A Prospective, Observational, Multicentre Study Concerning Nontechnical Skills in Robot-assisted Radical Cystectomy Versus Open Radical Cystectomy.
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SUBMITTER: Beulens AJW
PROVIDER: S-EPMC8317860 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Introduction:Open radical cystectomy (ORC) has been the standard treatment for muscle-invasive bladder cancer, but this is associated with significant morbidity and mortality. Robot-assisted radical cystectomy (RARC) has been proposed as minimally invasive alternative with improved morbidity and acceptable oncological outcomes, but a large series featuring RARC and their comparison with ORC is still lacking in India despite more than a decade of its inception. We have conducted this study with an objective to see the feasibility of RARC in the Indian context and compare it with contemporary standard. Methods:This is a prospective cohort study conducted at two tertiary cancer institutes. We have evaluated the patients pertaining to operative and early post-operative factors from January 2014 to December 2015. Necessary statistical tests applied to see comparability of the arms and their outcomes. Results:A total of 170 patients underwent surgery for carcinoma bladder (45 ORC while 125 RARC). Intraoperative blood loss (RARC and ORC: 228 and 529 ml) and average transfusion rate were lower with RARC. A trend towards benefit was noted in favour of robotic arm in terms of mean complication rate (RARC and ORC: 54 and 39%). Conclusions:The present study has shown comparable surgical and early post-operative outcomes with clear advantage of robotic approach in terms of intraoperative blood transfusion and lymph node yield. Although the study was non-randomised in nature, it should provide substantial evidence on safety and feasibility of RARC in the Indian context and a reference point of evidence to look ahead.
| S-EPMC6130186 | biostudies-other
Project description:BackgroundOpen radical cystectomy (ORC) and urinary diversion in patients with bladder cancer (BCa) are associated with significant perioperative complication risk.ObjectiveTo compare perioperative complications between robot-assisted radical cystectomy (RARC) and ORC techniques.Design, setting, and participantsA prospective randomized controlled trial was conducted during 2010 and 2013 in BCa patients scheduled for definitive treatment by radical cystectomy (RC), pelvic lymph node dissection (PLND), and urinary diversion. Patients were randomized to ORC/PLND or RARC/PLND, both with open urinary diversion. Patients were followed for 90 d postoperatively.InterventionStandard ORC or RARC with PLND; all urinary diversions were performed via an open approach.Outcome measurements and statistical analysisPrimary outcomes were overall 90-d grade 2-5 complications defined by a modified Clavien system. Secondary outcomes included comparison of high-grade complications, estimated blood loss, operative time, pathologic outcomes, 3- and 6-mo patient-reported quality-of-life (QOL) outcomes, and total operative room and inpatient costs. Differences in binary outcomes were assessed with the chi-square test, with differences in continuous outcomes assessed by analysis of covariance with randomization group as covariate and, for QOL end points, baseline score.Results and limitationsThe trial enrolled 124 patients, of whom 118 were randomized and underwent RC/PLND. Sixty were randomized to RARC and 58 to ORC. At 90 d, grade 2-5 complications were observed in 62% and 66% of RARC and ORC patients, respectively (95% confidence interval for difference, -21% to -13%; p=0.7). The similar rates of grade 2-5 complications at our mandated interim analysis met futility criteria; thus, early closure of the trial occurred. The RARC group had lower mean intraoperative blood loss (p=0.027) but significantly longer operative time than the ORC group (p<0.001). Pathologic variables including positive surgical margins and lymph node yields were similar. Mean hospital stay was 8 d in both arms (standard deviation, 3 and 5 d, respectively; p=0.5). Three- and 6-mo QOL outcomes were similar between arms. Cost analysis demonstrated an advantage to ORC compared with RARC. A limitation is the setting at a single high-volume, referral center; our findings may not be generalizable to all settings.ConclusionsThis trial failed to identify a large advantage for robot-assisted techniques over standard open surgery for patients undergoing RC/PLND and urinary diversion. Similar 90-d complication rates, hospital stay, pathologic outcomes, and 3- and 6-mo QOL outcomes were observed regardless of surgical technique.Patient summaryOf 118 patients with bladder cancer who underwent radical cystectomy, pelvic lymph node dissection, and urinary diversion, half were randomized to open surgery and half to robot-assisted laparoscopic surgery. We compared the rate of complications within 90 d after surgery for the open group versus the robotic group and found no significant difference between the two groups.Trial registrationClinicalTrials.gov identifier NCT01076387, www.clinicaltrials.gov.
