Implementation of the Exeter Enhanced Recovery Programme for patients undergoing radical cystectomy

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1 Implementation of the Exeter Enhanced Recovery Programme for patients undergoing radical cystectomy Thomas J. Dutton, Mark O. Daugherty, Robert G. Mason and John S. McGrath Exeter Surgical Health Services Research Unit, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK Objectives To describe our experience with the implementation and refinement of an enhanced recovery programme (ERP) for radical cystectomy (RC) and urinary diversion. To assess the impact on length of stay (LOS), complication and readmission rates. Patients and Methods In all, 165 consecutive patients undergoing open RC (ORC) and urinary diversion between January 2008 and April 2013 were entered into an ERP. A retrospective case note review was undertaken. Outcomes recorded included LOS, time to mobilisation, complication rates within the first 30 days (Clavien-Dindo classification) and readmissions. Results All patients were successfully entered into the ERP. As enhanced recovery principles became embedded in the unit, LOS reduced from a mean of 14 days over the initial year of the ERP to a mean of 9.2 days. The complication rate was 6.6% for Clavien 3, and 43.5% for Clavien 2. The 30-day mortality rate was 1.2%. The 30-day readmission rate was 13.9%. In the most contemporary subset of 52 patients: the median time after ORC to sit out of bed, mobilise and open bowels was day 1, 2 and 6, respectively. Conclusions The ERP described for patients undergoing ORC appears to be safe. Benefits include early feeding, mobilisation and hospital discharge. The ERP will continue to develop with the incorporation of advancing evidence and technology, in particular the introduction of robot-assisted RC. Keywords enhanced recovery programme, open radical cystectomy Introduction Radical cystectomy (RC) continues to be associated with one of the highest overall morbidity rates and protracted lengths of in-patient stay when compared with other major urological procedures. The national Health Episodes Statistics data (HES) in the UK has highlighted significant differences in both the length of stay (LOS) and readmission rates between individual surgical units for all major pelvic procedures and this variation is being addressed through a national Enhanced Recovery Partnership Programme (UK Department of Health) [1]. Enhanced recovery programmes (ERPs) aim to deliver a coordinated, evidence-based package of care designed to minimise the overall physiological impact of the surgical procedure, thereby facilitating an early return to mobility and an earlier discharge from hospital care. They focus not just on the procedure but also on the whole pathway from patient referral to subsequent discharge from hospital. The patient plays an active role in their own recovery. The reduction in LOS should not be seen as the primary goal but rather it is a useful surrogate marker for the effectiveness of improved planning and consistency in the delivery of care. ERPs were first popularised in colorectal surgery by Wilmore et al. [2] in 2001 in Denmark and, consequently, much of the evidence-base relates to the management of colorectal disease. The evidence for their use in RC is sparse by comparison, although the published series suggest that the benefits seen in colorectal surgery can be replicated in urological surgery [3,4]. Intuitively this should be the case, given the comparability of the surgical procedures and corresponding patient pathways. The present study describes our experience with the implementation and refinement of an ERP for RC and urinary diversion, assessing the impact on LOS, complications and readmission rates. BJU International 2013 BJU International doi: /bju BJU Int 2014; 113: Published by John Wiley & Sons Ltd. wileyonlinelibrary.com

2 Dutton et al. Patients and Methods In all, 165 consecutive patients undergoing open RC (ORC) and urinary diversion between January 2008 and April 2013 were entered into an ERP. Surgery was performed in a designated cancer centre by one of three consultant surgeons (JM, RM or RP). Patient demographics and procedural aspects are summarised in Table 1, whilst indications for RC are described in Table 2. ERP Figure 1 details the chronological process of the Exeter ERP, which encompasses all patients undergoing ORC and urinary diversion (ileal conduit or neobladder). Further details of the inpatient aspect of the ERP are described in Table 3. The ERP addresses each step of the patient pathway and the philosophy is encompassed by the phrase in the patient information booklet as helping patients get better sooner. The aim is for each patient to be familiarised with the ERP before hospital admission