Quality-of-life outcomes of the ROBOtic-assisted versus Conventional Open Partial nephrectomy (ROBOCOP) II trial.

OBJECTIVES: To comprehensively compare quality-of-life (QoL) outcomes between open partial nephrectomy (OPN) and robot-assisted PN (RAPN) from the randomised ROBOtic-assisted versus Conventional Open Partial nephrectomy (ROBOCOP) II trial, as QoL data comparing OPN and RAPN are virtually non-existent, especially not from randomised controlled trials (RCTs). PATIENTS AND METHODS: The ROBOCOP II was a single-centre, open-label RCT between OPN and RAPN. The pre-planned analyses of QoL outcomes are presented. Data were analysed descriptively in a modified intention-to-treat population. RESULTS: A total of 50 patients underwent surgery. At postoperative Day 90 (POD90), there was no significant difference for the Kidney Disease Quality of Life-Short Form questionnaire score (mean [sd] OPN 72 [20] vs RAPN 76 [15], P = 0.850), while there were advantages for RAPN in the subdomains of 'Pain' (P = 0.006) and 'Physical functioning' (P = 0.011) immediately after surgery. For the European Organisation for Research and Treatment of Cancer quality of life questionnaire 30-item core there were overall advantages directly after surgery (mean [sd] score OPN 63 [20] vs RAPN 75 [17], P = 0.031), as well as for the subdomains 'Fatigue' (P = 0.026), 'Pain' (P = 0.002) and 'Constipation' (P = 0.045) but no differences at POD90. There were no differences for the EuroQoL five Dimensions five Levels questionnaire at POD90 (mean [sd] score OPN 70 [22] vs RAPN 72 [17], P = 1.0) or at any other time point. Finally, no significant differences were found for the overall Convalescence and Recovery Evaluation questionnaire score at POD90 (mean [sd] OPN 84 [13] vs RAPN 86 [10], P = 0.818) but less pain in the RAPN group (P = 0.017) directly after surgery. CONCLUSIONS: Pain and physical functioning as subdomains of QoL are improved after RAPN compared to OPN in the early postoperative course, while there are no differences anymore after 3 months.

Maximizing efficiency and ensuring safety: Exploring the outcomes of 2 consecutive open radical cystectomies by the same team within a single surgical day.

BACKGROUND: The purpose of this study was to evaluate the outcomes of performing 2 consecutive open radical cystectomies (RCs) within 1 day by the same surgical team. PATIENTS AND METHODS: A retrospective analysis was conducted on data from patients who underwent RC at a single tertiary care center from January 2015 to February 2023. Patient characteristics, perioperative outcomes and endpoints were analyzed. Univariable and multivariable logistic regression models were created to predict major complications. RESULTS: A total of 657 patients were included in the final cohort, containing 64 paired RCs (32 RC1 and 32 RC2) and 593 single RCs. Major complications occurred in 24.7% of the entire cohort, with no significant differences between single RC vs. RC1 and RC2. Paired RCs showed significantly shorter operative time (OT; p = 0.001) and length of stay (LOS; p = 0.047) compared to single RCs. There were no significant differences in transfusion rates, 30-day readmission, 30-day mortality, or histopathological results between paired and single RCs. Multivariable analysis identified patient characteristics such as age (OR = 1.67, p = 0.03), sex (OR = 0.45, p = 0.008), BMI (OR = 1.98, p = 0.007), ASA-score (OR = 1.61, p = 0.04), and OT (OR = 1.87, p = 0.008) as independent predictors of major complications. CONCLUSION: Performing 2 consecutive open RCs within 1 day by the same surgical team is a safe approach in experienced hands. This strategy optimizes the utilization of surgical resources and addresses the growing demand for urologic care while maintaining high-quality patient care. Preoperative planning should consider patient-specific factors to minimize risks associated with major complications. MICRO ABSTRACT: This study evaluates the outcomes of performing 2 consecutive open radical cystectomies (RC) in a single day by the same surgical team. Data from 657 patients who underwent RC at a single tertiary medical center proved that this approach is safe, with no significant differences in major complications. Preoperative planning should consider patient-specific factors for efficient utilization of surgical resources.

Peritoneal Flap for Lymphocele Prophylaxis Following Robotic-assisted Radical Prostatectomy with Lymph Node Dissection: The Randomised Controlled Phase 3 PELYCAN Trial.

