Published online Dec 21, 2023.
https://doi.org/10.4111/icu.20230282
Implementation of the enhanced recovery after surgery protocol for radical cystectomy patients: A single centre experience
,1
Brendan H. Dias,1,2
Niall M. Corcoran,1,2,3
Homayoun Zargar,1,2
Conrad Bishop,1
Sue Wallace,1
Diana Hayes,1
and James G. Huang1
Abstract
Purpose
The enhanced recovery after surgery (ERAS) protocol for radical cystectomy aims to facilitate postoperative recovery and hasten a return to normal daily activities. This study aims to report on the perioperative outcomes of implementation of an ERAS protocol at a single Australian institution.
Materials and Methods
We identified 73 patients with pT1–T4 bladder cancer who underwent open radical cystectomy at Western Health, Victoria between June 2016 and August 2021. A retrospective analysis of a prospectively maintained database was performed. Perioperative outcomes included length of hospital stay, nasogastric tube requirement and duration of postoperative ileus.
Results
The median age was 74 years (interquartile range [IQR] 66–78) for the ERAS group and 70 years (IQR 65–78) for the pre-ERAS group patients. All patients in each group underwent ileal conduit formation. The median length of hospital stay was 7.0 days (IQR 7.0–9.3) for the ERAS group and 12.0 days (IQR 8.0–16.0) for the pre-ERAS group (p=0.003). Within the ERAS group, 25.0% had a postoperative ileus, and 25.0% had a nasogastric tube inserted, compared with 64.9% (p=0.001) and 45.9% (p=0.063) respectively within pre-ERAS group. The median bowel function recovery time, defined as duration from surgery to first bowel action, was 5.0 days (IQR 4.0–7.0) in the ERAS group and 7.5 days (IQR 5.0–8.5) in the pre-ERAS group (p=0.016).
Conclusions
Implementation of an ERAS protocol is associated with a reduction in hospital length of stay, postoperative ileus and bowel function recovery time.
INTRODUCTION
Radical cystectomy with pelvic lymph node dissection for the treatment of non-metastatic muscle-invasive and high-risk non-muscle-invasive bladder cancer remains a highly morbid procedure with a significant risk of complications. Enhanced recovery after surgery (ERAS) protocols are multimodal, multidisciplinary care pathways designed to reduce the profound stress response following surgery and optimise physiological function. These evidence-based protocols are aimed at standardising medical care, lowering healthcare costs and improving health outcomes.
An ERAS protocol for radical cystectomy was first described in 2013 by the ERAS Society [1]. Health institutions have implemented various aspects of this protocol based on their own unique circumstances and availability of resources. Amongst previously published series, all ERAS protocols favoured preoperative carbohydrate loading, opioid-sparing multimodal analgesia, intraoperative normothermia, early mobilisation, early oral feeding, avoidance of mechanical bowel preparation, and avoidance of routine nasogastric tube placement [2, 3, 4]. ERAS protocols for radical cystectomy have demonstrated an association with reduced hospital length of stay (LOS), earlier return of bowel function, and earlier resumption of normal daily activities without an increase in rates of complications or readmissions, compared with traditional approaches to postoperative management [5, 6].
Despite the well-known benefits of implementing ERAS protocols for radical cystectomies globally, there has been variable uptake of ERAS protocols across various health institutions. Furthermore, there are few published data reporting on outcomes derived from Australian population series.
This study therefore aims to report on post-cystectomy outcomes following implementation of the ERAS protocol at a single Australian institution. In doing so, it aims to determine whether management in accordance with ERAS is associated with a decreased hospital LOS and more rapid return to normal daily activities.
MATERIALS AND METHODS
1. Development and implementation of the ERAS protocol
An ERAS protocol was developed and implemented at Western Health in June 2019, in line with radical cystectomy perioperative guidelines published by the ERAS Society in 2013 [1]. This was implemented following extensive consultation with key stakeholders involved in the care of a patient undergoing cystectomy at Western Health: Stomal Therapy, Urology Nursing, Pre-Admission Clinic, Allied Health, Anaesthetics, Pharmacy, Intensive Care and Pain Services. The ERAS protocol can be divided into pre-, intra- and postoperative phases. The key elements of the ERAS protocol in use at Western Health are shown in Table 1.
