Ten-Year Oncologic Outcomes Following Robot-Assisted Radical Cystectomy: Results from the International Robotic Cystectomy Consortium.

PURPOSE: Radical cystectomy is the gold standard for nonmetastatic muscle invasive bladder cancer and for refractory nonmuscle invasive disease. Compared to open radical cystectomy, robot-assisted radical cystectomy has been shown to provide comparable early oncologic outcomes and improved perioperative outcomes. However, there is a paucity of data on long-term oncologic outcomes and concerns about a higher incidence of local recurrence after robot-assisted radical cystectomy. We report 10-year oncologic outcomes following robot-assisted radical cystectomy using a multinational database. MATERIALS AND METHODS: We retrospectively reviewed the prospective International Robotic Cystectomy Consortium database. Consecutive patients who underwent robot-assisted radical cystectomy 10 years ago or earlier were included in analysis. Data were reviewed for demographics, and perioperative, pathological and oncologic outcomes. Kaplan-Meier curves were used to depict recurrence-free, disease specific and overall survival. Multivariate stepwise Cox regression models were applied to identify variables associated with recurrence-free, disease specific and overall survival. RESULTS: We identified 446 patients with a median age of 67 years (IQR 59-76). Of the patients 10% received neoadjuvant chemotherapy, 51% experienced any complication, 23% had high grade complications and 4% died within 3 months of robot-assisted radical cystectomy. Disease was pT3 or greater in 43% of patients and pN+ in 24% while a positive soft tissue surgical margin was observed in 7%. At a median followup of 5 years (IQR 2-10, maximum 14) local and distant recurrence had developed in 15% and 29% of patients, respectively. Ten-year recurrence-free, disease specific and overall survival rates were 59%, 65% and 35%, respectively. Patients with pT3 or greater and pN+ disease showed worse recurrence-free, disease specific and overall survival. CONCLUSIONS: Long-term oncologic outcomes, and recurrence rates and patterns after robot-assisted radical cystectomy seem comparable to those in open series. Advanced disease stage and positive surgical margins remain the main determinants of survival after radical cystectomy.

Development and validation of a tool for non-technical skills evaluation in robotic surgery-the ICARS system.

BACKGROUND: Non-technical skills (NTS) are being increasingly recognised as vital for safe surgical practice. Numerous NTS rating systems have been developed to support effective training and assessment. Yet despite the additional challenges posed by robotic surgery, no NTS rating systems have been developed for this unique surgical environment. This study reports the development and validation of the first NTS behavioural rating system for robotic surgery. METHODS: A comprehensive index of all relevant NTS behaviours in robotic surgery was developed through observation of robotic theatre and interviews with robotic surgeons. Using a Delphi methodology, a panel of 16 expert surgeons was consulted to identify behaviours important to NTS assessment. These behaviours were organised into an appropriate assessment template. Experts were consulted on the feasibility, applicability and educational impact of ICARS. An observational trial was used to validate ICARS. 73 novice, intermediate and expert robotic surgeons completed a urethrovesical anastomosis within a simulated operating room. NTS were tested using four scripted scenarios of increasing difficulty. Performances were video recorded. Robotic and NTS experts assessed the videos post hoc using ICARS and the standard behavioural rating system, NOn-Technical Skills for Surgeons (NOTSS). RESULTS: 28 key non-technical behaviours were identified by the expert panel. The finalised behavioural rating system was organised into four principle domains and seven categories. Expert opinion strongly supported its implementation. ICARS was found to be equivalent to NOTSS on Bland-Altman analysis and accurately differentiated between novice, intermediate and expert participants, p = 0.01. Moderate agreement was found between raters, Krippendorff's alpha = 0.4. The internal structure of ICARS was shown to be consistent and reliable (median Cronbach alpha = 0.92, range 0.85-0.94). CONCLUSION: ICARS is the first NTS behavioural rating system developed for robotic surgery. Initial validation has shown it to be an effective and reliable tool. Implementation of ICARS will supported structured training and assessment of NTS within the robotic surgical curriculum.

Training in minimally invasive surgery in urology: European Association of Urology/International Consultation of Urological Diseases consultation.

OBJECTIVES: To describe the progress being made in training for minimally invasive surgery (MIS) in urology. METHODS: A group of experts in the field provided input to agree on recommendations for MIS training. A literature search was carried out to identify studies on MIS training, both in general and specifically for urological procedures. RESULTS: The literature search showed the rapidly developing options for e-learning, box and virtual training, and suggested that box training is a relatively cheap and effective means of improving laparoscopic skills. Development of non-technical skills is an integral part of surgical skills training and should be included in training curricula. The application of modular training in surgical procedures showed more rapid skills acquisition. Training curricula for MIS in urology are being developed in both the USA and Europe. CONCLUSION: Training in MIS has shifted from 'see-one-do-one-teach-one' to a structured learning, from e-learning to skills laboratory and modular training settings.

