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Background: Lower fitness is a predictor of adverse outcomes after radical cystectomy. Lockdown measures during the COVID-19 pandemic affected daily physical activity. We hypothesised that lockdown during the pandemic was associated with a reduction in preoperative aerobic fitness and an increase in postoperative complications in patients undergoing radical cystectomy. Methods: We reviewed routine preoperative cardiopulmonary exercise testing (CPET) data collected prior to the pandemic (September 2018 to March 2020) and after lockdown (March 2020 to July 2021) in patients undergoing radical cystectomy. Differences in CPET variables, Postoperative Morbidity Survey (POMS) data, and length of hospital stay were compared. Results: We identified 267 patients (85 pre-lockdown and 83 during lockdown) who underwent CPET and radical cystectomy. Patients undergoing radical cystectomy throughout lockdown had lower ventilatory anaerobic threshold (9.0 [7.9-10.9] vs 10.3 [9.1-12.3] ml kg-1 min-1; P=0.0002), peak oxygen uptake (15.5 [12.9-19.1] vs 17.5 [14.4-21.0] ml kg-1 min-1; P=0.015), and higher ventilatory equivalents for carbon dioxide (34.7 [31.4-38.5] vs 33.4 [30.5-36.5]; P=0.030) compared with pre-lockdown. Changes were more pronounced in males and those aged >65 yr. Patients undergoing radical cystectomy throughout lockdown had a higher proportion of day 5 POMS-defined morbidity (89% vs 75%, odds ratio [OR] 2.698, 95% confidence interval [CI] 1.143-6.653; P=0.019), specifically related to pulmonary complications (30% vs 13%, OR 2.900, 95% CI 1.368-6.194; P=0.007) and pain (27% vs 9%, OR 3.471, 95% CI 1.427-7.960; P=0.004), compared with pre-lockdown on univariate analysis. Conclusions: Lockdown measures in response to the COVID-19 pandemic were associated with a reduction in fitness and an increase in postoperative morbidity among patients undergoing radical cystectomy.
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BACKGROUND: There is a need to standardize training in robotic surgery, including objective assessment for accreditation. This systematic review aimed to identify objective tools for technical skills assessment, providing evaluation statuses to guide research and inform implementation into training curricula. METHODS: A systematic literature search was conducted in accordance with the PRISMA guidelines. Ovid Embase/Medline, PubMed and Web of Science were searched. Inclusion criterion: robotic surgery technical skills tools. Exclusion criteria: non-technical, laparoscopy or open skills only. Manual tools and automated performance metrics (APMs) were analysed using Messick's concept of validity and the Oxford Centre of Evidence-Based Medicine (OCEBM) Levels of Evidence and Recommendation (LoR). A bespoke tool analysed artificial intelligence (AI) studies. The Modified Downs-Black checklist was used to assess risk of bias. RESULTS: Two hundred and forty-seven studies were analysed, identifying: 8 global rating scales, 26 procedure-/task-specific tools, 3 main error-based methods, 10 simulators, 28 studies analysing APMs and 53 AI studies. Global Evaluative Assessment of Robotic Skills and the da Vinci Skills Simulator were the most evaluated tools at LoR 1 (OCEBM). Three procedure-specific tools, 3 error-based methods and 1 non-simulator APMs reached LoR 2. AI models estimated outcomes (skill or clinical), demonstrating superior accuracy rates in the laboratory with 60 per cent of methods reporting accuracies over 90 per cent, compared to real surgery ranging from 67 to 100 per cent. CONCLUSIONS: Manual and automated assessment tools for robotic surgery are not well validated and require further evaluation before use in accreditation processes.PROSPERO: registration ID CRD42022304901.
BACKGROUND: Robotic surgery is increasingly used worldwide to treat many different diseases. The robot is controlled by a surgeon, which may give them greater precision and better outcomes for patients. However, surgeons' robotic skills should be assessed properly, to make sure patients are safe, to improve feedback and for exam assessments for certification to indicate competency. This should be done by experts, using assessment tools that have been agreed upon and proven to work. AIM: This review's aim was to find and explain which training and examination tools are best for assessing surgeons' robotic skills and to find out what gaps remain requiring future research. METHOD: This review searched for all available studies looking at assessment tools in robotic surgery and summarized their findings using several different methods. FINDINGS AND CONCLUSION: Two hundred and forty-seven studies were looked at, finding many assessment tools. Further research is needed for operation-specific and automatic assessment tools before they should be used in the clinical setting.