Table 1
Elements of our institution’s ERAS protocol for radical cystectomy
2. Setting, population, and study design
This retrospective study was conducted within a large, high-volume urology unit at a metropolitan tertiary centre. Patients included in the study were ≥18 years of age, diagnosed with bladder cancer and who underwent open radical cystectomy at Western Health, Victoria between June 2016 and August 2021. The exclusion criteria were radical cystectomy performed in an emergency setting, concomitant pelvic exenteration or salvage radical cystectomy. All patients who underwent radical cystectomy during this time period were eligible for the study and all underwent ileal conduit formation as the method of urinary diversion. This equated to a total of 73 patients. All patients underwent standard template lymphadenectomy by default with dissection extending up to the common iliac artery bifurcation superiorly, genitofemoral nerve laterally and internal iliac artery inferiorly. Extended templates up to the aortic bifurcation were performed in patients who had clinically advanced disease (≥cN1). A pre-post comparison study design was used, with two groups (pre-ERAS and ERAS). The pre-ERAS group consisted of 36 patients who underwent radical cystectomy prior to implementation of the ERAS protocol from June 2016 to May 2019. The ERAS group consisted of 37 patients who underwent radical cystectomy and were managed postoperatively in accordance with the ERAS protocol from June 2019 to August 2021. Data was obtained from a prospectively maintained radical cystectomy departmental database. Organisational ethics approval was obtained from the Research Ethics and Governance Committee at Western Health (QA2021.52). This project did not involve experiments on humans and/or the use of human tissue samples. The requirement for informed consent was waived by the Western Health Research Ethics Committee because of the retrospective nature of the study. All methods were carried out in accordance with relevant guidelines and regulations (such as the Declaration of Helsinki).
3. Outcome measures
Demographic characteristics included in the study were gender, age at surgery, fitness status prior to surgery as determined by the American Society of Anaesthesiologist (ASA) score, body mass index and uptake of neoadjuvant chemotherapy. Cystectomy tumor characteristics were obtained from the database, which included pathologic tumor (T) and nodal (N) stage, concomitant carcinoma-in-situ, tumor grade and histology. Intraoperative characteristics such as mean duration of surgery, mean estimated blood loss and mean crystalloid volume were obtained.
Postoperative outcome measures such as median length of intensive care unit (ICU) stay, median hospital LOS, postoperative ileus, nasogastric tube requirements and duration (days) from surgery to first bowel action were collected. Bowel function recovery time was defined as the number of days from surgery to first bowel action.
Finally, postoperative complications were measured by recording the number of episodes of postoperative complications, categorised into two groups based on the Clavien–Dindo (CD) scoring system (<3 or ≥3). A score of 3 represents those complications which require surgical endoscopic or radiological intervention [7]. Patients admitted to ICU in the immediate postoperative period for haemodynamic monitoring only were classified as CD<3; however, if the patient required vasopressors or had a clinical deterioration in ICU requiring intervention, then they were assigned a CD score≥3. We also calculated the number of patients who were readmitted to hospital within 90 days of hospital discharge.
There are varying definitions of postoperative ileus described in the literature. We utilised Forbes et al.’s [8] definition of postoperative ileus as a clinical state of nausea, abdominal distension or vomiting requiring nasogastric tube insertion or failure to advance to a solid diet by the seventh postoperative day.
Descriptive statistics were used to report baseline characteristics of the two groups. Continuous variables were analysed using one-way analysis of variance. A p-value of <0.05 (two-sided) was considered statistically significant.
RESULTS
Table 2 summarises the patient characteristics in the two groups. No significant differences were found in the baseline characteristics of patients in the two groups. The distribution of ASA scores across the cohort appeared consistent, therefore, differences in premorbid status were likely minimal. In keeping with contemporary practice, 7 patients in the ERAS group received neoadjuvant chemotherapy.
Table 2
Demographic, cystectomy tumor, and intraoperative characteristics
In terms of radical cystectomy tumor characteristics, interestingly, the majority of patients had non-muscle invasive disease on the final cystectomy specimen histology (52.8% in ERAS vs. 48.6% in pre-ERAS groups, p=0.775). In both cohorts, around half had carcinoma-in-situ present (50.0% in ERAS vs. 54.1% in pre-ERAS groups, p=0.733). The most common tumor grade was high-grade (77.8% in ERAS vs. 75.7% in pre-ERAS groups, p=0.765) and the most common histological type was pure urothelial carcinoma (75.0% in ERAS vs. 70.3% in pre-ERAS groups, p=0.758).
The only significant difference in intraoperative characteristics was a shorter duration of surgery in the ERAS cohort (342 minutes in ERAS vs. 387 minutes in pre-ERAS groups, p=0.026).
