Best Practices in Robot-assisted Radical Cystectomy and Urinary Reconstruction: Recommendations of the Pasadena Consensus Panel

doi:10.1016/j.eururo.2014.12.009

European Urology

Volume 67, Issue 3, March 2015, Pages 363-375

https://doi.org/10.1016/j.eururo.2014.12.009 Get rights and content

Abstract

Context

Robot-assisted surgery is increasingly used for radical cystectomy (RC) and urinary reconstruction. Sufficient data have accumulated to allow evidence-based consensus on key issues such as perioperative management, comparative effectiveness on surgical complications, and oncologic short- to midterm outcomes.

Objective

A 2-d conference of experts on RC and urinary reconstruction was organized in Pasadena, California, and the City of Hope Cancer Center in Duarte, California, to systematically review existing peer-reviewed literature on robot-assisted RC (RARC), extended lymphadenectomy, and urinary reconstruction. No commercial support was obtained for the conference.

Evidence acquisition

A systematic review of the literature was performed in agreement with the PRISMA statement.

Evidence synthesis

Systematic literature reviews and individual presentations were discussed, and consensus on all key issues was obtained. Most operative, intermediate-term oncologic, functional, and complication outcomes are similar between open RC (ORC) and RARC. RARC consistently results in less blood loss and a reduced need for transfusion during surgery. RARC generally requires longer operative time than ORC, particularly with intracorporeal reconstruction. Robotic assistance provides ergonomic value for surgeons. Surgeon experience and institutional volume strongly predict favorable outcomes for either open or robotic techniques.

Conclusions

RARC appears to be similar to ORC in terms of operative, pathologic, intermediate-term oncologic, complication, and most functional outcomes. RARC consistently results in less blood loss and a reduced need for transfusion during surgery. RARC can be more expensive than ORC, although high procedural volume may attenuate this difference.

Patient summary

Robot-assisted radical cystectomy (RARC) is an alternative to open surgery for patients with bladder cancer who require removal of their bladder and reconstruction of their urinary tract. RARC appears to be similar to open surgery for most important outcomes such as the rate of complications and intermediate-term cancer-specific survival. Although RARC has some ergonomic advantages for surgeons and may result in less blood loss during surgery, it is more time consuming and may be more expensive than open surgery.

Introduction

Bladder cancer is one of the most common [1] and expensive malignancies to manage [2]. Radical cystectomy (RC) with urinary reconstruction is a complex, time-consuming surgery associated with significant morbidity [3]. Approximately 7000 RCs were performed annually from 2001 to 2010 in the United States [4]. The number of these procedures performed with robotic assistance rose dramatically (0.6–12.8%) from 2004 to 2010 [5].

The expanding evidence base for robot-assisted RC (RARC) now allows preliminary conclusions to be drawn about the comparative effectiveness of RARC versus open RC (ORC). This consensus summarizes existing data using up-to-date systematic reviews of the literature (presented elsewhere in this issue of European Urology [6], [7]) and best practices for cystectomy and urinary reconstruction as developed by an international panel of expert ORC and RARC surgeons who met in Pasadena, California, and at the City of Hope Cancer Center, Duarte, California, USA, in May 2014.

Section snippets

Evidence acquisition

A systematic review of published literature related to RARC was performed in September 2013 using Medline, Scopus, and Web of Science, with an update performed in April 2014. The keywords robot-assisted radical cystectomy, da Vinci radical cystectomy, and robot* radical cystectomy were used across these search fields: surgical series (prospective and retrospective) and comparative studies (prospective and retrospective, randomized and nonrandomized) evaluating RARC. Partial cystectomy,

Perioperative management

Perioperative management of patients undergoing RARC is identical to that for patients undergoing ORC. The PCP considered systematic review data, recent high-quality studies, and existing guidelines of the European Association of Urology (EAU) [9], the International Consultation on Urological Diseases [10], and the Enhanced Recovery After Surgery (ERAS) Society [11]. The evidence-based guidelines for pre- and postoperative care after RC developed by ERAS, in particular, were judged to provide

Conclusions

Robot-assisted techniques are increasingly used for RC and urinary reconstruction. This paper summarized existing data using a current set of systematic literature reviews and presented recommendations from an international panel of leading surgeons. RARC appears to be broadly equivalent to ORC in terms of morbidity and mortality, oncologic outcomes, and complication rates. RARC appears to result in less EBL and a reduced need for transfusion during surgery, and it provides ergonomic value for

