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.

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.

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.

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.

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.

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.

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.

Robust ultrasound probe tracking: initial clinical experiences during robot-assisted partial nephrectomy.

PURPOSE: In order to assist in the identification of renal vasculature and tumour boundaries in robot-assisted partial nephrectomy, robust ultrasound probe calibration and tracking methods are introduced. Contemporaneous image guidance during these crucial stages of the procedure should ultimately lead to improved safety and quality of outcome for the patient, through reduced positive margin rates, segmental clamping, shorter ischaemic times and nephron-sparing resection. METHODS: Small KeyDot markers with circular dot patterns are attached to a miniature pickup ultrasound probe. Generic probe calibration is superseded by a more robust scheme based on a sequence of physical transducer measurements. Motion prediction combined with a reduced region-of-interest in the endoscopic video feed facilitates real-time tracking and registration performance at full HD resolutions. RESULTS: Quantitative analysis confirms that circular dot patterns result in an improved translational and rotational working envelope, in comparison with the previous chessboard pattern implementation. Furthermore, increased robustness is observed with respect to prevailing illumination levels and out-of-focus images due to relatively small endoscopic depths of field. CONCLUSION: Circular dot patterns should be employed in this context as they result in improved performance and robustness. This facilitates clinical usage and interpretation of the combined video and ultrasound overlay. The efficacy of the overall system is demonstrated in the first human clinical case.

Management of erectile dysfunction post-radical prostatectomy.

Radical prostatectomy is a commonly performed procedure for the treatment of localized prostate cancer. One of the long-term complications is erectile dysfunction. There is little consensus on the optimal management; however, it is agreed that treatment must be prompt to prevent fibrosis and increase oxygenation of penile tissue. It is vital that patient expectations are discussed, a realistic time frame of treatment provided, and treatment started as close to the prostatectomy as possible. Current treatment regimens rely on phosphodiesterase 5 inhibitors as a first-line therapy, with vacuum erection devices and intraurethral suppositories of alprostadil as possible treatment combination options. With nonresponders to these therapies, intracavernosal injections are resorted to. As a final measure, patients undergo the highly invasive penile prosthesis implantation. There is no uniform, objective treatment program for erectile dysfunction post-radical prostatectomy. Management plans are based on poorly conducted and often underpowered studies in combination with physician and patient preferences. They involve the aforementioned drugs and treatment methods in different sequences and doses. Prospective treatments include dietary supplements and gene therapy, which have shown promise with there proposed mechanisms of improving erectile function but are yet to be applied successfully in human patients.

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.

The current and future use of imaging in urological robotic surgery: a survey of the European Association of Robotic Urological Surgeons.

BACKGROUND: With the development of novel augmented reality operating platforms the way surgeons utilise imaging as a real-time adjunct to surgical technique is changing. METHODS: A questionnaire was distributed via the European Robotic Urological Society mailing list. The questionnaire had three themes: surgeon demographics, current use of imaging and potential uses of an augmented reality operating environment in robotic urological surgery. RESULTS: 117 of the 239 respondents (48.9%) were independently practising robotic surgeons. 74% of surgeons reported having imaging available in theatre for prostatectomy 97% for robotic partial nephrectomy and 95% cystectomy. 87% felt there was a role for augmented reality as a navigation tool in robotic surgery. CONCLUSIONS: This survey has revealed the contemporary robotic surgeon to be comfortable in the use of imaging for intraoperative planning it also suggests that there is a desire for augmented reality platforms within the urological community.

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 61.12years. 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 % (9.48grams) 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. .

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.

Image guidance for all--TilePro display of 3-dimensionally reconstructed images in robotic partial nephrectomy.

OBJECTIVE: To determine the feasibility of a novel low-barrier-to-entry image guidance system. METHODS: Initially a randomized crossover study was performed to establish the interface (iPad or 3-dimensional mouse) that minimized both the amount of time required to perform a manual image registration and the error of that registration. A subsequent clinical feasibility study was undertaken on 5 patients undergoing robot-assisted partial nephrectomy. Randomized crossover study primary outcomes were time to task completion, NASA-Task Load Index score, and alignment error (translational and rotational). The Mann-Whitney U test was used to compare groups. Surgeon feedback was sought when assessing the system in a clinical setting. RESULTS: In the initial randomized crossover study, the iPad-based system was able to achieve adequate alignment accuracy (Frobenius norm of 0.3; total error of 20.8 mm) in significantly less time (33 seconds; P<.01) than the 3-dimensional mouse interface. The platform received good feedback from the operating surgeon in all instances with the surgeon commenting particularly on the improved appreciation of hilar vascular anatomy. CONCLUSION: In this study, we have demonstrated the feasibility of a "low-barrier-to-entry" image guidance system in a clinical setting. The system was able to achieve swift and sufficiently accurate alignment, with little impact on the surgical workflow.