Enhanced Recovery After Robot-assisted Radical Cystectomy: EAU Robotic Urology Section Scientific Working Group Consensus View

EURURO-6826; No. of Pages 12 EUROPEAN UROLOGY XXX (2016) XXX–XXX

available at www.sciencedirect.com journal homepage: www.europeanurology.com

Review – Bladder Cancer

Enhanced Recovery After Robot-assisted Radical Cystectomy: EAU Robotic Urology Section Scientific Working Group Consensus View Justin W. Collins a, Hiten Patel b, Christofer Adding a, Magnus Annerstedt c, Prokar Dasgupta d, Shamim M. Khan d, Walter Artibani e, Richard Gaston f, Thierry Piechaud f, James W. Catto g, Anthony Koupparis h, Edward Rowe h, Matthew Perry i, Rami Issa i, John McGrath j, John Kelly k, Martin Schumacher l, Carl Wijburg m, Abdullah E. Canda n, Meviana D. Balbay o, Karel Decaestecker p, Christian Schwentner q, Arnulf Stenzl q, Sebastian Edeling r, Sasa Pokupic´ r, Michael Stockle s, Stefan Siemer s, Rafael Sanchez-Salas t, Xavier Cathelineau t, Robin Weston u, Mark Johnson v, Fredrik D’Hondt w, Alexander Mottrie w, Abolfazl Hosseini a, Peter N. Wiklund a,* a

Department of Urology, Karolinska University Hospital, Stockholm, Sweden;

b

c

Department of Urology, University Hospital of Northern Norway, Tromsø,

Norway; Department of Urology, Stockholm Urology Clinic, Stockholm, Sweden;

d

Department of Urology, Guys Hospital, London, UK;

Urology, Verona University Hospital, Verona, Italy; f Clinique Saint Augustin, Bordeaux, France; Sheffield, UK;

h

g

e

Department of

Department of Urology, Sheffield University Hospital,

Department of Urology, Bristol Urological Institute, Bristol, UK; i Department of Urology, St Georges, London, UK; j Department of Urology,

Royal Devon and Exeter Hospital, Exeter, UK; k Department of Urology, UCL, London, UK; l Department of Urology, Hirslanden Klinik, Aarau, Switzerland; m

Department of Urology, Rijnstate, Arnhem, Netherlands;

Memorial Sisli Hospital, Istanbul, Turkey; Tubingen, Germany;

r

p

n

Department of Urology, Ankara Ataturk Hospital, Ankara, Turkey;

Department of Urology, Ghent University, Ghent, Belgium;

Department of Urology, Da Vinci Zentrum, Hanover, Germany;

s

q

o

Department of Urology,

Department of Urology, University of Tuebingen,

Department of Urology, Universittatsklinikum des Saarlandes,

Homburg, Germany; t Department of Urology, L’Institut Mutualiste Montsouris, Paris, France; u Department of Urology, Royal Liverpool Hospital, Liverpool, UK; v Department of Urology, Newcastle upon Tyne Hospitals, Newcastle, UK;

w

Department of Urology, O.L.V, Aalst, Belgium

Article info

Abstract

Article history: Accepted May 12, 2016

Context: Radical cystectomy (RC) is associated with frequent morbidity and prolonged length of stay (LOS) irrespective of surgical approach. Increasing evidence from colorectal surgery indicates that minimally invasive surgery and enhanced recovery programmes (ERPs) can reduce surgical morbidity and LOS. ERPs are now recognised as an important component of surgical management for RC. However, there is comparatively little evidence for ERPs after robot-assisted radical cystectomy (RARC). Due to the multimodal nature of ERPs, they are not easily validated through randomised controlled trials. Objective: To provide a European Association of Urology (EAU) Robotic Urology Section (ERUS) policy on ERPs to guide standardised perioperative management of RARC patients. Evidence acquisition: The guidance was formulated in four phases: (1) systematic literature review of evidence for ERPs in robotic, laparoscopic, and open RC; (2) an online questionnaire survey formulated and sent to ERUS Scientific Working Group members; (3) achievement of consensus from an expert panel using the Delphi process; and (4) a standardised reporting template to audit compliance and outcome designed and approved by the committee.

Associate Editor: Giacomo Novara Keywords: Enhanced recovery protocol Robot-assisted radical cystectomy RARC Radical cystectomy Enhanced recovery after surgery ERAS

* Corresponding author. Department of Molecular Medicine and Surgery, Section of Urology, Karolinska Institutet, 171 76 Stockholm, Sweden. Tel. +46 8 517 728 54; Fax: +46 8 517 735 99. E-mail address: [email protected] (P.N. Wiklund). http://dx.doi.org/10.1016/j.eururo.2016.05.020 0302-2838/# 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Please cite this article in press as: Collins JW, et al. Enhanced Recovery After Robot-assisted Radical Cystectomy: EAU Robotic Urology Section Scientific Working Group Consensus View. Eur Urol (2016), http://dx.doi.org/10.1016/j.eururo.2016.05.020

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Evidence synthesis: Consensus was reached in multiple areas of an ERP for RARC. The key principles include patient education, optimisation of nutrition, RARC approach, standardised anaesthetic, analgesic, and antiemetic regimens, and early mobilisation. Conclusions: This consensus represents the views of an expert panel established to advise ERUS on ERPs for RARC. The ERUS Scientific Working Group recognises the role of ERPs and endorses them as standardised perioperative care for patients undergoing RARC. ERPs in robotic surgery will continue to evolve with technological and pharmaceutical advances and increasing understanding of the role of surgery-specific ERPs. Patient summary: There is currently a lack of high-level evidence exploring the benefits of enhanced recovery programmes (ERPs) in patients undergoing robot-assisted radical cystectomy (RARC). We reported a consensus view on a standardised ERP specific to patients undergoing RARC. It was formulated by experts from high-volume RARC hospitals in Europe, combining current evidence for ERPs with experts’ knowledge of perioperative care for robotic surgery. # 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.

