Background: The utilisation of robot-assisted radical cystectomy with intracorporeal reconstruction (iRARC) has increased in recent years. Little is known about the length of the learning curve (LC... Show moreBackground: The utilisation of robot-assisted radical cystectomy with intracorporeal reconstruction (iRARC) has increased in recent years. Little is known about the length of the learning curve (LC) for this procedure. Objective: To study the length of the LC for iRARC in terms of 90-d major complications (MC90; Clavien-Dindo grade >= 3), 90-d overall complications (OC90, Clavien-Dindo grades 1-5), operating time (OT), estimated blood loss (EBL), and length of hospital stay (LOS). Design, setting, and participants: This was a retrospective analysis of all consecutive iRARC cases from nine European high-volume hospitals with >= 100 cases. All patients had bladder cancer for which iRARC was performed, with an ileal conduit or neobladder as the urinary diversion. Outcome measurements and statistical analysis: Outcome parameters used as a proxy for LC length were the number of consecutive cases needed to reach a plateau level in two-piece mixed-effects models for MC90, OC90, OT, EBL, and LOS. Results and limitations: A total of 2186 patients undergoing iRARC between 2003 and 2018were included. The plateau levels for MC90 and OC90 were reached after 137 cases (95% confidence interval [CI] 80-193) and 97 cases (95% CI 41-154), respectively. The mean MC90 rate at the plateau was 14% (95% CI 7-21%). The plateau level was reached after 75 cases (95% CI 65-86) for OT, 88 cases (95% CI 70-106) for EBL, and 198 cases (95% CI 130-266) for LOS. A major limitation of the study is the difference in the balance of urinary diversion types between centres. Conclusions: This multicentre retrospective analysis for the iRARC LC among nine European centres showed that 137 consecutive cases were needed to reach a stable MC90 rate. Patient summary: We carried out a multicentre analysis of the surgical learning curve for robot-assisted removal of the bladder and bladder reconstruction in patients with bladder cancer. We found that 137 consecutive cases were needed to reach a stable rate of serious complications. Show less
Dell'Oglio, P.; Turri, F.; Larcher, A.; D'Hondt, F.; Sanchez-Salas, R.; Bochner, B.; ... ; YAU Working Grp Robot-Assisted Sur 2022
Robot-assisted radical cystectomy (RARC) continues to expand, and several surgeons start training for this complex procedure. This calls for the development of a structured training program, with... Show moreRobot-assisted radical cystectomy (RARC) continues to expand, and several surgeons start training for this complex procedure. This calls for the development of a structured training program, with the aim to improve patient safety during RARC learning curve. A modified Delphi consensus process was started to develop the curriculum structure. An online survey based on the available evidence was delivered to a panel of 28 experts in the field of RARC, selected according to surgical and research experience, and expertise in running training courses. Consensus was defined as >80% agreement between the responders. Overall, 96.4% experts completed the survey. The structure of the RARC curriculum was defined as follows: (1) theoretical training; (2) preclinical simulation-based training: 5-d simulation-based activity, using models with increasing complexity (ie, virtual reality, and dry-and wet-laboratory exercises), and nontechnical skills training session; (3) clinical training: modular console activity of at least 6 mo at the host center (a RARC case was divided into 11 steps and steps of similar complexity were grouped into five modules); and (4) final evaluation: blind review of a video-recorded RARC case. This structured training pathway will guide a starting surgeon from the first steps of RARC toward independent completion of a full procedure. Clinical implemen-tation is urgently needed. Patient summary: Robot-assisted radical cystectomy (RARC) is a complex procedure. The first structured training program for RARC was developed with the goal of aiding surgeons to overcome the learning curve of this procedure, improving patients' safety at the same time. (c) 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved. Show less
