Implementation of the Enhanced Recovery After Surgery Protocol for Radical Cystectomy Patients – A Single Centre Experience

doi:10.21203/rs.3.rs-2320094/v1

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Implementation of the Enhanced Recovery After Surgery Protocol for Radical Cystectomy Patients – A Single Centre Experience

https://doi.org/10.21203/rs.3.rs-2320094/v1

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Introduction and Objectives

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.

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 assessed include length of hospital and ICU stay, nasogastric tube requirement and duration of postoperative ileus.

Results

The median age was 74 years (IQR 66 to 78) for the ERAS group and 70 years (IQR 65 to 78) for the non-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 to 9.3) for the ERAS group and 12.0 days (IQR 8.0 to 16.0) for the non-ERAS group (p = 0.003). Within the ERAS group, 25% had a postoperative ileus, and 25% had a nasogastric tube inserted, compared with 65% (p = 0.001) and 46% (p = 0.063) respectively within non-ERAS group. The median duration from surgery to first bowel motion was 5.0 days (IQR 4.0 to 6.0) in the ERAS group and 7.5 days (IQR 4.0 to 8.0) in the non-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.

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. These evidence-based protocols are aimed at standardising medical care, lowering healthcare costs, while 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, and avoidance of mechanical bowel preparation and routine nasogastric tube placement.(2–4) 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.

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, 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
Preoperative
Pre-admission clinic	• ERAS cystectomy oral and written information • Preoperative medical assessment and optimisation • Smoking cessation
Oral mechanical bowel preparation	• Avoidance of mechanical bowel preparation
Fasting	• Regular diet until day of surgery • Solid diet until 6 hours preoperatively • Clear fluid until 2 hours preoperatively
Intraoperative
Pre-medication	• Oral paracetamol • Carbohydrate loading • Antimicrobial prophylaxis and skin preparation
Anaesthetics	• Prewarming and maintenance of normothermia • Avoid long-acting sedative medications • Regional anaesthetic techniques for planned open surgeries • Antimicrobial prophylaxis and skin preparation • Opioid-sparing analgesic regimen • Complete reversal of neuromuscular blockade • Evidence-based prophylaxis of postoperative nausea and vomiting • Evidence-based glycaemic control for diabetic patients
Antimicrobial prophylaxis	• Appropriate antibiotics given 30–60 minutes before incision
Thromboprophylaxis	• Mechanical thromboprophylaxis and prophylactic clexane
Postoperative
Chewing gum	• Commence on day 1 until passage of flatus
Diet	• Day 1: Comfort sips with chewing gum • Day 2: Free fluids as tolerated • High energy protein diet after passage of flatus • Nasogastric tube only if vomiting or uncomfortable and with approval at level of Urology registrar or above
Early mobilisation	• Day 1: Out of bed for at least 6 hours and walk 10–20 metres • Day 2: Walk 100 metres • ≥ Day 3: Walk > 100 metres
Thromboprophylaxis	• 28 days of self-administered clexane

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. A total of 73 patients were included in the study and all underwent ileal conduit formation as the method of urinary diversion. A pre-post comparison study design was used, with two groups (non-ERAS and ERAS). The non-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).

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, BMI and uptake of neoadjuvant chemotherapy. Cystectomy tumour characteristics were obtained from the database, which included pathologic tumour (T) and nodal (N) stage, concomitant carcinoma-in-situ, tumour 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 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 scoring system (< 3 or ≥ 3). A score of 3 represents those complications which require surgical endoscopic or radiological intervention.(7) 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 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.(8)

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.

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 pre-morbid status were likely minimal. In keeping with contemporary practice, 7 patients in the ERAS group received neoadjuvant chemotherapy.

Table 2

– Demographic, Cystectomy Tumour and Intraoperative Characteristics
	ERAS (n = 36)	Non-ERAS (n = 37)	P value
Demographic Characteristics
Sex, n (%) Male Female	26 (72) 10 (28)	31 (84) 6 (16)	0.238
Median (Q1-Q3) age at surgery, years	74 (66–78)	70 (65–78)	0.575
ASA score, n (%) 1 2 3 >3	2 (6) 16 (44) 18 (50) 0 (0)	1 (3) 12 (43) 21 (49) 3 (5)	0.087
Median (Q1-Q3) BMI, kg/m²	27.3 (25.8–29.7)	26.5 (24.3–29.1)	0.709
Neoadjuvant chemotherapy, n (%)	7 (19)	0 (0)	0.004*
Cystectomy Tumour Characteristics
Pathologic T stage, n (%)^§ <pT2 pT2 pT3 pT4	19 (53) 5 (14) 9 (25) 3 (8)	18 (49) 6 (16) 8 (22) 5 (14)	0.775
Node positive, n (%)	5 (14)	5 (14)	0.963
Concomitant carcinoma-in-situ, n (%)	18 (50)	20 (54)	0.733
Tumour Grade, n (%) pT0 Low grade High grade	6 (17) 2 (6) 28 (78)	7 (19) 1 (3) 28 (76)	0.765
Histology, n (%) Pure urothelial carcinoma pT0 Mixed	27 (75) 6 (17) 3 (8)	26 (70) 7 (19) 4 (11)	0.758
ORC Intraoperative Characteristics
Mean duration of surgery, mins^†	342	387	0.026*
Urethrectomy, n (%)	12 (33)	13 (35)	0.873
Ileal conduit diversion, n (%)	36 (100)	37 (100)	0.965
Mean estimated blood loss, mL	997	653	0.081
Mean crystalloid volume, mL	3258	3394	0.649
* Statistically significant. ^§ Based on 2017 TNM classification of urinary bladder cancer. ^† Measured by calculating total anaesthetic time; ASA, American Society of Anaesthesiologist; BMI, body mass index. ORC, open radical cystectomy.