BACKGROUND: Symptomatic lymphoceles (SLCs) after transperitoneal robotic-assisted radical prostatectomy with pelvic lymph node dissection (PLND) are common. Evidence from randomised controlled trials (RCTs) on the impact of peritoneal flaps (PFs) on lymphocele (LC) reduction is inconclusive. OBJECTIVE: To show that addition of PFs leads to a reduction of postoperative SLCs. DESIGN, SETTING, AND PARTICIPANTS: An investigator-initiated, prospective, parallel, double-blinded, adaptive, phase 3 RCT was conducted. Recruitment took place from September 2019 until December 2021; 6-month written survey-based follow-up was recorded. Stratification was carried out according to potential LC risk factors (extended PLND, diabetes mellitus, and anticoagulation) and surgeons; 1:1 block randomisation was used. Surgeons were informed about allocation after completion of the last surgical step. INTERVENTION: To create PFs, the ventral peritoneum was incised bilaterally and fixated to the pelvic floor. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was SLCs. Secondary endpoints included asymptomatic lymphoceles (ALCs), perioperative parameters, and postoperative complications. RESULTS AND LIMITATIONS: In total, 860 men were screened and 551 randomised. Significant reductions of SLCs (from 9.1% to 3.7%, p = 0.005) and ALCs (27.2% to 10.3%, p < 0.001) over the follow-up period of 6 mo were observed in the intention-to-treat analysis. Operating time was 11 min longer (p < 0.001) in the intervention group; no significant differences in amount (80 vs 103, p = 0.879) and severity (p = 0.182) of postoperative complications (excluding LCs) were observed. The survey-based follow-up might be a limitation. CONCLUSIONS: This is the largest RCT evaluating PF creation for LC prevention and met its primary endpoint, the reduction of SLCs. The results were consistent among all subgroup analyses including ALCs. Owing to the subsequent reduction of burden for patients and the healthcare system, establishing PFs should become the new standard of care. PATIENT SUMMARY: A new technique-creation of bilateral peritoneal flaps-was added to the standard procedure of robotic-assisted prostatectomy for lymph node removal. It was safe and decreased lymphocele development, a common postoperative complication and morbidity. Hence, it should become a standard procedure.

Randomized Controlled Feasibility Trial of Robot-assisted Versus Conventional Open Partial Nephrectomy: The ROBOCOP II Study.

BACKGROUND: There is no evidence from randomized controlled trials (RCTs) comparing robot-assisted partial nephrectomy (RAPN) and open partial nephrectomy (OPN). OBJECTIVE: To assess the feasibility of trial recruitment and to compare surgical outcomes between RAPN and OPN. DESIGN, SETTING, AND PARTICIPANTS: ROBOCOP II was designed as single-center, open-label, feasibility RCT. Patients with suspected localized renal cell carcinoma referred for PN were randomized at a 1:1 ratio to either RAPN or OPN. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the feasibility of recruitment, assessed as the accrual rate. Secondary outcomes included perioperative and postoperative data. Data were analyzed descriptively in a modified intention-to-treat population consisting of randomized patients who underwent surgery. RESULTS AND LIMITATIONS: A total of 50 patients underwent RAPN or OPN (accrual rate 65%). In comparison to OPN, RAPN had lower blood loss (OPN 361 ml, standard deviation [SD] 238; RAPN 149 ml, SD 122; difference 212 ml, 95% confidence interval [CI] 105-320; p < 0.001), less need for opioids (OPN 46%; RAPN 16%; difference 30%, 95% CI 5-54; p = 0.024), and fewer complications according to the mean Comprehensive Complication Index (OPN 14, SD 16; RAPN 5, SD 15; difference 9, 95% CI 0-18; p = 0.008). OPN has a shorter operative time (OPN 112 min, SD 29; RAPN 130 min, SD 32; difference -18 min, 95% CI -35 to -1; p = 0.046) and warm ischemia time (OPN 8.7 min, SD 7.1; RAPN 15.4 min, SD 7.0; difference 6.7 min, 95% CI -10.7 to -2.7; p = 0.001). There were no differences between RAPN and OPN regarding postoperative kidney function. CONCLUSIONS: This first RCT comparing OPN and RAPN met the primary outcome of the feasibility of recruitment; however, the window for future RCTs is closing. Each approach has advantages over the other, and both remain safe and effective options. PATIENT SUMMARY: For patients with a kidney tumor, open surgery and robot-assisted keyhole surgery are both feasible and safe approaches for partial removal of the affected kidney. Each approach has known advantages. Long-term follow-up will explore differences in quality of life and cancer control outcomes.

Effects of individualised positive end-expiratory pressure titration on respiratory and haemodynamic parameters during the Trendelenburg position with pneumoperitoneum: A randomised crossover physiologic trial.

