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Enhanced recovery after surgery program for elective major abdominal surgery at three Victorian hospitals
Report to the Department of Health
Professor Paul Myles
Alfred Health
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This document is also available in PDF format on the internet at:
www.health.vic.gov.au/surgery/eras
© Copyright, State of Victoria, Department of Health, 2011
This publication is copyright, no part may be reproduced by any process except in accordance with
the provisions of the Copyright Act 1968.
Department of Health,
Victoria.
September 2011
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4
Acknowledgements
Steering group
Alfred Health: Professor Paul Myles (anaesthesia), Professor Jonathan Serpell (surgery)
Barwon Health: Dr Simon Tomlinson (anaesthesia), Professor David Watters (surgery)
Eastern Health: Dr David Bielby (anaesthesia), Mr Richard Cade (surgery)
Executive sponsors
Alfred Health: Andrew Stripp
Barwon Health: Peter Watson
Eastern Health: Ian Jackson
Project Officer: Ms Sophie Wallace, The Alfred Hospital
Funding
The project is funded by a grant from the Commonwealth Government Elective Surgery Waiting List
Reduction Plan (Stage Two).
Victorian ERAS collaboration
Alfred Health
Anaesthesia: Paul Myles, Georgina Thompson, Michele Joseph
Surgery: Jonathan Serpell, Peter Nottle, Roger Wale
Nursing: Anne Spranklin (CRS coordinator), Ross O'Brien (UGIS coordinator)
Allied Health: Ibolya Nyulasi (nutrition), Jim Sayer (physiotherapy), Kristen Payne (occupational
therapy)
Barwon Health
Anaesthesia:, Simon Tomlinson, Simon Gower
Surgery: David Watters, Glenn Guest, Simon Crowley, Darrin Goodall Wilson
Nursing: Vanessa Cuthbert; Vicki Wall
Allied Health: Gemma Taylor (Physiotherapy); Stefan Demur (Stomal therapy); Sarah Jukes
(Dietician)
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Eastern Health
Anaesthesia: David Beilby
Surgery: Richard Cade, Mal Steele, Michael Grigg
Nursing: Wendy Brack (project officer), Sarah Burns and Lauren Savage (coordinators)
Allied Health: Val Bulmer and Pratichi Vasavada (physiotherapy), Michelle McPhee and Anna
Boltong (nutrition)
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Summary
This project evaluated the potential benefits of an enhanced recovery after surgery (ERAS)
program for elective abdominal surgery patients in three Victorian hospitals (The Alfred, Box Hill
and Geelong). A growing body of literature, emanating mostly from Europe, clearly demonstrates
that evidence-based ERAS clinical pathways for major abdominal surgery can enhance efficiency of
care without adversely affecting outcomes, and this can be associated with a substantial reduction
in length of stay after surgery.
The overall aim of this project was to assess to what extent a predefined ERAS program for
abdominal surgical patients can be achieved in Victoria. Secondly, we wanted to investigate
whether training of doctors and nurses in the application of this program improved the quality of
care for these patients. We collected data from sequential patients undergoing elective abdominal
surgery at each of the three Victorian hospitals. We used a before-and-after design such that the
first cohort representing existing traditional practice, for which we collected data between July and
December 2009, represented the control group being compared with the post-ERAS
implementation cohort conducted from February to June 2010.
We found that most ERAS-recommended interventions had been substantially implemented in the
post-implementation period: much greater use of oral nutritional supplementation, targeted
antiemetic prophylaxis, shorter surgical incisions, less opioid administration in the 48–72-hour
postoperative period, earlier oral fluid and food intake after surgery, and faster ambulation after
surgery. There was a substantial reduction in intraoperative and postoperative IV fluid
administration.
Most measures of comfort and restoration of normal functioning after surgery were significantly
improved in the ERAS cohort.
ERAS patients had a significantly shorter hospital stay, geometric mean (SD) 5.7 (2.5) versus 7.4
(2.1) days, P = 0.006.
We conclude that current perioperative and surgical practices can be readily modified to facilitate
an enhanced recovery after surgery program in Victorian hospitals, and this is associated with a
reduction in length of stay after surgery. The additional resources required are modest and likely to
be offset by a reduction in hospital stay, substantial improvements in recovery profile, and a
possible reduction in postoperative complications.
We recommend that current perioperative and surgical practices should be modified to facilitate an
ERAS program for elective abdominal surgery in Victorian hospitals.
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Contents
Acknowledgements ...................................................................................................... 4 Steering group ................................................................................................................................................................4 Executive sponsors ......................................................................................................................................................4 Funding .............................................................................................................................................................................4 Victorian ERAS collaboration ..................................................................................................................................4
Summary ...................................................................................................................... 6
Contents ....................................................................................................................... 7
Background .................................................................................................................. 8 Introduction ....................................................................................................................................................................8 Literature review ..........................................................................................................................................................8 Workforce and organisational change issues ................................................................................................ 10
Aims ............................................................................................................................11 Specific aims ................................................................................................................................................................ 11
Methods ......................................................................................................................11 Study design ................................................................................................................................................................. 11 Definition of the ERAS bundle (Fearon et al. 2005; Lemmens et al. 2009) ....................................... 12
1. Preoperative management .................................................................................................................................. 12 2. Intraoperative management ............................................................................................................................... 12 3. Postoperative management ................................................................................................................................. 13 4. Enhanced postoperative recovery ..................................................................................................................... 13 Early discharge ............................................................................................................................................................... 14
Data acquisition .......................................................................................................................................................... 14 Outcome measures (Lemmens et al. 2009) .................................................................................................... 14
Clinical ................................................................................................................................................................................ 14 Service ................................................................................................................................................................................. 15 Process ................................................................................................................................................................................ 15
Statistical analyses .................................................................................................................................................... 15
Results .........................................................................................................................16 Study populations: case mix .................................................................................................................................. 16 Surgery ........................................................................................................................................................................... 18 Characteristics of anaesthesia and perioperative care .............................................................................. 19 Recovery profile and hospital stay ..................................................................................................................... 21 Postoperative complications ................................................................................................................................ 23
Discussion ....................................................................................................................24 Key findings.................................................................................................................................................................. 24 Additional findings .................................................................................................................................................... 24 Methodological considerations ............................................................................................................................ 25 Other relevant literature ........................................................................................................................................ 25 Implications of findings........................................................................................................................................... 26 Conclusions .................................................................................................................................................................. 27
Recommendations .......................................................................................................27
References ...................................................................................................................28
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Background
Introduction
The Australian Safety and Efficacy Register of New Interventional Procedures – Surgical
(ASERNIPS) produced a report in March 2009 (Sturm and Cameron 2009) which aimed to assess
the safety and efficacy of fast-track surgery programs on patient outcomes through a systematic
review of the literature, and to explore the status of fast-track surgery in Australia. A survey of
surgeons (n = 4) included in the ASERNIPS report suggested that there was no uniform approach
to fast-track surgery in Australia or New Zealand, despite many surgeons accepting its principles.