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Cited by (160)

Robot-assisted Radical Cystectomy with Totally Intracorporeal Urinary Diversion Versus Open Radical Cystectomy: 3-Year Outcomes from a Randomised Controlled Trial
2024, European Urology
Randomised controlled trials (RCTs) comparing open radical cystectomy (ORC) and robot-assisted RC (RARC) have involved an extracorporeal approach for urinary diversion (UD), undermining the potential benefits of a totally robotic procedure. Our objective was to compare 3-yr outcomes from a RCT comparing ORC to RARC with totally intracorporeal UD (iUD).
Patients with cT2–4 N0 M0 or bacillus Calmette-Guérin–failed high-grade non–muscle-invasive urothelial carcinoma who were candidates for RC without absolute contraindications to robotic surgery were included. A covariate adaptive randomisation process based on body mass index, American Society of Anesthesiologists score, preoperative haemoglobin, type of UD, neoadjuvant chemotherapy, and cT stage was used. The primary endpoint was to investigate the superiority of RARC with iUD in terms of a 50% reduction in transfusion rate. Secondary outcomes included adherence to an early recovery after surgery protocol, perioperative and postoperative outcomes, readmission and complication rates, a cost analysis, and functional, oncological, and health-related quality-of-life outcomes.
Overall, 116 patients were enrolled. The primary endpoint was confirmed, as the overall perioperative transfusion rate was significantly lower in the RARC cohort, with an absolute risk reduction of 19% (95% confidence interval 2–36%; p = 0.046). No differences in perioperative and postoperative complications and 3-yr oncological outcomes were observed between the groups. Despite the superiority of ORC on quantitative analysis of night-time pad use, there were no differences in the probabilities of recovery of daytime and night-time continence. Body image was significantly better in the RARC cohort. Cost analysis confirmed that RARC is a more expensive surgical procedure.
Our findings support RARC with iUD as a safe surgical option; the transfusion rate was reduced by 50% and the complication rates and 3-yr oncological outcomes were comparable to those with ORC. The minimally invasive nature of RARC was reflected in better body image perception in this cohort. The probabilities of daytime and night-time continence recovery were comparable between the groups. Higher costs remain a drawback of robotic surgery.
This RCT demonstrated a 50% transfusions rate’s reduction compared to ORC. We confirmed safety and feasibility of RARC with i-UD providing comparable peri- and postoperative complication rates, as well as, 3yr oncologic outcomes to those of ORC. Patients receiving either RARC-iUD or ORC had comparable probabilities of urinary continence recovery after surgery.
Atlas of Intracorporeal Orthotopic Neobladder Techniques After Robot-assisted Radical Cystectomy and Systematic Review of Clinical Outcomes
2024, European Urology
Multiple and heterogeneous techniques have been described for orthotopic neobladder (ONB) reconstruction after robot-assisted radical cystectomy. Nonetheless, a systematic assessment of all the available options is lacking.
To provide the first comprehensive step-by-step description of all the available techniques for robotic intracorporeal ONB together with individual intraoperative, perioperative and functional outcomes based on a systematic review of the literature.
We performed a systematic review of the literature, and MEDLINE/PubMed, Embase, Scopus, and Web of Science databases were searched to identify original articles describing different robotic intracorporeal ONB techniques and reporting intra- and perioperative outcomes. Studies were categorized according to ONB type, providing a synthesis of the current evidence. Video material was provided by experts in the field to illustrate the surgical technique of each intracorporeal ONB.
Nine different ONB types were identified: Studer, Hautmann, Y shape, U shape, Bordeaux, Pyramid, Shell, Florence Robotic Intracorporeal Neobladder, and Padua Ileal Neobladder.
Continuous and categorical variables are presented as mean ± standard deviation and as frequencies and proportions, respectively.
Of 2587 studies identified, 19 met our inclusion criteria. No cohort studies or randomized control trials comparing different neobladder types are available. Available techniques for intracorporeal robotic ONB reconstruction have similar operative time, estimated blood loss, intraoperative complications, and length of stay. Major variability exists concerning postoperative complications and functional outcomes, likely related to reporting bias.