BACKGROUND: The Trendelenburg position with pneumoperitoneum during surgery promotes dorsobasal atelectasis formation, which impairs respiratory mechanics and increases lung stress and strain. Positive end-expiratory pressure (PEEP) can reduce pulmonary inhomogeneities and preserve end-expiratory lung volume (EELV), resulting in decreased inspiratory strain and improved gas-exchange. The optimal intraoperative PEEP strategy is unclear. OBJECTIVES: To compare the effects of individualised PEEP titration strategies on set PEEP levels and resulting transpulmonary pressures, respiratory mechanics, gas-exchange and haemodynamics during Trendelenburg position with pneumoperitoneum. DESIGN: Prospective, randomised, crossover single-centre physiologic trial. SETTING: University hospital. PATIENTS: Thirty-six patients receiving robot-assisted laparoscopic radical prostatectomy. INTERVENTIONS: Randomised sequence of three different PEEP strategies: standard PEEP level of 5 cmH 2 O (PEEP 5 ), PEEP titration targeting a minimal driving pressure (PEEP ΔP ) and oesophageal pressure-guided PEEP titration (PEEP Poeso ) targeting an end-expiratory transpulmonary pressure ( PTP ) of 0 cmH 2 O. MAIN OUTCOME MEASURES: The primary endpoint was the PEEP level when set according to PEEP ΔP and PEEP Poeso compared with PEEP of 5 cmH 2 O. Secondary endpoints were respiratory mechanics, lung volumes, gas-exchange and haemodynamic parameters. RESULTS: PEEP levels differed between PEEP ΔP , PEEP Poeso and PEEP5 (18.0 [16.0 to 18.0] vs. 20.0 [18.0 to 24.0]vs. 5.0 [5.0 to 5.0] cmH 2 O; P  < 0.001 each). End-expiratory PTP and lung volume were lower in PEEP ΔP compared with PEEP Poeso ( P  = 0.014 and P  < 0.001, respectively), but driving pressure, lung stress, as well as respiratory system and dynamic elastic power were minimised using PEEP ΔP ( P  < 0.001 each). PEEP ΔP and PEEP Poeso improved gas-exchange, but PEEP Poeso resulted in lower cardiac output compared with PEEP 5 and PEEP ΔP . CONCLUSION: PEEP ΔP ameliorated the effects of Trendelenburg position with pneumoperitoneum during surgery on end-expiratory PTP and lung volume, decreased driving pressure and dynamic elastic power, as well as improved gas-exchange while preserving cardiac output. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00028559, date of registration 2022/04/27). https://drks.de/search/en/trial/DRKS00028559.

Perioperative Outcome of Thulium Laser Enucleation of the Prostate versus Robot-Assisted Simple Prostatectomy: A Propensity Score-Matched Analysis.

INTRODUCTION: The aim of this study was to investigate and compare clinical safety and efficiency of Thulium laser enucleation of the prostate (ThuLEP) and robot-assisted simple prostatectomy (RASP) for the treatment of large gland benign prostatic hyperplasia in a tertiary care center. METHODS: Perioperative data of 39 patients who underwent RASP in our institution from 2015 to 2021 was collected. Propensity score matching using prostate volume, patient age, and body mass index (BMI) was performed from a database of 1,100 Patients treated by ThuLEP from 2009 to 2021. A total of 76 patients were matched. Preoperative parameters such as BMI, age, and prostate volume, as well as intra- and postoperative parameters such as operation time, resection weight, transfusion rate, postoperative catheterization time, length of hospital stay (LoS), hemoglobin drop, postoperative urinary retention (PUR), Clavien-Dindo Classification (CDC), and the Combined Complication Index (CCI), were evaluated. RESULTS: There was no difference in mean hemoglobin drop (2.2 vs. 1.9 g/dL, p = 0.34), yet endoscopic surgery showed superiority in mean operation time (109 vs. 154 min, p < 0.001), mean postoperative catheterization time (3.3 vs. 7.2 days, p < 0.001), and mean LOS (5.4 vs. 8.4 days, p < 0.001). Complication rates evaluated by CDC (p = 0.11) and CCI (p = 0.89) were similar in both groups. Within the documented complications, transfusion rate (0 vs. 3, p = 0.08) and the occurrence of PUR (1 vs. 2, p = 0.5) showed no significant difference. CONCLUSION: ThuLEP and RASP show similar perioperative efficacy and a low rate of complications. ThuLEP had shorter operation times, shorter catheterization time, and a shorter LoS.

Baseline Modified Glasgow Prognostic Score (mGPS) Predicts Radiologic Response and Overall Survival in Metastatic Hormone-sensitive Prostate Cancer Treated With Docetaxel Chemotherapy.