There was a general view that fast-track surgery was cost-efficient and could result in beneficial
outcomes for patients, and that fast-track surgery protocols were relatively generic and could be
applied to many elective surgery protocols.
The ASERNIPS report concluded that further work is required to define the key aspects of
optimised surgery, together with the indications and possible patient groups who are most likely to
benefit. They noted that a number of clinical trials are currently being undertaken.
The (then) Victorian Department of Human Services sought a collaboration to investigate this
further, and so we formed a team to investigate current practices, to explore the feasibility of
establishing a fast-track elective surgical program in Victorian hospitals, and to determine measures
of successful implementation.
Literature review
Recovery from surgery is typically accompanied by discomfort and impaired functioning (Prytherch
et al. 1998; Tekkis et al. 2003; Rigg et al. 2002; Myles and Leslie 2006; Myles et al. 2007; Fearon et
al. 2005). In some cases (10–20 per cent) serious complications such as wound infection,
pneumonia, thromboembolism, myocardial infarction, and death can occur (Prytherch et al. 1998;
Tekkis et al. 2003; Rigg et al. 2002; Myles and Leslie 2006; Myles et al. 2007; Fearon et al. 2005;
Story et al. in press; Warrilow et al. 2010; Caplan et al. 1998a; Caplan et al. 1998b). The need for
hospitalisation is dictated by routines of care, and adverse effects after surgery and anaesthesia.
Patient (age, comorbidity, social factors) and institutional factors (surgeon preferences, bed
availability and hospital discharge policies) also influence the eventual duration of hospital stay
(Tekkis et al. 2003; Story et al. in press).
‘Demand factors’ stem from the patient’s need for care, but it is ‘supply factors’ – surgeon and
hospital policies for postoperative care and discharge – that most often determine length of hospital
stay (Maessen et al. 2007).
The literature demonstrates clinical pathways to enhance the quality of care by improving patient
outcomes, promoting patient safety, increasing patient satisfaction and optimizing the use of
resources (Kahokehr et al. 2009; Lemmens et al. 2009; Lemmens et al. 2008; Maessen et al. 2009;
Zargar-Shoshtari and Hill 2008). Such pathways typically include multiple interventions, ideally
evidence-based, into routine clinical practice (Myles 2006; Fearon 2005; Nygren et al. 2005; Muller
et al. 2009; Maessen et al. 2007; Kahokehr et al. 2009; Lemmens et al. 2009; Lemmens et al. 2008;
Maessen et al. 2009; Zargar-Shoshtar and Hill 2008). Clinical pathways for major abdominal
surgery can enhance efficiency of care without adversely affecting outcome. A variety of indicators
have been used to evaluate such pathways, including measures of pain control, restoration of
bowel function, and patient mobilisation (Lemmens 2008). There is a particular interest in facilitating
earlier hospital discharge after colorectal and other abdominal surgery – so called ‘fast-track’, or
enhanced recovery from surgery (ERAS) programs (Fearon et al. 2004; Muller et al. 2007;
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Maessen et al. 2007; Kahokehr et al. 2009; Lemmens et al. 2009; Lemmens et al. 2008; Maessen
et al. 2009; Zargar-Shoshtar and Hill 2008). See Figure 1.
Figure 1: Main elements of an ERAS program (Fearon et al. 2005)
Henrik Kehlet, Olle Ljungqvist and other European surgeons have been leading proponents of
ERAS (Fearon et al. 2005; Nygren et al. 2005). However there is limited evidence for this approach
in abdominal surgical patients in the Australian setting (Sturm and Cameron 2009; Zargar-Shoshtari
and Hill 2008).
A recent review of such a program was undertaken in five European hospitals (Nygren et al. 2005).
They reported on case mix, clinical management, and clinical outcomes of patients undergoing
colorectal surgery. A total of 333 consecutive patients receiving conventional surgical and
perioperative care (Sweden, n = 109; UK, n = 87; Netherlands, n = 76, Norway, n = 61) were
compared with Kehlet’s ERAS cohort (Denmark, n=118). Based on P-POSSUM scores, the case
mix was similar between centres. There were no differences in morbidity or 30-day mortality. The
median length of stay was 2 days in Denmark and 7–9 days in the other centres (P < 0.05).
However, of some concern is that the readmission rate was 22 per cent in Denmark and 2–16 per
cent in the other centres (P < 0.05). Thus it seems that ERAS can reduce hospital stay without an
adverse impact on morbidity and mortality, but there is a greater risk of hospital re-admission.
Perhaps the most compelling data have just been published (Muller et al. 2009). A randomised trial
comparing an ERAS program with traditional care in 156 patients undergoing colorectal surgery
was stopped early because of clear-cut benefits (Muller et al. 2009). The ERAS protocol
significantly decreased the number of complications (21 per cent versus 50 per cent, P = 0.001),
and resulted in a shorter hospital stay (median, 5 versus 9 days, P < 0.001). There was a trend
toward less severe complications in the fast-track group. A multiple logistic regression analysis
revealed excess IV fluids (OR 4.2 [95 per cent CI 1.7–10]; P = 0.002) and a non-functioning
epidural (OR 3.4 [95 per cent CI 1.4–8.3; P = 0.008) as independent predictors of postoperative
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complications. The authors concluded that a fast-track program reduces postoperative
complications and hospital stay, and should be considered as standard care.