| S-EPMC4424172 | biostudies-literature
Project description:ImportanceThe value to payers of robot-assisted radical cystectomy with intracorporeal urinary diversion (iRARC) when compared with open radical cystectomy (ORC) for patients with bladder cancer is unclear.ObjectivesTo compare the cost-effectiveness of iRARC with that of ORC.Design, setting, and participantsThis economic evaluation used individual patient data from a randomized clinical trial at 9 surgical centers in the United Kingdom. Patients with nonmetastatic bladder cancer were recruited from March 20, 2017, to January 29, 2020. The analysis used a health service perspective and a 90-day time horizon, with supplementary analyses exploring patient benefits up to 1 year. Deterministic and probabilistic sensitivity analyses were undertaken. Data were analyzed from January 13, 2022, to March 10, 2023.InterventionsPatients were randomized to receive either iRARC (n = 169) or ORC (n = 169).Main outcomes and measuresCosts of surgery were calculated using surgery timings and equipment costs, with other hospital data based on counts of activity. Quality-adjusted life-years were calculated from European Quality of Life 5-Dimension 5-Level instrument responses. Prespecified subgroup analyses were undertaken based on patient characteristics and type of diversion.ResultsA total of 305 patients with available outcome data were included in the analysis, with a mean (SD) age of 68.3 (8.1) years, and of whom 241 (79.0%) were men. Robot-assisted radical cystectomy was associated with statistically significant reductions in admissions to intensive therapy (6.35% [95% CI, 0.42%-12.28%]), and readmissions to hospital (14.56% [95% CI, 5.00%-24.11%]), but increases in theater time (31.35 [95% CI, 13.67-49.02] minutes). The additional cost of iRARC per patient was £1124 (95% CI, -£576 to £2824 [US $1622 (95% CI, -$831 to $4075)]) with an associated gain in quality-adjusted life-years of 0.01124 (95% CI, 0.00391-0.01857). The incremental cost-effectiveness ratio was £100 008 (US $144 312) per quality-adjusted life-year gained. Robot-assisted radical cystectomy had a much higher probability of being cost-effective for subgroups defined by age, tumor stage, and performance status.Conclusions and relevanceIn this economic evaluation of surgery for patients with bladder cancer, iRARC reduced short-term morbidity and some associated costs. While the resulting cost-effectiveness ratio was in excess of thresholds used by many publicly funded health systems, patient subgroups were identified for which iRARC had a high probability of being cost-effective.Trial registrationClinicalTrials.gov Identifier: NCT03049410.
| S-EPMC10314306 | biostudies-literature
Project description:BACKGROUND:Despite the fact that the cost-effectiveness of robot-assisted radical cystectomy (RARC) is not yet proven, and open radical (ORC) cystectomy is recommended as the standard of care in patients with high-risk non-muscle-invasive and muscle-invasive bladder cancer, the use of RARC is still increasing. The objective of the current ongoing comparative effectiveness trial therefore is to study the (cost-)effectiveness of RARC compared to ORC, both in terms of objective (complication rates, oncological outcomes) and patient-reported (health-related quality of life) outcome measures. METHODS:This study is designed as a non-randomized, multicentre comparative effectiveness trial. Centres with an annual caseload of >?20 radical cystectomies can include patients after informed consent has been given. Centres that perform RARC must have passed the (initial) learning curve of 40 cases. A total of 338 (2?×?169) patients will be enrolled from 23 participating centres (12 ORC, 10 RARC and 1 LRC). Follow-up visits will be scheduled at 1, 3, 6 and 12 months. During each follow-up visit, clinical data and health-related quality of life questionnaires will be administered. Costs will be studied using a monthly resource usage questionnaire. Impact on complications and quality of life will be calculated as the average difference between the groups with 95% confidence intervals, adjusted for potential baseline differences by means of propensity score matching. DISCUSSION:This study aims to contribute to the development of evidence-based guidelines regarding the most cost-effective surgical technique for radical cystectomy. TRIAL REGISTRATION:Nederlands Trial Register/Dutch Trial Registry, trial identifying number: NTR5362. Registered on 14 August 2015. ( http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5362 ).