BACKGROUND/AIM: To assess the baseline inflammatory markers modified Glasgow Prognostic Score (mGPS), systemic immune-inflammation index (SII), and neutrophile-to-lymphocyte ratio (NLR) as pragmatic tools for predicting response to chemohormonal therapy (docetaxel plus ADT) and prognosis in men with metastatic hormone-sensitive prostate cancer (mHSPC). PATIENTS AND METHODS: Male patients who received docetaxel at a tertiary university care center between 2014 and 2019 were screened for completion of 6 cycles. NLR, SII, mGPS, overall survival (OS), three-year survival, and radiologic response were assessed. Complete response (CR), partial response (PR), and stable disease (SD) were analyzed alone and in combination. RESULTS: Thirty-six mHSPC-patients were included. In thirty patients, baseline mGPS was assessed and was either 0 (n=22) or 2 (n=8). In Cochran-Armitage Trend Test, mGPS showed significant association with the combined radiologic endpoint of "CR, PR, or SD" (p=0.01), three-year survival (p=0.02), and OS (p<0.01). Next to prostate-specific antigen (PSA) (HR per 100 units 1.16, 95%CI=1.04-1.30, p<0.01), NLR (HR=1.31, 95%CI=1.03-1.66, p=0.03), and mGPS (2 vs. 0, HR=6.53, 95%CI=1.6-27.0, p<0.01) at baseline showed significant association with OS in univariable cox regression. However, mGPS remained the only independent predictor for OS in multivariable cox regression (p<0.01) and for the combined radiologic endpoint of "CR, PR or SD" (p=0.01) in multivariable logistic regression. SII showed no statistical relevance. CONCLUSION: Baseline mGPS seems to be a pragmatic tool for clinical decision-making in patients with mHSPC in daily routine.

Robot-Assisted Simple Prostatectomy vs Endoscopic Enucleation of the Prostate: A Systematic Review and Meta-Analysis of Comparative Trials.

Context: Robot-assisted simple prostatectomy (RASP) and endoscopic enucleation of the prostate (EEP) are two minimally invasive alternatives to simple prostatectomy, which is considered the standard treatment in large prostate glands. It remains unclear which of the two is superior in terms of outcome and complications. Objective: To compare perioperative and functional outcomes of RASP vs EEP. Evidence Acquisition: A systematic review and meta-analysis was conducted according to the recommendations of the Cochrane Collaboration and in line with the PRISMA criteria. The database search included clinicaltrials.gov, Medline (via PubMed), CINAHL, and Web of Science and was using the PICO criteria. All comparative trials were considered. Risk of bias was assessed with the revised ROBINS-I tool. Evidence Synthesis: Seven hundred sixty studies were identified, 4 of which were eligible for qualitative and quantitative analysis, reporting on a total of 901 patients with follow-up up to 24 months. Hemoglobin drop (mean difference [MD] confidence interval [CI]: 0.34 g/dL [0.09-0.58]), the rate of blood transfusions (odds ratio [OR] [CI]: 5.01 [1.60-15.61]) catheterization time (MD [CI]: 3.26 days [1.30-5.23]), and length of hospital stay (LoS) (MD [CI]: 1.94 days [1.11-2.76]) were significantly lower in EEP. No significant differences were seen in operating time and enucleation weight. No significant differences were observed in the incidence of postoperative urinary retention, postoperative transient incontinence, and complications graded according to the Clavien-Dindo classification. Functional results were similar, with no significant differences in International Prostate Symptom Score and maximum urinary flow rate at follow-up. Conclusion: Both EEP and RASP offer excellent improvement of symptoms due to prostatic hyperplasia. EEP has lower blood loss, shorter catheterization time, and LoS and should be the first choice if available. RASP remains an attractive alternative for extremely large glands, in concomitant diseases, or whenever EEP is not available. Review Registration Number (PROSPERO): CRD42021226901.

ROBOCOP II (ROBOtic assisted versus conventional open partial nephrectomy) randomised, controlled feasibility trial: clinical trial protocol.

INTRODUCTION: Randomised controlled trials comparing robotic-assisted partial nephrectomy (RAPN) and open PN (OPN) are lacking. Therefore, we aim to report the study protocol and a trial update for a randomised controlled feasibility trial comparing RAPN versus OPN for renal neoplasms. METHODS AND ANALYSIS: The ROBOtic assisted versus conventional Open Partial nephrectomy II trial is designed as a single-centre, randomised, open-label, feasibility trial. Participation will be offered to patients with renal neoplasms and deemed feasible for both, OPN and RAPN. We aim to enrol 50 patients within 15 months using a 1:1 allocation ratio. The primary endpoint of the trial is feasibility of recruitment and will be successful if one third of eligible patients agree to participate. Secondary endpoints include perioperative results, health-related quality of life, inflammatory response as well as surgical ergonomics of the operating team. If the primary outcome, feasibility of recruitment, is successful, the secondary results of the trial will be used for planning a confirmative phase III trial. ETHICS AND DISSEMINATION: Ethical approval was obtained from the local institutional review board (Ethik-Kommission II at Heidelberg University: 2020-542N). Results will be made publicly available in peer-reviewed scientific journals and presented at appropriate congresses and social media. TRIAL REGISTRATION NUMBER: NCT04534998.