1.

Introduction

An enhanced recovery programme (ERP) describes a standardised multimodal perioperative care pathway that aims to minimise the physiologic and psychological stress effects of surgery. ERPs are also known as enhanced recovery after surgery (ERAS) or fast-track surgery programmes. The concept of ERAS was first introduced in the 1990s in colorectal surgery as a means to improve postoperative recovery and shorten length of stay (LOS) [1]. Despite improvements in care, radical cystectomy (RC) continues to be associated with frequent morbidity, high complication rates, and prolonged LOS [2,3]. The goal of a modern ERP is to have a positive impact on patient care from diagnosis, through surgery, to return of normal function. However, there is a lack of high-level evidence for ERPs following RC, and hence many principles applied to ERP in urologic practice have been imported from colorectal surgery [4]. There is increasing evidence from open colorectal surgery research that implemented ERPs can successfully reduce complication rates, LOS, and the time taken to get back to normal activities following major pelvic surgery [5]. It is also recognised that minimally invasive surgery (MIS) reduces the surgical stress response compared with open surgery [6]. Robot-assisted radical cystectomy (RARC) aligns itself with the original stated principles of enhanced recovery that MIS is advantageous to aid quicker patient recovery [7]. Several meta-analyses have highlighted that RARC compared with open RC decreases blood loss and transfusion rates, has a shorter time to normal diet, and reduces LOS [2,8,9]. RARC has also been found to be advantageous in patient groups susceptible to complications, such as the elderly [10]. An approach that combines robotic surgery with an ERP optimised for RARC patients has the potential to further improve patient outcomes. However, due to the multimodal nature of ERPs and inability to blind, they are difficult to study in randomised controlled trials (RCTs) [11]. Given current levels of evidence for the benefits of ERPs, there are also ethical issues with performing RCTs [11]. Therefore, to address the gaps in knowledge on how best to combine current evidence for ERPs with the evidence for patient management specific to robotic surgery, the European Association of Urology (EAU) Robotic

Urology Section (ERUS) Scientific Working Group formed a panel of experts to formulate the guidelines for an ERP specifically designed for patients undergoing RARC. The purpose of this paper was to examine current evidence for ERPs for RC, seeking to assess critically the depth and breadth of implementation of the current ERAS society guidelines for RC [4]. We also sought an expert panel consensus view on whether an optimised ERP for robotic surgery might differ from current ERAS guidelines for open RC. Additional future goals of this task force are to collect prospective audit data on ERP implementation. There is a potential need for both the adaptation of current ERPs that are tailored to the specifics of robotic surgery and standardised reporting templates. Such a reporting template would enable comparison of outcomes between centres, assess implementation, and provide a structure for quality assessment of future interventions. Our consensus statement therefore aims to guide health care providers on the important elements of a standardised ERP that is specific to RARC and provide a suitable reporting template. 2.

2.1.

Materials and methods

In April 2015, the ERUS Scientific Working Group established a working panel tasked with formulating a consensus view on an ERP optimised for patients undergoing RARC. Chaired by Peter Wiklund, the expert panel included ERUS members with a specialist interest in robotic cystectomy surgery and/or enhanced recovery protocols. The project was carried out in four phases: (1) a systematic literature review of current evidence for ERPs in robotic, laparoscopic and open RC was completed; (2) a survey was then generated and sent to panel members using the current evidence; (3) a Delphi process using the Internet and panel-based consensus findings was completed to agree on and formulate guidance; and (4) a standardised reporting template to audit compliance and outcome was designed and approved by the committee. 2.2.

Review of the literature

In April 2015, we undertook a comprehensive computerised search using PubMed, Medline, and Cochrane databases. We systematically searched using Medical Subject Headings

Please cite this article in press as: Collins JW, et al. Enhanced Recovery After Robot-assisted Radical Cystectomy: EAU Robotic Urology Section Scientific Working Group Consensus View. Eur Urol (2016), http://dx.doi.org/10.1016/j.eururo.2016.05.020

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including radical cystectomy and all 22 elements of an ERP, as defined by the ERAS society guidelines for perioperative management of RC [4]. Articles of interest included single-centre series reporting an ERP for RC, meta-analyses, RCTs, and systematic reviews published between January 1997 and the first landmark review on ERP published [1] and April 2015. Other significant studies cited in the reference list of selected papers were evaluated, as well as studies of interest published after the systematic search. 2.3.

Study selection (inclusion and exclusion criteria)

Two reviewers independently selected papers for detailed review (J.W.C. and H.R.P.), evaluating the abstract and, if necessary, the full-text manuscript. Potential discrepancies were resolved by open discussion. The electronic search yielded a total of 973 potential studies. Fig. 1 shows the selection process. 2.4.