Several techniques are described for intracorporeal ONB during robot-assisted radical cystectomy with comparable perioperative outcomes. We provide the first step-by-step surgical atlas for robot-assisted ONB reconstruction. Further comparative studies are needed to assess any advantage of one technique over others.
Patients elected for radical cystectomy should be aware that multiple techniques for robotic orthotopic neobladder are available, but that current evidence does not favor one type over the others.
Stentless florence robotic intracorporeal neobladder (FloRIN), a feasibility prospective randomized clinical trial
2024, European Journal of Surgical Oncology
Aim of the study was to evaluate perioperative, postoperative and mid-term functional outcomes of Florence intracorporeal neobladder (FloRIN) configuration technique performed with stentless procedure.
This single institution randomized 1:1 prospective series included consecutive patients treated with Robot-Assisted Radical Cystectomy (RARC) and FloRIN reconfiguration from January 2021 to February 2022. Postoperative complications were graded according to Clavien Dindo classification and divided in early (<30 days from discharge) and delayed (>30 days).
Overall, 63 patients were included in the analysis. Among these 32 (50.8 %) were treated with RARC + stentless FloRIN while 31 (49.2 %) underwent stent placement procedure. No differences were found in terms of baseline characteristics between the two groups. Stentless procedure was associated with significant shorter console time 328 vs 374 min (p = 0.04) and lower estimated blood loss (EBL) 330 vs 350 ml (p = 0.04) comparing to stent group. As regards perioperative features, no significant differences were recorded in terms of canalization (p = 0.58) and time to drainage removal (p = 0.11) while a shorter length of hospital stay was found in case of stentless procedure (p = 0.04). Early postoperative complications Clavien ≥ 3a occurred in 9.3 % and 12.9 % of patients while delayed major complications were recorded in the 3.1 % and 9.6 % of patients treated with stentless and stent FloRIN, respectively (p = 0.09). As regards the mid-term functional outcomes, no differences were found in terms of kidney function loss in both 3rd and 6th month assessment (p = 0.13 and p = 0.14, respectively).
In conclusion, Stentless FloRIN is a feasible and safe IntraCorporeal Neobladder technique, as confirmed by the worthy functional and perioperative outcomes achieved in comparison with the standard FloRIN ureteral management strategy.
Perioperative and Functional Results for Robot-assisted Radical Cystectomy with Totally Intracorporeal Neobladder in Male Patients via the Vesica Patavina (Ves.Pa.) Technique: IDEAL Stage 2a Report
2023, European Urology Open Science
Robot-assisted radical cystectomy (RARC) offers several advantages over open surgery, but intracorporeal neobladder construction (INC) is a challenging procedure. The vesica patavina (Ves.Pa.) refinement is a modification of the original technique that simplifies the neobladder configuration and reduces the risk of complications.
To present a stage 2a IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up) report on RARC with INC using the Ves.Pa. technique.
This was a prospective study of consecutive male patients undergoing RARC and Ves.Pa. INC performed by a single surgeon for muscle-invasive or non–muscle-invasive, bacillus Calmette-Guérin–refractory urothelial bladder cancer in a tertiary referral center.
RARC with INC using the refined Ves.Pa. technique.
Complications were classified using the Clavien-Dindo scheme, and functional outcomes were assessed using validated questionnaires.
A total of 20 male patients were treated. The median operative time was 382 min, and the median estimated blood loss was 350 ml. The incidence of high-grade complications was extremely low, with only one patient experiencing a grade IIIa complication. All patients had clear surgical margins. At median follow-up of 12 mo, statistically significant differences in all the functional scores measured were observed. Specifically, 6-mo parameters were all significantly worse than at baseline (all p < 0.05). No patients required intermittent catheterization. Severe urinary incontinence was experienced by approximately 25% of the patients. The median number of pad used was 0 during the day and 1 at night. The study is limited by its small sample size, single-center design, and short follow-up.
RARC with the refined Ves.Pa. technique for INC is safe, feasible, and replicable. The technique simplifies the procedure and reduces the risk of complications. The study results suggest acceptable oncological and functional outcomes over short-term follow-up.
