Dataset Information

Intracorporeal versus extracorporeal urinary diversion in robot-assisted radical cystectomy: a systematic review and meta-analysis.

ABSTRACT: This systematic review and meta-analysis aimed to assess and compare the perioperative and oncological outcomes of intracorporeal (ICUD) and extracorporeal (ECUD) urinary diversion following robot-assisted radical cystectomy (RARC). A systematic literature search of articles was performed in PubMed^®, Web of Science^®, and Scopus^® databases according to the Preferred Reporting Items for Systematic Review and Meta-Analysis statement. We included studies that compared patients who underwent RARC with ICUD to those with ECUD. Twelve studies including 3067 patients met the eligibility criteria. There were no significant differences between ICUD and ECUD in overall and major complications, regardless of the period (short-term [≤ 30 days] or mid-term [> 30 days]). Subgroup analyses demonstrated that ICUD performed by high-volume centers exhibited a significantly reduced risk of major complications (short-term: OR 0.57, 95% CI 0.37-0.86, p = 0.008, mid-term: OR 0.66, 95% CI 0.46-0.94, p = 0.02). Patients who underwent ICUD had lower estimated blood loss (MD -102.3 ml, 95% CI - 132.8 to - 71.8, p < 0.00001), less likely to receive blood transfusion rates (OR 0.36, 95% CI 0.20-0.62, p = 0.00003); and these findings were consistent in subgroup analyses by low-volume centers (MD-121.6 ml, 95% CI - 160.9 to - 82.3, p < 0.00001 and OR 0.36, 95% CI 0.20-0.62, p = 0.00003, respectively). ICUD had a higher lymph node yield (MD 3.68, 95% CI 0.80-6.56, p = 0.01). Patients receiving ICUD provided comparable complications, superior perioperative outcomes, and similar oncological outcomes compared with ECUD. Centralization of patients may contribute to a reduction of postoperative complications, while maintaining the advantages.

SUBMITTER: Katayama S

PROVIDER: S-EPMC8364906 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

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.

Project description:BackgroundRobot-assisted radical cystectomy (RARC) with urinary diversion has become a standard surgical procedure because of its three-dimensional high-definition surgical field of view, flexibility, and stability. However, because of the highly complex steps of surgery, postoperative complications cannot be ignored.MethodsThis retrospective, single-center, observational cohort study investigated the postoperative complications following RARC at a non-high-volume center in Japan. From August 2019 to March 2023, 50 consecutive patients who underwent RARC for histologically proven muscle-invasive bladder cancer (MIBC) or high-risk non-MIBC with an indication for radical cystectomy according to the Japanese Urological Association Guideline 2019 were included. Factors correlated with the selection of extracorporeal urinary diversion (ECUD) or cutaneous ureterostomy rather than intracorporeal urinary diversion (ICUD) for urinary diversion were also investigated.ResultsIn total, 33 (66%) and 31 (62%) patients experienced complications during the first 90 and 30 days after RARC, respectively. Among them, 19 (38%) and 18 (36%) patients developed Clavien-Dindo classification G2 complications, and 12 (24%) and 11 (22%) developed G3 or higher (major) complications during the first 90 and 30 days after RARC, respectively. The most common complications were gastrointestinal complications (26%) and urinary tract infections (22%). Nine patients (18%) underwent surgical intervention within 90 days of undergoing RARC. Higher infusion volume during the operations was significantly correlated with the occurrence of major complications within 90 days (P=0.025) and 30 days (P=0.0158) after RARC. Nineteen patients (38%) underwent non-ICUD. Twelve patients received ECUD as an ileal conduit or neobladder, and among them, three patients received ECUD due to intraabdominal adhesion for previous abdominal surgery or radiation, while four patients received ECUD ileal conduit due to comorbidities and advanced cases (palliative surgery) to shorten the surgery time.ConclusionsSurgical complications related to the initial experience with RARC at a non-high-volume center in Japan cannot be ignored. Although this complicated surgical procedure requires a learning curve to achieve a stable rate of much fewer major complications after RARC, careful assessment of patients' status before surgery and critical postoperative management may reduce complication rates more quickly, even at non-high-volume centers.