Objectives To evaluate the postoperative complication and mortality rate following laparoscopic radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) in octogenarians.Patients and... Show moreObjectives To evaluate the postoperative complication and mortality rate following laparoscopic radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) in octogenarians.Patients and Methods We conducted a retrospective analysis comparing postoperative complication and mortality rates depending on age in a consecutive series of 1890 patients who underwent RARC with ICUD for bladder cancer between 2004 and 2018 in 10 European centres. Outcomes of patients aged <80 years and those aged >= 80 years were compared with regard to postoperative complications (Clavien-Dindo grading) and mortality rate. Cancer-specific mortality (CSM) and other-cause mortality (OCM) after surgery were calculated using the non-parametric Aalen-Johansen estimator.Results A total of 1726 patients aged <80 years and 164 aged >= 80 years were included in the analysis. The 30- and 90-day rate for high-grade (Clavien-Dindo grades III-V) complications were 15% and 21% for patients aged <80 years compared to 11% and 13% for patients aged >= 80 years (P = 0.2 and P = 0.03), respectively. In a multivariable logistic regression analysis adjusting for pre- and postoperative variables, age >= 80 years was not an independent predictor of high-grade complications (odds ratio 0.6, 95% confidence interval 0.3-1.1; P = 0.12). The non-cancer-related 90-day mortality was 2.3% for patients aged >= 80 years and 1.8% for those aged <80 years, respectively (P = 0.7). The estimated 12-month CSM and OCM rates for those aged <80 years were 8% and 3%, and for those aged >= 80 years, 15% and 8%, respectively (P = 0.009 and P < 0.001).Conclusions The minimally invasive approach to RARC with ICUD for bladder cancer in well-selected elderly patients (aged >= 80 years) achieved a tolerable high-grade complication rate; the 90-day postoperative mortality rate was driven by cancer progression and the non-cancer-related rate was equivalent to that of patients aged <80 years. However, an increased OCM rate in this elderly group after the first year should be taken into account. These results will support clinicians and patients when balancing cancer-related vs treatment-related risks and benefits. Show less
Mottrie, A.; Mazzone, E.; Wiklund, P.; Graefen, M.; Collins, J.W.; Groote, R. de; ... ; Gallagher, A.G. 2020
Objective To develop and seek consensus from procedure experts on the metrics that best characterise a reference robot-assisted radical prostatectomy (RARP) and determine if the metrics... Show moreObjective To develop and seek consensus from procedure experts on the metrics that best characterise a reference robot-assisted radical prostatectomy (RARP) and determine if the metrics distinguished between the objectively assessed RARP performance of experienced and novice urologists, as identifying objective performance metrics for surgical training in robotic surgery is imperative for patient safety.Materials and methods In Study 1, the metrics, i.e. 12 phases of the procedure, 81 steps, 245 errors and 110 critical errors for a reference RARP were developed and then presented to an international Delphi panel of 19 experienced urologists. In Study 2, 12 very experienced surgeons (VES) who had performed >500 RARPs and 12 novice urology surgeons performed a RARP, which was video recorded and assessed by two experienced urologists blinded as to subject and group. Percentage agreement between experienced urologists for the Delphi meeting and Mann-Whitney U- and Kruskal-Wallis tests were used for construct validation of the newly identified RARP metrics.Results At the Delphi panel, consensus was reached on the appropriateness of the metrics for a reference RARP. In Study 2, the results showed that the VES performed similar to 4% more procedure steps and made 72% fewer procedure errors than the novices (P = 0.027). Phases VIIa and VIIb (i.e. neurovascular bundle dissection) best discriminated between the VES and novices. Limitations: VES whose performance was in the bottom half of their group demonstrated considerable error variability and made five-times as many errors as the other half of the group (P = 0.006).Conclusions The international Delphi panel reached high-level consensus on the RARP metrics that reliably distinguished between the objectively scored procedure performance of VES and novices. Reliable and valid performance metrics of RARP are imperative for effective and quality assured surgical training. Show less
Witjes, J.A.; Babjuk, M.; Bellmunt, J.; Bruins, H.M.; Reijke, T.M. de; Santis, M. de; ... ; Horwich, A. 2020
Background: Although guidelines exist for advanced and variant bladder cancer management, evidence is limited/conflicting in some areas and the optimal approach remains controversial.Objective: To... Show moreBackground: Although guidelines exist for advanced and variant bladder cancer management, evidence is limited/conflicting in some areas and the optimal approach remains controversial.Objective: To bring together a large multidisciplinary group of experts to develop consensus statements on controversial topics in bladder cancer management.Design: A steering committee compiled proposed statements regarding advanced and variant bladder cancer management which were assessed by 113 experts in a Delphi survey. Statements not reaching consensus were reviewed; those prioritised were revised by a panel of 45 