Workforce and organisational change issues
Should ERAS become a standard of care in Victorian hospitals? And if so, how is this best
achieved? The key challenge seems to be organisational change more than specific surgical or
anaesthetic interventions (Maessen et al. 2007; Kahokehr et al. 2009; Lemmens et al. 2009;
Lemmens et al. 2008) – accepting and adopting a mindset of protocol- or pathway-directed care.
Important aspects of the ERAS philosophy should not be overlooked, including patient counselling,
teamwork and attitude change amongst surgeons, anaesthetists, allied health and nursing staff.
Such changes to traditional practice are not easy. For example, there is reluctance to discharge
patients from hospital early despite sufficient functional recovery (Maessen et al. 2007). Barriers to
change need to be identified (Sturm and Cameron 2009; Kahokehr et al. 2009). This project was
designed to maximise multidisciplinary collaboration, aiming to ensure sustainability of change in
each of the three Victorian hospitals.
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Aims
The overall aim of this project was to assess to what extent a predefined ERAS program for
abdominal surgical patients can be achieved. Secondly, we wanted to investigate whether training
of doctors and nurses in the application of this program improved the quality of care in these
patients.
Specific aims
1. To measure current indicators (processes and outcomes of care) or performance
(Lemmens et al. 2009) in elective surgical patients undergoing major abdominal surgery.
2. To measure change: completeness of the implementation of a suite of evidence-based
interventions designed for ERAS.
3. To identify improvements in care:
reduction in hospital stay
pain scores
no increase in serious complications (non-inferiority design).
Methods
After obtaining approval from each of the three hospital ethics committees, and endorsement of the
waiver for patient consent in view of this being a quality-improvement audit project, we collected
data from sequential patients undergoing elective abdominal surgery at each of the three Victorian
hospitals (The Alfred, Box Hill and Geelong). Adult patients undergoing elective abdominal surgery
involving a laparotomy incision, or laparoscopic colorectal surgery, were included. We excluded
vascular, gynaecological and urological surgery, hernia surgery, and emergency or trauma surgery.
Patient demographic, comorbidity, surgical and anaesthetic data were collected for all patients. A
predetermined ERAS treatment bundle was defined before commencing the study (see below).
Casemix was determined using the ASA classification and the Physiological and Operative Severity
Score for Enumeration of Mortality and Morbidity (P-POSSUM) scoring system (Prytherch et al.
1998; Tekkis et al 2003).
Study design
We used a before-and-after design that consisted of three phases:
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1. Baseline phase: between July and December 2009, a specially trained team of project
officers collected perioperative data of eligible patients undergoing surgery according to
existing (traditional) practices.
2. Education phase: a change team consisting of senior anaesthetists, a surgeon, nurses,
allied health, and a local project officer and perioperative care coordinator were formed to
train staff managing abdominal surgical patients (December 2009 to January 2010). The
evidence-based background to ERAS was sent to all surgical, anaesthetic and nursing staff
by the change team. After a two-month teaching period, the change team monitored
compliance to the ERAS bundle, aiming to maximise understanding and uptake into
practice for the remainder of the project.
3. Post-intervention phase: between February and June 2010, the above perioperative data
were collected.
We anticipated that around 400 elective abdominal surgical patients would be included in the study.
We established a multi-disciplinary working group to identify the key steps in ERAS. Project staff
included:
project officer
perioperative care coordinator
anaesthetist (+ fellow)
surgeon (+ fellow)
allied health: physiotherapy, nutrition, occupational therapy
ward (surgical) and hospital-in-the-home nursing staff.
Definition of the ERAS bundle (Fearon et al. 2005; Lemmens et al. 2009)
The ERAS bundle was determined from recent systematic reviews addressing interventions in
major abdominal surgery (Myles and Leslie 2006; Fearon et al. 2005; Zargar-Shoshtari and Hill
2008). A clinical pathway was designed, aiming for hospital discharge on day five (Muller et al.
2009; Maessen et al. 2009).
Complete bundle adherence was defined as fulfilment of key elements of the ERAS program:
1. Preoperative management
a. Pre-admission education: elective patients received oral and written information describing
what will happen during their hospital stay, what they could expect, and what their role was
in their recovery.
b. Patients were to not receive oral bowel preparation.
c. Patients were to be fasted for a minimal time, two hours for liquids and six hours for solids;
oral preoperative fluid carbohydrate loading was recommended.
2. Intraoperative management
a. Anti-microbial prophylaxis: patients were to receive single-dose antibiotic prophylaxis
against both aerobic and (for colorectal surgery) anaerobic pathogens within 60 minutes of
skin incision.
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b. Regional block: epidural or transversus abdominal plane (TAP) block, though not essential,
was recommended if there were no contraindications. Those receiving an epidural were to
have it inserted at the mid-thoracic level and containing local anaesthetic in combination
with a low-dose opioid.
c. Surgical incision: patients were to undergo laparotomy using an abdominal incision of
minimum length. If possible, and according to surgeon experience, a laparoscopic
technique was recommended.
d. Nasogastric tube: a nasogastric tube was not to be used as a routine in the postoperative
period.
e. Fluid therapy: IV fluids were to be restricted to crystalloid at less than five millilitres per
kilogram per hour, and if there is excessive bleeding, IV colloids at equivolume;
vasopressors were to be used in preference to additional fluid during and early after
surgery to maintain blood pressure.
f. Avoid intraoperative hypothermia: intraoperative maintenance of normothermia with
infusion of warmed fluids and an upper-body forced-air warming blanket were to be used
routinely, and body temperature measured throughout surgery, with the aim of avoiding
hypothermia (less than 36º C) on admission to the recovery room.
g. Drain tubes were to be avoided: they were not recommended following routine colonic
resection.
h. Antithrombotic prophylaxis: patients were to receive antithrombotic prophylaxis according to
local protocol.
i. Postoperative nausea and vomiting (PONV) prophylaxis consisting of at least double-
therapy were to be administered in all patients with at least two risk factors for PONV (Gan
et al. 2007).
j. Multimodal postoperative analgesia, including an NSAID or a COX-II inhibitor (unless
contraindicated) was to be used. Paracetamol could be considered but was not
recommended unless in patients undergoing laparoscopic surgery.