Data extraction and quality assessment

The quality of available studies was low. Considering multimodal interventions, we identified 16 articles reporting

3

results of their ERPs for RC, 4 of which incorporated RARC (Table 1). ERP consistency was variable. Commonly used elements included avoidance of mechanical bowel preparation and preoperative carbohydrate loading. Intraoperatively, it included epidural analgesia, opioid-sparing analgesia, avoiding hypothermia, and careful fluid management. Postoperatively it included avoidance or early removal of nasogastric (NG) tube with early mobilisation and early oral feeding. Since the publication of the ERAS society guidelines [4], six systematic reviews of ERPs specific to RC have been published. Considering single interventions, we identified 1 meta-analysis, 6 RCTs, and 23 single-intervention studies. 2.5.

Review of the literature

2.5.1.

Internet survey and Delphi process

An advisory committee was formed that included experts in the fields of RARC and/or ERPs from 23 institutions in Europe (Supplement 1, Supplementary Table 1). An Internet survey (Google forms) was generated and sent to all ERP panel members. Supplementary Table 2 shows a full list of the survey questions. An e-consensus–finding exercise using the Delphi methodology was then applied. The Delphi method structures group communications so that

Fig. 1 – Summary of literature review: identification, screening, eligibility, and selection. ERP = enhanced recovery programme; RCT = randomised controlled trial.

Please cite this article in press as: Collins JW, et al. Enhanced Recovery After Robot-assisted Radical Cystectomy: EAU Robotic Urology Section Scientific Working Group Consensus View. Eur Urol (2016), http://dx.doi.org/10.1016/j.eururo.2016.05.020

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Table 1 – Current published series on enhanced recovery after surgery protocols for radical cystectomy Study

No. of patients (No. receiving ERP)

Comparative control group included

No. of ERAS recommendations included

Arumainayagam et al [12] Pruthi et al [13] Shah and Abaza [14] Maffezzini et al [15] Mukhtar et al [16] Saar et al [17] Karl et al [18] Dutton et al [19]

112 (56) 362 (362) 30 (30) 68 (68) 77 (51) 63 (31) 101(62) 165 (165)

Yes No (evolved ERP) No No Yes Yes RCT (2:1) No (evolved ERP)

6 7 10 6 12 9 5 19

No No Yes No No Yes No No

Daneshmand et al [20]

110 (110)

Yes (historical)

7

No

Smith et al [21]

133 (64)

Yes

Guan et al [22] Cerruto et al [23] Persson et al [24] Koupparis al [25] Xu et al [26] Collins et al [27]

115 31 70 270 205 221

Yes No Yes Yes Yes Yes

(60) (31) (31) (102) (124) (135)

RARC included

No

7 17 13 10 17 20

No No No Yes No Yes

Additional elements to ERAS recommendations

– – – – – – – Rectus sheath analgesia catheter; intraoperative cell salvage; telephone contact given Paraincisional subfascial catheter Rectus sheath catheter; intraoperative cell salvage; 24-h ERP telephone helpline Laparoscopic approach

Intracorporeal urinary diversion Intracorporeal urinary diversion

Level of evidence

3b 3b 3b 3b 3b 3b 2b 3b

3b 3b

3b 3b 3b 3b 3b 3b

ERAS = enhanced recovery after surgery; ERP = enhanced recovery program; RARC = robot-assisted radical cystectomy; RCT = randomised controlled trial.

the process is effective in allowing a group of individuals to deal with a complex problem. Questions in which there was 100% consensus were removed from the next round of the survey. Repeated iterations of anonymous voting continued over three rounds, where an individual’s vote in the next round was informed by knowledge of the entire group’s results in the previous round. Using SAS v.9.4 software (SAS Institute Inc., Cary, NC, USA), outcomes of the e-consensus at each round were displayed as histograms so the result could be reflected on before selecting a response in the next round. After the three rounds, the consensus views included in the final guidance needed to reach a consensus view that represented at least 80% of the panel (Table 2). 3.

Evidence synthesis

3.1.

Formulation of guidance

Consensus was reached in multiple areas of an ERP for RARC. Table 3 summarises the main findings. 3.2.

Preoperative considerations

3.2.1.

Preoperative counselling and patient education

Preoperative verbal and written information for patients and their caregivers is important for both knowledge and to ensure compliance. Information should include details on the operation, hospital stay, a description of the ERP, discharge criteria, stoma care information for conduit patients, and catheter care information for neobladder patients. Comprehensive patient information has been shown to empower patients, improve recovery, and can reduce complications after surgery [28]. Information about urinary diversion options is also critical to prevent misunderstandings that may have a negative impact on

quality of life [29]. The committee reached a 75% consensus view that patient information videos are beneficial to understanding the surgery; however, only 7% currently have them available at their institutions. Future developments are likely to include educational videos. 3.2.2.

