Is Health-Related Quality of Life after Radical Cystectomy Using Validated Questionnaires Really Better in Patients with Ileal Orthotopic Neobladder Compared to Ileal Conduit: A Meta-Analysis of Retrospective Comparative Studies.
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SUBMITTER: Cerruto MA
PROVIDER: S-EPMC5527227 | biostudies-other | 2017 Jul
REPOSITORIES: biostudies-other
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Project description:PurposeThe aim of this study was to compare the body images of patients who underwent radical cystectomy with an orthotopic ileal neobladder or an ileal conduit.Materials and methodsA total of 114 adult patients who underwent radical cystectomy between March 2006 and December 2012 at a single institution, Ewha Womans University Mokdong Hospital in Korea, were evaluated in this retrospective chart-review study. Forty-two patients (29 orthotopic ileal neobladder and 13 ileal conduit) who completed questionnaires were included in the final analysis; the remaining patients were excluded. The patients were assessed with two questionnaires: the Korean version of the Body Image Scale (K-BIS) and the self-designed questionnaire.ResultsThe results did not differ significantly by age at surgery, time from surgery to survey, pathologic stage, grade, histologic subtype, education, residency, or Eastern Cooperative Oncology Group performance status, but did differ significantly by age at survey and sex. The mean summary score for K-BIS showed significant differences between the two groups (p=0.001). We found that patients who underwent an orthotopic ileal neobladder had a significantly better body image. The self-designed questionnaire score was not significantly different between the two groups (p=0.572).ConclusionsIn our retrospective analysis, patients who underwent orthotopic ileal neobladder had a superior body image compared with those who underwent an ileal conduit.
| S-EPMC3956943 | biostudies-literature
Project description:BackgroundRadical cystectomy (RC) with urinary diversion is the recommended treatment for selected cases of non-metastatic high-risk non-muscle-invasive and muscle-invasive bladder cancer. It remains unknown whether robot-assisted laparoscopic cystectomy (RARC) offers any advantage in terms of safety compared to open cystectomy (ORC) in an Enhanced Recovery After Surgery (ERAS) setup. Blinded randomised controlled trials (RCTs) between RARC versus ORC have never been conducted in cystectomy patients. We will investigate the feasibility of conducting a double-blinded RCT comparing ORC with RARC with intra-corporal ileal conduit (iRARC) in an ERAS setup.MethodsThis is a single-centre, double-blinded, randomised (1:1) clinical feasibility study for patients with non-metastatic high-risk non-muscle-invasive or muscle-invasive bladder cancer scheduled for cystectomy. All participants are recruited from Rigshospitalet, Denmark. The planned sample size is 50 participants to investigate whether blinding of the surgical technique is feasible. Participants and postoperative caring physicians and nurses are blinded using a pre-study designed abdominal dressing and blinding of the patient's electronic health record. Study endpoints are assessed 90 days postoperatively. The primary aim is to study the frequency and pattern of unplanned unblinding after surgery and the number of participants who cannot guess the surgical technique at the day of discharge. Eleven secondary endpoints are assessed: length of stay, days alive and out of hospital, in-hospital complication rate, 30-day complication rate, 90-day complication rate, readmission rate, quality of life, blood loss, pain, rate of moderate/severe post-anaesthesia care unit (PACU) complications, and delirium. Participants are managed in an ERAS setup in both arms of the trial.DiscussionWe report on the design and objectives of a novel experimental feasibility study investigating whether blinding of the surgical technique in cystectomy patients is possible. This information is essential for the design of future blinded trials comparing ORC to RARC. There is a continued need to compare RARC and ORC in terms of both efficacy, safety, and oncological outcomes. Estimated end of study is March 2021.Trial registrationClinicalTrials.gov ID: NCT03977831. Registered on the 6th of June 2019.
| S-EPMC9838067 | biostudies-literature
Project description:ObjectiveIleal conduit urinary diversion (ICUD) is the most common procedure after radical cystectomy. Although complications have been reported, few patients with ICUD and bladder preservation controls have been available for long-term follow-up. This study compared the long-term effect of structural changes after cystectomy with ICUD to that in bladder preservation controls.DesignA retrospective nationwide cohort study.SettingData retrieved from the Taiwan National Health Insurance Research Database.ParticipantsThe National Health Insurance database was explored for patients diagnosed with bladder cancer between 1997 and 2006. Only cancer-free patients without chemotherapy and other types of urinary diversion who lived for >5 years were included in the analysis.Outcome measuresPatient characteristics, comorbidity and postoperative urinary tract disease were statistically analysed and compared. Cox proportional hazards model was used to evaluate the incidence rates of outcomes after adjustment for covariates. Propensity scores analysis was used to balance the clinical parameters between groups. The primary outcomes were postoperative new-onset urinary tract disease such as urinary tract infection (UTI), UTI with septicaemia and chronic kidney disease (CKD), or calculus of kidney and ureter.ResultsThere were 11?185 patients included in our cohort, among which 703 (6.3%) and 10?482 (93.7%) patients received ICUD and bladder preservation procedure, respectively. Compared with patients who only underwent a bladder preservation procedure, those who had undergone ICUD after cystectomy were independently associated with postoperative de novo urinary tract disease. Propensity score analysis (1:4) was also performed. ICUD contributed to significantly higher new-onset UTI, UTI with sepsis and CKD (HR=1.30, 3.16, 1.35, respectively) compared with bladder preservation procedure after adjustment for age, gender and comorbidities.ConclusionICUD after radical cystectomy was associated with a higher incidence of UTI, UTI with septicaemia and CKD during long-term follow-up than the incidences following a bladder preservation procedure.
