Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial.

OBJECTIVE: To demonstrate the noninferiority of the fundamentals of robotic surgery (FRS) skills curriculum over current training paradigms and identify an ideal training platform. SUMMARY BACKGROUND DATA: There is currently no validated, uniformly accepted curriculum for training in robotic surgery skills. METHODS: Single-blinded parallel-group randomized trial at 12 international American College of Surgeons (ACS) Accredited Education Institutes (AEI). Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016. Benchmarks (proficiency levels) on the 7 FRS Dome tasks were established based on expert performance. Participants were then randomly assigned to 4 training groups: Dome (n = 29), dV-Trainer (n = 30), and DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula. The primary outcome was participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test). Secondary outcomes included cognitive test scores, GEARS ratings, and robot familiarity checklist scores. RESULTS: All groups demonstrated significant performance improvement after skills training (P < 0.01). Participating residents and fellows performed tasks faster (DOME and DVSS groups) and with fewer errors than controls (DOME group; P < 0.01). Inter-rater reliability was high for the checklist scores (0.82-0.97) but moderate for GEARS ratings (0.40-0.67). CONCLUSIONS: We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test. We therefore argue for its implementation across training programs before surgeons apply these skills clinically.

Traumatic renal injury in a UK major trauma centre - current management strategies and the role of early re-imaging.

OBJECTIVES: To analyse the contemporary management of renal injuries in a UK major trauma centre and to evaluate the utility and value of re-imaging. PATIENTS AND METHODS: The prospectively maintained 'Trauma Audit and Research Network' database was interrogated to identify patients with urinary tract injuries between January 2014 and December 2017. Patients' records and imaging were reviewed to identify injury grades, interventions, outcomes, and follow-up. RESULTS: Renal injury was identified in 90 patients (79 males and 11 females). The mean (sd; range) age was 35.5 (17.4; 1.5-94) years. Most of the renal traumas were caused by blunt mechanisms (74%). The overall severity of injuries was: 18 (20%) Grade I, 19 (21%) Grade II, 27 (30%) Grade III, 22 (24%) Grade IV, and four (4%) Grade V. Most patients (84%) were managed conservatively. Early intervention (<24 h) was performed in 14 patients (16%) for renal injuries. Most of these patients were managed by interventional radiology techniques (nine of 14). Only two patients required an emergency nephrectomy, both of whom died from extensive polytrauma. In all, 19 patients underwent laparotomy for other injuries and did not require renal exploration. The overall 30-day mortality was 13%. Re-imaging was performed in 66% of patients at an average time of 3.4 days from initial scan. The majority of re-imaging was planned (49 patients) and 12% of these scans demonstrated a relevant finding (urinoma, pseudoaneurysm) that altered management in three of the 49 patients (6.1%). CONCLUSION: Non-operative management is the mainstay for all grades of injury. Haemodynamic instability and persistent urine leak are primary indications for intervention. Open surgical management is uncommon. Repeat imaging after injury is advocated for stable patients with high-grade renal injuries (Grade III-V), although more research is needed to determine the optimal timing.

Evaluating the impact of image guidance in the surgical setting: a systematic review.

BACKGROUND: Image guidance has been clinically available for over a period of 20 years. Although research increasingly has a translational emphasis, overall the clinical uptake of image guidance systems in surgery remains low. The objective of this review was to establish the metrics used to report on the impact of surgical image guidance systems used in a clinical setting. METHODS: A systematic review of the literature was carried out on all relevant publications between January 2000 and April 2016. Ovid MEDLINE and Embase databases were searched using a title strategy. Reported outcome metrics were grouped into clinically relevant domains and subsequent sub-categories for analysis. RESULTS: In total, 232 publications were eligible for inclusion. Analysis showed that clinical outcomes and system interaction were consistently reported. However, metrics focusing on surgeon, patient and economic impact were reported less often. No increase in the quality of reporting was observed during the study time period, associated with study design, or when the clinical setting involved a surgical specialty that had been using image guidance for longer. CONCLUSIONS: Publications reporting on the clinical use of image guidance systems are evaluating traditional surgical outcomes and neglecting important human and economic factors, which are pertinent to the uptake, diffusion and sustainability of image-guided surgery. A framework is proposed to assist researchers in providing comprehensive evaluation metrics, which should also be considered in the design phase. Use of these would help demonstrate the impact in the clinical setting leading to increased clinical integration of image guidance systems.