Preoperative medical optimisation and nutrition

Cystectomy patients have multiple risk factors for malnutrition (eg, increased age, reduced appetite, nausea, pain, chemotherapy, comorbidities), and studies estimate between 23% and 87% of patients are malnourished [30,31]. Malnourished patients are at higher risk for postoperative complications and mortality following RC [32,33]. Perioperative enteral nutritional support has been shown to reduce complications significantly and aid recovery in gastrointestinal surgery [34–36]. Studies have shown similar effects in RC patients [37]. Total parenteral nutrition following RC is not recommended [30,38]. Bladder cancer patients are often smokers or exsmokers. Overwhelming evidence indicates that cessation of smoking prior to major surgery reduces perioperative complications and readmission rates [39,40]. Cessation of smoking has also been shown to reduce the incidence of recurrence and progression in bladder cancer patients [41]. Current evidence supporting the benefits of increased physical exercise prior to RC is inconclusive. A recent RCT found no reduction in LOS with a preoperative and postoperative rehabilitation programme, although enhanced mobilisation was achieved [42]. 3.2.3.

Oral mechanical bowel preparation

There is level 1 evidence to advise omitting mechanical bowel preparation in colorectal surgery. Two prospective and one large retrospective study support this strategy in RC with ileal urinary diversion [43–45]. In RARC with

Please cite this article in press as: Collins JW, et al. Enhanced Recovery After Robot-assisted Radical Cystectomy: EAU Robotic Urology Section Scientific Working Group Consensus View. Eur Urol (2016), http://dx.doi.org/10.1016/j.eururo.2016.05.020

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Table 2 – Enhanced recovery programme elements that reached 80–100% agreement on the Google form survey using the Delphi process Level of agreement 100%

95%

90%

85%

80%

ERP consideration ERPs are relevant to RARC patients. There are differences in recovery after surgery between open RC patients and colorectal surgery patients. There are differences in recovery after surgery between open RC and RARC patients. Important principles for an optimised ERP for RARC include reduced bowel preparation, early mobilisation, standardised analgesic regimens with sparing use of opiates.  Minimum discharge criteria to be met prior to discharge include adequate pain control and patient being mobile (if normally mobile).  Preoperative counselling and education should include oral and written information on surgical method, plan of hospital stay, discharge criteria, stoma nurse information (for stoma patients).  Preoperative medical optimisation should include optimising comorbidities and preoperative nutrition.  Mechanical bowel preparation can be safely avoided. Guidance on preoperative fasting: Solids and clear fluids until 6 and 2 h, respectively, before anaesthesia. Encourage low-residue food in the 24 h before surgery.  Preanaesthesia medication is appropriate in selected patients if short-acting sedatives are used. May be beneficial in anxious patients.  Thromboembolic prophylaxis should include low molecular weight heparin for 4 wk.  Antibiotic prophylaxis should consist of limited broad-spectrum antibiotics. Principle is to avoid several days of unnecessary antibiotic administration.  A standardised anaesthetic protocol is important to outcome.  Current anaesthetic protocols are variable in RARC, an area that would benefit from further study.  To prevent hypothermia, an intraoperative device to maintain normal body temperature is important.  Patients should be mobilised within 24 h of surgery.  Audit is an important part of an ERP for RARC. Patients should be audited for compliance and outcomes.  There are differences in recovery after surgery between RARC with extracorporeal urinary diversion and intracorporeal urinary diversion.  Preoperative counselling and education should include oral and written information on catheter care information (for neobladder patients).  Oral diet should be started as soon as possible after surgery, as tolerated by the patient.  Important principles for an optimised ERP for RARC include patient education and counselling.  Minimum discharge criteria to be met prior to discharge includes patient on regular diet and normal bowel function (bowels opened).  Aim is to optimise fluid balance perioperatively and avoid overhydration.  Restricted administration of opioids; use only when required.  Patients may benefit from future/additional elements to an ERP for RARC such as patient information videos.  Important principles for an optimised ERP for RARC include early feeding.  Preoperative carbohydrate loading should be given in suitable patients.  Thromboembolic prophylaxis should include compression stockings.  Epidural analgesia can be routinely omitted during RARC with intracorporeal urinary diversion.  Perioperative fluid management is an important area that can affect patient outcome and would benefit from further future studies.  Postoperative analgesia should include standard oral analgesia regimens and additional PRN medication: regular oral analgesics to include paracetamol (acetaminophen).  Prevention of postoperative ileus, nausea, and vomiting requires multimodal approach including prokinetic agents and chewing gum.  A core surgical theatre team is crucial to achieving good outcomes.  Minimum discharge criteria to be met prior to discharge include stoma competence (for conduit patients) and catheter competence (for neobladder patients).  Pelvic-site drain can be removed on day 1 if serum creatinine levels in drain fluid indicate only serous fluid. Drain fluid can be sent for creatinine level day 1 post-RARC.  Early removal of NG tube can be safely performed in the recovery unit.    

ERP = enhanced recovery program; NG = nasogastric; PRN = as needed; RARC = robot-assisted radical cystectomy; RC = radical cystectomy.

intracorporeal urinary reconstruction, cleaning of the bowel segment can be problematic, and nondigestible vegetables can be seeded into the peritoneum with spillage from the opened ileum. Consequently, vegetables should be avoided for 24 h before surgery [6].

3.2.5.

3.2.6. 3.2.4.

Preoperative carbohydrate loading

Preoperative oral intake of a clear fluid rich in complex carbohydrates 2–3 h before anaesthesia reduces thirst, anxiety, postoperative insulin resistance, loss of protein, and inflammatory responses [28]. Carbohydrate loading may also improve postoperative muscle strength, promote earlier return of gut function, and reduce LOS [46].