| S-EPMC6122745 | biostudies-literature
Project description:BackgroundWe have performed the direct and network meta-analysis to evaluate the safety and efficacy of robot-assisted (RARC) versus laparoscopic (LRC) versus open radical cystectomy (ORC) for bladder cancer (BCa).MethodsA systematic search of PubMed, Cochrane Library, and Embase was performed up until Dec 20, 2019. Outcome indexes include oncologic outcomes (the recurrence rate, mortality), pathologic outcomes (lymph node yield (LNY), positive lymph node (PLN), positive surgical margins (PSM)), perioperative outcomes (operating time (OP), estimated blood loss (EBL), blood transfusion rate, the length of hospital stay (LOS) and the time to regular diet) and postoperative 90-day complications.ResultsWe have analyzed 6 RCTs, 23 prospective studies, and 25 retrospective studies (54 articles: 6382 patients). On one hand, the direct meta-analysis shows RARC is better than LRC or ORC. On the other hand, the clinical effects of the recurrence rate, Morbidity, PSM, LNY, PLN, and postoperative 90-day complications of RARC, LRC and ORC are all no statistical significance by network meta-analysis. Moreover, the probability rank shows that the comprehensive rank of RARC is better than LRC or ORC. The clinical effects of OP, EBL, LOS, blood transfusion rate and the time to regular diet are all statistical significance by network meta-analysis. There are ORC > LRC > RARC in the EBL ranking. Patients with RARC exhibited a decrease of LOS compared to those with LRC or ORC. Patients with RARC exhibited a decrease in blood transfusion rate and the time to regular diet compared to those with ORC. Patients with ORC exhibited an increase of OP compared to those with RARC or LRC. The heterogeneity tests of most studies are < 50%. Most studies have no publication bias and the quality of the selected studies is good.ConclusionThe direct meta-analysis and network meta-analysis suggest that RARC is better than LRC or ORC according to comprehensive analysis. However, we need a large sample size and more high-quality studies to verify and improve in the further.
| S-EPMC7769378 | biostudies-literature
Project description:INTRODUCTION:Bladder cancer (BC) is a common malignancy and one of the most expensive to manage. Radical cystectomy (RC) with pelvic lymphadenectomy is a gold standard treatment for high-risk BC. Reductions in morbidity and mortality from RC may be achieved through robot-assisted RC (RARC). Prospective comparisons between open RC (ORC) and RARC have been limited by sample size, use of extracorporeal reconstruction and use of outcomes important for ORC. Conversely, while RARC is gaining in popularity, there is little evidence to suggest it is superior to ORC. We are undertaking a prospective randomised controlled trial (RCT) to compare RARC with intracorporeal reconstruction (iRARC) and ORC using multimodal outcomes to explore qualitative and quantitative recovery after surgery. METHODS AND ANALYSIS: iROC is a multicentre prospective RCT in English National Health Service (NHS) cancer centres. We will randomise 320 patients undergoing RC to either iRARC or ORC. Treatment allocation will occur after trial entry and consent. The primary outcome is days alive and out of hospital within the first 90 days from surgery. Secondary outcomes will measure functional recovery (activity trackers, chair-to-stand tests and health related quality of life (HRQOL) questionnaires), morbidity (complications and readmissions), cost-effectiveness (using EuroQol-5 Domain-5 levels (EQ-5D-5L) and unit costs) and surgeon fatigue. Patients will be analysed according to intention to treat. The primary outcome will be transformed and analysed using regression. All statistical assumptions will be investigated. Secondary outcomes will be analysed using appropriate regression methods. An internal feasibility study of the first 30 patients will evaluate recruitment rates, acceptance of randomised treatment choice, compliance outcome collection and to revise our sample size. ETHICS AND DISSEMINATION:The study has ethical approval (REC reference 16/NE/0418). Findings will be made available to patients, clinicians, funders and the NHS through peer-reviewed publications, social media and patient support groups. TRIAL REGISTRATION NUMBERS:ISRCTN13680280 and NCT03049410.