3. Postoperative management
a. Fluid therapy: patients were to commence oral fluids two to four hours post-surgery on the
day of surgery. Target intake was at least 2000 ml oral fluids on the day of operation.
Patients were to have IV fluids discontinued on the first morning after surgery. IV fluids
were to be restricted to less than four millilitres per kilogram per hour.
b. If used, a urinary catheter was to be removed on the first morning after surgery (unless an
epidural was in situ).
c. Transition to oral analgesia at the earliest opportunity (day two or three): regular oral
NSAID or a COX-II inhibitor, and add paracetamol, using oxycodone for breakthrough pain.
4. Enhanced postoperative recovery
a. Nutrition: patients were to be encouraged to commence an oral nutrient supplement
(approximately 400 millilitres) at four hours after surgery. Oral supplements were to be
continued until a normal level of food intake was achieved.
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b. Early mobilisation: patients were to be nursed in an environment that encouraged
independence and mobilisation. Breathing exercises and physiotherapy were
recommended. A care plan that facilitated patients being nursed out of bed for two hours on
the day of surgery and six hours thereafter was recommended.
Early discharge
a. Discharge criteria: planning the discharge process was to begin when the patient attended
the surgeon’s rooms or preadmission clinic. Defined discharge criteria were to be followed.
b. Follow-up: patients need adequate follow-up and continuity of care. In view of the greater
likelihood of re-admission (for example anastomotic leak or other major complication), a
clinic-based review service was to be established to enable stabilisation and discharge, or
expedited hospital admission.
A score of one was given to 14 of the items above that could be quantified in our database (1b, 1c,
2a, 2b, 2d, 2e, 2f, 2g, 2h, 2i, 3a, 3b, 4a, 4b). A score of eight or more was deemed to be ERAS-
program successful.
Data acquisition
The extent of surgery was classified as minor, moderate, major or complex major according to the
degree and expected duration of surgery, as well as the likely postoperative inflammatory response.
The P-POSSUM score was calculated from data within 24 hours of admission, and the risk of
mortality was estimated from the following equation (Prytherch et al. 1998; Tekkis et al. 2003):
Ln R/1-R = -9.065 + (0.1692 x physiological score) + (0.1550 x operative severity score)
where R = predicted risk of mortality.
Anaesthetic and other intraoperative data were recorded in real-time by the attending anaesthetist.
During the daily audits by the local project officer, current surgical and perioperative practices were
recorded from hospital paper and electronic data sources. We used an 11-point verbal rating scale
to measure pain intensity at rest and on movement. We used a validated measure of the intensity of
PONV, such that a score of 50 or more defined clinically important PONV (Wengritzky et al. 2010).
Postoperative oral oxycodone dosage was converted to morphine equivalents, using a ratio of 2:3
(Myles et al. 1999).
Outcome measures (Lemmens et al. 2009)
Clinical
complications
hospital re-admission
mortality
IV fluid volume
timing of removal of bladder catheter
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time to remove nasogastric tube
time to defaecation
time to return to enteral feeding or normal diet hospital stay
time to mobilise
pain and nausea scores
need for re-operation
ICU stay
Service
global quality of recovery score (QoR score) (Mehta et al. 2007)
Process
appropriate use of antibiotics
completeness and quality of documentation (compliance)
Wound infection and other postoperative complications were classified according to established
criteria (ref). Acute kidney injury was defined by the Acute Kidney Injury Network (AKIN) criteria
(Andreson et al. 2001), using an absolute increase in serum creatinine of ≥0.3 mg/dl (≥26.4 μmol/l)
or a relative increase in serum creatinine of 50 per cent or more.
Statistical analyses
The primary endpoint of the study was adherence to the ERAS bundle. Secondary endpoints
included hospital stay and each of the outcome measures. A sample-size calculation based on a
change in successful pathway from 50 to 65 per cent or greater, required 450 patients (225 pre-
intervention, 225 post-intervention), at an α value of 0.05 and a β value of 0.2. Patients undergoing
colorectal surgery were analysed as a subgroup. Inferential statistics were calculated by the Mann-
Whitney-U-test or in case of frequencies with the chi-square test. Continuous data are reported as
mean (SD) and/or or median and interquartile range. A P value of less than 0.05 was considered
statistically significant. Linear regression analysis was used to adjust for P-POSSUM physiological
and operative severity scores, and extent of surgery to adjust for imbalance in casemix of degree of
surgery in the intergroup comparison of the geometric-mean hospital stay. Data were analysed with
SPSS 17.0 for Windows (SPSS Inc, Chicago, Illinois).
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Results
Study populations: case mix
In most respects the pre- and post-ERAS cohorts had comparable demographic and perioperative
characteristics, as well as P-POSSUM scores (Tables 1 and 2). However, the post-implementation
ERAS patients tended to be older, with higher rates of hypertension and coronary artery disease,
and were classified as being at higher risk of PONV.
