 immune-oncology (I-O)-related proteins in this setting. METHODS: Baseline blood level of LRG1 from patients treated with ADT and RT enrolled in the CuPCa (n = 128) and IMRT (n = 81) studies was measured using ELISA. A longitudinal cohort with matched blood samples from start of ADT, start of RT, and end of RT protocol from 47 patients from the IMRT cohort was used to establish levels of I-O proteins by high-multiplexing Proximal Extension Assay by Olink Proteomics. Statistical analyses using Kaplan-Meier, Cox regression, and LIMMA analyses were applied to predict the prognostic value of LRG1 and its correlation to I-O proteins. RESULTS: High baseline levels of LRG1 predicted a low frequency of treatment failure in patients undergoing ADT + RT in both the CuPCa and the IMRT cohorts. LRG1 was moderately correlated with CD4, IL6, and CSF1. We identified I-O proteins predicting metastatic failure (MF) at different timepoints. CONCLUSION: LRG1 biomarker is associated with I-O proteins and can be used to improve stratification and monitoring of prostate cancer patients undergoing ADT + RT. This work will require further in-depth analyses in independent cohorts with treatment outcome data.

Surgical gestures can be used to assess surgical competence in robot-assisted surgery : A validity investigating study of simulated RARP.

To collect validity evidence for the assessment of surgical competence through the classification of general surgical gestures for a simulated robot-assisted radical prostatectomy (RARP). We used 165 video recordings of novice and experienced RARP surgeons performing three parts of the RARP procedure on the RobotiX Mentor. We annotated the surgical tasks with different surgical gestures: dissection, hemostatic control, application of clips, needle handling, and suturing. The gestures were analyzed using idle time (periods with minimal instrument movements) and active time (whenever a surgical gesture was annotated). The distribution of surgical gestures was described using a one-dimensional heat map, snail tracks. All surgeons had a similar percentage of idle time but novices had longer phases of idle time (mean time: 21 vs. 15 s, p < 0.001). Novices used a higher total number of surgical gestures (number of phases: 45 vs. 35, p < 0.001) and each phase was longer compared with those of the experienced surgeons (mean time: 10 vs. 8 s, p < 0.001). There was a different pattern of gestures between novices and experienced surgeons as seen by a different distribution of the phases. General surgical gestures can be used to assess surgical competence in simulated RARP and can be displayed as a visual tool to show how performance is improving. The established pass/fail level may be used to ensure the competence of the residents before proceeding with supervised real-life surgery. The next step is to investigate if the developed tool can optimize automated feedback during simulator training.

Efficacy of High-Dose Dexamethasone in Reducing the Symptoms of Postembolization Syndrome Following Prostatic Artery Embolization: Results of a Double-Blind Randomized Controlled Trial.

PURPOSE: To evaluate the efficacy of a single perioperative dose of dexamethasone in reducing postembolization syndrome following prostatic artery embolization. MATERIALS AND METHODS: We conducted a single-center double-blind randomized controlled trial from March 2021 to May 2022 (NCT04588857). Participants were randomized to receive either i.v. 24 mg dexamethasone or saline. The primary outcome measures were temperature, pain, and quality of life in the first 5 days following prostatic artery embolization. Sample size of 60 patients was needed for the assessment of primary outcomes. Participants were followed for 6 months and assessed for a variety of secondary outcome measures including inflammatory markers and lower urinary tract symptoms severity. RESULTS: Due to lack of clinical effect and mild symptoms in the control group, the trial was terminated early. 31 participants (16 dexamethasone vs. 15 control) were enrolled and analyzed. A difference in mean temperature was observed on day 1 (37.23 ± 0.64 °C control vs 36.74 ± 0.41 °C dexamethasone, p = 0.02, 95% CI 0.09-0.89). Difference in pain (score out of 10) was seen only on day 5 (1.48 ± 1.2 control vs. 2.9 ± 2.24 dexamethasone, p = 0.04, 95% CI - 2.78-- 0.04). A difference in C-reactive protein values was observed on day 2 (108 [54-161] mg/l control vs 10 [5-33] mg/l dexamethasone, p < 0.01). No significant differences in other outcomes were observed. No side effects were recorded. CONCLUSIONS: Twenty-four milligrams of dexamethasone bolus is safe but does not reduce postembolization syndrome following prostatic artery embolization.

Skills transfer from the DaVinci® system to the Hugo™ RAS system.