Table 3 demonstrates our postoperative outcomes and complications with pre- and post-ERAS implementation. The median hospital LOS for patients in the ERAS group was 7.0 days (interquartile range [IQR] 7.0–9.3 days), compared with 12.0 days in the pre-ERAS group (IQR 8.0–16.0 days, p=0.003). There were also significant reductions in time to important postoperative recovery milestones in the ERAS group. The incidence of postoperative ileus was significantly less in the ERAS cohort (25.0% in ERAS vs. 64.9% in pre-ERAS cohorts, p=0.001). There were no patients in both groups who developed a mechanical bowel obstruction postoperatively. The median bowel function recovery time for the ERAS group was 5.0 days (IQR 4.0–7.0 days), compared with 7.5 days for the pre-ERAS group (IQR 5.0–8.5 days, p=0.016). The median duration from surgery to first solid food was 5.0 days for ERAS group (IQR 4.0–6.0 days) compared with 6.0 days for the pre-ERAS group (IQR 4.0–8.0 days, p=0.058). Furthermore, the percentage of patients requiring total parenteral nutrition postoperatively was significantly less in the ERAS group (2.8%) compared with the pre-ERAS group (21.6%, p=0.014).
Table 3
Perioperative outcomes and postoperative complications
Postoperative complication rates were not statistically significant in the two groups. For complications which were a CD score<3, this was 77.8% in the ERAS group and 91.9% in the pre-ERAS group, p=0.194. For complications which were a CD score≥3, this was 27.8% in the ERAS group and 35.1% in the pre-ERAS group, p=0.505. The 90-day readmission rate was not statistically significant in the two groups (44.4% in ERAS vs. 37.8% in pre-ERAS groups, p=0.573).
DISCUSSION
To the best of our knowledge, this is one of the few Australian studies to date that reports on outcomes following implementation of an ERAS protocol for patients undergoing radical cystectomy with radical pelvic lymph node dissection. Internationally, the ERAS protocol has proven beneficial in improving perioperative outcomes and shorter recovery time with more rapid return to normal daily activities following radical cystectomy. Additionally, implementation of ERAS has demonstrated a considerable reduction in overall healthcare costs attributable to a reduced rate of readmission and complications [9].
Previous studies have frequently employed hospital LOS as a marker of success when assessing outcomes of ERAS [6, 10]. Our finding of a reduction in median hospital LOS by 5 days correlates well with previous international studies, which have reported a median reduction in LOS ranging from 3 to 5 days [9, 11]. A likely key factor contributing to this reduction is the circumvention of bowel preparation [10]. Mechanical bowel preparation is known to have association with severe side effects such as electrolyte disturbance or acid-base imbalances and dehydration [12]. The liberal fluid infusion that is typically employed to re-establish intravascular volume and correct electrolyte disturbances may result in huge fluid shifts, thus resulting in tissue oedema, the prolongation of wound recovery and bowel function recovery time [13]. Furthermore, as demonstrated in our data (Table 2), most patients who require radical cystectomy are greater than the age of 70 years and medical comorbidities are common. These factors are associated with impaired physiological reserve and a reduced ability to compensate for fluctuations in environmental conditions, thus increasing the risk of morbidity and mortality [14]. Studies have since shown no advantage gained by preoperative bowel preparation in radical cystectomy and ileal conduit formation [15, 16].
A reduction in bowel function recovery time by 2.5 days (p=0.016), was also observed in the ERAS group, consistent with internationally published data. Previously published series on as ERAS protocol have demonstrated a reduction in bowel function recovery time of 2–3 days compared with traditional approaches to postoperative care [6, 9]. There was also a significant reduction in postoperative ileus and the need for total parenteral nutrition in the ERAS group, suggesting that enteral nutrition was better tolerated in the ERAS group.
The overall reductions in LOS and bowel function recovery time point to the importance of strict adherence to ERAS and collaboration between multiple disciplines to achieve ERAS targets. Strict compliance presents a huge challenge with a recent study of ERAS in our institution’s colorectal surgery reporting a adherence rate to ≥70% postoperative ERAS recommendations of as low as 34% [17]. Several factors have been identified, including the lack of collaboration and effective communication between interdisciplinary team members, a lack of clear understanding of all components of the institution’s ERAS protocol, a shortage of medical and human resources, and insufficient financial support for effective ERAS application [18]. Therefore, health systems should aim to address the structural barriers associated with ERAS implementation.
The systematic reporting of postoperative complications following radical cystectomy remains a challenge with variations in the methodology of reporting within the literature [19]. Our method of reporting, which divides complications into low-grade (CD<3) and high-grade (CD≥3), has previously been described [20, 21]. Our study revealed that within the ERAS cohort, the proportion of patients who experienced any low-grade or high-grade complication within 90 days following radical cystectomy was 77.8% and 27.8% respectively. There is currently no general consensus on the expected 90-day complication rate following radical cystectomy with previous studies reporting a low-grade complication incidence rate ranging from 54% to 70%, whilst the incidence rate of a high-grade complication is approximately 25% [22, 23, 24]. The rates of complications following radical cystectomy in our cohort however appears slightly higher compared with what has been reported in the literature.