In terms of radical cystectomy tumour characteristics, interestingly, the majority of patients had non-muscle invasive disease on the final cystectomy specimen histology (53% in ERAS vs 49% in non-ERAS groups). In both cohorts, around half had carcinoma-in-situ present. The most common tumour grade was high-grade (78% in ERAS vs 76% in non-ERAS groups) and the most common histological type was pure urothelial carcinoma (75% in ERAS vs 70% in non-ERAS groups).

The only significant difference in intraoperative characteristics was a shorter duration of surgery in the ERAS cohort (342 in ERAS vs 387 in non-ERAS groups).

Table 3 demonstrates our postoperative outcomes and complications with pre- and post-ERAS implementation. The median hospital LOS for patients on the ERAS protocol was 7 days (interquartile range 7–9 days). This was 5 days shorter than the median hospital LOS for patients not on the ERAS protocol (median 12 days; interquartile range 8–16 days, p = 0.003). There were also significant reductions in time to important postoperative recovery milestones. The incidence of postoperative ileus was significantly less in the ERAS cohort (25% in ERAS vs 65% in non-ERAS cohorts, p = 0.001). The median postoperative days to first stool for patients managed on ERAS was 5 days (interquartile range 4–7 days). This was 3 days less compared with patients managed on non-ERAS (median 8 days; interquartile range 5–9 days; p = 0.016). The postoperative days to first solid food was 5 days for ERAS group (interquartile range 4–6 days) compared with 6 days for non-ERAS group (interquartile range 4–8 days, p = 0.058). Furthermore, the percentage of patients requiring total parenteral nutrition postoperatively was significantly less in the ERAS group (3%) compared with the non-ERAS group (22%, p = 0.014).

Table 3

– Perioperative Outcomes and Postoperative Complications
	ERAS (n = 36)	Non-ERAS (n = 37)	P-value
Post-operative ICU requirement, n (%)	18 (50)	25 (68)	0.131
Median (Q1-Q3) length of ICU stay, days	1.5 (1.0–2.8)	2.0 (1.0–3.0)	0.101
Median (Q1-Q3) length of hospital stay, days	7.0 (7.0–9.3)	12.0 (8.0–16.0)	0.003*
Postoperative ileus, n (%)^‡	9 (25)	24 (65)	0.001*
Nasogastric tube inserted, n (%)	9 (25)	17 (46)	0.063
Median (Q1-Q3) duration of NGT in situ, days	2.0 (1.0–3.0)	3.0 (2.0–3.5)	0.148
Median (Q1-Q3) duration from surgery to tolerating solid oral intake, days	5.0 (4.0–6.0)	6.0 (4.0–8.0)	0.058
Median (Q1-Q3) duration from surgery to bowels open, days	5.0 (4.0–7.0)	7.5 (5.0–8.5)	0.016*
Total parenteral nutrition requirement, n (%)	1 (3)	8 (22)	0.014*
Postoperative complications within 90 days Clavien-Dindo score < 3, n (%) Clavien-Dindo score ≥ 3, n (%)	28 (78) 10 (28)	34 (92) 13 (35)	0.194 0.505
90-day readmission, n (%)	16 (44)	14 (38)	0.573
* Statistically significant. ‡ Defined as 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. NGT, nasogastric tube.

Postoperative complication rates were similar in the two groups and not statistically significant (16% in the ERAS group and 18% in the non-ERAS group for a Clavien-Dindo complication score ≥ 3). The 90-day readmission rate was not statistically significant in the two groups.

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 time to first bowel action 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 duration to first bowel action 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 (Clavien-Dindo < 3) and high-grade (Clavien-Dindo ≥ 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 78% and 28% 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% – 70%, whilst the incidence rate of a high-grade complication is approximately 25%.(22–24) 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 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.(8) 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). Therefore, our purposeful avoidance of nasogastric tube insertion as part of the ERAS protocol, as demonstrated by a 21% reduction of nasogastric tube insertion in the ERAS group (25% in ERAS group vs 46% in non-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 56% of patients enrolled under the ERAS pathway, compared with 22% 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.

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.

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 means a lack of contemporary controls for comparing complication and readmission rates.

Ethics Approval and Consent to Participate

The research protocol was approved by the Western Health Research Ethics Committee (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).

Registry and the Registration No. of the study/trial – Not Applicable

Animal Studies – Not Applicable

Consent for Publication – Not Applicable

Availability of Data and Materials – The datasets generated and/or analysed during the current study are not publicly available due to storage on secured, confidential REDCap data platform as per protocol guidelines but are available from the corresponding author on reasonable request.

Competing Interests – There are no competing interests or conflicts of interest to be declared.

Funding – No funding was sought for this project.

Author’s Contribution

BA Yanada: Protocol/project development, Data collection or management, Data analysis, Manuscript writing/editing

BH Dias: Protocol/project development, Data analysis, Manuscript writing/editing

S Wallace: Manuscript writing/editing

D Hayes: Manuscript writing/editing

H Zargar: Manuscript writing/editing

C Bishop: Manuscript writing/editing

NM Corcoran: Protocol/project development, Manuscript writing/editing

JG Huang: Protocol/project development, Manuscript writing/editing

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

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No competing interests reported.

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Implementation of the Enhanced Recovery After Surgery Protocol for Radical Cystectomy Patients – A Single Centre Experience

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Abstract

Introduction and Objectives

Methods

Results

Conclusions

Introduction

Methods

Development and implementation of the ERAS protocol

Setting, population and study design

Outcome measures

Results

Discussion

Limitations

Declarations

References

Additional Declarations

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