Table 1: Study population: case mix. Mean (SD), median (IQR) or no. (%)
Variables
Pre-ERAS
(n=154)
ERAS
(n=169)
P value
Male gender 82 (53%) 85 (50%) 0.60
Age, years 59 (16) 63 (15) 0.045
Height, cm 166 (12) 167 (10) 0.76
Weight, kg 79.7 (22) 76 (16) 0.14
BMI, kg/m2 29 (9) 27 (5) 0.056
Systolic BP, mmHg 131 (19) 133 (19) 0.32
Diastolic BP, mmHg 77 (11) 76 (11) 0.32
Resting pulse rate, b/min 76 (11) 75 (14) 0.36
Past medical history
Current smoker
cigs/day in last 6 weeks
29 (19%)
10 (5–20)
28 (17%)
13 (5–25)
0.59
0.48
Hypertension 56 (37%) 88 (52%) 0.005
Coronary artery disease 16 (10%) 36 (21%) 0.008
Heart failure 5 (3.2%) 8 (4.7%) 0.50
Cardiomyopathy 2 (1.3%) 5 (3%) 0.45
Myocardial infarction 11 (7%) 19 (11%) 0.2
Peripheral vascular disease 3 (1.9%) 9 (5.4%) 0.1
Diabetes 28 (18%) 31 (18%) 0.97
Chronic liver disease 4 (2.6%) 4 (2.4%) >0.99
Peripheral oedema 4 (3%) 9 (5%) 0.21
Previous laparotomy 68 (44%) 91 (54%) 0.08
Chronic pain 22 (14%) 16 (10%) 0.18
Lives alone 36 (23%) 34 (20%) 0.48
Usual medications
Opioids 13 (8%) 16 (9%) 0.75
Aspirin within 5 days 13 (8%) 24 (14%) 0.11
Clopidogrel within 7 days 1 (0.6%) 1 (0.6%) >0.99
Warfarin within 7 days 3 (1.9%) 4 (2.4%) >0.99
17
Nitrates 4 (3%) 18 (11%) 0.004
COX-II Inhibitor 2 (1%) 2 (1%) >0.99
ACE inhibitor 33 (21%) 56 (33%) 0.019
Beta-blocker 18 (12%) 33 (20%) 0.054
Statin 38 (25%) 51 (30%) 0.27
Calcium channel blocker 21 (14%) 23 (14%) 0.99
Diuretic 20 (13%) 16 (10%) 0.32
Digoxin 4 (3%) 7 (4%) 0.45
Amiodarone 1 (0.6%) 0 0.48
Oral hypoglycaemic 14 (9%) 19 (11%) 0.51
Insulin 3 (1.9%) 5 (3%) 0.73
LMWH 8 (5%) 5 (3%) 0.31
Chemotherapy 12 (8%) 18 (11%) 0.38
Blood tests
Haemoglobin, g/L 130 (18)
132 (21)
0.51
White cell count, x109/L 7.8 (3.7)
8 (2.8)
0.69
Albumin, g/L 37 (5)
38 (5)
0.22
Creatinine, μmol/L 83 (51)
75 (18)
0.53
Urea, mmol/L 6.2 (2.9)
5.9 (2.9)
0.33
Potassium, mmol/L 4.2 (0.4)
4.3 (0.5)
0.19
Table 2: Study population: risk scores. Mean (SD), median (IQR) or no. (%)
Variables
Pre-ERAS
(n=154)
ERAS
(n=169)
P value
ASA
1
2
3
4
16 (10%)
72 (47%)
56 (36%)
10 (7%)
17 (10%)
90 (53%)
59 (35%)
3 (1.8%)
0.16
Duke activity score 29.7 (16) 30 (13.2) 0.92
Achieve METS ≥4 131 (86%) 148 (89%) 0.42
P-POSSUM
physiological score
operative severity score
predicted mortality, %
17 (14–22)
11 (10–14)
1.4 (0.7–3.4)
17 (14–23)
11 (9–14)
1.6 (0.8–4.2)
0.14
0.39
0.29
18
PONV risk
Previous PONV
Motion sickness
16 (11%)
3 (1.9%)
26 (15%)
8 (4.7%)
0.19
0.17
Apfel score
0
1
2
3
4
6 (3.9%)
39 (25%)
70 (46%)
34 (22%)
5 (3.2%)
1 (0.6%)
27 (16%)
77 (46%)
50 (30%)
14 (8.3%)
0.013
Surgery
The post-ERAS implementation cohort were more likely to undergo colorectal and hepatobiliary
surgery, but also underwent less extensive surgery (Table 3).
Table 3: Study population: surgery, no. (%)
Variables
Pre-ERAS
(n=154)
ERAS
(n=169)
P value
Type of surgery
Colorectal
Gastric
Small bowel
Hepatobiliary
Oesophageal
Other
71 (46%)
24 (16%)
20 (13%)
17 (11%)
6 (4%)
16 (10%)
94 (56%)
7 (4%)
19 (11%)
43 (25%)
6 (4%)
0
<0.0001
Extent of surgery
Minor
Moderate
Major
Complex major
4 (3%)
38 (25%)
100 (65%)
12 (8%)
11 (7%)
74 (44%)
70 (41%)
14 (8%)
0.001
Surgery technique
Laparoscopic
Laparoscopic-assisted
Open
36 (23%)
8 (5%)
110 (71%)
33 (20%)
19 (11%)
117 (69%)
0.13
Surgery site
Upper abdominal
Lower abdominal
72 (47%)
82 (53%)
53 (31%)
116 (69%)
0.005
Peritoneal contamination
No soiling
Minor soiling
Pus or blood
119 (77%)
35 (23%)
0
122 (72%)
44 (26%)
3 (1.8%)
0.13
19
Malignancy status
None
Primary only
Local/distant metastases
71 (46%)
63 (41%)
20 (13%)
93 (55%)
58 (34%)
18 (11%)
0.16
Red cell transfusion
intraoperatively 8 (5%)
7 (4%)
0.65
Total operation time, min 149 (92–224)
135 (89–208)
0.43
Characteristics of anaesthesia and perioperative care
ERAS-recommended items were significantly more often used in the post-implementation period:
more oral nutrition supplementation, antiemetic prophylaxis, shorter surgical incisions, less opioid
administration in the 48–72-hour postoperative period, earlier oral fluid and food intake after
surgery, faster ambulation after surgery (Table 4). There was a substantial reduction in
intraoperative and postoperative fluid administration (Table 5).
Rates of admission to HDU and ICU were not significantly different in both periods, pre- versus
post-ERAS, 4.5 per cent versus 2.4 per cent (P = 0.28) and 7.8 per cent versus 6.0 per cent (P =
0.52), respectively.