with pre-optimisation of any comorbidities. A preparation-for-surgery visit takes place where, in addition to Table 1 Demographic and procedural details of patients undergoing ORC in the ERP. addressing comorbidities, social aspects of the patient discharge from hospital can be anticipated and planned for. Patient education runs simultaneously to this and is delivered by the wider multi-disciplinary team including the surgeon, uro-oncology nurse specialist and preparation-for-surgery practitioner. The Exeter ERP works to a protocol that standardises the patient s postoperative recovery. As detailed in Fig. 1, this involves rapid resumption of normal oral intake, clear fluids commence on the evening of surgery, free fluids are offered on postoperative day 1, with full diet from postoperative day 2 onwards. In patients who develop an ileus, oral intake is reduced until nausea or vomiting settles and normal bowel activity resumes. Pain relief is standardised with all patients having rectus sheath catheters (RSCs) placed preoperatively (Fig. 1 and Table 3) and all receive regular paracetamol and NSAIDs unless contraindicated. Opiate-based patient-controlled analgesia can be used depending on individual patient s needs. RSCs are removed at day 5 postoperatively or sooner if the patient s pain relief requirements are adequately controlled by oral analgesia. Variable Value Operative Detail Number of patients 165 Mean (range) age, years (37 83) Sex (Male : Female), n 122:43 ASA grade, n: not recorded 21 Mean total procedural time, min Diversion, n: ileal conduit 131 neobladder 34 Analgesic method, n: RSC 140 epidural 25 The exenterative component of the procedure is all performed extraperitoneally using a small infra-umbilical incision. The peritoneal cavity is then opened to perform the urinary diversion. Haemostasis is achieved using a haemostatic energy device (LigaSure TM, Coviden, Boulder, CO, USA). Bowel anastomosis is made using a continuous monofilament hand-sutured single seromuscular layer technique with closure of the mesenteric defect. Bilateral single J stents are placed and brought out in the stoma or neobladder. Occasionally, an absorbable haemostatic agent (Surgicel Fibrillar, Ethicon, Somerville, NJ, USA) is used in the pelvis at the end of the procedure to control oozing from the dorsal venous complex. RSC, rectus sheath catheter. Discharge Criteria Table 2 Indication for surgery (preoperative clinical staging). Indication Number TCC Muscle invasive T2 104 > T2 20 Metastatic N2 M0 1 Non-muscle invasive BCG failure 17 Unable to tolerate BCG 9 Failure of endoscopic control 6 Other Squamous cell carcinoma 7 Small cell carcinoma 1 Patients were discharged from hospital once they had fulfilled the following criteria: pain adequately controlled by oral analgesia, oral intake resumed, bowels opened, and patient independently mobile and competent with stoma or neobladder care. Data analysis After approval by the institution s audit committee, a retrospective case notes review was undertaken and the data were compiled onto a Microsoft Excel Spreadsheet to allow descriptive analysis. Outcomes recorded included LOS, time to mobilisation, and complication rates within the first 30 days 720 BJU International 2013 BJU International

3 The Exeter Enhanced Recovery Programme Fig. 1 The Exeter ERP for ORC. Pre-referral Medical comorbidities addressed by family doctor e.g. diabetic control, hypertension, anaemia. Out-patient assessment Surgical options discussed. Seen by Nurse Specialist. Verbal and written information offered. Preparation for surgery Outstanding medical issues identified Preoperative investigations Patient education about ERP (verbal and written) Preoperative education on stoma or neobladder care Cardiopulmonary exercise testing where indicated Social issues identified and discharge planned Admission Surgery Postoperative care Follow-up No bowel preparation Day of surgery admission Consent for procedure Carbohydrate loading up to 2 h preoperatively (2 200 ml) Walk to theatre Single dose of antibiotics Extra-peritoneal approach to surgery Rectus sheath analgesia catheters Intraoperative cell salvage (Cobe Brat 2) Prevention of hypothermia (Bair Hugger ) No routine nasogastric tube Goal-directed fluid therapy VTE prophylaxis (TED stockings, mechanical calf pumps, low molecular weight heparin) Initial overnight care on the High Dependency Unit Early drain removal (if drain placed) Early oral fluids and diet (free clear fluid day 0, free fluids day 1, full diet as tolerated day 2) Early mobilisation (sit up day 0, sit out day 1,walk day 2) Analgesia rectus sheath catheters +/ PCA and regular paracetamol/nsaid/tramadol Regular metoclopramide and omeprazole Ureteric stents remove from day 5 if well 28-day once daily prophylactic