Patient-Specific Simulation of Pneumoperitoneum for Laparoscopic Surgical Planning.

Gas insufflation in laparoscopy deforms the abdomen and stretches the overlying skin. This limits the use of surgical image-guidance technologies and challenges the appropriate placement of trocars, which influences the operative ease and potential quality of laparoscopic surgery. This work describes the development of a platform that simulates pneumoperitoneum in a patient-specific manner, using preoperative CT scans as input data. This aims to provide a more realistic representation of the intraoperative scenario and guide trocar positioning to optimize the ergonomics of laparoscopic instrumentation. The simulation was developed by generating 3D reconstructions of insufflated and deflated porcine CT scans and simulating an artificial pneumoperitoneum on the deflated model. Simulation parameters were optimized by minimizing the discrepancy between the simulated pneumoperitoneum and the ground truth model extracted from insufflated porcine scans. Insufflation modeling in humans was investigated by correlating the simulation's output to real post-insufflation measurements obtained from patients in theatre. The simulation returned an average error of 7.26 mm and 10.5 mm in the most and least accurate datasets respectively. In context of the initial discrepancy without simulation (23.8 mm and 19.6 mm), the methods proposed here provide a significantly improved picture of the intraoperative scenario. The framework was also demonstrated capable of simulating pneumoperitoneum in humans. This study proposes a method for realistically simulating pneumoperitoneum to achieve optimal ergonomics during laparoscopy. Although further studies to validate the simulation in humans are needed, there is the opportunity to provide a more realistic, interactive simulation platform for future image-guided minimally invasive surgery.

Assessing the impact of mass media public health campaigns. Be Clear on Cancer 'blood in pee': a case in point.

OBJECTIVES: To assess the impact on suspected cancer referral burden and new cancer diagnosis of Public Health England's recent Be Clear on Cancer 'blood in pee' mass media campaign. METHODS: A retrospective cohort study design was used. For two distinct time periods, August 2012 to May 2013 and August 2013 to May 2014, all referrals of patients deemed to be at risk of urological cancer by the referring primary healthcare physician to Imperial College NHS Healthcare Trust were screened. Data were collected on age and sex and whether the referral was for visible haematuria, non-visible haematuria or other suspected urological cancer. In addition to referral data, hospital episode data for all new renal cell (RCC) and upper and lower tract transitional cell carcinoma (TCC), as well as testicular and prostate cancer diagnoses for the same time periods were obtained. RESULTS: Over the campaign period and the subsequent 3 months, the number of haematuria referrals increased by 92% (P = 0.013) when compared with the same period a year earlier. This increase in referrals was not associated with a significant corresponding rise in cancer diagnosis; instead changes of 26.8% (P = 0.56) and -3.3% (P = 0.84) were seen in RCC and TCC, respectively. CONCLUSIONS: This study has shown that the Be Clear on Cancer 'blood in pee' mass media campaign significantly increased the number of new suspected cancer referrals, but there was no significant change in the diagnosis of target cancers across a large catchment. Mass media campaigns are expensive, require significant planning and appropriate implementation and, while the findings of this study do not challenge their fundamental objective, more work needs to be done to understand why no significant change in target cancers was observed. Further consideration should also be given to the increased referral burden that results from these campaigns, such that pre-emptive strategies, including educational and process mapping, across primary and secondary care can be implemented.

Inattention blindness in surgery.