PURPOSE: Recently, the robotic surgical system, Hugo™ was approved for clinical use. The transfer of skills is important for understanding the implementation of surgical innovation. We explored the transfer of skills from the DaVinci® to the Hugo™ by studying the learning curve and short-term patient outcomes during radical prostatectomy (RARP). METHODS: We examined the transfer of skills from one surgeon performing RARP from the first case with the Hugo™ system in April 2022. The surgeon had previously performed > 1000 RARPs using DaVinci®. Perioperative and clinical outcomes were collected for procedures on both Hugo™ and DaVinci®. Patient follow-up time was 3 months. RESULTS: Nineteen Hugo™ cases and 11 DaVinci® cases were recorded. No clinically relevant difference in procedure time was found when transferring to Hugo™. Patients operated using Hugo™ had more contacts postoperatively compared to the DaVinci®, all Clavien-Dindo (CD) grade 1 (53% vs 18%). Three patients from the Hugo™ group were re-admitted within 30 days with catheter malfunction (CD grade 1), infection without a focus (CD grade 2), and ileus due to a hernia in the port hole (CD grade 3b). The 3-month follow-up showed similar results in prostate-specific antigen levels (PSA) and erectile dysfunction between the two robotic systems, but a higher incidence of incontinence was found for the Hugo™. CONCLUSION: We observed that the skills of an experienced robotic surgeon are transferable from DaVinci® to Hugo™ when performing RARP. No obvious benefits were found for using Hugo™ compared to DaVinci® for RARP although this needs confirmatory studies.

Microbial Trends in Infection-related Readmissions Following Radical Cystectomy for Bladder Cancer.

OBJECTIVE: To report microbial pathogens detected at infection-related readmissions, including their susceptibility to antimicrobials. MATERIALS AND METHODS: A retrospective review of 785 patients who underwent radical cystectomy for bladder cancer at a tertiary center in Denmark between 2009 and 2019. All patients received prophylactic cefuroxime preoperatively and pivmecillinam at stent- or catheter removal. Data were collected through the national medical records and microbiology database. The primary outcome was readmission rate and pathogens detected at infection-related readmissions. Univariable and multivariable regression analyses were carried out to identify risk factors of readmission. RESULTS: Within 90days of surgery, 225 (29%) patients experienced at least one infection-related readmission. The most common pathogen identified was Enterococcus spp (24% of all positive samples). In blood cultures, the most dominant species were Escherichia coli (29%) and Staphylococcus spp (26%). Due to the heterogeneity in microbial species identified, more than one-third of the bacteria where mecillinam was tested showed resistance. Most isolates were susceptible to piperacillin+tazobactam. Orthotopic neobladder and continent cutaneous reservoir were associated with the highest risk of infection-related readmission compared to ileal conduit (odds ratios 2.78 [95%CI 1.66;4.65] and 3.08 [95%CI 1.58;5.98], respectively). Patients with diabetes had an increased risk of infection-related readmission compared to patients without diabetes (odds ratio 1.67 [95%CI 1.02;2.73]). CONCLUSION: Nearly one-third of all patients experienced at least one postoperative infection-related readmission with a wide range of microbial etiologies. Generalizability of our results is uncertain, but the data can be used to plan interventional trials of antibiotic prophylaxis.

First experience with the Hugo™ robot-assisted surgery system for endometriosis: A descriptive study.

INTRODUCTION: The Medtronic Hugo™ Robot-assisted Surgery (RAS) system was recently approved for clinical use. We explored the safety and feasibility of this system for endometriosis surgery. The primary outcome was safe case completion without major surgical complications (Clavien-Dindo grade ≤2) and no conversion to open surgery or laparoscopy. MATERIAL AND METHODS: Surgeries for endometriosis performed at the Department of Gynecology, Rigshospitalet, on the Medtronic Hugo™ RAS system were included. Two experienced robotic surgeons performed all surgeries with their usual robotic team. The variables included were patient demographics, peri- and postoperative data, complications and 30-day readmission rate. We used the IDEAL framework 1/2a for surgical innovation in this descriptive study. RESULTS: The first 12 patients were included. All cases were completed without intraoperative complications or conversion. Four patients experienced Clavien-Dindo grade 1 postoperative complications. No patients were re-admitted within 30 days. Median docking time (17 minutes), console time (87.5 minutes), blood loss (40 mL) and length of hospital stay (1 day) were acceptable compared with previous literature. CONCLUSIONS: In this pilot study, we found the Medtronic Hugo™ RAS system safe and feasible for robot-assisted surgery for endometriosis. The advent of new robotic systems is welcomed to accelerate the development of technology that will advance surgical care for patients across the globe.

Laypersons versus experienced surgeons in assessing simulated robot-assisted radical prostatectomy.