experts prior to voting during a consensus conference.Setting: Online Delphi survey and consensus conference.Participants: The European Association of Urology (EAU), the European Society for Medical Oncology (ESMO), experts in bladder cancer management.Outcome measurements and statistical analysis: Statements were ranked by experts according to their level of agreement: 1-3 (disagree), 4-6 (equivocal), and 7-9 (agree). A priori (level 1) consensus was defined as >= 70% agreement and <= 15% disagreement, or vice versa. In the Delphi survey, a second analysis was restricted to stakeholder group(s) considered to have adequate expertise relating to each statement (to achieve level 2 consensus).Results and limitations: Overall, 116 statements were included in the Delphi survey. Of these statements, 33 (28%) achieved level 1 consensus and 49 (42%) achieved level 1 or 2 consensus. At the consensus conference, 22 of 27 (81%) statements achieved consensus. These consensus statements provide further guidance across a broad range of topics, including the management of variant histologies, the role/limitations of prognostic biomarkers in clinical decision making, bladder preservation strategies, modern radiotherapy techniques, the management of oligometastatic disease, and the evolving role of checkpoint inhibitor therapy in metastatic disease.Conclusions: These consensus statements provide further guidance on controversial topics in advanced and variant bladder canceir management until a time when further evidence is available to guide our approach.Patient summary: This report summarises findings from an international, multistake-holder project organised by the EAU and ESMO. In this project, a steering committee identified areas of bladder cancer management where there is currently no good-quality evidence to guide treatment decisions. From this, they developed a series of proposed statements, 71 of which achieved consensus by a large group of experts in the field of bladder cancer. It is anticipated that these statements will provide further guidance to health care professionals and could help improve patient outcomes until a time when good-quality evidence is available. (C) 2019 European Society of Medical Oncology and European Association of Urology. Published by Elsevier B.V. All rights reserved. Show less
Horwich, A.; Babjuk, M.; Bellmunt, J.; Bruins, H.M.; Reijke, T.M. de; Santis, M. de; ... ; Witjes, J.A. 2019
Background: Although guidelines exist for advanced and variant bladder cancer management, evidence is limited/conflicting in some areas and the optimal approach remains controversial.Objective: To... Show moreBackground: Although guidelines exist for advanced and variant bladder cancer management, evidence is limited/conflicting in some areas and the optimal approach remains controversial.Objective: To bring together a large multidisciplinary group of experts to develop consensus statements on controversial topics in bladder cancer management.Design: A steering committee compiled proposed statements regarding advanced and variant bladder cancer management which were assessed by 113 experts in a Delphi survey. Statements not reaching consensus were reviewed; those prioritised were revised by a panel of 45 experts before voting during a consensus conference.Setting: Online Delphi survey and consensus conference.Participants: The European Association of Urology (EAU), the European Society for Medical Oncology (ESMO), experts in bladder cancer management.Outcome measurements and statistical analysis: Statements were ranked by experts according to their level of agreement: 1-3 (disagree), 4-6 (equivocal), 7-9 (agree). A priori (level 1) consensus was defined as >= 70% agreement and <= 15% disagreement, or vice versa. In the Delphi survey, a second analysis was restricted to stakeholder group(s) considered to have adequate expertise relating to each statement (to achieve level 2 consensus).Results and limitations: Overall, 116 statements were included in the Delphi survey. Of these, 33 (28%) statements achieved level 1 consensus and 49 (42%) statements achieved level 1 or 2 consensus. At the consensus conference, 22 of 27 (81%) statements achieved consensus. These consensus statements provide further guidance across a broad range of topics, including the management of variant histologies, the role/limitations of prognostic biomarkers in clinical decision making, bladder preservation strategies, modern radiotherapy techniques, the management of oligometastatic disease and the evolving role of checkpoint inhibitor therapy in metastatic disease.Conclusions: These consensus statements provide further guidance on controversial topics in advanced and variant bladder cancer management until a time where further evidence is available to guide our approach. Show less
Parmar, P.; Lowry, E.; Cugliari, G.; Suderman, M.; Wilson, R.; Karhunen, V.; ... ; GLOBAL Meth QTL 2018