BACKGROUND: Inattention blindness (IB) can be defined as the failure to perceive an unexpected object when attention is focussed on another object or task. The principal aim of this study was to determine the effect of cognitive load and surgical image guidance on operative IB. METHODS: Using a randomised control study design, participants were allocated to a high or low cognitive load group and subsequently to one of three augmented reality (AR) image guidance groups (no guidance, wireframe overlay and solid overlay). Randomised participants watched a segment of video from a robotic partial nephrectomy. Those in the high cognitive load groups were asked to keep a count of instrument movements, while those in the low cognitive load groups were only asked to watch the video. Two foreign bodies were visible within the operative scene: a swab, within the periphery of vision; and a suture, in the centre of the operative scene. Once the participants had finished watching the video, they were asked to report whether they had observed a swab or suture. RESULTS: The overall level of prompted inattention blindness was 74 and 10 % for the swab and suture, respectively. Significantly higher levels of IB for the swab were seen in the high versus the low cognitive load groups, but not for the suture (8 vs. 47 %, p < 0.001 and 90 vs. 91 %, p = 1.000, for swab and suture, respectively). No significant difference was seen between image guidance groups for attention of the swab or suture (29 vs. 20 %, p = 0.520 and 22 vs. 22 %, p = 1.000, respectively). CONCLUSIONS: The overall effect of IB on operative practice appeared to be significant, within the context of this study. When examining for the effects of AR image guidance and cognitive load on IB, only the latter was found to have significance.

Quantifying innovation in surgery.

OBJECTIVES: The objectives of this study were to assess the applicability of patents and publications as metrics of surgical technology and innovation; evaluate the historical relationship between patents and publications; develop a methodology that can be used to determine the rate of innovation growth in any given health care technology. BACKGROUND: The study of health care innovation represents an emerging academic field, yet it is limited by a lack of valid scientific methods for quantitative analysis. This article explores and cross-validates 2 innovation metrics using surgical technology as an exemplar. METHODS: Electronic patenting databases and the MEDLINE database were searched between 1980 and 2010 for "surgeon" OR "surgical" OR "surgery." Resulting patent codes were grouped into technology clusters. Growth curves were plotted for these technology clusters to establish the rate and characteristics of growth. RESULTS: The initial search retrieved 52,046 patents and 1,801,075 publications. The top performing technology cluster of the last 30 years was minimally invasive surgery. Robotic surgery, surgical staplers, and image guidance were the most emergent technology clusters. When examining the growth curves for these clusters they were found to follow an S-shaped pattern of growth, with the emergent technologies lying on the exponential phases of their respective growth curves. In addition, publication and patent counts were closely correlated in areas of technology expansion. CONCLUSIONS: This article demonstrates the utility of publically available patent and publication data to quantify innovations within surgical technology and proposes a novel methodology for assessing and forecasting areas of technological innovation.

Difference between actual vs. pathology prostate weight in TURP and radical robotic-assisted prostatectomy specimen.

INTRODUCTION: To investigate and highlight the effect of formaldehyde induced weight reduction in transurethral resection of prostate (TURP) and radical robotically-assisted prostatectomy (RALP) specimen as a result of standard chemical fixation. MATERIALS AND METHODS: 51 patients were recruited from January 2013 to June 2013 who either underwent a TURP (n=26) or RALP (n=25). Data was collected prospectively by the operating surgeon who measured the native, unfixed histology specimen directly after operation. The specimens were fixed in 10% Formaldehyde Solution BP and sent to the pathology laboratory where after sufficient fixation period was re-weighed. RESULTS: Overall mean age 64.78 years, TURP mean age 68.31 years RALP mean age 61.12 years. We found that the overall prostatic specimen (n=51) weight loss after fixation was a mean of 11.20% (3.78 grams) (p ≤ 0.0001). Subgroup analysis of the native TURP chips mean weight was 16.15 grams and formalin treated mean weight was 14.00 grams (p ≤ 0.0001). Therefore, TURP chips had a mean of 13.32 % (2.15 grams) weight loss during chemical fixation. RALP subgroup unfixed specimen mean weight was 52.08 grams and formalin treated mean weight was 42.60 grams (p ≤ 0.0001), a 19.32 % (9.48 grams) mean weight reduction. CONCLUSION: It has not been known that prostatic chips and whole human radical prostatectomy specimen undergo a significant weight reduction. The practical significance of the accurate prostate weight in patient management may be limited, however, it is agreed that this should be recorded correctly, as data is potential interest for research purposes and vital for precise documentation.

Effectiveness of procedural simulation in urology: a systematic review.