| S-EPMC6292418 | biostudies-literature
Project description:Robot-assisted/laparoscopic intracorporeal ileal conduit (ICIC) has been reported in many experienced centers. Whether laparoscopic ICIC is superior to extracorporeal ileal conduit (ECIC) and whether laparoscopic ICIC should be promoted is still controversial. The aim of the study was to compare surgical and early oncological outcomes between patients undergoing laparoscopic radical cystectomy (LRC) with ICIC and ECIC.From January 2011 to June 2016, a total of 45 patients with bladder cancer underwent LRC with ileal conduit at our department, of whom 20 patients underwent LRC with ECIC and 25 patients underwent LRC with ICIC. Data of each patient's characteristics, surgical outcomes, and short-term oncological outcomes were collected and analyzed.LRC with ileal conduit was performed successfully on all 45 patients. There were no significant differences in patients' characteristics, mean total operative time, and mean estimated blood loss between the ICIC and ECIC groups. Median time of flatus and oral intake was shorter in the ICIC group compared with the ECIC group (3 vs. 5 days, P = 0.035; 4 vs. 5 days, P = 0.002). The complications rates did not show significant difference between the two groups within the first 90 days postoperatively (P = 0.538). Cancer staging showed 45% of patients in the ECIC group and 36% in the ICIC group had a pathologic stage of T3 or T4, and 50% of patients in the ECIC group and 44% in the ICIC group had a pathologic stage of N1 or N1+. Kaplan-Meier analysis showed no significant difference in overall survival at 24 months (60% vs. 62%, P = 0.857) between the ECIC and ICIC groups.ICIC after LRC may be successful with the benefits of faster recovery time. No significant difference was found in complications and oncological outcomes between ICIC and ECIC. However, larger series with longer follow-up are needed to validate this procedure.
| S-EPMC5887736 | biostudies-literature
Project description:BackgroundBladder cancer (BCa) is the most common urinary malignancy. The standard surgical treatment for patients with muscle-invasive BCa is cystectomy plus urinary diversion. Ileal conduit (IC) or orthotopic neobladder (ON), which have different indications, are the most commonly performed urinary diversions.Methods and materialsWe sampled 5480 BCa patients from the Surveillance, Epidemiology, and End Results (SEER) database from 2004 to 2015. Kaplan-Meier method with the log-rank test was used to assess cancer-specific survival (CSS) and overall survival (OS). Univariate and multivariate Cox's proportional hazard model was conducted to evaluate the hazard ratio of cancer-specific mortality and all-cause mortality before and after propensity score matching (PSM).ResultsWe identified 5480 patients who received radical cystectomy (RC) plus IC (n = 5071) or ON (n = 409) with a median follow-up period of 33 months (interquartile range, 13-78 months). Patients in the ON group tended to be male and younger, with a higher percentage of married individuals, early pathological T stage, lymphadenectomy, and non-radiotherapy (all P < .05). After 1:1 PSM, 409 matched pairs were selected. Univariate and multivariate analysis showed that the ON group had better CSS and OS probabilities than the IC group in the overall cohort [hazard ratio (HR): 0.692, 95% confidence intervals (CI): 0.576-0.831, P < .001; HR: 0.677, 95% CI: 0.579-0.793, P < .001 respectively]. However, subgroup analysis revealed that only patients with pathological T2 stage benefited from ON diversion after PSM in the context of CSS (P = .016) and OS (P <.001).ConclusionsYoung, married, and male patients with early pathological T stage, especially T2 stage, were more suitable to receive RC plus ON surgery, which could improve their probability of survival.
| S-EPMC7571812 | biostudies-literature
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:Open radical cystectomy (ORC) and urinary diversion in patients with bladder cancer (BCa) are associated with significant perioperative complication risk.To compare perioperative complications between robot-assisted radical cystectomy (RARC) and ORC techniques.A 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.Standard ORC or RARC with PLND; all urinary diversions were performed via an open approach.Primary 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.The 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.This 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.Of 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.ClinicalTrials.gov identifier NCT01076387, www.clinicaltrials.gov.
| S-EPMC4424172 | biostudies-literature
Project description:Our aim was to illustrate our technique of sex-sparing (SS)-robot-assisted radical cystectomy (RARC) in female patients receiving an intracorporeal neobladder (iN). From January 2013 to June 2018, 11 female patients underwent SS-RARC-iN at a single tertiary referral center. Inclusion criteria were a cT ? 2 N0 M0 bladder tumor at baseline imaging (CT or MRI) and an absence of tumors in the bladder neck, trigone and urethra at TURB. Baseline, perioperative, and outcomes at one year were reported. The median operative time was 255 min and the median hospital stay was seven days. Low-grade Clavien complications occurred in four patients (36.3%), while high-grade complications were not observed in any. Seven patients (63.7%) had an organ-confined disease at the pathologic specimen; nodal involvement and positive surgical margins were not detected in any of the cases. At a median follow-up of 28 months (IQR 14-51), no patients developed new onset of chronic kidney disease stage 3b. After one year, daytime and nighttime continence rates were 90.9% and 86.4% respectively. Quality of life as well as physical and emotional functioning improved significantly over time (all p ? 0.04), while urinary symptoms and sexual function worsened at three months with a significant recovery taking place at one year (all p ? 0.04). Overall, 8 out of 11 patients (72.7%) were sexually active at the 12-month evaluation. In select female patients, SS-RARC-iN is an oncologically sound procedure associated with favorable perioperative and functional outcomes.
| S-EPMC7073846 | 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: Not available
| S-EPMC8317860 | biostudies-literature