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488
Results
We identified over 300 articles related to the topic of interest, including 15 meta-
analyses and systematic reviews of trials comparing ERP to TC (Table 43.3). These
reviews encompass a total of 32 different randomized controlled trials, controlled
clinical trials, and retrospective reviews, and provide some insight in each of the
outcomes of interest for our clinical question.
Complications
Several large meta-analyses of randomized controlled trials, including a Cochrane
review, have examined morbidity and mortality after colectomy in patients manage
by ERP versus TC (Table 43.3). Mortality is a rare event after colorectal surgery
with consistent rates of around 1 % and no significant difference between ERP and
TC in any series. The three largest and most recent meta-analyses to examine post-
operative complications, by Greco [3], Yin [30], and Zhuang [31] respectively, all
found a significant risk reduction for overall complications with ERP as compared
to TC [Greco RR = 0.60 (95 % CI 0.46 – 0.76); Yin RR = 0.58 (95 % CI 0.43 – 0.77);
Zhuang RR = 0.71 (95 % CI 0.58 – 0.86)]. Some reviews examined sub-categories
of complications. Two studies found a significant decrease in non-surgical, but not
surgical complications [3, 31] with ERP. The Cochrane review by Spanjersberg
et al. found a significant reduction in overall complications with ERP [RR = 0.52
(95 % CI 0.38 – 0.71), though significance did not hold up when examining major
complications or minor complications separately. The definition of complications
and the way in which they were recorded is not constant and many studies fail to
note whether complications occurring after discharge were measured; nonetheless,
the findings remain consistent across multiple large studies and it is unlikely that
major complications were missed.
Readmission
After assuring safety, the most obvious concern with implementing pathways
designed to get patients home sooner, is if this makes them more likely to be read-
mitted to the hospital. In each of the studies cited above there was no difference in
the rate of readmission among patients managed by ERP or TC [3, 30, 31, 41]. In
the largest of these series, including over 1,600 patients, the overall readmission rate
was 4 – 5 % in each group. This outcome is consistent and has very low heterogene-
ity in multiple meta-analyses. There is a risk of observational error if patients were
readmitted to a different hospital, but there is no reason to suspect this phenomenon
more frequently in one group versus the other.
W.C. Mustain and C.P. Delaney
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Table 43.3 Meta-analyses and systematic reviews of enhanced recovery pathways vs. traditional
care for colectomy
Author Year Studies
Inclusion
criteria
Included
studies
Primary
outcomes
Secondary
outcomes
Greco et al.
[3]
2014 RCT Open or
laparoscopic
Minimum 4
ERAS
elements
Anderson
[4],
Delaney
[5],
Garcia-
Botello [6],
Gatt [7],
Ionescu [8],
Khoo [9],
Lee [10],
Muller
[11], Ren
[12],
Serclova
[13], Vlug
[14], Wang
[15], Wang
[16], Wang
[17], Wang
[18], Yang
[19]
Overall
morbidity
Surgical
complications
Nonsurgical
complications
Primary LOS
Readmission
Mortality
Ileus
Lee et al.
[20]
2014 RCT
CCT
a
RR
b
Open or
laparoscopic
Minimum 5
ERAS
elements
Cost data
included
Ren [12],
Vlug [14],
Archibald
[21]
a
,
Bosio [22]
a
,
Folkerson
[23]
a
,
Jurowich
[24]
a
,
Kariv [25]
a
,
King [26]
a
,
Sammour
[27]
a
,
Stephen
[28]
b
Cost N/A
Lemanu
et al. [29]
2014 RCT
CCT
a
RR
b
Open or
laparoscopic
No minimum
ERAS
elements
Cost data
included
Ren [12],
Vlug [14]
Archibald
[21]
a
, Kariv
[25]
a
,
King [26]
a
,
Sammour
[27]
a
,
Stephen
[28]
b
Cost Primary LOS
Readmission
Morbidity
(continued)
43 Quality Improvement: Enhanced Recovery Pathways for Open Surgery
490
Table 43.3 (continued)
Author Year Studies
Inclusion
criteria
Included
studies
Primary
outcomes
Secondary
outcomes
Yin et al.
[30]
2014 RCT Open or
laparoscopic
No minimum
ERAS
elements
Anderson
[4], Gatt
[7],
Ionescu [8],
Khoo [9],
Muller
[11],
Serclova
[13],
Vlug [14],
Wang [16],
Yang [19]
Total LOS
Readmission
Morbidity
Mortality
GI function
Zhuang et al.