Our complication figures should also be interpreted in the context of variations in the definition of postoperative ileus within the literature. This variation is another factor which makes direct comparison of complications across studies difficult, and it has been noted that postoperative ileus accounts for a significant proportion of complications [8, 25]. For the purposes of this study, we utilised Forbes et al.’s [8] definition of postoperative ileus as a clinical state of nausea, abdominal distension or vomiting requiring nasogastric tube insertion or failure to advance to a solid diet by the seventh postoperative day. This definition aimed to be broadly inclusive and incorporate elements from various published definitions [26, 27]. Our results show that postoperative ileus incidence was significantly less in the ERAS group (p=0.001). Our data may appear to suggest that all patients in the ERAS group with postoperative ileus had a nasogastric tube inserted, compared with 70.9% of patients in the pre-ERAS group; however, it should be noted that our postoperative ileus data has been formulated from the number of patients needing a nasogastric tube due to nausea, abdominal distension or vomiting, or failure to progress to solid diet by postoperative day 7, as per Forbes et al.’s [8] definition. Therefore, our purposeful avoidance of nasogastric tube insertion as part of the ERAS protocol, as demonstrated by a 20.9% reduction of nasogastric tube insertion in the ERAS group (25.0% in ERAS group vs. 45.9% in pre-ERAS group), is a likely key contributor to a significant reduction in the reported incidence rate of postoperative ileus in our ERAS group. Despite attempts within the literature at standardising the reporting of complications post radical cystectomy, direct comparisons across studies remain challenging.
Although a formal cost impact analysis was not performed, the ERAS protocol achieved a significant result of a day 7 discharge in 55.5% of patients enrolled under the ERAS pathway, compared with 21.6% under no ERAS. A reduction in 90-day postoperative complication rates was also noted in the ERAS group, although this result was not statistically significant. We believe that the shorter hospital LOS following implementation of an ERAS protocol for radical cystectomy would have contributed to significant cost savings for the healthcare network. In the era of robotic surgery, emerging data on perioperative outcomes with robot-assisted radical cystectomy (RARC) are proving favourable compared with the open approach, with a shorter duration of postoperative ileus and less reliance on opioid analgesia [28, 29]. We expect there to be synergy between ERAS and RARC, which could translate into long-term cost savings for health services.
There are several limitations to this study. The retrospective study design without randomisation makes it susceptible to bias. Our study did not measure the degree of adherence to every element stipulated in our ERAS protocol for radical cystectomy. Furthermore, the study design comparing outcomes before and after implementation of an ERAS protocol (pre-ERAS and ERAS groups) meant that each group were not included in the study during the same period, which could have biased the results of this study. Lastly, our sample size was relatively small (73 cases) and our patient cohort was limited to those who underwent open radical cystectomy with ileal conduit formation, thus our results may not be generalisable to other surgical approaches and urinary diversion types.
CONCLUSIONS
Implementation of an ERAS protocol for patients undergoing radical cystectomy has demonstrated a significant reduction in postoperative hospital LOS and faster return of normal bowel actions with no increase in the overall complication rate. This points to the benefit of implementing ERAS for radical cystectomy to improve patient outcomes while reducing hospitalisation costs.
CONFLICTS OF INTEREST:The authors have nothing to disclose.
FUNDING:None.
AUTHORS’ CONTRIBUTIONS:
Research conception and design: Brendan A. Yanada, Brendan H. Dias, and Niall M. Corcoran.
Data acquisition: Brendan A. Yanada and Sue Wallace.
Statistical analysis: Brendan A. Yanada and Brendan H. Dias.
Data analysis and interpretation: Brendan A. Yanada, Brendan H. Dias, and Niall M. Corcoran.
Drafting of the manuscript: all authors.
Critical revision of the manuscript: Brendan A. Yanada, Brendan H. Dias, Niall M. Corcoran, Sue Wallace, Diana Hayes, and James G. Huang.
Administrative, technical, or material support: Brendan A. Yanada, Sue Wallace, and Diana Hayes.
Supervision: James G. Huang and Niall M, Corcoran.
Approval of the final manuscript: all authors.
ACKNOWLEDGMENTS
We would like to acknowledge the following healthcare professionals for their contributions to the development of the ERAS protocol at Western Health: Lynda Breen, Suzannah Beasley, Sharon Busch, Nina Leggett, Caroline Calkin, Dr. Joshua Szental, Dr. Grace Huang, A/Prof. Justin Yeung.
References
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Brandstrup B, Tønnesen H, Beier-Holgersen R, Hjortsø E, Ørding H, Lindorff-Larsen K, et al. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg 2003;238:641–648.
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Yamada S, Abe T, Sazawa A, Katano H, Suzuki H, Takeuchi I, et al. Comparative study of postoperative complications after radical cystectomy during the past two decades in Japan: radical cystectomy remains associated with significant postoperative morbidities. Urol Oncol 2022;40:11.e17–11.e25.
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