Preoperative fasting

No evidence indicates an increased anaesthetic risk to patients allowed solids up to 6 h and liquids up to 2 h before surgery [6,47]. Anaesthesia premedications

To date no studies have evaluated the role of anaesthetic premedication in either open or robotic cystectomy patients. A Cochrane review on premedication with anxiolytics before surgery concluded that anxiolytics impair patients’ ability to mobilise and eat and drink in the early postoperative period [48]. Long-acting sedatives should be avoided. The committee reached

Please cite this article in press as: Collins JW, et al. Enhanced Recovery After Robot-assisted Radical Cystectomy: EAU Robotic Urology Section Scientific Working Group Consensus View. Eur Urol (2016), http://dx.doi.org/10.1016/j.eururo.2016.05.020

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Table 3 – Consensus view on structured enhanced recovery programme for robot-assisted radical cystectomy patients (preoperative, perioperative, and postoperative care) Consensus view on an ERP for patients undergoing RARC Outpatient assessment Preoperative counselling and education. Verbal and written information supplied on operation and urinary diversion options and planned ERP Preparation for surgery 1. Preoperative medical optimisation 2. Preoperative nutritional optimisation 3. Seen by stoma nurse specialist; advice on stoma and neobladder care 4. Cardiopulmonary exercise testing if indicated 5. 6. Day 1.

Advice and support for cessation of smoking Social issues addressed and discharge planning before radical cystectomy No bowel preparation

2. Carbohydrate loading [28,46] Day of radical cystectomy: day 1 1. Solids up to 6 h and clear fluids up to 2 h preoperative including carbohydrate loading [28,46] 2. Avoidance of long-acting sedatives 3. Thrombosis prophylaxis: compression stockings and low molecular weight heparin 4. Limited antimicrobial prophylaxis and skin preparation with chlorhexidine-alcohol (or equivalent solution) 5. Standard anaesthetic protocol to attenuate surgical stress response: intraoperative maintenance of haemodynamic control, central and peripheral oxygenation, muscle relaxation, optimised depth of anaesthesia with spinal and appropriate analgesia avoiding opiates with peripheral action 6. RARC approach 7. Goal-directed fluid management with judicious use of fluid restriction [59] 8. Prevention of hypothermia (Bair Hugger; 3M Medical, Diegem, Belgium) 9. Removal of nasogastric tube in recovery

Day 2–4 1. Prevention of postoperative nausea and vomiting: regular antiemetics may be of benefit (metoclopramide) 2. Chewing gum [73] 3. Unrestricted diet 4. Drain fluid routinely sent for creatinine day 2 and drain removed day 2 if drain fluid indicates serum creatinine levels 5. Thrombosis prophylaxis: compression stockings and low molecular weight heparin 6. Regular analgesia: standardised polypharmacologic opioid-sparing analgesia to include paracetamol 7. Early mobilisation 8. Daily nutritional supplements with nutrition goal 900 kcal/d 9. Fluid/electrolyte (30 ml/kg per day) 10. Encourage self-care (catheter care/flushing if neobladder and stoma bag care if ileal conduit) Day 4 onwards 1. Continue as previous; increase daily nutritional goal to 1500 kcal/d 2. Discharge home when criteria met: Pain adequately controlled Independently mobile Regular diet/normal bowel function Competent with neobladder or stoma care

Postdischarge 1. Stents out day 10 (no stentogram) 2. Removal of clips at day 10 3. Contact with specialist nurse via telephone 4. Audit cycle of compliance and outcomes

ERP = enhanced recovery program; RARC = robot-assisted radical cystectomy.

100% consensus that anaesthesia premedication is appropriate in selected anxious patients, provided shortacting sedatives are used. 3.2.7.

Thromboembolic prophylaxis

Venous thromboembolism is a major complication after RC with an incidence of 4–8% irrespective of surgical approach [49–51]. Thromboembolism is the most common cause of death within 30 d of oncologic surgery [51]. Patients treated with neoadjuvant chemotherapy have a potentially higher risk for postoperative thromboembolism [52]. The committee reached 85% consensus on recommending compression stockings perioperatively and 100% consensus on recommending prolonged use (4 wk postoperatively) of low molecular weight heparin [4]. 3.3.

Intraoperative considerations

3.3.1.

Epidural analgesia

The use of thoracic epidurals is recommended for patients undergoing open RC [4]. However, epidurals can result in peripheral vasodilatation and postural hypotension

hampering patient mobilisation and prolonging hospitalisation. Patients undergoing RARC can safely avoid epidurals, patient-controlled morphine pumps, and rectus sheath catheters [27], although the surgical approach to urinary diversion may affect this decision. The committee reached 89% consensus that epidural analgesia can be routinely omitted during RARC with intracorporeal urinary diversion, and 75% agreed on routine omission with an extracorporeal urinary diversion. 3.3.2.

Minimally invasive surgical approach

At the time of publication, ERAS guidelines for RC did not recommend RARC outside trial settings due to the lack of long-term oncologic results [4]. However, we are now starting to see the first multi-institutional papers reporting long-term outcomes showing equivalent outcomes to open series [53]. The committee reached 100% consensus that there are differences in recovery between open RC and RARC and a 96% consensus on differences in recovery between RARC with an extracorporeal urinary diversion and a completely minimally invasive approach incorporating intracorporeal urinary diversion.