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Laparoscopy , Robotic Surgical Procedures , Robotics , Humans , Robotic Surgical Procedures/education , Artificial Intelligence , Clinical Competence , Laparoscopy/educationABSTRACT
BACKGROUND: For non-muscle-invasive bladder cancer (NMIBC) requiring radical surgery, limited data are available comparing robotic-assisted radical cystectomy with intracorporeal urinary diversion (iRARC) to open radical cystectomy (ORC). The objective of this study was to compare the two surgical techniques. METHODS: A multicentric cohort of 593 patients with NMIBC undergoing iRARC or ORC between 2015 and 2020 was prospectively gathered. Perioperative and pathologic outcomes were compared. RESULTS: A total of 143 patients operated on via iRARC were matched to 143 ORC patients. Operative time was longer in the iRARC group (p = 0.034). Blood loss was higher in the ORC group (p < 0.001), with a consequent increased post-operative transfusion rate in the ORC group (p = 0.003). Length of stay was longer in the ORC group (p = 0.007). Post-operative complications did not differ significantly (all p > 0.05). DFS at 60 months was 55.9% in ORC and 75.2% in iRARC with a statistically significant difference (p = 0.033) found in the univariate analysis. CONCLUSION: We found that iRARC for patients with NMIBC is safe, associated with a lower blood loss, a lower transfusion rate and a shorter hospital stay compared to ORC. Complication rates were similar. No significant differences in survival analyses emerged across the two techniques.
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BACKGROUND: Efforts to improve recovery after radical cystectomy (RC) are needed. OBJECTIVE: To investigate wrist-worn wearable activity trackers in RC participants. DESIGN, SETTING, AND PARTICIPANTS: An observational cohort study was conducted within the iROC randomised trial. INTERVENTION: Patients undergoing RC at nine cancer centres wore wrist-based trackers for 7 days (d) at intervals before and after surgery. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Step counts were compared with participant and operative features, and recovery outcomes. RESULTS AND LIMITATIONS: Of 308 participants, 284 (92.2%) returned digital activity data at baseline (median 17 d [interquartile range: 8-32] before RC), and postoperatively (5 [5-6] d) and at weeks 5 (43 [38-43] d), 12 (94 [87-106] d), and 26 (192 [181-205] d) after RC. Compliance was affected by the time from surgery and a coronavirus disease 2019 pandemic lockdown (return rates fell to 0-7%, chi-square p < 0.001). Step counts dropped after surgery (mean of 28% of baseline), before recovering at 5 weeks (wk) (71% of baseline) and 12 wk (95% of baseline; all analysis of variance [ANOVA] p < 0.001). Baseline step counts were not associated with postoperative recovery or death. Patients with extended hospital stays had reduced postoperative step counts, with a difference of 2.2 d (95% confidence interval: 0.856-3.482 d) between the lowest third and highest two-third tertiles (linear regression analysis; p < 0.001). Additionally, they spent less time out of the hospital within 90 d of RC (80.3 vs 74.3 d, p = 0.013). Lower step counts at 5, 12, and 26 wk were seen in those seeking medical help and needing readmission (ANOVA p ≤ 0.002). CONCLUSIONS: Baseline step counts were not associated with recovery. Lower postoperative step counts were associated with longer length of stay at the hospital and postdischarge readmissions. Studies are required to determine whether low step counts can identify patients at a risk of developing complications. PATIENT SUMMARY: Postoperative step counts appear to be a promising tool to identify patients in the community needing medical help or readmission. More work is needed to understand which measures are most useful and how best to collect these.
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Introduction Traumatic brain injury (TBI) necessitates identifying patients at risk of fatal outcomes. Classic biomarkers used clinically today in other organ systems are quantitative in nature. This aspect largely restricts the prognostic ability of a theoretical quantitative brain biomarker. This study aimed to explore biochemical markers and imaging findings reflecting the severity of cerebral damage to predict outcomes. Methodology In this study, 61 TBI cases with moderate to severe brain injury were prospectively observed, and various indices including random blood sugar (RBS), hemoglobin, international normalized ratio (INR), lactate dehydrogenase (LDH), cortisol, and CT findings were assessed. Glasgow Outcome Scores (GOS) determined the outcomes. Statistical analysis was carried out to assess correlations. Results The mean RBS level of those who did not survive was 259.58 mg/dL, whereas in those who survived the value was 158.48 mg/dL. Analysis indicated that patients with high RBS value on admission had a higher risk of mortality (p=0.000). We noted that the mean serum cortisol levesl on both Days 1 and 5 were higher in patients who died and were able to establish a statistically significant correlation between both the values and outcome. A statistically significant negative correlation between Day 1 and Day 5 serum LDH levels and outcomes was evident from our study (p=0.000 for both). Among the components of the Rotterdam score, the presence of intraventricular hemorrhage (IVH) in the CT scan had a significant association with unfavorable outcomes (p=0.01) while midline shift was significantly associated with a low GCS (p=0.04). Conclusion Biochemical markers such as INR, RBS, serum cortisol, and LDH at admission can serve as valuable indicators of prognosis in TBI patients. Furthermore, a persistent increase in LDH and cortisol levels between Days 1 and 5, along with the Glasgow Coma Scale and Rotterdam Scoring system, are good predictors of mortality.