20
Table 4: Mean (SD), median (IQR) or no. (%)
Intraoperative
Pre-ERAS
(n=154)
ERAS
(n=169)
P value
Preoperative oral nutritional support 9 (6%)
123 (73%)
<0.0001
Bowel preparation used 41 (27%)
57 (33%)
0.18
IV fluid warmer 120 (78%)
115 (68%)
0.046
Forced air warmer 150 (97%)
166 (98%)
0.71
Nasogastric tube 52 (34%)
44 (26%)
0.13
Urinary catheter 118 (77%)
117 (69%)
0.14
Surgical drain 80 (52%)
71 (42%)
0.074
Thromboprophylaxis 123 (80%)
142 (84%)
0.33
Local anaesthetic techniques
Epidural 18 (12%)
18 (11%)
0.77
Spinal 0
4 (2.4%)
0.12
TAP block 32 (21%)
36 (21%)
0.91
Nerve block 4 (2.6%)
1 (0.6%)
0.20
Wound infusion catheter 10 (7%)
6 (4%)
0.22
Local infiltration 83 (54%)
114 (68%)
0.012
Oesophageal Doppler monitor 3 (1.9%)
2 (1.2%)
0.67
Morphine, mg 10 (1.5–15) 10 (0–10) 0.077
Antiemetic prophylaxis
Antiemetic
at least 2 antiemetics
If Apfel score
0 or 1 (n=73)
≥2 (n=250)
123 (80%)
115 (75%)
39 (87%)
109 (100%)
153 (91%)
142 (84%)
27 (96%)
141 (100%)
0.004
0.037
0.17
-
Time from antibiotic administration to
surgery start, min
no. administered before start of
15 (20-4)
135 (89%)
15 (30-6)
0.007
21
surgery 144 (92%) 0.39
Length of incision, cm 15 (5.3-25) 10 (5-15) 0.006
No of dermatomes involved 5 (3-6) 4 (3-5) 0.024
Lowest body temperature, °C 36.3 (0.6) 36.4 (0.5) 0.23
ERAS
No. of items achieved 8 (7–9)
9 (8–10)
<0.0001
ERAS (≥8 items) implemented
104 (68%)
141 (83%)
<0.0001
Table 5: Perioperative IV fluid therapy, mean (SD)
IV fluids
Pre-ERAS
(n=154)
ERAS
(n=169)
P value
Intraoperative
Crystalloid+colloid, ml
Total infusion rate, ml/kg/hr
2269 (1284)
12 (6.6)
1590 (1073)
9.0 (5.1)
<0.0001
<0.0001
Cumulative IV fluid
Recovery room, ml
2802 (1570)
1950 (1281)
<0.0001
At 24 hr, ml
5315 (1973)
4225 (2295)
<0.0001
At 48 hr, ml
7248 (2475)
5510 (3222)
<0.0001
At 72 hr, ml
8603 (2992)
6434 (3986)
<0.0001
Recovery profile and hospital stay
ERAS patients had their urinary catheters removed more quickly and had higher rates of
postoperative oral nutritional supplementation. Many markers of comfort and restoration of normal
functioning, including pain scores and nausea scores, were significantly improved in the ERAS
cohort (Table 6). There was no apparent difference in the global quality of recovery on the first
morning after surgery.
ERAS patients had a significantly shorter hospital stay, geometric mean (SD) 5.7 (2.5) versus 7.4
(2.1) days, P = 0.006.
Other significant factors associated with length of stay included the physiological and operative P-
POSSUM scores, and extent of surgery (all P < 0.001). When the effect of ERAS was adjusted for
differences in each of these covariates the reduction in length of stay remained significant (P =
0.012).
22
Table 6: Recovery measures: mean (SD), median (IQR) or no. (%)
Variables
Pre-ERAS
(n=154)
ERAS
(n=169)
P value
Removal of drains and tubes, hr
urinary catheter
nasogastric tube
surgical drain
82(47–120)
90 (24–167)
139 (89–193)
51 (26–106)
81 (42–117)
153 (114–327)
0.003
0.36
0.84
Recovery room
Body temperature on arrival, °C 36.5 (4.2) 36.9 (0.4) 0.38
Pain score at rest 3.5 (3) 2.6 (2.8) 0.008
Pain score on movement 5.4 (9) 3.2 (3.1) 0.01
Morphine, mg 5.4 (6.8) 4.6 (6.3) 0.25
Discharge from recovery, min 110 (80–146)
106 (75–151)
0.94
Postoperative oral nutritional
supplementation 22 (14%)
122 (72%)
<0.0001
At 24 hours post op
PONV score 1 (0–2) 1 (0–1) 0.012
Time to oral fluids, hr 16 (6–28) 6.0 (3.7–19) <0.0001
Time to oral solids, hr 68 (27–120) 25 (17–52) <0.0001
Time to defaecation, hr 80 (48–130) 73 (44–117) 0.23
Time to ambulation, hr 23 (19–45) 19 (8.3–25) <0.0001
Morphine 0–24 hr, mg 33 (10–58) 27 (11–49) 0.29
Pain score at rest 2 (2.2) 2.5 (2.4) 0.047
Pain score on movement 4.4 (2.7) 4.6 (3) 0.61
Quality of recovery score 13.6 (2.7) 13.5 (3.0) 0.72
At 48 Hours post op
PONV score 0.7 (0–1) 0 (0–1) 0.016
Morphine 0–48, mg 48 (18–89) 36 (15–68) 0.067
Pain score at rest 2.0(2.1) 2.0 (2.2) 0.87
Pain score on movement 4.32 3.57 0.023
At 72 hours post op
PONV score 0.5 (0–1) 0 (0–1) 0.019
PONV score (total) 1 (0–12) 0 (0–2) 0.016
Morphine 0–72, mg 58 (21–117) 40 (17–97) 0.10
ASEPSIS score 0 (0–3) 0 (0–3) 0.25
Length of stay, days
Median (IQR)
Geometric mean (SD)
7.0 (5.0–11)
7.4 (2.1)
6.2 (4.0–10)
5.7 (2.5)
0.026
0.006
23
Postoperative complications
There were no significant differences in the rates of complications after surgery, including rates of
hospital re-admission (Table 7). The overall rates of complications (excluding PONV, re-operation
and re-admission) were comparable, 31 per cent versus 32 per cent (P = 0.78).
Table 7: Postoperative complications: no. (%).
Complications
Pre-ERAS
(n=154)
ERAS
(n=169)
P value
Clinically important PONV 13 (8.4%)
11 (6.5%)
0.51
Reoperation 9 (5.8%)
9 (5.3%)
0.84
Hospital re-admission 24 (16%)
19 (11%)
0.25
Deep vein thrombosis 0
3 (1.8%)
0.25
Myocardial infarction 2 (1.3%)
3 (1.8%)
>0.99
Respiratory 3 (1.9%)
6 (3.6%)
0.51
Urinary tract infection 5 (3.2%)
12 (7.1%)
0.12
Acute kidney injury 10 (6.5%)
15 (8.9%)
0.42
Ileus 10 (6.5%)
14 (8.3%)
0.54
Intra-abdominal collection 8 (5.2%)
3 (1.8%)
0.091
Wound infection 24 (16%)
24 (14%)
0.73
30-day mortality 2 (1.3%)
2 (1.2%)
>0.99
24
Discussion
Key findings
We undertook a survey of existing perioperative and surgical practices across three Victorian
hospitals, noting some variation in service delivery of anaesthetic, surgical, nursing and allied
health staff employed throughout the perioperative period. This included aspects of routine
postoperative care, and criteria for hospital discharge and post-discharge review. With modest
communications and a consensus meeting of relevant clinical staff from each of the three hospitals,
including some follow-up staff education and ongoing support, we were able to implement a
comprehensive ERAS program over a one-to two-month period.