BACKGROUND: Feedback is important for surgical trainees but it can be biased and time-consuming. We examined crowd-sourced assessment as an alternative to experienced surgeons' assessment of robot-assisted radical prostatectomy (RARP). METHODS: We used video recordings (n = 45) of three RARP modules on the RobotiX, Simbionix simulator from a previous study in a blinded comparative assessment study. A group of crowd workers (CWs) and two experienced RARP surgeons (ESs) evaluated all videos with the modified Global Evaluative Assessment of Robotic Surgery (mGEARS). RESULTS: One hundred forty-nine CWs performed 1490 video ratings. Internal consistency reliability was high (0.94). Inter-rater reliability and test-retest reliability were low for CWs (0.29 and 0.39) and moderate for ESs (0.61 and 0.68). In an Analysis of Variance (ANOVA) test, CWs could not discriminate between the skill level of the surgeons (p = 0.03-0.89), whereas ES could (p = 0.034). CONCLUSION: We found very low agreement between the assessments of CWs and ESs when they assessed robot-assisted radical prostatectomies. As opposed to ESs, CWs could not discriminate between surgical experience using the mGEARS ratings or when asked if they wanted the surgeons to perform their robotic surgery.

Outcomes of Biopsy Grade Group 1 Prostate Cancer Diagnosis in the Danish Population.

BACKGROUND: Debate regarding a nomenclature change for grade group 1 (GG 1) prostate cancer to noncancer has been revived, as this could be a powerful tool in reducing the overtreatment of indolent disease. OBJECTIVE: To describe outcomes for all men diagnosed with GG 1 prostate cancer in the Danish population, with a focus on men followed conservatively. DESIGN, SETTING, AND PARTICIPANTS: This was a population-based observational study using data from the Danish Prostate Registry. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We measured the cumulative incidence of curative treatment, endocrine treatment, and cause-specific mortality. RESULTS AND LIMITATIONS: The cumulative incidence of endocrine therapy at 10 yr was 5.3% (95% confidence interval [CI] 4.3-6.3%) for men with initial active surveillance and 21% (95% CI 19-23%) for men with initial watchful waiting for localized GG 1. In the GG1 cohort, the prostate cancer-specific mortality rate at 15 yr was 14% (95 CI% 11-16%) for men on watchful waiting, 10% (95 CI% 6.7-14%) for men with prostate-specific antigen <10 ng/ml on watchful waiting, and 16% (95 CI% 13-19%) for men who did not receive curative-intent treatment or histological assessment. The study is limited by the historic nature of the observations over a period during which diagnostic procedures and treatments have evolved. CONCLUSIONS: GG 1 cancer can lead to disease-specific mortality in men with localized prostate cancer, and changing the nomenclature for all men may lead to undertreatment. PATIENT SUMMARY: Key opinion leaders have suggested that prostate cancers of Gleason grade group 1 (GG 1) should be renamed as noncancer to reduce overtreatment. The argument is that low-grade cancer does not metastasize. However, our nationwide population-based study showed that death from prostate cancer can occur in some men diagnosed with GG 1 disease. These men should be considered in discussions on changing the name for GG 1 prostate cancer.

Acute Kidney Injury Within 90Days of Radical Cystectomy for Bladder Cancer: Incidence and Risk Factors.

OBJECTIVE: To report incidence of acute kidney injury (AKI) following radical cystectomy (RC) for bladder cancer and evaluate risk factors for AKI as well as the impact of AKI on development of long-term renal insufficiency. METHODS: A retrospective analysis of patients undergoing RC between 2010 and 2020 at a high-volume tertiary referral center. AKI was graded according to the Kidney Disease Improving Global Outcome (KDIGO) criteria within 90days of surgery. Long-term renal insufficiency was defined as estimated glomerular function <45 mL/min. Cumulative incidence and Cox Proportional Hazards models were used to evaluate both short- and long-term loss of renal function and investigate their association with pre- and perioperative variables. RESULTS: AKI occurred in 332 out of 755 patients (44%) within 90days. Preoperative chronic hypertension and obesity were independent preoperative risk factors. Robot-assisted RC was associated with a higher risk of AKI compared to open RC in multivariable analyses. The absolute risk of developing long-term renal insufficiency was 8.7% (95%CI: 5.6-12) after 5years in patients without AKI and 26% (95%CI: 16-36) in patients with KDIGO-stage ≥2. In multivariable analysis, both KDIGO-stage 1 and ≥2 were independently associated with long-term estimated glomerular filtration rate <45 mL/min. CONCLUSION: A significant number of patients experienced AKI after RC, and even patients with KDIGO-stage 1 were at increased risk of long-term renal insufficiency. Recognizing pre- and perioperative risk factors can identify patients where close surveillance and early intervention may help minimize renal function decline following RC.