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CONTEXT: Radical cystectomy is considered a procedure of high complexity with a relative high complication rate. OBJECTIVE: To systematically summarize the literature regarding the complications of radical cystectomy and the factors that contribute to them. EVIDENCE ACQUISITION: We searched MEDLINE/PubMed, ClinicalTrials.gov, and Cochrane Library, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines for randomized controlled trials (RCTs) on complications related to radical cystectomy. EVIDENCE SYNTHESIS: A total of 3766 studies were screened, and 44 studies were included in this systematic review and meta-analysis. Complications following radical cystectomy are quite common. The most common complications were gastrointestinal complications (20%), infectious complications (17%), and ileus (14%). The majority of complications occurring were Clavien I-II (45%). Specific measurable patient factors are related to certain complications and can be used to stratify risk and assist in preoperative counseling, while proper design of high-quality RCTs may better reflect real-life complication rates. CONCLUSIONS: In our study, RCTs with a low risk of bias had higher complication rates than studies with a high risk of bias, underlining the need for further improvement on complication reporting in order to refine surgical outcomes. PATIENT SUMMARY: Radical cystectomy is usually followed by high complication rates, which affect patients and are, in turn, strongly associated with patients' preoperative health status.
Subject(s)
Robotic Surgical Procedures , Urinary Bladder Neoplasms , Humans , Cystectomy/adverse effects , Cystectomy/methods , Urinary Bladder Neoplasms/surgery , Urinary Bladder Neoplasms/complications , Robotic Surgical Procedures/methods , Postoperative Complications/etiology , Treatment Outcome , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: Blood transfusions (BT) have been associated with adverse oncologic outcomes in multiple malignancies including open radical cystectomy (ORC) for urothelial carcinoma of the bladder (UCB). Robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) delivers similar oncologic outcomes compared to ORC, yet with lower blood loss and reduced transfusions. However, the impact of BT after robotic cystectomy is still unknown. METHODS: This is a multicenter study including patients treated for UCB with RARC and ICUD in 15 academic institutions, between January 2015 and January 2022. BT were administered during surgery (intraoperative blood transfusions, iBT) or during the first 30 days after surgery (post-operative blood transfusions, pBT). The association of iBT and pBT with recurrence-free survival (RFS), cancer-specific survival (CSS) and overall survival (OS) were evaluated by univariate and multivariate regression analysis. RESULTS: A total of 635 patients were included in the study. Overall, 35/635 patients (5.51%) received iBT while 70/635 (11.0%) received pBT. After a mean follow-up of 23±18 months, 116 patients (18.3%) had died, including 96 (15.1%) from bladder cancer. Recurrence occurred in 146 patients (23%). iBT were associated with decreased RFS, CSS and OS (P<0.001) on univariate Cox analysis. After adjusting for clinicopathologic covariates, iBT were associated only with the risk of recurrence (HR: 1.7; 95% CI, 1.0-2.8, P=0.04). pBT were not significantly associated to RFS, CSS or OS on univariate and multivariate Cox regression models (P>0.05). CONCLUSIONS: In the present study, patients treated by RARC with ICUD for UCB have a higher risk of recurrence after iBT, yet no significant association with CSS and OS was found. pBT are not associated with worse oncological prognosis.