PURPOSE: We analyzed studies validating the effectiveness and deficiencies of simulation for training and assessment in urology. We documented simulation types (synthetic, virtual reality and animal models), participant experience level and tasks performed. The feasibility, validity, cost-effectiveness, reliability and educational impact of the simulators were also evaluated. MATERIALS AND METHODS: The MEDLINE®, EMBASE™ and PsycINFO® databases were systematically searched until September 2010. References from retrieved articles were reviewed to broaden the search. RESULTS: The study included case reports, case series and empirical studies of training and assessment in urology using procedural simulation. The model name, training tasks, participant level, training duration and evaluation scoring were extracted from each study. We also extracted data on face, content and construct validity. Most studies suitably addressed content, construct and face validation as well as the feasibility, educational impact and cost-effectiveness of simulation models. Synthetic, animal and virtual reality models were demonstrated to be effective training and assessment tools for junior trainees. Few investigators looked at the transferability of skills from simulation to real patients. CONCLUSIONS: Current simulation models are valid and reliable for the initial phase of training and assessment. For advanced and specialist level skill acquisition animal models can be used but availability is limited due to supply shortages and ethical restrictions. More research is needed to validate simulated environments for senior trainees and specialists.

The volume-outcome relationship for radical cystectomy in England: an analysis of outcomes other than mortality.

OBJECTIVE: •To evaluate the volume-outcome relationship for radical cystectomy in England using outcomes other than mortality. PATIENTS AND METHODS: •Patients undergoing an elective radical cystectomy were extracted from administrative hospital data for financial years 2000/1 to 2006/7. •Institutional and surgeon volume was assessed against postoperative re-intervention, postoperative complications and emergency readmission within 28 days, using a set of models accounting for patient case-mix, the 'clustered' nature of the data and structural and process of care measures. RESULTS: •In the final model, the odds of re-intervention within 14 and 30 days of operation for medium-volume institutions compared to low-volume institutions were found to be 63% (odds ratio, OR, 1.63; 95% CI 1.15-2.32; P= 0.01) and 52% (OR, 1.52; 95% CI, 1.13-2.04; P= 0.01) higher, respectively. •In the summary of adjusted probabilities, low-volume institutions appeared to have a lower re-intervention rate than both medium- and high-volume institutions. •By contrast, high-volume surgeons were associated with a reduced odds (OR, 0.68; 95% CI, 0.51-0.91; P= 0.01) of early re-intervention (within 14 days) compared to low-volume surgeons. •This surgeon volume-outcome effect became apparent only after adjusting for the influence of the institution and structural and process of care confounders. •There was no statistically significant relationship between volume and complication or readmission rates. CONCLUSIONS: •Radical cystectomy measures of re-intervention rates can be used as outcome measures to discern differences across institutional or surgeon volume providers when the institutional and surgeon volume are co-examined and adjustment for structural and process of care confounders is performed. •The finding of a lower risk of re-intervention in low-volume institutions needs to be explored further.

What is the role of risk-adjusted funnel plots in the analysis of radical cystectomy volume-outcome relationships?

OBJECTIVE: • To explore whether risk-adjusted funnel plots are a useful adjunct to analyse volume-outcome data and to further facilitate our understanding of institutional performance data by combining funnel-plot methodology with an incremental statistical modelling approach. PATIENTS AND METHODS: • Risk-adjusted funnel plots were generated for mortality and re-intervention rates after elective radical cystectomy using administrative data from NHS Hospital Trusts between 2000/01 and 2006/07. Trusts were divided into volume tertiles based on their average annual cystectomy rate. • A funnel plot was produced for each of the following four incremental statistical models: model one (no adjustment), model two (adjusted for patient case mix variables), model three (case mix and 'clustering' of patients) and model four (additional adjustment for institutional structural and process-of-care variables). RESULTS: • In the final complex model (model four), no Trusts had abnormally high mortality or re-intervention rates. • Comparison of the funnel plots showed the importance of adjusting for certain confounding factors, such as the surgeon, at the institutional level, before they could be labelled as having truly outlying performance. CONCLUSION: • Risk-adjusted funnel plots have a useful role to play as a component of a methodological framework for investigating the volume-outcome relationship at the institutional level. They can act as a complementary method of validating data by displaying disaggregated outcomes at provider level and account for unmeasured confounders, so reducing the opportunity for spurious labelling of outliers.