low-molecular weight heparin s.c. injection Telephone contact given Stoma care and district nurse informed of discharge Neobladder care where applicable (every 2 weeks). Out-patient follow-up at 6 weeks with histology Our standard antibiotic regimen is a single dose of Cefuroxime and Metronidazole at induction of anaesthesia. No further antibiotics are given unless the procedure is > 4 h. No postoperative antibiotics are given unless specifically indicated. This regimen is in line with available evidence from the colorectal literature [5]. The standard analgesia was originally epidural-based. An early modification of the ERP was the introduction of rectus sheath catheters (RSCs). RSCs allow the repeated infiltration of local anaesthetic into the space between the posterior aspect of the rectus muscle and the posterior rectus sheath, thereby blocking the ventral rami of the intercostal nerves supplying the anterior abdominal wall. This technique has previously been reported within the authors unit [6,7]. BJU International 2013 BJU International 721

4 Dutton et al. Table 3 In-patient pathway for patients undergoing ORC in the Exeter ERP. Day of surgery Preoperative Intraoperative Postoperative Postoperative day 1 Postoperative day 2 Postoperative day 3 5 Day 5 onwards (according to the Clavien classification [8]), as well as re-admissions during that period. Evolution of the ERP Anticipated activities 2 carbohydrate drinks up to 2 h before anaesthesia Preoperative medication omeprazole 20 mg Knee-length anti-embolism stockings Walk to theatre Rectus sheath analgesia catheters (RSC) Single dose of antibiotics (cefuroxime and metronidazole i.v.) Extraperitoneal approach to surgery Intraoperative cell salvage (Cobe Brat 2) Prevention of hypothermia (Bair Hugger ) No routine nasogastric tube No routine placement of drains Goal-directed fluid therapy Mechanical calf pumps Sit upright in recovery area Clear fluids Low molecular weight heparin Regular metoclopramide and omeprazole Local anaesthetic boluses to RSC at 4 6 h intervals Regular paracetamol and NSAIDs oral medication Tramadol as required Sit out and walk to end of bed Free oral fluids and remove IV fluids Continue RSC boluses and prescribed pain relief Full diet as tolerated Mobilise around ward Continue RSC boluses Increase oral diet and mobilisation Commence stoma care or neobladder education Remove RSC when no longer required Remove stents from day 5 onwards (removed the night before the date of planned discharge if patient progressing well) Discharge when criteria met: Pain adequately controlled Independently mobile Competent with stoma or neobladder care ERPs are built on the principle of continuous quality improvement and the on-going incorporation of new evidence. Consequently, the programme is characterised by constant evolution as new techniques, technologies and clinical experience become incorporated. For example, in the present series regional anaesthesia was originally based on a thoracic epidural but rapidly moved to RSC blocks on account of the benefits previously published [6,7]. Other changes incorporated during the series included admission on the day of surgery, avoidance of routine drain placement and extended thrombo-prophylaxis at home for 28 days postoperatively. The latter amendment followed national guidance from the UK National Institute for Clinical Excellence, citing the body of evidence in support of extended thrombo-prophylaxis in patients undergoing major pelvic cancer surgery [9]. Table 4 Complications during in-patient stay for all patients (n = 165). Complication Incidence, n (%) Major (Clavien Grade 3) Re-laparotomy 5 (3.0) Intra-abdominal collection (non-surgical management) 4 (2.4) Death (cardiac arrest) 2 (1.2) Minor (Clavien Grade 2) Ileus 35 (21.2) UTI 14 (8.5) Infection after ureteric stent removal 5 (3.0) Diarrhoea and vomiting 3 (1.8) Lower respiratory tract infection 5 (3.0) Superficial wound dehiscence 2 (1.2) Wound infection 3 (1.8) Weak leg flexor muscles 2 (1.2) Acute kidney injury 2 (1.2) Transient confusion 1 (0.6) Results All patients were successfully entered into the ERP, which was universally applied irrespective of age, cancer stage or comorbid status. The mean age was 67 years and most patients were recorded as American Society of Anesthesiologists (ASA) grade 2. Almost one in four patients underwent orthotopic neobladder reconstruction. Neoadjuvant chemotherapy was administered in almost 70% of cases with a 4 6 weeks interval between the end of chemotherapy and admission for surgery. All patients being treated radically are considered for neoadjuvant chemotherapy according to our institutional standard. Exclusions to this include non-tcc histology, severe renal impairment, or bladder symptoms precluding delay in surgery. Gemcitabine