Please cite this article in press as: Collins JW, et al. Enhanced Recovery After Robot-assisted Radical Cystectomy: EAU Robotic Urology Section Scientific Working Group Consensus View. Eur Urol (2016), http://dx.doi.org/10.1016/j.eururo.2016.05.020

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3.3.3.

Resection-site drainage

No randomised studies have currently assessed the value of resection-site drainage following RC. The practice of leaving drains aims to prevent local haematoma/seromas and allow drainage of urine should a leak occur after urinary reconstruction. However, the drain has the potential to affect bowel recovery, and some centres have shown that it can be omitted [19]. The committee reached only 61% consensus that a pelvic drain can be avoided in selected patients. Current consensus (82%) guidance is that a 21CH passive silicone drainage tube is placed through a port-site incision at the end of surgery and removed the first postoperative day, if there is no evidence of urinary leakage. This can be confirmed by sending drain fluid for serum creatinine levels on the morning after surgery. 3.3.4.

Anaesthetic technique and analgesia planning

Current protocols are variable in RARC, and this is an area that would benefit from further study. A standardised anaesthetic protocol is important to outcome (100% consensus). RARC requires the lithotomy position with steep Trendelenburg, pneumoperitoneum, and limited anaesthetist access to the patient. Presenting anaesthetic challenges that can cause physiologic effects or complications include subcutaneous carbon dioxide emphysema, pressure sores, and compartment syndromes [56]. Attention should be paid to maintaining normoglycemia and adequate lung ventilation, taking into account the Trendelenburg position [57]. The key aims during anaesthesia are to prevent hypothermia (100% consensus), hypoxaemia, and hypovolaemia while avoiding overhydration (93% consensus) and to avoid opioid-based analgesics and their effects on bowel recovery (100% consensus) [14]. Although high levels of evidence for a standardised anaesthetic approach are currently limited [58], careful monitoring and good communication between team members is critical to reduce surgical and anaesthetic complications. 3.3.6.

Doppler monitoring during RC led to reduced incidences of postoperative ileus and nausea and vomiting [60]. A double-blind randomised trial using norepinephrine with deferred rehydration concluded that detrimental hypotensive effects of general anaesthesia were avoided and resulted in significantly reduced postoperative complication rates and decreased LOS [61,62]. The same group also concluded that this approach was associated with reduced intraoperative blood loss and blood transfusions [63]. A subsequent 1-yr follow-up study also showed significantly better daytime continence and erectile function in these patients [64]. This finding may be explained by improved surgical views due to reduced blood in the operative field. Although more fit patients may be more tolerant of hypovolaemia, all patients should benefit from individualised goal-directed fluid management.

Antimicrobial prophylaxis and skin preparation

There is high-level evidence for prophylactic intravenous antibiotics and chlorhexidine-alcohol skin preparation to reduce surgical-site infections in colorectal surgery [54]. The American Urological Association as well as the EAU recommend single-dose broad-spectrum antibiotic prophylaxis with cephalosporin given <60 min before skin incision [55], avoiding prolonged unnecessary antibiotic administration (100% consensus). Skin preparation with a suitable antiseptic solution such as chlorhexidine helps prevent wound infections (96% consensus). 3.3.5.

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Perioperative fluid management

General anaesthesia effects can be compounded in RARC by long operation times and significant blood loss [2]. Both overhydration with excess fluid replacement and hypovolaemia can provoke splanchnic hypoperfusion, resulting in postoperative ileus, increased morbidity, and increased LOS. Goal-directed fluid management is key to achieving optimum fluid balance and avoiding complications [59]. An RCT assessing goal-directed fluid therapy with

3.3.7.

Preventing intraoperative hypothermia

There was 100% consensus that maintaining body temperature during surgery with a warming device is advantageous. Normothermia during surgery has been shown to help prevent wound infection, morbid cardiac events, bleeding, pain, and oxygen consumption [65]. 3.4.

Postoperative care

3.4.1.

Nasogastric intubation

A Cochrane analysis found that early removal of the NG tube reduces postoperative complications [66]. It has also been shown to be safe in RC patients in RCT settings [67,68]. There was 82% consensus that the NG tube can be removed soon after extubation in the recovery unit. 3.4.2.

Urinary drainage

There is currently no study evaluating the optimal timing of removal of ureteric stents after RC or the transurethral catheter following RC and orthotopic neobladder. Early removal of a transurethral urinary catheter following abdominal and thoracic surgery reduces the incidence of urinary tract infection [69], but timing of catheter removal following orthotopic neobladder should not compromise patient safety. No consensus was reached regarding optimum timing of the catheter removal for orthotopic neobladder patients, with 71% of the committee stating that they currently leave the catheter for a minimum of 14 d. There was also no consensus on the timing of the removal of stents in ileal conduit patients with 36% removing the stents at 5–7 d and 64% at 8–14 d. For orthotopic neobladder patients, 32% removed the stents at 5–7 d, 36% at 8–14 d, and 32% after a minimum of 14 d. Clean intermittent selfcatheterisation is variable between patients. 3.4.3.

