Dataset Information

Health-related Quality of Life After Robotic-assisted vs Open Radical Cystectomy: Analysis of a Randomized Trial.

ABSTRACT:

Purpose

We compare health-related quality of life using a broad range of validated measures in patients randomized to robotic-assisted radical cystectomy vs open radical cystectomy.

Methods

We retrospectively analyzed patients that had enrolled in both a randomized controlled trial comparing robotic-assisted laparoscopic radical cystectomy vs open radical cystectomy and a separate prospective study of health-related quality of life. The prospective health-related quality of life study collected 14 patient-reported outcomes measures preoperatively and at 3, 6, 12, 18, and 24 months postoperatively. Linear mixed-effects models with an interaction term (study arm×time) were used to test for differences in mean domain scores and differing effects of approach over time, adjusting for baseline scores.

Results

A total of 72 patients were analyzed (n=32 robotic-assisted radical cystectomy, n=40 open radical cystectomy). From 3-24 months post-radical cystectomy, no significant differences in mean scores were detected. Mean differences were small in the following European Organization for Research and Treatment of Cancer QLQ-C30 (Core Quality of Life Questionnaire) domains: Global Quality of Life (-1.1; 95% CI -8.4, 6.2), Physical Functioning (-0.4; 95% CI -5.8, 5.0), Role Functioning (0.7; 95% CI -8.6, 10.0). Mean differences were also small in bladder cancer-specific domains (European Organization for Research and Treatment of Cancer QLQ-BLM30 [Muscle Invasive Bladder Cancer Quality of Life Questionnaire]): Body Image (2.9; 95% CI -7.2, 13.1), Urinary Symptoms (8.0; 95% CI -3.0, 19.0). In Urostomy Symptoms, there was a significant interaction term (P < .001) due to lower open radical cystectomy scores at 3 and 24 months. Other domains evaluating urinary, bowel, sexual, and psychosocial health-related quality of life were similar.

Conclusions

Over a broad range of health-related quality of life domains comparing robotic-assisted radical cystectomy and open radical cystectomy, there are unlikely to be clinically relevant differences in the medium to long term, and therefore health-related quality of life over this time period should not be a consideration in choosing between approaches.

SUBMITTER: Clements MB

PROVIDER: S-EPMC10150857 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

Health-related Quality of Life After Robotic-assisted vs Open Radical Cystectomy: Analysis of a Randomized Trial.

Clements Matthew B MB Beech Benjamin B BB Atkinson Thomas M TM Dalbagni Guido M GM Li Yuelin Y Vickers Andrew J AJ Herr Harry W HW Donat S Machele SM Sjoberg Daniel D DD Tin Amy L AL Coleman Jonathan A JA Rapkin Bruce D BD Laudone Vincent P VP Bochner Bernard H BH

The Journal of urology 20230201 5

<h4>Purpose</h4>We compare health-related quality of life using a broad range of validated measures in patients randomized to robotic-assisted radical cystectomy vs open radical cystectomy.<h4>Methods</h4>We retrospectively analyzed patients that had enrolled in both a randomized controlled trial comparing robotic-assisted laparoscopic radical cystectomy vs open radical cystectomy and a separate prospective study of health-related quality of life. The prospective health-related quality of life s ...[more]

PMID: 36724053

Similar Datasets

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.

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.

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:BackgroundBladder cancer is the ninth most common type of cancer worldwide. In the past, radical cystectomy via open surgery has been considered the gold-standard treatment for muscle invasive bladder cancer. However, in recent years there has been a progressive increase in the use of robot-assisted laparoscopic radical cystectomy. The aim of the current project is to investigate the surgical, oncological, and functional outcomes of patients with bladder cancer who undergo radical cystectomy comparing three different surgical techniques (robotic-assisted, laparoscopic, and open surgery). Pre-, peri- and post-operative factors will be examined, and participants will be followed for a period of up to 24 months to identify risks of mortality, oncological outcomes, hospital readmission, sexual performance, and continence.MethodsWe describe a protocol for an observational, prospective, multicenter, cohort study to assess patients affected by bladder neoplasms undergoing radical cystectomy and urinary diversion. The Italian Radical Cystectomy Registry is an electronic registry to prospectively collect the data of patients undergoing radical cystectomy conducted with any technique (open, laparoscopic, robotic-assisted). Twenty-eight urology departments across Italy will provide data for the study, with the recruitment phase between 1st January 2017-31st October 2020. Information is collected from the patients at the moment of surgical intervention and during follow-up (3, 6, 12, and 24 months after radical cystectomy). Peri-operative variables include surgery time, type of urinary diversion, conversion to open surgery, bleeding, nerve sparing and lymphadenectomy. Follow-up data collection includes histological information (e.g., post-op staging, grading, and tumor histology), short- and long-term outcomes (e.g., mortality, post-op complications, hospital readmission, sexual potency, continence etc).DiscussionThe current protocol aims to contribute additional data to the field concerning the short- and long-term outcomes of three different radical cystectomy surgical techniques for patients with bladder cancer, including open, laparoscopic, and robot-assisted. This is a comparative-effectiveness trial that takes into account a complex range of factors and decision making by both physicians and patients that affect their choice of surgical technique.Trial registrationClinicalTrials.gov , NCT04228198 . Registered 14th January 2020- Retrospectively registered.

Dataset Information

Health-related Quality of Life After Robotic-assisted vs Open Radical Cystectomy: Analysis of a Randomized Trial.

Purpose

Methods

Results

Conclusions

Publications

Health-related Quality of Life After Robotic-assisted vs Open Radical Cystectomy: Analysis of a Randomized Trial.

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