Dataset Information

Cost-Effectiveness of Robot-Assisted Radical Cystectomy vs Open Radical Cystectomy for Patients With Bladder Cancer.

ABSTRACT:

Importance

The 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.

Objectives

To compare the cost-effectiveness of iRARC with that of ORC.

Design, setting, and participants

This 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.

Interventions

Patients were randomized to receive either iRARC (n = 169) or ORC (n = 169).

Main outcomes and measures

Costs 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.

Results

A 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 relevance

In 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 registration

ClinicalTrials.gov Identifier: NCT03049410.

SUBMITTER: Dixon S

PROVIDER: S-EPMC10314306 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Cost-Effectiveness of Robot-Assisted Radical Cystectomy vs Open Radical Cystectomy for Patients With Bladder Cancer.

Dixon Simon S Hill Harry H Flight Laura L Khetrapal Pramit P Ambler Gareth G Williams Norman R NR Brew-Graves Chris C Kelly John D JD Catto James W F JWF

JAMA network open 20230601 6

<h4>Importance</h4>The 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.<h4>Objectives</h4>To compare the cost-effectiveness of iRARC with that of ORC.<h4>Design, setting, and participants</h4>This economic evaluation used individual patient data from a randomized clinical trial at 9 surgical centers in the United Kingdom. Patients with nonmetastatic blad ...[more]

PMID: 37389878

Similar Datasets

Project description:ObjectivesTo assess the comparative effectiveness of robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) vs open radical cystectomy (ORC) for bladder cancer (BC).Patients and methodsWe conducted a real-life monocentric study including all consecutive patients who underwent RARC with ICUD or ORC for BC at our institution from 2014 to 2023. Uni- and multivariable logistic and Cox regression analyses were used to compare perioperative, oncological and stricture outcomes between both groups by calculating odds (ORs) and hazard (HRs) ratios with their corresponding 95% confidence intervals (CIs), respectively.ResultsOverall, 316 patients underwent either RARC with ICUD (n = 228 [72.2%]) or ORC (n = 88 [27.8%]). The perioperative benefits of RARC vs ORC included decreased risks of major blood loss (OR 0.10, 95% CI 0.04-0.23; P < 0.001), perioperative transfusion (OR 0.30, 95% CI 0.16-0.57; P < 0.001), 90-day major complications (OR 0.56, 95% CI 0.29-0.99; P = 0.04), and prolonged initial length of hospital stay (OR 0.20, 95% CI 0.09-0.35; P < 0.001), as well as more days alive and out of the hospital within 90 days of surgery (OR 2.56, 95% CI 1.46-4.6; P < 0.01). In addition, the use of RARC vs ORC was associated with a higher lymph node (LN) count (OR 3.35, 95% CI 1.83-6.30; P < 0.001), while there was no significant difference in recurrence-free (HR 0.72, 95% CI 0.49-1.07; P = 0.1), cancer-specific (HR 0.69, 95% CI 0.43-1.10; P = 0.1), overall (HR 0.76, 95% CI 0.47-1.20; P = 0.3) and uretero-ileal stricture-free (HR 1.18, 95% CI 0.62-2.25; P = 0.6) survival between both groups after a median (interquartile range) follow-up of 42.3 (16.4-73.8) months.ConclusionOur real-world study supports the effectiveness of RARC with ICUD vs ORC for BC. We generally observed better perioperative outcomes, as well as similar oncological-except for higher LN count-and uretero-ileal stricture outcomes after RARC with ICUD vs ORC.

Project description:ImportanceMortality rates resulting from bladder cancer have remained unchanged for more than 30 years. The surgical community has put hope in robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) in an effort to improve surgical outcomes and bladder cancer survival without strong supporting evidence.ObjectiveTo evaluate perioperative, safety, and survival outcome differences between RARC with ICUD and open radical cystectomy (ORC).Design, setting, and participantsThis nationwide population-based cohort study used data from the Swedish National Register of Urinary Bladder Cancer and population-based Cause of Death Register, which includes clinical information on tumor characteristics, treatment, and survival and covers approximately 97% of patients with urinary bladder cancer in Sweden. All patients who underwent radical cystectomy for bladder cancer in any hospital between January 2011 and December 2018 were included. Follow-up data were collected until December 2019. Data analysis was conducted from June to December 2020.ExposuresRARC or ORC.Main outcomes and measuresThe main outcomes were all-cause and cancer-specific mortality between RARC and ORC, compared using propensity score matching. Secondary outcomes were differences in perioperative outcomes after the different surgical approaches.ResultsThroughout the observation period, 889 patients underwent RARC and 2280 patients underwent ORC at 24 Swedish hospitals. The median (IQR) age was 71 (66-76) years and 2386 patients (75.3%) were men. After a median (IQR) follow-up of 47 (28-71) months, the 5-year cancer-specific mortality rates were 30.2% (variance, 1.59) for ORC and 27.6% (variance, 3.12) for RARC, and the overall survival rates were 57.7% (variance, 2.46) for ORC and 61.4% (variance, 5.11) for RARC. In the propensity score-matched analysis, RARC was associated with a lower all-cause mortality (hazard ratio, 0.71; 95% CI, 0.56-0.89; P = .004). Compared with ORC, RARC was associated with a lower estimated blood loss (median [IQR] 150 [100-300] mL vs 700 [400-1300] mL; P < .001), intraoperative transfusion rate (odds ratio [OR], 0.05; 95% CI, 0.03-0.08; P < .001), and shorter length of stay (median [IQR], 9 [6-13] days vs 13 [10-17] days; P < .001), and with a higher lymph node yield (median [IQR], 20 [15-27] lymph nodes vs 14 [8-24] lymph nodes; P < .001) and 90-day rehospitalization rate (OR, 1.28; 95% CI, 1.02-1.60; P = .03). The RARC group, compared with the ORC group had lower risk of Clavien-Dindo grade III or higher complications (OR, 0.62; 95% CI, 0.43-0.87; P = .009).Conclusions and relevanceThese findings suggest that compared with ORC, RARC with ICUD was associated with a lower overall mortality rate, fewer high-grade complications, and more favorable perioperative outcomes.

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.

Project description:ImportanceRobot-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.ObjectivesTo compare recovery and morbidity after robot-assisted radical cystectomy with intracorporeal reconstruction vs open radical cystectomy.Design, setting, and participantsRandomized 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.InterventionsParticipants were randomized to receive robot-assisted radical cystectomy with intracorporeal reconstruction (n = 169) or open radical cystectomy (n = 169).Main outcomes and measuresThe 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.ResultsAmong 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 relevanceAmong 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 registrationISRCTN Identifier: ISRCTN13680280; ClinicalTrials.gov Identifier: NCT03049410.

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.

Dataset Information

Cost-Effectiveness of Robot-Assisted Radical Cystectomy vs Open Radical Cystectomy for Patients With Bladder Cancer.

Importance

Objectives

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Cost-Effectiveness of Robot-Assisted Radical Cystectomy vs Open Radical Cystectomy for Patients With Bladder Cancer.

Similar Datasets

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