[31]
2013 RCT Open or
laparoscopic
Minimum 7
ERAS
elements
Anderson
[4],
Garcia-
Botello [6],
Gatt [7],
Ionescu [8],
Khoo [9],
Muller
[11], Ren
[12],
Serclova
[13], Vlug
[14], Wang
[17], Wang
[18], van
Bree [32],
Yang [19]
Primary LOS
Total LOS
Readmission
Total
complications
Surgical
complications
Nonsurgical
complications
Mortality
Time to first
flatus and
stool
Hospital
costs
Lvet al. [33] 2012 RCT Open surgery
only
No minimum
ERAS
elements
Anderson
[4],
Delaney
[5],
Gatt [7],
Khoo [9],
Muller
[11],
Serclova
[13], Vlug
[14]
Primary LOS Readmission
Morbidity
Mortality
(continued)
W.C. Mustain and C.P. Delaney
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491
Table 43.3 (continued)
Author Year Studies
Inclusion
criteria
Included
studies
Primary
outcomes
Secondary
outcomes
Adamina
et al. [34]
2011 RCT Open or
laparoscopic
Minimum 4
ERAS
elements
Anderson
[4],
Delaney [5]
Gatt [7],
Khoo [9],
Muller
[11],
Serclova
[13]
Primary LOS
Readmission
Morbidity
Mortality
N/A
Rawlinson
et al. [35]
2011 RCT
CCT
a
RR
b
Open or
laparoscopic
Minimum 4
ERAS
elements
Anderson
[4],
Delaney
[5],
Gatt [7],
Khoo [9],
Muller
[11],
Serclova
[13]
Basse [36]
a
,
Kariv [25]
a
,
Polle [37]
a
,
Raue [38]
a
,
Teeuwen
[39]
a
,
Wichmann
[40]
a
,
Stephen
[28]
b
Primary LOS
Total LOS
Readmission
Morbidity
Mortality
N/A
Spanjersberg
et al. [41]
2011 RCT Open or
laparoscopic
Minimum 7
ERAS
elements
Anderson
[4], Gatt
[7], Khoo
[9],
Serclova
[13]
Mortality
Total
complications
Major
complications
Minor
complications
Operative
time
Economic
impact
QoL
(continued)
43 Quality Improvement: Enhanced Recovery Pathways for Open Surgery
492
Table 43.3 (continued)
Author Year Studies
Inclusion
criteria
Included
studies
Primary
outcomes
Secondary
outcomes
Khan et al.
[42]
2010 RCT
CCT
a
Open or
laparoscopic
No minimum
ERAS
elements
QoL or
satisfaction
data included
Anderson
[4],
Delaney
[5],
Gatt [7],
Henriksen
[43],
Basse [36]
a
,
Jakobsen
[44]
a
,
King [26]
a
,
Polle [37]
a
,
Raue [38]
a
,
Zargar
[45]
a
QoL
Patient
satisfaction
Varadhan
et al. [46]
2010 RCT Open surgery
only
Minimum 4
ERAS
elements
Anderson
[4],
Delaney
[5],
Gatt [7],
Khoo [9],
Muller
[11],
Serclova
[13]
Primary LOS Readmission
Morbidity
Mortality
Eskicioglu
et al. [47]
2009 RCT Open or
laparoscopic
No minimum
ERAS
elements
Anderson
[4],
Delaney [5]
Gatt [7],
Khoo [9]
Primary LOS
Total LOS
Readmission
Morbidity
Mortality
Gouvas et al.
[48]
2009 RCT
CCT
a
RR
b
Open or
laparoscopic
No minimum
ERAS
elements
Anderson
[4],
Delaney
[5],
Gatt [7],
Khoo [9]
Basse [36]
a
,
Bradshaw
[49]
a
,
Kariv [25]
a
,
Polle [37]
a
,
Raue [38]
a
,
Wichmann
[40]
a
,
Stephen
[28]
b
Primary LOS
Total LOS
Readmission
Morbidity
Mortality
NG required
Lung
function
Pain, fatigue,
quality of life
scores
(continued)
W.C. Mustain and C.P. Delaney
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Length of Stay
Perhaps the most consistent positive finding in the literature regarding ERP after
colectomy is a decrease in hospital LOS with ERP as compared to TC. There are
likely differences in the definition of “traditional” care between hospitals, and espe-
cially between countries, as evidenced by the wide variation in mean LOS in the TC
cohorts of many recent series, ranging from 7 to 12 days [11–13, 15, 19]. However,
there is high quality evidence showing a consistent reduction in LOS of around 2
days with implementation of ERP [3, 30, 31, 34, 46]. There is a risk for observer
bias in some studies where discharge criteria were less than explicit and were
assessed by non-blinded investigators.
Cost
Economic and cost-effectiveness analyses of healthcare technologies and systems
are frequently plagued by imprecise and unclear methodology [52]. This is the case
for the limited data available to examine cost-effectiveness of ERP as compared
with TC. In 2014, two systematic reviews [20, 29] on the economic impact of ERP
in colorectal surgery were published encompassing a total of 10 studies, including
two randomized controlled trials (Table 43.3). The authors found significant
Table 43.3 (continued)
Author Year Studies
Inclusion
criteria
Included
studies
Primary
outcomes
Secondary
outcomes
Walter et al.
