Dataset Information

Morbidity and mortality after robot-assisted radical cystectomy with intracorporeal urinary diversion in octogenarians: results from the European Association of Urology Robotic Urology Section Scientific Working Group.

ABSTRACT:

Objectives

To evaluate the postoperative complication and mortality rate following laparoscopic radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) in octogenarians.

Patients and methods

We 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.

Results

A 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).

Conclusions

The 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.

SUBMITTER: Mortezavi A

PROVIDER: S-EPMC8246851 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe utilisation of robot-assisted radical cystectomy with intracorporeal reconstruction (iRARC) has increased in recent years. Little is known about the length of the learning curve (LC) for this procedure.ObjectiveTo study the length of the LC for iRARC in terms of 90-d major complications (MC90; Clavien-Dindo grade ≥3), 90-d overall complications (OC90, Clavien-Dindo grades 1-5), operating time (OT), estimated blood loss (EBL), and length of hospital stay (LOS).Design setting and participantsThis was a retrospective analysis of all consecutive iRARC cases from nine European high-volume hospitals with ≥100 cases. All patients had bladder cancer for which iRARC was performed, with an ileal conduit or neobladder as the urinary diversion.Outcome measurements and statistical analysisOutcome parameters used as a proxy for LC length were the number of consecutive cases needed to reach a plateau level in two-piece mixed-effects models for MC90, OC90, OT, EBL, and LOS.Results and limitationsA total of 2186 patients undergoing iRARC between 2003 and 2018were included. The plateau levels for MC90 and OC90 were reached after 137 cases (95% confidence interval [CI] 80-193) and 97 cases (95% CI 41-154), respectively. The mean MC90 rate at the plateau was 14% (95% CI 7-21%). The plateau level was reached after 75 cases (95% CI 65-86) for OT, 88 cases (95% CI 70-106) for EBL, and 198 cases (95% CI 130-266) for LOS. A major limitation of the study is the difference in the balance of urinary diversion types between centres.ConclusionsThis multicentre retrospective analysis for the iRARC LC among nine European centres showed that 137 consecutive cases were needed to reach a stable MC90 rate.Patient summaryWe carried out a multicentre analysis of the surgical learning curve for robot-assisted removal of the bladder and bladder reconstruction in patients with bladder cancer. We found that 137 consecutive cases were needed to reach a stable rate of serious complications.

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.

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Project description:Introduction and Objective:Robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) has become an increasingly utilized approach to treating various bladder pathologies requiring extirpation. As surgeons have become more experienced with ICUD, especially with lesser-used diversions such as continent cutaneous reservoirs, the technique has evolved. Methods:We describe our technique and recent advances in the practical creation of robotic ICUD with a continent catheterizable pouch (CCP) built upon the open principles of the previously described "Indiana Pouch, " which uses the distal ileum and right colon. Modifications in anatomic mobilization and exposure, bowel segmentation using novel robotic bowel staplers, catheterizable channel creation, and addition of ileal chimney for uretero-enteric anastomoses are highlighted. The addition of the ileal chimney allows for ease of reconstruction in a fashion familiar to surgeons accustomed to performing intracorporeal ileal conduit and, therefore, may result in lower ureteroenteric stricture rates. Table 1 demonstrates the supplies used intraoperatively. Use of indocyanine green to assess vascularity in bowel and ureter intraoperatively is demonstrated. The port configurations are demonstrated using the DaVinci ® Xi platform. Also described are short-term outcomes of our initial experience. Results:Eleven consecutive patients (5 female) who have undergone ICUD with CCP were included. Of the eleven seven had malignant indications (bladder or urethral cancer) while 4 were for benign causes (2 radiation cystitis 2 interstitial cystitis). Mean blood loss was 235cc (range 100-500cc) and mean operative time was 8.5 h (range 7-13). There were no conversions to an open procedure and no patient required a blood transfusion. Hospital stay was 7.2 days on average (range 4-18) with no 30-day post-discharge readmissions. One patient had a Clavien grade 3 or greater complication at 30 days (Table 2). No urine leaks or bowel leaks were observed and no patien experienced stomal stenosis or uretero-enteric stenosis. At three months follow up, all patients were continent and satisfied with their diversion. Conclusions:RARC with CCP ICUD is a safe and effective approach to bladder removal and reconstruction. As more surgeons utilize RARC, growing attention to techniques of intracorporeal reconstruction will allow further implementation of this technique to cystectomy patients. Patients with adequate renal function (glomerular filtration rate of 40 mL/min or greater) and hepatic function, who understand the requirement for regular clean intermittent-catheterization and who possess mental acuity and manual dexterity to empty their pouch 4-6 times daily should be offered CCP ICUD as a reconstructive option following RARC.