Subject(s)
Carcinoma, Transitional Cell , Robotic Surgical Procedures , Robotics , Urinary Bladder Neoplasms , Urinary Diversion , Humans , Cystectomy/adverse effects , Cystectomy/methods , Urinary Bladder/surgery , Carcinoma, Transitional Cell/surgery , Carcinoma, Transitional Cell/pathology , Urinary Bladder Neoplasms/pathology , Treatment Outcome , Robotic Surgical Procedures/adverse effects , Robotic Surgical Procedures/methods , Urinary Diversion/adverse effects , Urinary Diversion/methodsABSTRACT
Robotic surgery training has lacked evidence-based standardisation. We aimed to determine the effectiveness of adjunctive interactive virtual classroom training (VCT) in concordance with the self-directed Fundamentals of Robotic Surgery (FRS) curriculum. The virtual classroom is comprised of a studio with multiple audio-visual inputs to which participants can connect remotely via the BARCO weConnect platform. Eleven novice surgical trainees were randomly allocated to two training groups (A and B). In week 1, both groups completed a robotic skills induction. In week 2, Group A received training with the FRS curriculum and adjunctive VCT; Group B only received access to the FRS curriculum. In week 3, the groups received the alternate intervention. The primary outcome was measured using the validated robotic-objective structured assessment of technical skills (R-OSAT) at the end of week 2 (time-point 1) and 3 (time-point 2). All participants completed the training curriculum and were included in the final analyses. At time-point 1, Group A achieved a statistically significant greater mean proficiency score compared to Group B (44.80 vs 35.33 points, p = 0.006). At time-point 2, there was no significant difference in mean proficiency score in Group A from time-point 1. In contrast, Group B, who received further adjunctive VCT showed significant improvement in mean proficiency by 9.67 points from time-point 1 (95% CI 5.18-14.15, p = 0.003). VCT is an effective, accessible training adjunct to self-directed robotic skills training. With the steep learning curve in robotic surgery training, VCT offers interactive, expert-led learning and can increase training effectiveness and accessibility.
Subject(s)
Robotic Surgical Procedures , Robotics , Simulation Training , Humans , Robotic Surgical Procedures/methods , Prospective Studies , Computer Simulation , Clinical Competence , Robotics/education , CurriculumABSTRACT
BACKGROUND: Robotic-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) is surging worldwide. Aim of the study was to perform a multicentric cost-analysis of RARC by comparing the gross cost of the intervention across hospitals in four different European countries. METHODS: Patients who underwent RARC + ICUD were recruited from eleven European centers in four European countries (Belgium, France, Netherlands, and UK) between 2015 and 2020. Costs were divided into six parts: cost for hospital stay, cost for ICU stay, cost for surgical theater occupation, cost for transfusion, cost for robotic instruments, and cost for stapling instruments. These costs were individually assessed for each patient. RESULTS: A total of 490 patients were included. Median operative time was 300(270-360) minutes and median hospital length-of-stay was 11(8-15) days. The average total cost of RARC was 14.794 (95%CI 14.300-15.200). A significant difference was found for the total cost, as well as the various subcosts abovementioned, between the four included countries. Different sets and types of robotic instruments were used by each center, leading to a difference in cost of robotic instrumentation. Nearly 84% of costs of RARC were due to hospital stay (42%), ICU stay (3%) and operative time (39%), while 16% of costs were due to robotic (8%) and stapling (8%) instruments. CONCLUSION: Costs and subcosts of RARC + ICUD vary significantly across European countries and are mainly dependent of hospital length-of-stay and operative time rather than robotic instrumentation. Decreasing length-of-stay and reducing operative time could help to decrease the cost of RARC and make it more widely accessible.
Subject(s)
Robotic Surgical Procedures , Robotics , Urinary Bladder Neoplasms , Urinary Diversion , Humans , Cystectomy , Urinary Bladder Neoplasms/surgery , Postoperative Complications/surgery , Europe , Treatment OutcomeABSTRACT
Introduction: The majority of the open access publishing allows the researchers to publish their articles for a fee and at the same time enables the readers to access the research without paying the expensive journal subscription charges. Under the garb of open access publishing, predatory journals run a scam to dupe the researchers of money. This study was conducted to highlight the characteristics of pseudojournals and increase the awareness about their modus operandi. Methods: The email inboxes of 3 academic urologists (APS, AS, and KP) were searched for emails soliciting articles for open access journals. A list of all such journals was compiled. These journals were checked for metrics from the Journal Citation Reports and the Scimago Journal Rankings. All these journals were then cross-checked with the available whitelists and blacklists. Features pointing toward a pseudo journal were identified as red flag signs for these journals and were noted. A literature search was performed on open access publishing and predatory journals, and the salient points were noted. A checklist of red flag signs was compiled. Results: A total of 71 emails soliciting article submissions from 68 journals were received by the three urologists (APS, AS, KP). Of these, 54 were highly suggestive of being a pseudojournal, 5 journals were operating in the gray zone between genuine open access journals and outright predatory journals, and 9 were genuine open access journals. A total of 33 articles on predatory journals were reviewed after the literature search as per the PRISMA guidelines. The red flag signs identified along with the literature review were used to create the SAFEiMAP checklist, which can be used to identify predatory journals. Conclusion: Predatory journals have infiltrated the whitelists, and the indexing databases like PubMed and no blacklist is all-inclusive. Understanding the concept and the types of open access publishing gives the researchers a better idea on how to differentiate fake journals from the genuine ones. Using a checklist will help to identify the red flag signs of such journals and identify those journals that operate in the gray zone.
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Background: The accuracy of multi-parametric MRI (mpMRI) in the pre-operative staging of prostate cancer (PCa) remains controversial. Objective: The purpose of this study was to evaluate the ability of mpMRI to accurately predict PCa extra-prostatic extension (EPE) on a side-specific basis using a risk-stratified 5-point Likert scale. This study also aimed to assess the influence of mpMRI scan quality on diagnostic accuracy. Patients and Methods: We included 124 men who underwent robot-assisted RP (RARP) as part of the NeuroSAFE PROOF study at our centre. Three radiologists retrospectively reviewed mpMRI blinded to RP pathology and assigned a Likert score (1-5) for EPE on each side of the prostate. Each scan was also ascribed a Prostate Imaging Quality (PI-QUAL) score for assessing the quality of the mpMRI scan, where 1 represents the poorest and 5 represents the best diagnostic quality. Outcome measurements and statistical analyses: Diagnostic performance is presented for the binary classification of EPE, including 95% confidence intervals and the area under the receiver operating characteristic curve (AUC). Results: A total of 231 lobes from 121 men (mean age 56.9 years) were evaluated. Of these, 39 men (32.2%), or 43 lobes (18.6%), had EPE. A Likert score ≥3 had a sensitivity (SE), specificity (SP), NPV, and PPV of 90.4%, 52.3%, 96%, and 29.9%, respectively, and the AUC was 0.82 (95% CI: 0.77-0.86). The AUC was 0.76 (95% CI: 0.64-0.88), 0.78 (0.72-0.84), and 0.92 (0.88-0.96) for biparametric scans, PI-QUAL 1-3, and PI-QUAL 4-5 scans, respectively. Conclusions: MRI can be used effectively by genitourinary radiologists to rule out EPE and help inform surgical planning for men undergoing RARP. EPE prediction was more reliable when the MRI scan was (a) multi-parametric and (b) of a higher image quality according to the PI-QUAL scoring system.
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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) 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.
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Importance: Robot-assisted radical cystectomy is being performed with increasing frequency, but it is unclear whether total intracorporeal surgery improves recovery compared with open radical cystectomy for bladder cancer. Objectives: To compare recovery and morbidity after robot-assisted radical cystectomy with intracorporeal reconstruction vs open radical cystectomy. Design, Setting, and Participants: Randomized clinical trial of patients with nonmetastatic bladder cancer recruited at 9 sites in the UK, from March 2017-March 2020. Follow-up was conducted at 90 days, 6 months, and 12 months, with final follow-up on September 23, 2021. Interventions: Participants were randomized to receive robot-assisted radical cystectomy with intracorporeal reconstruction (n = 169) or open radical cystectomy (n = 169). Main Outcomes and Measures: The primary outcome was the number of days alive and out of the hospital within 90 days of surgery. There were 20 secondary outcomes, including complications, quality of life, disability, stamina, activity levels, and survival. Analyses were adjusted for the type of diversion and center. Results: Among 338 randomized participants, 317 underwent radical cystectomy (mean age, 69 years; 67 women [21%]; 107 [34%] received neoadjuvant chemotherapy; 282 [89%] underwent ileal conduit reconstruction); the primary outcome was analyzed in 305 (96%). The median number of days alive and out of the hospital within 90 days of surgery was 82 (IQR, 76-84) for patients undergoing robotic surgery vs 80 (IQR, 72-83) for open surgery (adjusted difference, 2.2 days [95% CI, 0.50-3.85]; P = .01). Thromboembolic complications (1.9% vs 8.3%; difference, -6.5% [95% CI, -11.4% to -1.4%]) and wound complications (5.6% vs 16.0%; difference, -11.7% [95% CI, -18.6% to -4.6%]) were less common with robotic surgery than open surgery. Participants undergoing open surgery reported worse quality of life vs robotic surgery at 5 weeks (difference in mean European Quality of Life 5-Dimension, 5-Level instrument scores, -0.07 [95% CI, -0.11 to -0.03]; P = .003) and greater disability at 5 weeks (difference in World Health Organization Disability Assessment Schedule 2.0 scores, 0.48 [95% CI, 0.15-0.73]; P = .003) and at 12 weeks (difference in WHODAS 2.0 scores, 0.38 [95% CI, 0.09-0.68]; P = .01); the differences were not significant after 12 weeks. There were no statistically significant differences in cancer recurrence (29/161 [18%] vs 25/156 [16%] after robotic and open surgery, respectively) and overall mortality (23/161 [14.3%] vs 23/156 [14.7%]), respectively) at median follow-up of 18.4 months (IQR, 12.8-21.1). Conclusions and Relevance: Among patients with nonmetastatic bladder cancer undergoing radical cystectomy, treatment with robot-assisted radical cystectomy with intracorporeal urinary diversion vs open radical cystectomy resulted in a statistically significant increase in days alive and out of the hospital over 90 days. However, the clinical importance of these findings remains uncertain. Trial Registration: ISRCTN Identifier: ISRCTN13680280; ClinicalTrials.gov Identifier: NCT03049410.