Robotic-Assisted Versus Conventional Open Partial Nephrectomy (Robocop): A Propensity Score-Matched Analysis of 249 Patients.

OBJECTIVES: The objective of this study was to compare open partial nephrectomy (OPN) and robotic-assisted PN (RAPN) based on a propensity score-matched sample and to test the Comprehensive Complication Index (CCI) as an end point for complications. METHODS: Patients undergoing PN from 2010 to 2018 at a university care center were included. OPN and RAPN cases were matched in a 2:1 ratio using propensity score-matching with age, gender, BMI, RENAL score, and tumor size as confounders. The primary end point was complications measured with the CCI as continuous score (0-100, 100 indicating death). RESULTS: Data of 570 patients were available. After matching, both cohorts (OPN = 166; RAPN = 83) showed no baseline differences. For the primary end point, CCI, RAPN was superior (RAPN 2.6 ± 7.9 vs. OPN 8.7 ± 13.9; p < 0.001). Additionally, RAPN was superior for length of stay (RAPN 6.5 ± 4.0 vs. OPN 7.4 ± 3.5 days; p < 0.001), hemoglobin drop (RAPN 2.8 ± 1.4 vs. OPN 3.8 ± 1.6 g/dL; p < 0.001), and drop of glomerular filtration rate (RAPN 11.4 ± 14.2 vs. OPN 19.5 ± 14.3 mL/min; p < 0.001). OPN had shorter operating times (RAPN 157 ± 43 vs. OPN 143 ± 45 min; p = 0.014) and less ischemia (RAPN 13% vs. OPN 28%; p = 0.016). CONCLUSIONS: RAPN provides superior short-term results regarding overall complications without compromising renal function for small and less complex tumors. However, OPN remains an important option for more complex and larger tumors.

Nephrometry Scores: Can Preoperative Assessment of Sectional Imaging Really Mirror Intraoperative Renal Tumor Anatomy?

INTRODUCTION: To compare RENAL, preoperative aspects and dimensions used for an anatomical (PADUA) classification, and Mayo Adhesive Probability (MAP) scores with the respective intraoperative findings and surgeon's assessment in predicting surgical outcome of patients undergoing partial nephrectomy. METHODS: Data of 150 eligible patients treated at the University Medical Center Mannheim between 2016 and 2018 were analyzed. Tumors were radiologically and intraoperatively assessed by PADUA, RENAL, and MAP scores and surgeon's assessment. Correlations and regression models were created to predict ischemia time (IT), major complications, and Trifecta (negative surgical margin, IT < 25 min, and absence of major complications). RESULTS: There were strong correlations between radiological and intraoperative RENAL (r = 0.68; p < 0.001) and PADUA scores (r = 0.72; p < 0.001). Radiological RENAL, PADUA, and MAP scores and surgeon's assessment were independent predictors of Trifecta (OR = 0.71, p = 0.015; OR = 0.77, p = 0.035; OR = 0.65, p = 0.012; OR = 0.40, p = 0.005, respectively). IT showed significant associations with radiological RENAL, PADUA, and surgeon's assessment (OR = 1.41, p = 0.033; OR = 1.34, p = 0.044; OR = 3.04, p = 0.003, respectively). MAP score proved as only independent predictor of major complications (OR = 2.12, p = 0.002). CONCLUSION: Radiologically and intraoperatively assessed scores correlated well with each other. Intraoperative nephrometry did not outperform radiological scores in predicting outcome confirming the value of the existing systems. MAP score correlates well with surgeon's assessment of perirenal fat and major complications underlining the importance of perirenal fat characteristics.

Prospective Feasibility Study of Single-Shot Antibiotic Prophylaxis in Transrectal Focal Ablation of Prostate Cancer.

INTRODUCTION: Urinary tract infections (UTI) represent the most frequent complications after transrectal focal ablation of prostate cancer. Single-shot antibiotic prophylaxis for prevention has not yet been described. METHODS: In this cohort study of patients who received a high-intensity focused ultrasound (HIFU) ablation of prostate cancer within a registered prospective single-arm trial, we analyzed posttreatment UTI (≤30 days after HIFU) related to perioperative antibiotic management in an exploratory analysis: single-shot prophylaxis or targeted treatment for bacteriuria. Potential risk factors associated with UTI were evaluated by uni- and multivariate regression analyses. RESULTS: In total, 55 patients were eligible for analysis. Of these, 76.4% received antibiotic single-shot prophylaxis. UTI occurred in 10.7% of all patients, 5.4% developed fever, 3.6% required hospitalization. An antibiotic single-shot prophylaxis helped to protect 90.5% of men from infectious complications. Estimated effects indicate that a longer posttreatment catheterization (OR 3.38, 95% CI 0.47-27.08) and larger ablation volume (OR 4.85, 95% CI 0.61-107.49) might be associated with the highest risk for UTI after treatment. CONCLUSION: Single-shot antibiotic prophylaxis compared to a targeted antibiotic treatment showed a similar effectivity to prevent patients from infectious complications and should be considered as an element of antibiotic stewardship. Further research on risk factors and antibiotic strategies is required.