and cisplatin is the preferred combination but carboplatin may be used if there is mild renal impairment or in more elderly patients. Table 4 describes the complications during the series. The 30-day mortality rate was 1.2%, one death was due to a cardiac arrest on postoperative day 9 and one due to a retroperitoneal bleed and overwhelming sepsis. Five patients (3.0%) required a re-laparotomy during their initial admission, three of these were due to persistent bleeding, one was performed due to small bowel leakage (necessitating a defunctioning loop ileostomy) and one due to a urine leak (for open drainage of an infected para-colic urinoma). Sub-group The most contemporary subset of 52 patients undergoing ORC with a fully implemented ERP (from September 2011) were analysed in greater detail with regard to bowel function and mobility after the incorporation of additional outcome metrics in the retained dataset. The median time to resumption of bowel activity (passing stool) was on day 6 postoperatively. The median time to sitting out of bed was the first day postoperatively and the second day postoperatively for fully mobilising (walking). 722 BJU International 2013 BJU International

5 The Exeter Enhanced Recovery Programme Fig. 2 LOS per year for the Exeter ERP for patients undergoing ORC. Length of stay, days LOS and Readmissions Mean Median Year of ERP Figure 2 shows the impact of the ERP on the LOS according to year for this longitudinal case series. In all, 23 patients (13.94%) were readmitted in the 30 days after ORC. Reasons for readmission were dehydration/general illness (four), urosepsis (four), superficial wound dehiscence (three), wound infection (two), pelvic collection (four), pulmonary embolism (one), rectal pain (one), incisional hernia (one), adhesional obstruction (one), urinary leak (one) and constipation (one). Discussion The present study describes the safe application of an ERP in patients undergoing ORC. The rates described for complications, readmission and 30-day mortality are consistent with other published major RC series [10 17]. The mean LOS is in the lowest decile by comparison with other units in England (HES data) [18]. These findings are consistent with the published data from Pruthi et al. [4] in North Carolina using a similar protocol. ERPs by their nature are multi-modal, multi-disciplinary and may even vary in the finer details between individual units according to local experience and expertise. The ERP described in this study certainly subscribes to this doctrine, although there are certain individual elements that the authors feel are paramount to the success of this programme. A central tenet of the programme is the education of staff, patients and relatives. Patients are informed at the earliest opportunity, often in the out-patient clinic and in preoperative assessment clinic, concerning the steps they would be expected to take through the programme, as well as encouraging the identification of social barriers that may prevent timely discharge. This is reinforced with written information. Actively managing the expectations of patients, carers and staff sets the tone for the entire pathway. Preoperative carbohydrate drinks (2 200 ml) are given 2 h before surgery. The benefits of these are multifactorial with likely benefits to include decreased patient anxiety, improved hydration, decreased insulin resistance, decreased inflammatory response, and possibly an earlier return of gut function. Again, evidence for this tends to be from colorectal sources [19]. The intraoperative strategy of goal-directed fluid therapy describes the use of cardiac output measurements to guide i.v. fluids (or inotropes) to maintain homeostasis within defined limits. This aims to ensure adequate tissue perfusion thereby improving oxygen delivery. Where appropriate, invasive or non-invasive, cardiac monitoring was used in the present series to achieve this. Intraoperative cell salvage was routinely used as part of the intraoperative fluid maintenance regime. This technique allows the patient s own blood, which is otherwise discarded, to be collected intraoperatively and then re-infused as washed red blood cells. The aim is to reduce the need for allogenic blood transfusion and thereby reduce the associated risks as described in our earlier publication [20]. Nasogastric tubes (NGTs) are not used routinely. This is a development of the techniques used by previous authors who described the increasingly early removal of NGTs (in combination with regular metoclopramide) to be associated with early return of bowel function [4,21]. We have found no disadvantage to abandoning the elective use of NGT at the time of surgery and now reserve their use to patients who develop a postoperative ileus. Again, there have been published