We have demonstrated a significant improvement in an ERAS bundle of care. This was associated
with marked improvement in a number of markers of postoperative recovery, including lower pain
scores and nausea scores, earlier feeding and faster ambulation. There was a reduction in hospital
stay, and this was achieved without any measurable risk of additional complications, reoperation or
readmission to hospital.
The ERAS program consisted of a number of recommended items (Fearon et al. 2005; Kahokehr et
al. 2009; Lemmens et al. 2008), most of which we were able to demonstrate substantial changes in
practice. Perioperative fluid administration, use of drain tubes and indwelling catheters, the length
of incision, and postoperative opioid administration were all reduced. The use of fluid warmers (not
evidence based) was reduced and forced air warming was near-universally implemented. There
was widespread use of perioperative oral nutritional supplements. Our re-operation (5.3 per cent)
and hospital re-admission rate (11 per cent) were lower than that reported by others (Warrilow et al.
2010; Caplan et al. 1998; Nygren 2005; Maessen 2007).
We did however note poor uptake and variation in some of the key ERAS items across the three
hospitals, and in any case few patients achieved high (more than 80 per cent) compliance. Future
progress will depend on better communication, teamwork and clinical pathway (protocol)-directed
care. We expect that the positive findings from this study will do much to facilitate such changes in
practice. In addition, there is scope to further improve multidisciplinary coordination of care, and
acknowledge previous findings that such teamwork is a necessary requirement of a successful
ERAS program (Kahokehr et al. 2009).
Additional findings
The conduct of our study led to far better and satisfying relationships across the various disciplines
caring for surgical patients throughout the hospital. We relied upon key personnel to lead in each of
these areas. Better coordinated and more complete patient follow-up after surgery, including after
hospital discharge, were found to greatly improve staff, patient and family satisfaction with care.
Each of the three hospitals reported very positive feedback from their ERAS patients regarding their
care before and after surgery. Many patients commented on the special value of receiving a
personalised telephone call from the hospital in the weeks after their surgery.
We found that a dietician-coordinated malnutrition screen could identify a substantial proportion (21
per cent) of elective surgical patients who were at increased risk of malnutrition.The benefits of
perioperative oral nutritional supplements are supported in the literature, and although this study
was not designed to specifically measure such a benefit, it seems intuitive that postoperative
recovery will be facilitated and complications may be reduced.
25
Other benefits of an ERAS program relate to the improved communication and collaboration
between anaesthetic, surgical, nursing, and allied health professionals aligned to the project.
Others have noted similar benefits, and the coordination of the team itself is believed to be
important (Kahokehr et al. 2009).
Despite demonstrating clear benefits of our ERAS program, there remain opportunities to extend it
further and more completely. We did not improve smoking cessation before elective surgery, largely
because there was no opportunity to do so given that most patients were reviewed for their surgery
in the pre-admission clinic at only one to two weeks before surgery. Others have been able reduce
hospital stay for colonic surgery patients to three days or less (Nygren et al. 2005; Maessen et al.
2007). Doctors are notoriously resistant to protocols (Lemmens et al. 2009). Further improvements
in an ERAS program could be achieved with more extensive nursing education and support for
those working in the pre-admission clinic or surgical wards. Others have reported on the importance
of staff education and support (Maessen et al. 2007; Kahokehr et al. 2009). A small increase in
nursing and allied staffing levels would make possible greater success. Allied health personnel
were not staffed to provide sufficient clinical service delivery on weekends, and most often could
not attend the pre-admission clinic. Lack of weekend staffing was particularly problematic for
physiotherapy, who were aiming to target a reduction in postoperative respiratory complications.
Methodological considerations
This was a before-and-after study design, for which there are several sources of bias. Although a
randomised trial is generally preferred when testing healthcare interventions, the likely cross-
contamination of some components of the ERAS bundle, along with a Hawthorne effect, make a
randomised design problematic. We thus explored our data to identify possible biases and
confounding. The most important would be differences in case mix and extent of surgery, but we
adjusted for this in an exploratory analysis and could not identify such a bias – the multivariate
adjusted analysis retained the significance of our key findings.
We cannot identify which of the many ERAS interventions were more important than others. Many
are strongly supported by high-level evidence (Sturm and Cameron 2009; Myles and Leslie 2006;
Lemmens et al. 2008). Some protagonists believe strongly in the need for epidural block for
abdominal surgery but the data are unconvincing (Myles and Leslie 2006). However there is no
such disagreement when targeting multimodal, opioid-sparing regimens that include a NSAID or
COX-II inhibitor. A recent clinical trial suggests that surgical-site preparation with chlorhexidine-
alcohol rather than povidone-iodine can prevent surgical-site infection (Darouiche 2010), and so
this may be added to a future ERAS program.
Other relevant literature
A group from Prince of Wales in Sydney (Caplan et al. 1998a; Caplan et al. 1998b) reported similar
success of their coordinated care program for minor elective surgery, which consisted of
laparoscopic cholecystectomy and inguinal hernia repair.