Project description:ObjectivesTo assess the utilisation trends of robot-assisted radical cystectomy (RARC), rates of performing continent urinary diversions (CUDs), and impact of diffusion of RARC on CUD rates.MethodsWe investigated the National Cancer Database for patients with muscle-invasive bladder cancer (MIBC) who underwent RC between 2004 and 2015. Patients were stratified by surgical technique into open (ORC) and RARC groups, and by type of urinary diversion into continent (CUD) and ileal conduit (ICUD) groups. Linear regression models were fitted to evaluate time trends for surgery and conversion techniques. Multivariate logistic regression models were utilised to identify independent predictors of RARC and CUD.ResultsA total of 14466 patients underwent RC for MIBC, of which 4914 (34%) underwent RARC. There was a significant increase in adoption of RARC from 22% in 2010 to 40% in 2015 (R2 = 0.96, P < 0.001), this was not associated with a change in the rates of CUD over the same period (P = 0.22). Across all years, ICUD was the primary type of urinary diversion, CUD was only offered in 12% in 2010 compared to 9.9% in 2015 (R2 = 0.33, P = 0.22). Multivariate analysis identified male gender (odds ratio [OR] 1.18, P = 0.03), academic centres (OR 1.74, P = 0.001), and lower T stage (T4 vs T2; OR 0.78, P = 0.03) as independent predictors of CUD, while surgical technique was not associated with odds of receiving CUD (P = 0.8).ConclusionsThere is significant nationwide increasing trend of adoption of RARC. This diffusion was not associated with a decline in CUD, which remains significantly underutilised in both ORC and RARC groups. Abbreviations CUD: continent urinary diversion; ICD-O: International Classification of Diseases for Oncology; ICUD: ileal conduit urinary diversion; (N)MIBC: (non-)muscle-invasive bladder cancer; NAC, neoadjuvant chemotherapy; NCDB: National Cancer Database; OR: odds ratio;(O)(RA)RC: (open) (robot-assisted) radical cystectomy.

Project description:BackgroundThe number of robotic assisted radical cystectomy (RARC) procedures is increasing despite the lack of Level I evidence showing any advantages over open radical cystectomy (ORC). However, several systematic reviews with meta-analyses including non-randomised studies, suggest an overall benefit for RARC compared to ORC. We performed a systematic review with meta-analysis of randomised controlled trials (RCTs) to evaluate the perioperative morbidity and efficacy of RARC compared to ORC in patients with bladder cancer.MethodsLiterature searches of Medline/Pubmed, Embase, Web of Science and clinicaltrials.gov databases up to 10th March 2016 were performed. The inclusion criteria for eligible studies were RCTs which compared perioperative outcomes of ORC and RARC for bladder cancer. Primary objective was perioperative and histopathological outcomes of RARC versus ORC while the secondary objective was quality of life assessment (QoL), oncological outcomes and cost analysis.ResultsFour RCTs (from 5 articles) met the inclusion criteria, with a total of 239 patients all with extracorporeal urinary diversion. Patient demographics and clinical characteristics of RARC and ORC patients were evenly matched. There was no significant difference between groups in perioperative morbidity, length of stay, positive surgical margin, lymph node yield and positive lymph node status. RARC group had significantly lower estimated blood loss (p<0.001) and wound complications (p = 0.03) but required significantly longer operating time (p<0.001). QoL was not measured uniformly across trials and cost analysis was reported in one RCTs. A test for heterogeneity did highlight differences across operating time of trials suggesting that surgeon experience may influence outcomes.ConclusionsThis study does not provide evidence to support a benefit for RARC compared to ORC. These results may not have inference for RARC with intracorporeal urinary diversion. Well-designed trials with appropriate endpoints conducted by equally experienced ORC and RARC surgeons will be needed to address this.

Project description:ObjectivesTo evaluate the postoperative complication and mortality rate following laparoscopic radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) in octogenarians.Patients and methodsWe conducted a retrospective analysis comparing postoperative complication and mortality rates depending on age in a consecutive series of 1890 patients who underwent RARC with ICUD for bladder cancer between 2004 and 2018 in 10 European centres. Outcomes of patients aged <80 years and those aged ≥80 years were compared with regard to postoperative complications (Clavien-Dindo grading) and mortality rate. Cancer-specific mortality (CSM) and other-cause mortality (OCM) after surgery were calculated using the non-parametric Aalen-Johansen estimator.ResultsA total of 1726 patients aged <80 years and 164 aged ≥80 years were included in the analysis. The 30- and 90-day rate for high-grade (Clavien-Dindo grades III-V) complications were 15% and 21% for patients aged <80 years compared to 11% and 13% for patients aged ≥80 years (P = 0.2 and P = 0.03), respectively. In a multivariable logistic regression analysis adjusting for pre- and postoperative variables, age ≥80 years was not an independent predictor of high-grade complications (odds ratio 0.6, 95% confidence interval 0.3-1.1; P = 0.12). The non-cancer-related 90-day mortality was 2.3% for patients aged ≥80 years and 1.8% for those aged <80 years, respectively (P = 0.7). The estimated 12-month CSM and OCM rates for those aged <80 years were 8% and 3%, and for those aged ≥80 years, 15% and 8%, respectively (P = 0.009 and P < 0.001).ConclusionsThe minimally invasive approach to RARC with ICUD for bladder cancer in well-selected elderly patients (aged ≥80 years) achieved a tolerable high-grade complication rate; the 90-day postoperative mortality rate was driven by cancer progression and the non-cancer-related rate was equivalent to that of patients aged <80 years. However, an increased OCM rate in this elderly group after the first year should be taken into account. These results will support clinicians and patients when balancing cancer-related vs treatment-related risks and benefits.

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.

Dataset Information

Intracorporeal versus extracorporeal urinary diversion in robot-assisted radical cystectomy: a systematic review and meta-analysis.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets