Dataset Information

Sex-Sparing Robot-Assisted Radical Cystectomy with Intracorporeal Padua Ileal Neobladder in Female: Surgical Technique, Perioperative, Oncologic and Functional Outcomes.

ABSTRACT: 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.

SUBMITTER: Tuderti G

PROVIDER: S-EPMC7073846 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Sex-Sparing Robot-Assisted Radical Cystectomy with Intracorporeal Padua Ileal Neobladder in Female: Surgical Technique, Perioperative, Oncologic and Functional Outcomes.

Tuderti Gabriele G Mastroianni Riccardo R Flammia Simone S Ferriero Mariaconsiglia M Leonardo Costantino C Anceschi Umberto U Brassetti Aldo A Guaglianone Salvatore S Gallucci Michele M Simone Giuseppe G

Journal of clinical medicine 20200220 2

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. ...[more]

PMID: 32093240

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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.

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: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.

Dataset Information

Sex-Sparing Robot-Assisted Radical Cystectomy with Intracorporeal Padua Ileal Neobladder in Female: Surgical Technique, Perioperative, Oncologic and Functional Outcomes.

Publications

Sex-Sparing Robot-Assisted Radical Cystectomy with Intracorporeal Padua Ileal Neobladder in Female: Surgical Technique, Perioperative, Oncologic and Functional Outcomes.

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