A recent multicentre cohort study of elderly (older than 70 years) patients undergoing major non-
cardiac surgery in 23 acute-care hospitals in Australia and New Zealand was undertaken to
determine the incidence of complications and mortality after surgery (Story et al. in press). Of the
4,158 consecutive patients, 68 per cent of which had pre-existing comorbidity, there was a 30-day
mortality of 5 per cent and 20 per cent had complications; 9.5 per cent of patients were admitted to
critical care services, 5 per cent planned, 4.5 per cent unplanned. On multivariate analysis,
26
important patient factors associated with mortality included age (80 to 89 years: OR 2.0, 95 per cent
CI: 1.6 to 2.8; 90+ years: OR 4.0, 95 per cent CI 2.6 to 6.2), worsening American Society of
Anesthesiologists (ASA) physical status ( ASA 3: OR 3.1 , 95 per cent CI: 1.8 to 5.5; ASA 4: OR
12.4, 95 per cent CI: 6.9 to 22.2), and preoperative albumin <30 g/l (OR: 2.5, 95 per cent CI: 1.8 to
3.5). Important complications included: acute renal impairment (OR 3.3, 95 per cent CI: 2.1 to 5.0),
unplanned ICU admission (OR 3.1, 95 per cent CI: 1.9 to 4.9), and systemic inflammation (OR 2.5,
95 per cent CI: 1.7 to 3.7). Patient factors often had stronger association with mortality than the
type of surgery.
A group from the Austin Hospital in Victoria did a retrospective study of perioperative fluid therapy,
complication rates and outcomes in 100 sequential patients undergoing major elective open
gastrointestinal surgery (Warrillow et al. 2010). Many were elderly and had multiple comorbidities.
Median delivered intraoperative fluid volume was 4.2 litres, followed by 6.3 litres over the
subsequent 24 hours. Our ERAS major surgery cohort received considerable less, being 2.1 litres
and 5.4 litres, respectively. Rates of serious complications were comparable, but we had a lower
rate of return to theatre because of postoperative complications.
Implications of findings
Health bureaucrats, clinicians and the community are increasingly calling for evidence-based
healthcare. An ERAS bundle of care to manage elective abdominal surgical population has been
published (Maessen et al. 2007), and there is strong support from many leading clinician-
researchers in this field (Myles and Leslie 2006; Fearon et al. 2005; Lemmens et al. 2009; Nelson
et al. 2007; Andersen et al. 2006). Maesson and colleagues (2007) identified 17 index elements for
audit and assessment of ERAS protocol compliance. We incorporated most of these in our
program, although were only able to properly quantify 13 items for assessment.
Kahokehr and colleagues offer the following recommendations for a successful ERAS program
(2009):
• Teamwork: all members of the team should be familiarised with the principles of ERAS and a
consensus of optimal patient care should be developed. This should include pre-admission staff,
nurses, physiotherapists, social workers, occupational therapists and doctors. The attitudes and
experience of each member of the team are important and will affect the success of the
program.
• The patient: provision of appropriate patient information and preoperative counselling is
essential to inform expectations and planning for recovery and hospital discharge. Medical and
social issues that may hinder recovery and discharge should be addressed early in the process.
• The ward: part of the surgical ward should be considered as a postoperative rehabilitation unit,
characterised by separation from acutely admitted patients. This ward should facilitate
independence with access to food and self-care facilities much like a rehabilitation unit.
• Restoring activity:
– The anaesthetist is a very important part of the team and a key to success in implementing
an ERAS program. The anaesthetist typically manages and administers antibiotics, fluid
therapy, PONV prophylaxis, and the multimodal analgesic regimen.
– The surgeon is the most vital ingredient for ERAS, and must be willing to overcome
traditional concepts of perioperative care. Surgeons may be concerned about readmission
or that patients may not wish to have a short hospital stay, plus the burden of recovery may
simply be transferred to outpatient and community services by discharging patients sooner.
However, based on the available evidence (Myles and Leslie 2006; Fearon et al. 2005;
27
Muller et al. 2009; Nelson et al. 2007; Andersen et al. 2006), including in Australia (Caplan
et al. 1998a; Caplan et al. 1998b), it is reasonable to conclude that multimodal ERAS-style
programs care should be accepted as the current standard of care in colorectal surgery.
The frequent turnover of surgical resident staff hinders consistent postoperative care. Nursing staff
should be educated and experienced in ERAS principles, and be supported by consultant
surgeons. The introduction of an ERAS nurse specialist – a care coordinator – should assist with
staff education and protocol compliance.
Cost-efficient care often requires initial outlays for staff training, infrastructure, IT support and new
technologies (for example to undertake less-invasive surgery), but these costs can be recouped or
even exceeded by the savings produced from reduced hospital stay and avoidance of
complications (Sturm and Cameron 2009). Decision support can facilitate identification of at-risk
patients (Kooij et al. 2008). Lack of adherence to clinical guidelines or pathways is most often
related to a lack of attention by busy staff or lack of physician awareness of their existence.
Decision-support systems, particularly when incorporated into an electronic clinical information
system, may help (Kooij et al 2008; Grimshaw and Russell 1993).
Evidence-based practice relies upon good quality research focusing on real-world clinical
environments (Prytherch et al 1998; Grimshaw and Russell 1993), dissemination of relevant and
reliable information, and sufficient resourcing. If these are delivered then best practice can be
achieved. An ERAS program requires informed and motivated health professionals and coordinated
multidisciplinary care (Maessen et al. 2007; Kahokehr 2009).
There has been some concern that an ERAS program is associated with increased readmission
rates (Nygren et al. 2005). We found no evidence of this in our study.
Conclusions
Current perioperative and surgical practices can be readily modified to facilitate an enhanced
recovery after surgery (ERAS) program in Victorian hospitals. The additional resources required are
modest and likely to be offset by a reduction in hospital stay, substantial improvements in recovery
profile, and a possible reduction in postoperative complications.
Recommendations
• Current perioperative and surgical practices should be modified to facilitate an enhanced
recovery after surgery (ERAS) program for elective abdominal surgery in Victorian hospitals.
• Consideration should be given to establishing ERAS-style programs across a range of surgical
procedures in all Victorian hospitals, ultimately to include orthopaedic, cardiac, thoracic and
other surgical specialities.
• Multidisciplinary groups should be established to coordinate the perioperative care of surgical
patients in all Victorian hospitals.
• Additional allied health (especially physiotherapy and nutrition) resources should be provided to
staff pre-admission clinics and, for physiotherapy, weekend service delivery.
• Surgical patients should be contacted by telephone on at least one occasion in the days or
weeks after surgery, to confirm an event-free recovery or ensure earlier intervention of
difficulties or complications should they arise.
28
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