Prevention of postoperative ileus

Postoperative ileus (POI) is a major issue following RC and urinary diversion. Most patients encounter some degree of POI, potentially resulting in delays to early discharge. Promotility drugs such as metoclopramide, serotonin receptor antagonists, erythromycin, a nonsteroidal antiinflammatory drug, or naloxone have not been shown to be

Please cite this article in press as: Collins JW, et al. Enhanced Recovery After Robot-assisted Radical Cystectomy: EAU Robotic Urology Section Scientific Working Group Consensus View. Eur Urol (2016), http://dx.doi.org/10.1016/j.eururo.2016.05.020

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effective in studies. However, the opioid receptor antagonist alvimopan appears promising, showing earlier return of bowel function and having an impact on both LOS and hospital costs in an RCT [70]. It was also shown to be of benefit in RARC [71], although there are some concerns for cardiovascular events [72]. Other treatments to prevent POI and enhance bowel recovery include chewing gum, which may act like early sham feeding, promoting intestinal functioning [73]. RARC itself has been shown to lead to faster return of bowel function when compared with open RC [74]. 3.4.4.

Prevention of postoperative nausea and vomiting

Multimodal antiemetic prophylaxis in selected patients with a high risk of postoperative nausea and vomiting (PONV) is advised [4]. Goal-directed fluid monitoring [60] and stenting of ureteroileal anastomosis [75] have also shown significant reductions in PONV. 3.4.5.

Postoperative analgesia

Optimised postoperative analgesia aims to enhance recovery without negatively affecting POI and PONV. The committee reached 100% consensus on recommending standardised poly-pharmacologic opioid-sparing analgesia. Baseline treatment should include regular paracetamol (acetaminophen). Epidural analgesia can be omitted for RARC patients [14,27,74]. Omitting the epidural promotes early mobilisation. 3.4.6.

Early mobilisation

There was 100% consensus that early mobilisation is beneficial. It is recognised that early mobilisation in intensive care unit patients is associated with improvements in functional independence, cardiovascular and respiratory function, level of consciousness, and psychological wellbeing [76]. A recent RCT studying the impact of pre- and postoperative rehabilitation compared with standard mobilisation did not find any significant difference in LOS, complications, readmissions, and mortality in patients undergoing RC. However, patients in the exercise programme were significantly more mobile in the first 7 d with improved ability to perform personal activities [42]. RARC also aids early mobilisation due to reduced postoperative pain and avoidance of epidural anaesthesia [14]. 3.4.7.

Early oral diet

No evidence supports prolonged fasting after RC. Early oral food intake stimulates gastrointestinal pathways and has been shown to decrease the time to first bowel movement and reduce LOS without increasing complication rates [77]. It also affects the brain–gut axis to positively affect higher cognitive function such as feelings and decision making [78]. The panel reached 96% consensus that oral diet after surgery should be started early, as tolerated by patients, avoiding parenteral nutrition. 3.4.8.

Discharge criteria

Discharge criteria do not currently form part of the ERAS guidelines, yet it is known that readmission rates are significant following RARC and open RC [2]. The committee

Table 4 – Auditing outcome data: a standardised template Recommended reporting elements for ERP Patient-specific details: Admission date Comorbidities (ASA grade) BMI Preoperative staging (TNM) Administration of neoadjuvant chemotherapy Y/N Smoker preoperatively Y/N Given guidance to help quit smoking Y/N Continued to smoke postoperatively Y/N Operation details: RARC and diversion type (ileal conduit or orthotopic neobladder, extracorporeal or intracorporeal) Pathologic staging (TNM) LOS in days (date of admission to date of actual discharge) Readmission Y/N (date of readmission) 30- and 90-d complications (Clavien-Dindo classification [87]) ERP-specific details: Tabular reporting of all elements included from guidelines and any additional elements Clearly explain all ERP elements including specific algorithms and pathways used in care pathway where applicable, for example: Medications/concentrations used Antibiotic prophylaxis Analgesia escalation strategies Intravenous infusion rates and criteria for goal-directed therapy Drain placement algorithms Epidural (if used)/regional level, single injection vs infusion/catheter placement Report compliance for all elements named in ERP. When failure of an ERP element occurs, it should be reported and reason for failure explained including adverse events related to an ERP element Discharge criteria should be reported. If a substitute for LOS such as ‘‘readiness for discharge’’ is used, there should be a report of actual LOS and a listing of reasons for nonmedical extension of hospitalisation ASA = American Society of Anesthesiologists; BMI = body mass index; ERP = enhanced recovery program; LOS = length of stay; N = no; RARC = robotassisted radical cystectomy; Y = yes.

reached consensus that key criteria for the safe discharge of patients include adequate pain control, regular diet, normal bowel function, mobilisation, and competence in stoma care for ileal conduit patients and catheter care for neobladder patients. 3.4.9.

Audit

Audit and reporting of results is essential to assess quality and guide improvements. However, comparison and interpretation of outcome reports from different centres is not currently straightforward, due to the lack of a standardised approach and standardised reporting systems. A standardised reporting template is key to evaluating ERPs and achieving quality improvement [79]. Table 4 describes a standardised approach to reporting audited outcomes. 3.4.10.