Subject(s)
Cystectomy , Robotic Surgical Procedures , Robotics , Urinary Bladder Neoplasms , Urinary Diversion , Aged , Cystectomy/adverse effects , Cystectomy/methods , Cystectomy/mortality , Female , Humans , Male , Morbidity , Neoplasm Recurrence, Local , Postoperative Complications/etiology , Quality of Life , Retrospective Studies , Robotic Surgical Procedures/adverse effects , Robotic Surgical Procedures/methods , Robotic Surgical Procedures/mortality , Treatment Outcome , Urinary Bladder Neoplasms/mortality , Urinary Bladder Neoplasms/pathology , Urinary Bladder Neoplasms/surgery , Urinary Diversion/adverse effects , Urinary Diversion/methods , Urinary Diversion/mortalityABSTRACT
Automatically recognising surgical gestures from surgical data is an important building block of automated activity recognition and analytics, technical skill assessment, intra-operative assistance and eventually robotic automation. The complexity of articulated instrument trajectories and the inherent variability due to surgical style and patient anatomy make analysis and fine-grained segmentation of surgical motion patterns from robot kinematics alone very difficult. Surgical video provides crucial information from the surgical site with context for the kinematic data and the interaction between the instruments and tissue. Yet sensor fusion between the robot data and surgical video stream is non-trivial because the data have different frequency, dimensions and discriminative capability. In this paper, we integrate multimodal attention mechanisms in a two-stream temporal convolutional network to compute relevance scores and weight kinematic and visual feature representations dynamically in time, aiming to aid multimodal network training and achieve effective sensor fusion. We report the results of our system on the JIGSAWS benchmark dataset and on a new in vivo dataset of suturing segments from robotic prostatectomy procedures. Our results are promising and obtain multimodal prediction sequences with higher accuracy and better temporal structure than corresponding unimodal solutions. Visualization of attention scores also gives physically interpretable insights on network understanding of strengths and weaknesses of each sensor.
Subject(s)
Robotic Surgical Procedures , Robotics , Biomechanical Phenomena , Gestures , Humans , Motion , Robotics/methodsABSTRACT
Robot-assisted radical prostatectomy (RARP) is the conventional surgical treatment option for localised prostate cancer. We investigated factors which may be associated with recovery of early urinary continence (EUC), including the use of the Retzius-sparing technique (RS-RARP). From March 2018 to December 2018, 501 consecutive patients underwent RARP at our high-volume institution. Four hundred and thirty-one patients had complete follow-up data and were included in our analyses. EUC was defined as zero pad use and social urinary continence (SUC) was defined as ≤ 1 pad/24-h period at 3 months following surgery. Patient demographics and clinical factors such as age, body mass index (BMI), neurovascular bundle (NVB) sparing, RS-RARP operative technique and operating surgeon (consultant, trainee) were recorded. Median age was 64.0 years (IQR 57.0-69.0 years) with a median BMI of 27.0 (IQR 25.0-29.9). RS-RARP accounted for 59 of the 431 (13.7%) patients. 196 (45.5%), 142 (32.9%) and 86 (20.0%) received a bilateral, unilateral and nil NVB sparing, respectively. EUC was achieved by 241 patients (55.9%) and SUC was achieved in 339 (78.7%) patients. Multivariable logistic regression analysis suggests younger age (HR 1.04, 95% CI 1.01-1.07, p = 0.014) and RS-RARP technique (HR 2.19, 95% CI 1.15-4.16, p = 0.017) were independently associated with EUC at 3 months even after adjusting for BMI, external membranous urethral length and NVB sparing. Our results suggest that RS-RARP technique is independently predictive of EUC even after accounting for confounding factors. These findings should be further validated in a prospective or randomised trial.