randomised controlled trials (RCTs) and meta-analyses in colorectal surgery confirming that routine use of NGT is not only unnecessary but may in fact be associated with deleterious effects [22]. Adequate and appropriate analgesia is essential to early postoperative mobilisation. Part of the ERP reported in this study uses RSCs to produce a block over the anterior abdomen that can be regularly topped up. These are used in the place of epidural analgesia and their use has been described by our group elsewhere [6,7]. In combination with simple analgesia (paracetamol and NSAIDS), we have found RSCs to be a highly effective method of analgesia that facilitates opiate minimisation and early patient mobilisation. A RCT of thoracic epidural vs RSC is currently underway at our centre (ISRCTN ) and it is likely that this analgesia regime will continue to evolve, for example, by incorporation of novel non-narcotic analgesics. Early mobilisation prevents muscle loss, maintains muscle strength, pulmonary function and tissue oxygenation and decreases the increased risk of thromboembolic disease BJU International 2013 BJU International 723

6 Dutton et al. associated with prolonged restriction to bed. The programme is aggressive in this area, encouraging all patients with the aid of nursing staff and physiotherapists to be mobilising by the second day after RC. We would expect the vast majority of patients to be sat out of bed on the first postoperative day and this expectation was borne out on analysis of the most recent data. Early resumption of oral nutrition is important for patient recovery and, in gynaecological oncology surgery, has been shown to be feasible, safe and associated with a decreased LOS and increased patient satisfaction [23]. It has also been shown to be safe in urological surgery, and forms a key component of the present ERP [24]. In concordance with Pruthi et al. [4], we have found the introduction of an early diet to be safe and associated with minimal problems of tolerance or gastro-intestinal dysfunction. We anticipate further modifications to the ERP described. Recent modifications since the present analysis include discontinuation of the routine use of wound drains and the introduction of 28-day post-discharge low molecular weight heparin as thrombo-prophylaxis. The discontinuation of the routine use of wound drainage was a pragmatic decision based on the very low rate of urinary leakage and a lack of observed benefit from drain insertion. We are not aware of any strong evidence to support routine drain usage in the prevention of postoperative collections, for which the option of percutaneous drainage is now readily available. It is likely that further aspects of the ERP will change, e.g. by incorporating the techniques used in other centres such as postoperative chewing gum [4], and μ-opioid receptor antagonists (e.g. alvimopan) for which there is increasing evidence [25]. We also anticipate that the recent introduction of robot-assisted surgery at our centre will complement the aims of the enhanced recovery protocol leading to a further improvement in mobility and reduction in the LOS. Interestingly, a small RCT comparing ORC and robot-assisted RC (RARC) did not find any significant difference in overall complication rate and LOS [26]. However, a more recent cohort study found RARC to have a lower transfusion rate and complication rate than either laparoscopic RC or ORC and also reported the mean LOS for ORC, laparoscopic RC and RARC to be 19, 16 and 10 days respectively [27]. This 10 days mean LOS for RARC is equivalent to the LOS reported in the present series and it will be of interest to assess whether combining a fully implemented ERP with the benefits of RARC will lead to further improvements. There are certainly important limitations to the analysis reported in the present study; in particular, it is retrospective and not a randomised trial of an intervention per se. However, it is an unselected, consecutive case series and represents the results of all surgeons at the centre implying there has been a paradigm shift in culture across the whole unit rather than an enthusiast s personal endeavour. We have attempted to accurately describe our current ERP for patients undergoing ORC to assist other centres in adopting similar changes in practices. In conclusion, we consider that the introduction of the ERP described for patients undergoing ORC has been safe and led to patient benefits including early feeding, early mobilisation and more rapid discharge from hospital. We have not seen any adverse consequences in terms of readmission rates, complications or 30-day mortality. The ERP will continue to evolve as evidence for improved practice emerges and as technology advances. 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