Future additional elements to an enhanced recovery

programme for robot-assisted radical cystectomy

An ERP describes a standardised approach, and the importance of a consistent core operating room team was raised by the panel, with 86% agreeing a core team is crucial to achieving good outcomes. It is recognised that RARC is complex surgery requiring a coordinated team approach [80]. However, the survey revealed that only 50% of surgeons on the panel had the same core team most of

Please cite this article in press as: Collins JW, et al. Enhanced Recovery After Robot-assisted Radical Cystectomy: EAU Robotic Urology Section Scientific Working Group Consensus View. Eur Urol (2016), http://dx.doi.org/10.1016/j.eururo.2016.05.020

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the time, with 11% having the same core team less than half the time and 21% stating that their surgical team members changed regularly, mostly due to management issues outside of their control. Other elements discussed included open access clinics and home monitoring via telemedicine with neither achieving >80% consensus. 3.5.

Discussion

The number of centres offering RARC continues to grow, and it is increasingly accepted as an alternative to open RC [80]. A RARC approach aligns itself with the original stated principles of ERP that MIS is advantageous to aid quicker patient recovery [7]. The effect of the surgical insult following RC depends on the stress response, which is affected by multiple aspects including preoperative care, surgical technique, length of operation, patient age, comorbidities, and tumour biology [81]. An ERP aims to have an impact on all stages of care from diagnosis, through treatment, to return to normal function, yet it is recognised that certain elements of an ERP, such as the surgical approach used, have a major impact on recovery [2,82]. A minimally invasive approach such as RARC is therefore likely to have a key role to play in enhanced recovery after RC surgery [4]. A growing body of evidence supports ERPs in RC patients, yet the adoption and uptake has been slow. A recent survey of surgeons with a specialist interest in RC found that 64% of respondents classified themselves as proponents of ERPs but that only 20% were practicing all interventions as proposed in ERAS society guidelines [83]. Our review of the literature highlights the significant variations in current published ERPs for RC (Table 1), indicating the need for more standardisation in this area. A recent UK audit of enhanced recovery protocols found that good compliance with an ERP was associated with a 3-d reduction in median LOS in urologic patients. However, this audit revealed large variations in ERPs between individual hospitals, leading the authors to conclude that changes in process, resulting from protocol-driven pathways, may be as important in reducing LOS as any individual element of the ERPs in isolation [84]. The evolution of high-volume centres for RC has created an environment capable of supporting the dedicated infrastructure and experience required to deliver more consistent high-quality standardised services within a multidisciplinary workforce [85]. Robotic surgery has itself contributed to the centralisation of oncologic surgery services [86]. This consensus statement aims to give robotic surgeons guidance on a standardised ERP that is specific to robotic surgery. We have also described a standardised template for reporting audit outcomes that will enable comparative measurement of quality improvements as new evidence becomes available. 4.

Conclusions

This consensus view was formulated by an expert panel specifically assembled by the ERUS Scientific Working Group. There was consensus that an optimised ERP for RARC differs from an ERP designed for either colorectal patients or open RC

9

patients. Recognised differences to an ERP designed for RARC, compared with open surgery, include a minimally invasive approach, less blood loss, avoidance of epidural, earlier mobilisation, and reduced postoperative analgesia requirements. A standardised enhanced recovery protocol for RARC is an important part of optimising patient care for elective RARC surgery. The ERUS Scientific Working Group recognises the role of ERPs and endorses this guidance on standardised perioperative care for patients undergoing RARC. The key principles include preoperative patient education, optimisation of nutrition, RARC approach, standardised anaesthetic, analgesic, and antiemetic regimens, and early mobilisation. ERPs in robotic surgery will continue to evolve with technological and pharmaceutical advances, and standardised reporting is therefore crucial to enable assessment of quality improvements. Author contributions: Justin W. Collins had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Wiklund, Collins, Adding, Patel, Hosseini. Acquisition of data: Collins, Patel, Adding, Annerstedt, Dasgupta, Khan, Artibani, Gaston, Piechaud, Catto, Koupparis, Rowe, Perry, Issa, McGrath, Kelly, Schumacher, Wijburg, Canda, Balbay, Decaestecker, Schwentner, Stenzl, Edeling, Pokupic´, Stockle, Siemer, Sanchez-Salas, Cathelineau, Weston, Johnson, D’Hondt, Mottrie, Hosseini A, Wiklund. Analysis and interpretation of data: Wiklund, Collins, Adding, Patel, Hosseini. Drafting of the manuscript: Wiklund, Collins, Adding, Patel, Hosseini. Critical revision of the manuscript for important intellectual content: Collins, Patel, Adding, Annerstedt, Dasgupta, Khan, Artibani, Gaston, Piechaud, Catto, Koupparis, Rowe, Perry, Issa, McGrath, Kelly, Schumacher, Wijburg, Canda, Balbay, Decaestecker, Schwentner, Stenzl, Edeling, Pokupic´, Stockle, Siemer, Sanchez-Salas, Cathelineau, Weston, Johnson, D’Hondt, Mottrie, Hosseini A, Wiklund. Statistical analysis: Wiklund, Collins, Adding, Patel. Obtaining funding: None. Administrative, technical, or material support: Wiklund, Collins, Patel. Supervision: Wiklund. Other (specify): None. Financial disclosures: Justin W. Collins certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: None. Funding/Support and role of the sponsor: None.

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