Subject(s)
Prostatic Neoplasms , Robotic Surgical Procedures , Robotics , Urinary Incontinence , Male , Humans , Middle Aged , Infant , Prospective Studies , Urinary Incontinence/etiology , Urinary Incontinence/prevention & control , Urinary Incontinence/surgery , Robotic Surgical Procedures/methods , Treatment Outcome , Prostatectomy/adverse effects , Prostatectomy/methods , Prostatic Neoplasms/surgeryABSTRACT
Background and Objective: The Clavien-Dindo Classification (CDC) only reports the postoperative complication of highest grade. It is thus of limited value for radical cystectomy, after which patients usually experience multiple complications. The Comprehensive Complication Index (CCI) is a novel scoring system, which incorporates all postoperative events in one single value. The study aimed to adopt the CCI for the evaluation of complications in patients undergoing robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) and explore its advantages in the analysis of the morbidity of RARC with ICUD. Patients and Methods: A multicentric cohort of 959 patients undergoing RARC+ICUD between 2015 and 2020, whose complications are encoded in local prospective registries. Postoperative complications at 30 days were assessed using both the CDC and CCI. The CCI was calculated using an online tool (assessurgery.com). Risk factors for overall, major complications (CDC ≥III), and CCI were evaluated using uni- and multivariable logistic and linear regressions. To analyze the potential advantage of using the CCI in clinical trials, a sample size calculation of a hypothetic clinical trial was performed using as endpoint reduction of morbidity with either the CDC or CCI. Results: Overall, 885 postoperative complications were reported in 507 patients (53%). The CCI improved the definition of postoperative morbidity in 22.6% of patients. Male sex and neobladder were associated with major complications and to a significant increase in CCI on adjusted regressions. In a hypothetical clinical trial, 80 patients would be needed to demonstrate a ten-point reduction in CCI, compared with 186 needed to demonstrate an absolute risk reduction of 20% in overall morbidity using the CDC. Conclusion: CCI improves the evaluation of postoperative morbidity by considering the cumulative aspect of complications compared with the CDC. Implementing the CCI for radical cystectomy would help reducing sample sizes in clinical trials. Clinical Trial Registration number: NCT03049410.
Subject(s)
Robotic Surgical Procedures , Robotics , Urinary Bladder Neoplasms , Urinary Diversion , Cystectomy/adverse effects , Cystectomy/methods , Humans , Male , Morbidity , Postoperative Complications/etiology , Postoperative Complications/surgery , Prospective Studies , Robotic Surgical Procedures/adverse effects , Robotic Surgical Procedures/methods , Treatment Outcome , Urinary Bladder Neoplasms/surgery , Urinary Diversion/adverse effects , Urinary Diversion/methodsABSTRACT
OBJECTIVES: To test the feasibility of randomisation to radical prostatectomy (RP) plus pelvic lymphadenectomy in addition to standard-of-care (SOC) systemic therapy in men with newly diagnosed oligo-metastatic prostate cancer. PATIENTS AND METHODS: A prospective, randomised, non-blinded, feasibility clinical trial with an embedded QuinteT Recruitment Intervention (QRI) to optimise recruitment was conducted in nine nationwide tertiary care centres undertaking high-volume robotic surgery. We aimed to randomise 50 men with synchronous oligo-metastatic prostate cancer within an 18-month recruitment period to SOC systemic therapy vs SOC plus RP (intervention arm). The main outcome measures were: ability to randomise patients, optimised by a QRI; EuroQoL five Dimensions five Levels (EQ-5D-5L) questionnaires to capture quality-of-life (QoL) data at baseline and 3 months post-randomisation; routine clinicopathological assessment to capture adverse events and prostate-specific antigen in both arms, plus standard perioperative parameters in the surgical arm. RESULTS: A total of 51 men were randomised within 14 months (one was subsequently deemed ineligible), with 60-83% accrual rate in centres that recruited at least two patients. All patients completed the trial follow-up; one patient in the intervention arm subsequently did not undergo the surgical intervention and one in the SOC arm refused all therapies. The QRI positively impacted recruitment. QoL data showed similarly high functioning in both study arms. Surgery for men with oligo-metastatic prostate cancer was found to be safe and had similar impact on early functional outcomes as surgery for standard indication. CONCLUSION: It is feasible to randomise men with synchronous oligo-metastatic prostate cancer to a surgical intervention in addition to standard systemic therapies. While surgery appeared safe with no substantial impact on QoL in this feasibility study, a large randomised controlled trial is now warranted to examine treatment effectiveness of this additional component in the multimodality management of oligo-metastatic prostate cancer.