Quality of Life and Decision Regret After Postoperative Radiation Therapy to the Prostatic Bed Region With or Without Elective Pelvic Nodal Radiation Therapy.

PURPOSE: To evaluate patient-reported health-related quality of life (HRQOL) and decision regret (DR surgery or DR radiation therapy) after radiation therapy to the prostatic bed (PBRT) with or without whole pelvic radiation therapy (WPRT). METHODS AND MATERIALS: Patients received 79.29 Gy (n = 78; R1/detectable tumors) or 71.43 Gy (n = 56; R0/undetectable tumors) equivalent dose in 2-Gy fractions (EQD-2). Out of 134 patients, 51 had received additional WPRT with 44 Gy. Decision regret was reported using a 5-item instrument (best/worst scores: 0-100); European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-PR25 questionnaires were used for HRQOL evaluation. RESULTS: At a median follow-up of 53 months, 134 valid questionnaires were returned. Most patients had locally advanced, node-positive (T3-4/N0 = 54.5%; N1 = 17.2%) or high-risk tumors (27.6%). Mean DR surgery was 17.61 and not associated with positive margins, salvage strategy, or radiation therapy regimen. Mean DR radiation therapy was 18.64 and better in patients who had PBRT compared with WPRT (P = .034; 24.39 vs. 15.24). Patient-reported bowel and urinary symptoms were worse after WPRT compared with PBRT (both P < .05); general HRQOL was numerically but not significantly better after PBRT without WPRT (P = .055). Subset analyses identified increased bowel and urinary symptom scores after WPRT irrespective of higher or lower dose cohorts (all P < .05). CONCLUSIONS: WPRT was associated with increased symptom burden and decision regret compared with PBRT. It is uncertain if the results can be extrapolated to lower-dose (<70 Gy) regimens. Further research is required to evaluate if specific decision support tools or treatment modifications according to the individual risk situation may be beneficial in this setting.

Postoperative elective pelvic nodal irradiation compared to prostate bed irradiation in locally advanced prostate cancer - a retrospective analysis of dose-escalated patients.

BACKGROUND: It is uncertain if whole-pelvic irradiation (WPRT) in addition to dose-escalated prostate bed irradiation (PBRT) improves biochemical progression-free survival (bPFS) after prostatectomy for locally advanced tumors. This study was initiated to analyze if WPRT is associated with bPFS in a patient cohort with dose-escalated (> 70 Gy) PBRT. METHODS: Patients with locally advanced, node-negative prostate carcinoma who had PBRT with or without WPRT after prostatectomy between 2009 and 2017 were retrospectively analyzed. A simultaneous integrated boost with equivalent-doses-in-2-Gy-fractions (EQD-2) of 79.29 Gy or 71.43 Gy to the prostate bed was applied in patients with margin-positive (or detectable) and margin-negative/undetectable tumors, respectively. WPRT (44 Gy) was offered to patients at an increased risk of lymph node metastases. RESULTS: Forty-three patients with PBRT/WPRT and 77 with PBRT-only were identified. Baseline imbalances included shorter surgery-radiotherapy intervals (S-RT-Intervals) and fewer resected lymph nodes in the WPRT group. WPRT was significantly associated with better bPFS in univariate (p = 0.032) and multivariate models (HR = 0.484, p = 0.015). Subgroup analysis indicated a benefit of WPRT (p = 0.029) in patients treated with rising PSA values who mostly had negative margins (74.1%); WPRT was not associated with a longer bPFS in the postoperative setting with almost exclusively positive margins (96.8%). CONCLUSION: We observed a longer bPFS after WPRT compared to PBRT in patients with locally advanced prostate carcinoma who underwent dose-escalated radiotherapy. In subset analyses, the association was only observed in patients with rising PSA values but not in patients with non-salvage postoperative radiotherapy for positive margins.

Association of training level and outcome of software-based image fusion-guided targeted prostate biopsies.