A persistent bladder erosion with ureteric involvement following mesh augmented repair of cystocele.

We present a case of a 57-year-old woman who sustained bladder erosion with extension to the left ureter after a mesh-augmented recurrent cystocele repair. The persistence of the eroding mesh eventually necessitated a partial cystectomy and distal left ureterectomy, using a Boari flap technique.

Delayed nephrectomy has comparable long-term overall survival to immediate nephrectomy for cT1a renal cell carcinoma: A population-based analysis.

OBJECTIVES: Early surgical resection remains the recommended treatment option for most small renal mass (≤4 cm). We examined the long-term overall survival (OS) of patients managed with delayed and immediate nephrectomy of cT1a renal cancer. PATIENT AND METHODS: We utilized the National Cancer Database (2005-2010) to identify 14,677 patients (immediate nephrectomy: 14,050 patients vs. late nephrectomy: 627 patients) aged <70 years with Charlson Comorbidity Index 0 and cT1aN0M0 renal cell carcinoma. Immediate nephrectomy and late nephrectomy were defined as nephrectomy performed <30 days and >180 days from diagnosis, respectively. Inverse probability of treatment weighting-adjusted Kaplan-Meier curves and Cox proportional hazards regression analyses were used to compare OS of patients in the 2 treatment arms. Influence of patient age and Charlson Comorbidity Index on treatment effect was tested by interactions. Sensitivity analysis was performed to explore the outcome of delaying nephrectomy for >12 months. RESULTS: Median patient age was 55 years with a median follow-up of 82.5 months. Inverse probability of treatment weighting-adjusted Kaplan-Meier curves suggest no significant difference between treatment arms (immediate nephrectomy [<30 days] vs. delayed nephrectomy [>180 days]) (Hazard ratio 0.96; 95% confidence interval 0.73-1.26; P = 0.77). This outcome was consistent between all patients regardless of age (P = 0.48). Sensitivity analysis reports no difference in OS even if nephrectomy was delayed by >12 months (P = 0.60). CONCLUSIONS: We report that delayed and immediate nephrectomy for cT1a renal cell carcinoma confers comparable long-term OS. These findings suggest that a period of observation of between 6 and 12 months is safe to allow identification of renal masses, which will benefit from surgical resection.

Assessing the quality of the volume-outcome relationship in uro-oncology.

OBJECTIVE: To assess systematically the quality of evidence for the volume-outcome relationship in uro-oncology, and thus facilitate the formulating of health policy within this speciality, as 'Implementation of Improving Outcome Guidance' has led to centralization of uro-oncology based on published studies that have supported a 'higher volume-better outcome' relationship, but improved awareness of methodological drawbacks in health service research has questioned the strength of this proposed volume-outcome relationship. METHODS: We systematically searched previous relevant reports and extracted all articles from 1980 onwards assessing the volume-outcome relationship for cystectomy, prostatectomy and nephrectomy at the institution and/or surgeon level. Studies were assessed for their methodological quality using a previously validated rating system. Where possible, meta-analytical methods were used to calculate overall differences in outcome measures between low and high volume healthcare providers. RESULTS: In all, 22 studies were included in the final analysis; 19 of these were published in the last 5 years. Only four studies appropriately explored the effect of both the institution and surgeon volume on outcome measures. Mortality and length of stay were the most frequently measured outcomes. The median total quality scores within each of the operation types were 8.5, 9 and 8 for cystectomy, prostatectomy and nephrectomy, respectively (possible maximum score 18). Random-effects modelling showed a higher risk of mortality in low-volume institutions than in higher-volume institutions for both cystectomy and nephrectomy (odds ratio 1.88, 95% confidence interval 1.54-2.29, and 1.28, 1.10-1.49, respectively). CONCLUSION: The methodological quality of volume-outcome research as applied to cystectomy, prostatectomy and nephrectomy is only modest at best. Accepting several limitations, pooled analysis confirms a higher-volume, lower-mortality relationship for cystectomy and nephrectomy. Future research should focus on the development of a quality framework with a validated scoring system for the bench-marking of data to improve validity and facilitate rational policy-making within the speciality of uro-oncology.

