Project description:ObjectivesTo investigate changes in quality of life (QoL) up to 8 years after radical cystectomy (RC) and compare QoL after RC with a gender- and age-matched Dutch normative population. Furthermore, we aimed to identify patient characteristics associated with QoL and QoL trajectories after RC.Patients and methodsPatients with bladder cancer were invited to complete QoL questionnaires at 3-month intervals in the first year and yearly thereafter. Follow-up data were available for a maximum of 8 years. We used linear mixed-effect models to investigate changes in QoL subscales (physical functioning [PF], emotional functioning [EF], and QoL summary score [QoL-sum]) over time, and to identify potential demographic and clinical correlates of QoL and QoL trajectories (i.e., interaction with time).ResultsData from 278 patients was included. Post-RC EF scores increased from 83.7 (95% confidence interval [CI] 81.7-85.6) to levels comparable to the normative population (90.1) 8 years after RC. PF (post-RC: 82.4, 95% CI 78.5-86.3) and QoL-sum (post-RC: 88.2, 95% CI 85.2-91.2) remained lower compared to the normative population (88.9 and 91.4, respectively) 8 years after RC. Compared to patients with an American Society of Anesthesiologists (ASA) score of 1 at diagnosis, those with ASA score 2 or ASA score 3 had significant lower post-RC PF (mean difference (MD) = -8 and -22, respectively; P < 0.001), EF (MD = -1 and -11; P = 0.5 and P < 0.01) and QoL-sum (MD = -2 and -9; P = 0.2 and P < 0.01). In addition, patients with a higher ASA score had a worse QoL-sum trajectory (Pinteraction = 0.01). Older patients had a worse PF trajectory (Pinteraction < 0.01) but higher post-RC EF (P < 0.01).ConclusionsDirectly after RC, patients have lower PF, EF and QoL-sum, compared to a normative population. Notably, EF recovers to normative levels over a period of 8 years after RC. Clinicians are encouraged to administer supportive care interventions to enhance the QoL for patients undergoing RC, especially targeting older patients and those with higher ASA scores.

Project description:BackgroundPhysical activity is thought to be a key component in reducing postoperative complications following major abdominal surgery. The available literature on exercise interventions following radical cystectomy in patients with bladder cancer is scarce but suggests that physical activity and exercise might improve physical function and health-related quality of life, thus calling for further investigation. The CanMoRe-trial is a single-blinded randomised controlled trial (Clinicals Trials NCT03998579 25/06/2019), aimed at evaluating the impact of an exercise intervention in primary care following robot-assisted radical cystectomy. This study seeks to explore patients' experiences of the exercise intervention in the CanMoRe-trial to gain a better understanding of facilitating aspects and potential barriers.MethodsA qualitative study was conducted involving 20 patients from the intervention group of the CanMoRe-trial who were interviewed individually between October 2020 and March 2023 using a semi-structured interview guide. The interviews were recorded and transcribed verbatim and reflexive thematic analysis was used to analyse the data.ResultsFour main themes were identified: Having to adapt to new circumstances, describing the challenges regarding physical activity patients face after discharge. Optimising conditions for rehabilitation, describing how practical conditions affect patients' ability to exercise. Motivated to get back to normal, describing patients´ desire to get back to normal life and factors influencing motivation. Importance of a supportive environment, describing the impact of social support, support from physiotherapists, and how the environment where exercise takes place impacts patients' ability to exercise.ConclusionThis study found that patients participating in the CanMoRe-trial are positive towards physical exercise in PC following radical RARC. They are motivated to get back to normal life but face major challenges when arriving home following surgery, which affect their ability to perform physical activity and engage in exercise. Conditions need to be optimised to support patients' ability to engage in exercise by providing an accessible PC location to perform exercise in. A supportive environment is also needed, including guidance from healthcare professionals regarding which type of exercise, intensity and amount of exercise that should be performed, enabling patients gradually to develop self-efficacy regarding exercise and focusing on goals related to patients' normal lives before surgery.