PURPOSE: The aim of this study was to assess the impact of experience on the outcome of image fusion-guided prostate biopsies performed by urologists working at a high-volume medical center. METHODS: The first 210 consecutive fusion biopsies were analyzed following installation of the software-based biopsy platform Artemis™ (Eigen, USA). The impact of training was measured in terms of changes in prostate cancer detection rates and biopsy duration over time. We sought to identify a threshold of experience for urologists, which predicts higher detection rates of targeted biopsies. The influence of various factors on prostate cancer detection rates was evaluated using bi- and multivariate analysis. RESULTS: Twenty-two urologists (n = 9 senior urologists, n = 13 urological residents) performed targeted biopsies followed by systematic 12-core biopsies. Overall, targeted biopsies yielded a positive result in 39.6% of 260 suspicious MRI lesions. A subgroup analysis of the six urologists who performed more than ten biopsies was then conducted, and their level of experience (i.e., performance of more than eight biopsies) was found to be associated with higher detection rates than those with less experience (49.0% and 23.0%, respectively; p < 0.001) in the targeted biopsies. Experience was likewise a significant and independent predictor of a cancer-positive targeted biopsy (p = 0.002). Experienced senior physicians did not outperform residents in their targeted biopsy results. Further, biopsy duration correlated negatively (r = - 0.5931, p < 0.001) with the total number of biopsies performed for all subgroups during the period of assessment. CONCLUSIONS: Experience is an important predictor of the rate of detection in targeted biopsies using software-based biopsy platforms with semi-robotic assistance. Moreover, the performance of just a few procedures appears sufficient to increase biopsy effectiveness significantly. Lastly, supervision by experts is recommended during the training phase.

Are there limits of robotic partial nephrectomy? TRIFECTA outcomes of open and robotic partial nephrectomy for completely endophytic renal tumors.

BACKGROUND: To compare the outcomes of robot-assisted (RAPN) and open partial nephrectomy (OPN) for completely endophytic renal tumors. METHODS: Consecutive patients undergoing OPN or RAPN for entirely endophytic tumors in four high-volume centers between 2008 and 2016 were identified. Endophytic masses were identified based on sectional imaging. Patient characteristics and surgical outcome were compared using Mann-Whitney-U-test and chi-squared-tests. Uni- and multivariate analyses were performed to identify predictors of TRIFECTA achievement and excisional volume loss. RESULTS: Out of 1128 patients, 10.9% (64) of RAPN and 13.9% (76) of OPN underwent surgery for entirely endophytic tumors. Operative time was longer for RAPN (169 vs 140 min, P = 0.03) while ischemia time was shorter (13 vs 18 min, P = 0.001). Complication rates were comparable (21% OPN vs 22% RAPN, P = 0.91) and TRIFECTA achievement was not different between the groups (68% OPN vs 75% RAPN, P = 0.39). In multivariate analyses type of surgery was not associated with TRIFECTA achievement or excisional volume loss. Here, only tumor complexity (OR 0.48, P = 0.001) and size (OR 1.01, P = 0.002) were independent predictors. CONCLUSION: For entirely endophytic tumors, both RAPN and OPN offer good TRIFECTA achievement. This encourages the use of NSS even for these highly complex tumors using the surgeon's preferred approach.

Nephrometry Scores: The Effect of Imaging on Routine Read-out and Prediction of Outcome of Nephron-sparing Surgery.

BACKGROUND/AIM: This study investigated the impact of available preoperative imaging on the reliability and predictive accuracy of RENAL and PADUA nephrometry-scoring systems for renal tumors. PATIENTS AND METHODS: Five urologists determined RENAL and PADUA scores using preoperative imaging data (computed tomography and magnetic resonance imaging) of 100 patients admitted for partial nephrectomy with the following combinations: T0: transverse planes without excretory phase (EP), TC0: transverse and coronal planes without EP, TC1: transverse and coronal planes with EP. Reference standard was obtained by a uro-radiologist. Ischemia time was used as surrogate for surgical complexity. RESULTS: Assignment of EP significantly reduced interobserver-variability among urologists (p<0.0001). Predictive accuracy for surgical complexity or correct assignment to nephrometry risk groups did not depend on image planes or EP. CONCLUSION: Interobserver variability, but not predictive accuracy of nephrometric systems, is affected by additional usage of EP.

Development Methodology of the Novel Endoscopic Stone Treatment Step 1 Training/Assessment Curriculum: An International Collaborative Work by European Association of Urology Sections.