Provision of radical pelvic urological surgery in England, and compliance with improving outcomes guidance.

OBJECTIVE: To investigate compliance with Improving Outcomes Guidance (IOG) for radical pelvic surgery in England, and explore the pattern of service provision for radical cystectomy (RC) and radical prostatectomy (RP) before and after the introduction of IOG. METHODS: For the period 2000/01-2006/07, all admissions for RC and RP were extracted from Hospital Episode Statistics (HES). At the institutional level, the numbers of RC and RP cases were combined to assess adherence to IOG. The IOG catchment populations for each institution were calculated by linking HES data to census ward population data. The pattern of service provision for RC and RP was independently assessed by assigning institutions into low-, medium- and high-volume groups of roughly equal volumes a priori, based on the ascending order of annual RC or RP rate, respectively. For RC it was also possible to explore the between-institution referral activity for RC by identifying the 'final endoscopic bladder procedure' that occurred immediately before the RC for each patient. This gave an indication of where the diagnosis and decision for RC had been made. RESULTS: The percentage of institutions achieving the recommended IOG minimal case volume of 50 per year increased significantly between 2000/01 and 2006/07 (36% in odds per year, P < 0.001; odds ratio 1.36, 95% confidence interval 1.24-1.50), although absolute numbers remained relatively low (34% in 2006/07). Only one institution had a catchment population greater than the recommended 1 million. The total number of institutions performing RC decreased significantly over the years (P = 0.03), whereas for RP the decrease was not significant (P = 0.6). The decrease reflected a decline in the number of low-volume institutions, both for RC and RP, although this decline was not more than expected by chance. There had been a significant increase in the percentage of patients referred to another provider for their RC, from 5.5% in 2000/01 to 19.6% in 2006/07 (28% rise in odds per year, P < 0.001: odds ratio 1.28, 95% confidence interval 1.23-1.33). CONCLUSION: There was evidence of centralization of radical pelvic urological surgery, although it is only relatively recently that this seems to have taken place with any certainty. The absolute numbers of providers achieving the IOG minimum caseload standard was relatively low. What impact this has had, if any, on the quality of patient care is yet to be fully determined.

Appraising the quality of care in surgery.

There is currently no validated measurement system available for quality of care assessment in surgery despite all of the inherent benefits of such an approach. A structured quality framework needs to be developed and incorporate measures that are truly reflective of several important dimensions of care within the entire treatment episode. Presently this has been only partially addressed. These measures of quality can be categorized into clinical pathway measures (structure of care, process of care, outcome of care, and economic measures of care) and patient-reported measures (patient-reported treatment outcomes, health-related quality of life measures, and patient satisfaction). Combining these measures to create an overall composite quality score can be made feasible only if it is supported by the use of robust statistical methodology. It is important to use appropriate display of performance data to facilitate provider engagement in quality improvement initiatives. This article was designed to present such a structured approach of a quality framework, which is required to appraise the quality of care in surgery to enhance future quality improvement programmes.

Using preoperative imaging for intraoperative guidance: a case of mistaken identity.

BACKGROUND: Surgical image guidance systems to date have tended to rely on reconstructions of preoperative datasets. This paper assesses the accuracy of these reconstructions to establish whether they are appropriate for use in image guidance platforms. METHODS: Nine raters (two experts in image interpretation and preparation, three in image interpretation, and four in neither interpretation nor preparation) were asked to perform a segmentation of ten renal tumours (four cystic and six solid tumours). These segmentations were compared with a gold standard consensus segmentation generated using a previously validated algorithm. RESULTS: Average sensitivity and positive predictive value (PPV) were 0.902 and 0.891, respectively. When assessing for variability between raters, significant differences were seen in the PPV, sensitivity and incursions and excursions from consensus tumour boundary. CONCLUSIONS: This paper has demonstrated that the interpretation required for the segmentation of preoperative imaging of renal tumours introduces significant inconsistency and inaccuracy. Copyright © 2015 John Wiley & Sons, Ltd.