| S-EPMC6089318 | biostudies-literature
Project description:BackgroundLittle is known about the outcomes of robot-assisted radical cystectomy (RARC) compared to open radical cystectomy (ORC) combined with perioperative chemotherapy for muscle-invasive urothelial bladder cancer (UBC).ObjectiveTo evaluate surgical and oncological outcomes for RARC and ORC in multimodal treatment.Design, setting, and participantsData from 28 centres were collected for cystectomies performed between January 2000 and July 2013.InterventionRARC or ORC combined with perioperative chemotherapy for UBC.Outcome measures and statistical analysisFisher's exact tests, χ2 tests, and Wilcoxon rank-sum tests were used to compare the RARC and ORC groups. Logistic and Cox regression analyses were performed to evaluate potential prognostic factors.Results and limitationsA total of 688 patients (n=603 ORC and n=85 RARC) were analysed; 60.6% received neoadjuvant chemotherapy, and 45.1% adjuvant chemotherapy. No significant differences in baseline characteristics were found between the groups. The median time from surgery to adjuvant chemotherapy was 1.9 mo for both RARC and ORC groups. The median number of lymph nodes removed was 21 (interquartile range [IQR] 14-35) for RARC and 13 (IQR 8-21) for ORC (p<0.001); the results were confirmed in subgroup analyses. Multivariable analyses revealed no difference in the rate of positive surgical margins (p=0.54 and p=0.78), rate of neobladder diversion (p=0.33 and p=0.51), relapse-free survival (p=0.31 and p=0.23), and overall survival (p=0.63 and p=0.69). The retrospective nature of the data is the major limitation.ConclusionsIn this study, no differences in efficacy outcomes or ability to deliver adjuvant chemotherapy were observed between RARC and ORC. The increasing use of RARC is justifiable from an oncological viewpoint.Patient summaryIn a retrospective study of patients who received perioperative chemotherapy for urothelial bladder cancer, we found no difference in key outcomes between robot-assisted radical cystectomy (RARC) and open radical cystectomy. Performing RARC seems to be justifiable in the multidisciplinary setting.
| S-EPMC5626651 | biostudies-literature
Project description:Robot-assisted radical cystectomy (RARC) is an evolving technique for the treatment of muscle-invasive bladder cancer (MIBC); however, its effectiveness compared with open radical cystectomy (ORC) - the established modality - is debated. Six specific areas of evidence are critically important for supporting the continuing use of RARC for MIBC, including technical aspects of surgery, perioperative outcomes, complications, oncological outcomes, functional outcomes, and financial costs. Considerable progress has been made regarding these aspects and data show that RARC replicates the technical benchmarks of ORC in terms of success of cystectomy, lymph node dissection, and urinary diversion, and could offer advantages over the more-established technique. Despite some clear benefits of RARC (such as reduced blood loss) other perioperative outcomes, including duration of inpatient stay and 30-90 day complication rates, seem to be similar to those of ORC. Current data on oncological and functional outcomes are promising, but robust data from prospective studies will help determine the indications for use of RARC for treating MIBC in the future.
| S-EPMC9084475 | biostudies-literature
Project description:Introduction and objectivesTo evaluate late complications in a large cohort of patients undergoing robot-assisted radical cystectomy (RARC) with totally intracorporeal urinary diversion (ICUD).Materials and methodsWe prospectively enrolled patients who underwent RARC and ICUD between August 2012 and June 2019. We excluded patients with Ejection fraction < 36%, retinal vasculopathy, ventriculoperitoneal shunts, and those treated without curative intent. All complications and their onset date have been recorded, defined, and graded according to Clavien classification adapted for radical cystectomy.Results210 patients were included, 76% of whom were men, with a mean age of 62 years. Urinary diversions used were Padua Ileal Bladder (PIB) in 80% of cases, and ileal conduit (IC) in 20% of patients (generally older and with more comorbidity). The mean follow-up was 30 ± 22 months. The stenosis rate of uretero-ileal anastomosis was 14%, while a reduction in eGFR (≥ 20%) was observed in about half of the cases. UTIs occurred in 37% of the patients, especially in the first 12 months. Only 2% of patients had bowel occlusion, whereas incisional hernia, lymphocele, and systemic events (metabolic acidosis and major cardiovascular events) occurred respectively in 20%, 10%, and 1% of cases.ConclusionsOur study evaluates first late complications in a cohort of patients who underwent RARC with ICUD. These data are encouraging and in line with findings from a historical series of open radical cystectomy (ORC). This study is a further step in supporting RARC as a safe and effective surgical option for the treatment of muscle-invasive bladder cancer (MIBC) in tertiary referral centers.
| S-EPMC8217047 | biostudies-literature
Project description:Radical cystectomy (RC) is the gold standard treatment for muscle-invasive and high-risk, noninvasive bladder cancer. Since 2003, robot-assisted radical cystectomy (RARC) has been gaining popularity. Metanalyses show that the primary advantage of RARC is less blood loss and the primary advantage of open radical cystectomy (ORC) is shorter operative times. There do not appear to be significant differences in complications, cancer-related outcomes or survival between the two approaches. Cost analyses comparing RARC and ORC are complicated by the often-ill-defined distinction between the cost to the hospital versus the cost to payors. However, it is likely that for both hospitals and payors, RARC is cost effective at high-volume centers. It is feasible that in the future, increased experience with RARC will lead to improved outcomes and justify the use of RARC over ORC.
| S-EPMC8185680 | biostudies-literature