Subject(s)
Prostatic Neoplasms , Quality of Life , Feasibility Studies , Humans , Male , Prospective Studies , Prostatectomy/methods , Prostatic Neoplasms/pathology , Treatment OutcomeABSTRACT
OBJECTIVE: This study evaluated the efficacy of virtual classroom training (VCT) in comparison to face-to-face training (FFT) and non-interactive computer-based learning (CBL) for basic surgical skills training. DESIGN: This was a parallel-group, non-inferiority, prospective randomised controlled trial with three intervention groups conducted in 2021. There were three intervention groups with allocation ratio 1:1:1. Outcome adjudicators were blinded to intervention assignment. Interventions consisted of 90-minute training sessions. VCT was delivered via the BARCO weConnect platform, FFT was provided in-person by expert instructors and CBL was carried out by participants independently. The primary outcome was post-intervention Objective Structured Assessment of Technical Skills score, adjudicated by two experts and adjusted for baseline proficiency. The assessed task was to place three interrupted sutures with hand-tied knots. SETTING: This multicentre study recruited from five medical schools in London. PARTICIPANTS: Inclusion criteria were medical student status and access to a personal computer and smartphone. One hundred fifty-nine eligible individuals applied online. Seventy-two participants were randomly selected and stratified by subjective and objective suturing experience prior to permuted block randomization. RESULTS: Twenty-four participants were allocated to each intervention, all were analysed per-protocol. The sample was 65.3% female with mean age 21.3 (SD 2.1). VCT was non-inferior to FFT (adjusted difference 0.44, 95% CI: -0.54 to 1.75, delta 0.675), VCT was superior to CBL (adjusted difference 1.69, 95% CI: 0.41-2.96) and FFT was superior to CBL (adjusted difference 1.25, 95% CI: 0.20-2.29). The costs per-attendee associated with VCT, FFT and CBL were £22.15, £39.69 and £16.33 respectively. Instructor hours used per student for VCT and FFT were 0.25 and 0.75, respectively. CONCLUSIONS: VCT provides greater accessibility and resource efficiency compared to FFT, with similar educational benefit. VCT has the potential to improve global availability and accessibility of surgical skills training.
Subject(s)
Students, Medical , Adult , Clinical Competence , Female , Humans , London , Male , Prospective Studies , Young AdultABSTRACT
OBJECTIVES: To evaluate whether continuing the antiplatelet drug acetylsalicylic acid≤100mg (ASA) during Robotic-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) increases the risk of peri-and postoperative hemorrhagic complications and overall morbidity. Indeed, guidelines recommend interrupting antiplatelet therapy before radical cystectomy; however, RARC with ICUD is associated to reduced estimated blood loss and blood transfusions compared to its open counterpart. METHODS: Data from a multicentric European database were analyzed. All participating centers maintained a prospective database of patients undergoing RARC with ICUD. We identified patients receiving antiplatelet therapy by acetylsalicylic acid ≤100mg. Patients were divided into three groups: those not taking acetylsalicylic acid (no-ASA), those where ASA was continued perioperatively (c-ASA) and those where ASA was interrupted perioperatively (i-ASA). Estimated blood loss and peri-and post-operative transfusions were recorded. Hemorrhagic complications, ischemic, thrombotic and cardiac morbidity was recorded and classified using the Clavien-Dindo score by a senior urologist. RESULTS: 640 patients were analyzed. Patients on acetylsalicylic acid were significantly older and had more comorbidities. No significant difference was found for estimated blood loss between no-ASA, c-ASA and i-ASA (280 vs. 300 vs. 200ml respectively; Pâ¯=â¯0.09). Similarly, no significant difference was found for intraoperative (5% vs. 9% vs. 11%; Pâ¯=â¯0.07) and postoperative transfusion rate (11% vs. 13% vs. 18%; Pâ¯=â¯0.17). Higher ischemic complications were noted in the i-ASA group compared to no-ASA and c-ASA (4% vs. 0.6% vs. 1.4%; Pâ¯=â¯0.03). On uni and multivariate logistic regression, continuing acetylsalicylic acid was not significantly associated to either major complications or post-operative transfusions. CONCLUSIONS: Peri-operative acetylsalicylic acid continuation in RARC with ICUD does not increase hemorrhagic complications. Interrupting acetylsalicylic acid peri-operatively may expose patients to a higher risk of ischemic events.