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:Radical Cystectomy (RC) and Urinary Diversion (UD) is a complex surgery associated with a significant impact on health-related quality of life (HRQoL). However, HRQoL assessment is too often overlooked, with survival and complications being the most commonly investigated outcomes. This study aimed to identify the most impaired HRQoL features in patients receiving RC, compared to a healthy population (HP) control, as well as patients' recovery after surgery, differentiating between patients receiving ORC and RARC. Patients with Bca, who were candidates for RC with curative intent, were enrolled in the "BCa cohort". HRQoL outcomes were collected with an EORTC QLQ-C30 questionnaire. These were collected at baseline, and then at 6-, 12- and 24 mo after surgery in the BCa cohorts, and at baseline in the HP cohort. A 1:1 propensity score matched (PSM)-analysis, adjusted for age, Charlson Comorbidity Index (CCI) and smoking history, was performed. Between January 2018 and February 2023, a total of 418 patients were enrolled in the study, 116 and 302 in the BCa and HP cohorts, respectively. After applying the 1:1 propensity scored match (PSM) analysis, two homogeneous cohorts were selected, including 85 patients in each group. Baseline HRQoL assessment showed a significant impairment in terms of emotional and cognitive functioning, appetite loss and financial difficulties for the BCa cohort. Among secondary outcomes, we investigated patients' recovery after RC and UD, comparing HRQoL outcome questionnaires between the HP and BCa cohorts at 6-, 12- and 24 mo after surgery, and a subgroup analysis was performed differentiating between patients receiving ORC and RARC with totally intracorporeal UD. Interestingly, ORC compared to RARC provided a major impact on HRQoL recovery across the early, mid and long term. In particular, the ORC cohort experienced a major impairment in terms of symptoms scales items such as fatigue, nausea and vomiting, pain and appetite loss. Consequently, comparing ORC and RARC vs. HP reported a major HRQoL impairment in the ORC cohort, possibly defining a benefit of RARC in early, mid- and long-term recovery. To conclude, this study confirmed the undeniable impact of RC on HRQoL. Interestingly, we highlighted the benefit of RARC in early, mid- and long-term recovery, expressed as less impairment of symptoms scales.

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:BackgroundThe benefit of adjuvant chemotherapy remains controversial in muscle-invasive bladder cancer (MIBC) after radical cystectomy. The present study's primary objective was to construct a predictive tool for the reasonable application of adjuvant chemotherapy.MethodsAll of the patients analyzed in the present study were recruited from the Surveillance Epidemiology and End Results program between 2004 and 2015. Propensity score matching (PSM) was used to reduce inherent selection bias. Cox proportional hazards models were applied to identify the independent prognostic factors of overall survival (OS) and cancer-specific survival (CSS), which were further used to construct prognostic nomogram and risk stratification systems to predict survival outcomes. The prognostic nomogram's performance was assessed by concordance index (C-index), receiver-operating characteristic (ROC) and calibration curves. Decision curve analysis (DCA) was performed to evaluate the clinical net benefit of the prognostic nomogram.ResultsA total of 6,384 patients with or without adjuvant chemotherapy were included after PSM. Several independent predictors for OS and CSS were identified and further applied to establish a nomogram for 3-, 5- and 10-year, respectively. The nomogram showed favorable discriminative ability for the prediction of OS and CSS, with a C-index of 0.709 [95% confidence interval (CI): 0.699-0.719] for OS and 0.728 (95% CI: 0.718-0.738) for CSS. ROC and calibration curves showed satisfactory consistency. The DCA revealed high clinical positive net benefits of the prognostic nomogram. The different risk stratification systems showed that adjuvant chemotherapy resulted in better OS (P<0.001) and CSS (P<0.001) than without adjuvant chemotherapy for high-risk patients; while the OS (P=0.350) and CSS (P=0.260) for low-risk patients were comparable.ConclusionsWe have constructed a predictive model and different risk stratifications for selecting a population that could benefit from postoperative adjuvant chemotherapy. Adjuvant chemotherapy was found to be beneficial for high-risk patients, while low-risk patients should be carefully monitored.

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Prospective evaluation of sexual health following radical cystectomy due to bladder cancer

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