We report our initial experience with robot-assisted removal of the bladder and construction of a new bladder using our modified technique, called Ves.Pa., in patients with bladder cancer. The technique is simple to perform. We observed a low rate of high-grade complications, and patients had surgical margins negative for cancer in all cases and fair functional outcomes at 12-month follow-up.
Robot-assisted Radical Cystectomy Versus Open Radical Cystectomy: A Systematic Review and Meta-analysis of Perioperative, Oncological, and Quality of Life Outcomes Using Randomized Controlled Trials
2023, European Urology
Differences in recovery, oncological, and quality of life (QoL) outcomes between open radical cystectomy (ORC) and robot-assisted radical cystectomy (RARC) for patients with bladder cancer are unclear.
This review aims to compare these outcomes within randomized trials of ORC and RARC in this context. The primary outcome was the rate of 90-d perioperative events. The secondary outcomes included operative, pathological, survival, and health-related QoL (HRQoL) measures.
Systematic literature searches of MEDLINE, Embase, Web of Science, and clinicaltrials.gov were performed up to May 31, 2022.
Eight trials, reporting 1024 participants, were included. RARC was associated with a shorter hospital length of stay (LOS; mean difference [MD] 0.21, 95% confidence interval [CI] 0.03–0.39, p = 0.02) than and similar complication rates to ORC. ORC was associated with higher thromboembolic events (odds ratio [OR] 1.84, 95% CI 1.02–3.31, p = 0.04). ORC was associated with more blood loss (MD 322 ml, 95% CI 193–450, p < 0.001) and transfusions (OR 2.35, 95% CI 1.65–3.36, p < 0.001), but shorter operative time (MD 76 min, 95% CI 39–112, p < 0.001) than RARC. No differences in lymph node yield (MD 1.07, 95% CI –1.73 to 3.86, p = 0.5) or positive surgical margin rates (OR 0.95, 95% CI 0.54–1.67, p = 0.9) were present. RARC was associated with better physical functioning or well-being (standardized MD 0.47, 95% CI 0.29–0.65, p < 0.001) and role functioning (MD 8.8, 95% CI 2.4–15.1, p = 0.007), but no improvement in overall HRQoL. No differences in progression-free survival or overall survival were seen. Limitations may include a lack of generalization given trial patients.
RARC offers various perioperative benefits over ORC. It may be more suitable in patients wishing to avoid blood transfusion, those wanting a shorter LOS, or those at a high risk of thromboembolic events.
This study compares robot-assisted keyhole surgery with open surgery for bladder cancer. The robot-assisted approach offered less blood loss, shorter hospital stays, and fewer blood clots. No other differences were seen.
Current best practice for bladder cancer: a narrative review of diagnostics and treatments
2022, The Lancet
Citation Excerpt :
Most guidelines recommend that a discussion of all variations of urinary diversion (non-continent diversion, continent diversion with orthotopic neobladder, or otherwise) should be made available to all patients, but the ultimate decision depends on the extent of tumour, comorbidities, age, and patient's motivation.12 Minimally invasive techniques, such as robot-assisted radical cystectomy, have shown equivalent oncological results compared with open cystectomy.60 The surgical procedure, individual patient factors, hospital volume, surgical skills, and experience contribute to surgical complications, mortality, and thus overall outcome.12
This Seminar presents the current best practice for the diagnosis and management of bladder cancer. The scope of this Seminar ranges from current challenges in pathology, such as the evolving histological and molecular classification of disease, to advances in personalised medicine and novel imaging approaches. We discuss the current role of radiotherapy, surgical management of non-muscle-invasive and muscle-invasive disease, highlight the challenges of treatment of metastatic bladder cancer, and discuss the latest developments in systemic therapy. This Seminar is intended to provide physicians with knowledge of current issues in bladder cancer.

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RARC Pasadena Consensus Panel – ReviewEditorial by Monish Aron and Inderbir S. Gill on pp. 361–362 of this issueBest Practices in Robot-assisted Radical Cystectomy and Urinary Reconstruction: Recommendations of the Pasadena Consensus Panel

Abstract

Context

Objective

Evidence acquisition

Evidence synthesis

Conclusions

Patient summary

Introduction

Section snippets

Evidence acquisition

Perioperative management

Conclusions

Eur Urol

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J Clin Epidemiol

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RARC Pasadena Consensus Panel – Review
Editorial by Monish Aron and Inderbir S. Gill on pp. 361–362 of this issue
Best Practices in Robot-assisted Radical Cystectomy and Urinary Reconstruction: Recommendations of the Pasadena Consensus Panel