Current status and effectiveness of mentorship programmes in urology: a systematic review.

The objectives of this review were to identify and evaluate the efficacy of mentorship programmes for minimally invasive procedures in urology and give recommendations on how to improve mentorship. A systematic literature search of the PubMed/Medline databases was carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. In all, 21 articles were included in the review and divided into four categories: fellowships, mini-fellowships, mentored skills courses and novel mentorship programmes. Various structures of mentorship programme were identified and in general, mentorship programmes were found to be feasible, having content validity and educational impact. Perioperative data showed equally good outcomes when comparing trainees and specialists. Mentorship programmes are effective and represent one of the best current methods of training in urology. However, participation in such programmes is not widespread. The structure of mentorship programmes is highly variable, with no clearly defined 'best approach' for postgraduate training. This review offers recommendations as to how this 'best approach' can be established.

Measuring the surgical 'learning curve': methods, variables and competency.

OBJECTIVES: To describe how learning curves are measured and what procedural variables are used to establish a 'learning curve' (LC). To assess whether LCs are a valuable measure of competency. PATIENTS AND METHODS: A review of the surgical literature pertaining to LCs was conducted using the Medline and OVID databases. RESULTS: Variables should be fully defined and when possible, patient-specific variables should be used. Trainee's prior experience and level of supervision should be quantified; the case mix and complexity should ideally be constant. Logistic regression may be used to control for confounding variables. Ideally, a learning plateau should reach a predefined/expert-derived competency level, which should be fully defined. When the group splitting method is used, smaller cohorts should be used in order to narrow the range of the LC. Simulation technology and competence-based objective assessments may be used in training and assessment in LC studies. CONCLUSIONS: Measuring the surgical LC has potential benefits for patient safety and surgical education. However, standardisation in the methods and variables used to measure LCs is required. Confounding variables, such as participant's prior experience, case mix, difficulty of procedures and level of supervision, should be controlled. Competency and expert performance should be fully defined.

Learning curves for urological procedures: a systematic review.

OBJECTIVE: To determine the number of cases a urological surgeon must complete to achieve proficiency for various urological procedures. PATIENT AND METHODS: The MEDLINE, EMBASE and PsycINFO databases were systematically searched for studies published up to December 2011. Studies pertaining to learning curves of urological procedures were included. Two reviewers independently identified potentially relevant articles. Procedure name, statistical analysis, procedure setting, number of participants, outcomes and learning curves were analysed. RESULTS: Forty-four studies described the learning curve for different urological procedures. The learning curve for open radical prostatectomy ranged from 250 to 1000 cases and for laparoscopic radical prostatectomy from 200 to 750 cases. The learning curve for robot-assisted laparoscopic prostatectomy (RALP) has been reported to be 40 procedures as a minimum number. Robot-assisted radical cystectomy has a documented learning curve of 16-30 cases, depending on which outcome variable is measured. Irrespective of previous laparoscopic experience, there is a significant reduction in operating time (P = 0.008), estimated blood loss (P = 0.008) and complication rates (P = 0.042) after 100 RALPs. CONCLUSIONS: The available literature can act as a guide to the learning curves of trainee urologists. Although the learning curve may vary among individual surgeons, a consensus should exist for the minimum number of cases to achieve proficiency. The complexities associated with defining procedural competence are vast. The majority of learning curve trials have focused on the latest surgical techniques and there is a paucity of data pertaining to basic urological procedures.

Development and content validation of a surgical safety checklist for operating theatres that use robotic technology.

OBJECTIVES: To identify and assess potential hazards in robot-assisted urological surgery. To develop a comprehensive checklist to be used in operating theatres with robotic technology. METHODS: Healthcare Failure Mode and Effects Analysis (HFMEA), a risk assessment tool, was used in a urology operating theatre with innovative robotic technology in a UK teaching hospital between June and December 2011. A 15-member multidisciplinary team identified 'failure modes' through process mapping and flow diagrams. Potential hazards were rated according to severity and frequency and scored using a 'hazard score matrix'. All hazards scoring ≥8 were considered for 'decision tree' analysis, which produced a list of hazards to be included in a surgical safety checklist. RESULTS: Process mapping highlighted three main phases: the anaesthesia phase, the operating phase and the postoperative handover to recovery phase. A total of 51 failure modes were identified, 61% of which had a hazard score ≥8. A total of 22 hazards were finalised via decision tree analysis and were included in the checklist. The focus was on hazards specific to robotic urological procedures such as patient positioning (hazard score 12), port placement (hazard score 9) and robot docking/de-docking (hazard score 12). CONCLUSIONS: HFMEA identified hazards in an operating theatre with innovative robotic technologies which has led to the development of a surgical safety checklist. Further work will involve validation and implementation of the checklist.