Background: Simulation-based technical skill assessment is a core topic of debate, especially in high-risk environments. After the introduction of the E-BLUS (European Basic Laparoscopic Urological Skills) exam for basic laparoscopy, no more technical training/assessment urological protocols have been developed in Europe. Objective: We describe the methodology used in the development of the novel Endoscopic Stone Treatment step 1 (EST s1) assessment curriculum. Materials and Methods: The "full life cycle curriculum development" template was followed for curriculum development. A cognitive task analysis was run to define the most important steps and details of retrograde intrarenal surgery, in accordance with European Association of Urology (EAU) Urolithiasis guidelines. Training tasks were created between April 2015 and September 2015. Tasks and metrics were further analyzed by a consensus meeting with the European Section of Urolithiasis (EULIS) board in February 2016. A review, aimed to study available simulators and their accordance with task requirements, was subsequently run in London in March 2016. After initial feedback and further tests, content validity of this protocol was achieved during European Urology Residents Education Programme (EUREP) 2016. Results: The EST s1 curriculum development, took 23 months. Seventy-two participants tested the five preliminary tasks during EUREP 2015, with sessions of 45 minutes each. Likert-scale questionnaires were filled out to score the quality of training. The protocol was modified accordingly and 25 participants tested the four tasks during the hands-on training sessions of the European Section of Uro-Technology (ESUT) 2016 congress. One hundred thirty-four participants finally participated in the validation study in EUREP 2016. During the same event, 10 experts confirmed content validity by filling out a Likert-scale questionnaire. Conclusion: We described a reliable and replicable methodology that can be followed to develop training/assessment protocols for surgical procedures. The expert consensus meetings, strict adherence to guidelines, and updated literature search toward an Endourology curriculum allowed correct training and assessment protocol development. It is the first step toward standardized simulation training in Endourology with a potential for worldwide adoption.

Magnetic Ureteral Stent Removal Without Cystoscopy: A Randomized Controlled Trial.

INTRODUCTION: Ureteral stenting is a common procedure in urology. The cystoscopic removal of Double-J stents (DJ) causes unpleasant side effects with a negative impact on patient's quality of life. The aim of our study was to evaluate this newly developed magnetic DJ and compare it with a standard DJ regarding quality of life with indwelling DJs as well as discomfort during the removal. MATERIAL AND METHODS: The magnetic DJ (Blackstar, Urotech [Achenmühle, Germany]) is a standard 7F ureteral stent with a small magnetic cube fixed through a string on the loop of the distal part of the stent. For DJ removal, a special catheter-like retrieval instrument with a magnetic tip is inserted, the two magnets connect and the retrieval instrument is removed with the DJ. We first tested this DJ in 20 cases. Afterward we evaluated 40 consecutive cases that required a DJ placement after ureterorenoscopy in a prospective randomized manner. The quality of life was assessed by the ureteral stent symptom questionnaire. A visual analogue scale was used to document the pain by DJ removal. RESULTS: There was a significant difference regarding the pain location with the indwelling DJ (p = 0.038). The maximum pain was located in the lower abdomen and/or around the bladder (48%) with the magnetic DJ, whereas the standard DJ caused flank pain in 54% of the patients. The mean time for the magnetic DJ removal including preparation and cleaning as for a transurethral catheter insertion was 9.55 [7-14] minutes, whereas the mean time for the cystoscopic DJ removal was 21.35 [18-30] minutes. The pain caused by the removal of the magnetic DJ was significantly less than that caused by the cystoscopic DJ removal (p = 0.019). CONCLUSION: The discomfort caused by the indwelling magnetic DJ is comparable with that caused by the standard DJ. However, the magnetic DJ removal is less painful and faster.

Pregnancy After Urinary Diversion at Young Ages-Risks and Outcome.

OBJECTIVE: To assess the urologic and obstetric outcomes during and after pregnancy following urinary diversion (UD) performed during childhood or adolescence. MATERIALS AND METHODS: From our UD database, we identified 25 women who became pregnant between 1981 and 2013. Reasons for UD were neurogenic bladder, exstrophy, trauma, sinus urogenitalis, and interstitial cystitis. Seventeen had continent cutaneous diversion, 4 had continent anal diversion, and 4 had colonic conduit. RESULTS: The average age at delivery was 27.8 (18-39) years. Thirty-seven pregnancies occurred; 1 patient decided for an induced abortion. Thirty-two healthy children were born. Five patients had a spontaneous abortion before the 12th week. Main urologic complications were urinary tract infections in 11 of 32 successful pregnancies. Twelve patients presented with dilatation of the upper urinary tract; 3 of them required a temporary nephrostomy tube. Four of 25 patients required an indwelling catheter because of difficulties of clean intermittent catheterization. One small bowel injury occurred during cesarean section. One patient with exstrophy developed uterine prolapse; 1 nipple prolapse was surgically repaired in the same anesthesia after the cesarean section. Two patients had 3 vaginal deliveries, whereas 28 had a cesarean section. All children were healthy, without malformation, and with mean Apgar scores of 7.8, 8.9, and 9.7 for the 1st, 5th, and 10th minutes of life, respectively. No persistent urologic complications were observed. CONCLUSION: After UD, pregnancy is possible without major complications. Because of an increased risk of pyelonephritis and dilatation of the upper urinary tract requiring intervention, these pregnancies should be considered high-risk pregnancies. Delivery should be carried out in a center of expertise with urologic standby.