Introducing the productive operating theatre programme in urology theatre suites.

BACKGROUND: The Productive Operating Theatre (TPOT) is a theatre improvement programme designed by the UK National Health Service. The aim of this study was to evaluate the implementation of TPOT in urology operating theatres and identify obstacles to running an ideal operating list. METHOD: TPOT was introduced in two urology operating theatres in September 2010. A multidisciplinary team identified and audited obstacles to the running of an ideal operating list. A brief/debrief system was introduced and patient satisfaction was recorded via a structured questionnaire. The primary outcome measure was the effect of TPOT on start and overrun times. RESULTS: Start times: 39-41% increase in operating lists starting on time from September 2010 to June 2011, involving 1,365 cases. Overrun times: Declined by 832 min between March 2010 and March 2011. The cost of monthly overrun decreased from September 2010 to June 2011 by GBP 510-3,030. Patient experience: A high degree of satisfaction regarding level of care (77%), staff hygiene (71%) and information provided (72%), while negative comments regarding staff shortages and environment/facilities were recorded. CONCLUSIONS: TPOT has helped identify key obstacles and shown improvements in efficiency measures such as start/overrun times.

Quality-of-care framework in urological cancers: where do we stand?

What's known on the subject? and What does the study add? Provision of high-quality care necessitates the identification and measurement of relevant quality indicators. Urological surgery currently does not have a validated quality-of-care framework to guide surgical quality improvement. This article aims to delineate quality of care processes, current status of quality indicators for major urological cancers as well as recommend a provisional framework for evaluation of quality for urological procedures. Growing demands for patient safety, lower cost and quality of care have resulted in several initiatives of quality measurement across urological surgery. Although candidate indicators have been proposed in various procedures, the field still lacks a valid quality framework. Better understanding of the interplay between patient selection, surgical expertise, preoperative-, intraoperative, postoperative processes and outcomes is needed. Consensus needs to be achieved in which validated structural, process and outcomes measures to employ, how this data should be collected, which agencies to share this data with and how to use this data to effect change in health policy. Compliance with quality framework needs to be continuously audited with its outcomes frequently benchmarked against international standards. Pursuit of quality improvement schemes require significant investment and need to be weighed against current budgetary constraints.

Urology training: past, present and future.

What's known on the subject? and What does the study add? Dedicated training hours for surgeons are falling as the complexity of techniques and patient expectations are increasing. Urologists therefore need to train in more sophisticated and effective ways. This article looks at past and current urological training and suggests emerging and innovative ways to teach the next generation of urologists. Since 2004 the estimated available training time, for all doctors, has dropped from 30, 000 h to ≈ 8, 000h. By decreasing the initial stages of the learning curve, medical simulation has the potential to compensate for the reduced time available to train urologists. The current urological training pathway consists of 2 years of foundation year training, 2 years of core surgical training, followed by 5 years of specialty training. Training time pressures and the expansion of treatment techniques have led to a trend towards increased sub-specialization in urology. To optimize patient care, training programmes must evolve, taking into account several key issues and in accordance with advances in urological care.

Current status of robot-assisted partial nephrectomy.

What's known on the subject? and What does the study add? The use of robotic assistance for the partial nephrectomy procedure has emerged as an alternative that may help some of the technical challenges of laparoscopic partial nephrectomy. The main concerns in laparoscopic partial nephrectomy relates to a steeper 'learning curve', prolonged warm ischaemia times and the potential for postoperative haemorrhage. The article delineates the dynamics of patient preparation, the surgical team, surgical technique & post-operative care to conclude that robotic-assisted partial nephrectomy is a viable alternative to both open and laparoscopic techniques. Partial nephrectomy has shown both improved overall patient survival and more effective preservation of renal function, when compared with radical nephrectomy. Robot-assisted partial nephrectomy has several potential advantages over the laparoscopic approach. Robotic assistance allows urologists to perform this complex reconstructive procedure more quickly, with improved precision and dexterity, tremor elimination and improved visualization. The present article aims to delineate the dynamics of patient preparation and surgical team, surgical technique and postoperative care. The oncological outcomes and disease-free survival of partial nephrectomy have been found to be equivalent to open partial nephrectomy [1-4].

Standard versus tubeless percutaneous nephrolithotomy: a systematic review.

OBJECTIVE: This article systematically analyses comparative studies to evaluate the efficacy and safety of tubeless percutaneous nephrolithotomy (PCNL) versus standard PCNL. METHODS: The Medline, EMBASE, PsycINFO, Cochrane and DARE databases were searched from 1997 to February 2011. Comparative studies evaluating outcomes from standard versus tubeless PCNL were included. Primary outcome measures were post-operative pain scoring, analgesic requirements, duration of hospitalisation/convalescence, operation time, major/minor complications and stone-free rates. RESULTS: Twenty-four studies were included (11 randomised control trials and 13 retrospective or prospective studies). Levels of pain recorded, analgesic requirements, duration of inpatient stay and convalescence time were all significantly reduced in the tubeless PCNL group. Cost was reduced in two studies. Morbidity was not significantly different between the groups. There was no significant difference between groups regarding stone-free status. DISCUSSION: This systematic review has demonstrated that tubeless PCNL is a viable alternative to tubed PCNL in uncomplicated cases. Benefits are as described above. There is no evidence suggesting that patient safety is compromised by the absence of post-operative nephrostomy. The tubeless method has been reported in challenging cases such as stag-horn stones, horseshoe or ectopic kidneys. Promising outcomes have been demonstrated in elderly patients and when clinical needs demand a supracostal approach. Multi-centre randomised controlled trials are needed to fully establish the effectiveness of the tubeless method.

Face and content validation of the prostatic hyperplasia model and holmium laser surgery simulator.

OBJECTIVE: Although a number of simulators have been introduced for prostate surgery, none have undergone validation for holmium laser enucleation of the prostate training. This study was carried out to assess the face and content validities as well as feasibility and acceptability of the new prostatic hyperplasia model and prostate surgery simulator for holmium laser enucleation of the prostate. DESIGN: This is a prospective, observational, and comparative study. Participants were given a 30-minute video tutorial followed by a 45-minute simulation session, with one-to-one mentoring. A survey with qualitative and quantitative fields was used to evaluate their experience. SETTING: This study was carried out in a 2-day modular teaching course hosted by the Holmium User Group at Cambridge University Hospitals, UK, and during the British Association of Urological Surgeons 2013 Annual Meeting. PARTICIPANTS: A total of 36 participants comprising 13 urology trainees and 23 senior urologists of varying levels from all around the globe were recruited. RESULTS: Overall, 87% of the participants believed that holmium laser enucleation of the prostate was an effective method of treatment, simulation-based training, and assessment essential for patient safety and 84% believed a validated simulator would be useful for training. Of the participants, 97% agreed that the simulation should be implemented into training programs and only 31% felt it should be part of accreditation. Participants ranked all components of the simulator greater than 7 of 10 on a global rating scale and believed it was a feasible and acceptable method of training and assessment. CONCLUSIONS: The new simulator for holmium laser enucleation of the prostate has been demonstrated to be useful as a training tool. This study has established face and content validities of the simulator. Senior and trainee urologists believed the simulator was an acceptable tool for training and assessment and its use feasible for novice trainees to acquire skills and knowledge to a predetermined level of proficiency.

Ureteric injury: a challenging condition to diagnose and manage.

Although ureteric injury is relatively uncommon, it is a serious event that can result in intra-abdominal sepsis, renal failure, and loss of the ipsilateral renal unit. Most injuries are iatrogenic and remain undiagnosed until the patient presents with symptoms postoperatively. In addition to compromising patient safety, missed ureteric injuries frequently result in litigation. Over the past 20 years, there has been a rapid uptake of laparoscopic and robotic techniques within urology and other surgical specialties. This trend, coupled with increased use of ureteroscopy, has increased the risk of injury to the ureter. The key to diagnosing and managing a ureteric injury is to have a low threshold for suspecting its presence. Diagnosis can be achieved using retrograde pyelography, ureteroscopy, CT, or intravenous urography. Initial management should involve ureteric stent placement or percutaneous nephrostomy drainage. In selected patients, surgical reconstruction might be the optimal approach. Decisions regarding surgical technique (open, laparoscopic, or robotic) are guided by the clinical situation and surgical expertise available.

Decision making in urological surgery.

CONTEXT: Non-technical skills are important behavioural aspects that a urologist must be fully competent at to minimise harm to patients. The majority of surgical errors are now known to be due to errors in judgment and decision making as opposed to the technical aspects of the craft. EVIDENCE ACQUISITION: The authors reviewed the published literature regarding decision-making theory and in practice related to urology as well as the current tools available to assess decision-making skills. Limitations include limited number of studies, and the available studies are of low quality. EVIDENCE SYNTHESIS: Decision making is the psychological process of choosing between alternative courses of action. In the surgical environment, this can often be a complex balance of benefit and risk within a variable time frame and dynamic setting. In recent years, the emphasis of new surgical curriculums has shifted towards non-technical surgical skills; however, the assessment tools in place are far from objective, reliable and valid. Surgical simulators and video-assisted questionnaires are useful methods for appraisal of trainees. CONCLUSION: Well-designed, robust and validated tools need to be implemented in training and assessment of decision-making skills in urology. Patient safety can only be ensured when safe and effective decisions are made.