[50]
2009 RCT
CCT
a
Open or
laparoscopic
Minimum 5
ERAS
elements
Anderson
[4], Gatt
[7]
Basse [36]
a
,
Raue [38]
a
Primary LOS Total LOS
Readmission
Morbidity
Mortality
Wind et al.
[51]
2006 RCT
CCT
a
Open or
laparoscopic
Minimum 4
ERAS
elements
Anderson
[4],
Delaney
[5],
Gatt [7]
Basse [36]
a
,
Bradshaw
[49]
a
, Raue
[38]
a
Primary LOS
Total LOS
Readmission
Morbidity
Mortality
N/A
a
CCT controlled clinical trial
b
RR retrospective review
RCT randomized controlled trial, ERAS enhanced recovery after surgery, Primary LOS initial post-
operative length of stay, Total LOS primary LOS + readmission LOS, QoL quality of life, NG naso-
gastric tube
43 Quality Improvement: Enhanced Recovery Pathways for Open Surgery
494
heterogeneity in the methods used to the calculate costs and the types of factors
considered. Most studies reported only direct hospital charges with few considering
hospital overhead, cost of implementation of the ERP, or indirect costs such as loss
of productivity by patients or caregivers. In total, eight of the 10 studies reported
lower costs with ERP as compared to TC, including all four American studies [21,
22, 25, 28], two Australasian studies [12, 27], and two out of four European studies
[14, 23, 24, 26]. Lee et al. were able to generate incremental cost-effectiveness
ratios for five of the 10 studies, with all five showing ERP to be dominant (less
costly and more effective) with regard to LOS [20]. Two studies published in 2015
reported cost data from retrospective comparisons of ERP and TC cohorts. Thiele
et al. [53] reported a significant decrease of $7,129/patient in direct costs, while
Ehrlich et al. [54] found a trend toward lower in-hospital costs with ERP that did not
reach statistical significance.
Quality of Life
The impact of ERP on patient satisfaction and QoL remains unclear. It stands to
reason that most patients place a high value on resuming normal activities and
returning to their homes. On the other hand, some patients may have a negative
perception of ERP if they feel rushed out of the hospital before they are ready.
Unfortunately, it is difficult to objectively measure these perceptions and their
relative importance to patients. A systematic review by Khan et al. examined the
available evidence regarding QoL and patient satisfaction of colorectal surgery
patients managed by ERP or TC [42]. The authors included four randomized
controlled trials and six comparative cohort studies, with mostly small numbers
of patients (Table 43.3). There was significant heterogeneity in the instruments
used for assessment, the outcomes examined, and the timing of measurements.
Only two studies used a validated global QoL index [5, 26] with neither finding
a difference between ERP and TC at time of discharge or post-operative day
(POD) 30.
Five studies compared pain scale values [4, 5, 7, 38, 43], though all at different
time periods. Three of these found no difference between the groups in pain scores
at any point [7, 38, 43]. One study found significantly increased pain in the TC
group on POD 1 [4], while another found increased pain at discharge in the ERP
group [5]. In the later study, the day of discharge was significantly earlier in the ERP
group so the discharge pain scores were closer to the date of surgery. Neither study
found a difference in pain scores between the groups at POD 7 or POD 30. Seven
studies assessed fatigue levels between the two approaches, with three finding no
difference at any time point [7, 36, 43] and another four finding increased fatigue in
the TC groups at various points in the early postoperative period [4, 38, 44, 45]. A
single included study reported patient satisfaction scores of ERP vs. TC patients.
The authors reported similar scores (50.4 and 49.8 out of a potential 80; p = 0.84)
between ERP and TC patients on a 16 question satisfaction survey, with an 80 %
W.C. Mustain and C.P. Delaney
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495
response rate in both groups. The Cochrane review concluded that more research is
necessary to clarify the effect of ERP on QoL [41].
Wang et al. recently published the results of a prospective trial of ERP vs. TC
after open colectomy for cancer [55]. Using validated, cancer-specific QoL instru-
ments, the authors found significantly better scores in multiple domains including
global QoL, physical and emotional functioning, pain, appetite, gastrointestinal
symptoms, and financial difficulties in patients treated by ERP as compared to
TC. The large, multicenter prospective trial by Vlug et al. examined QoL and patient
satisfaction in a four-armed study comparing laparoscopic and open colectomy with
or without ERP and found no differences in either outcome between the four groups
[14]. An ongoing multicenter prospective trial comparing open colectomy plus TC,
open colectomy plus ERP, and laparoscopic colectomy plus ERP aims to assess
QoL as a secondary outcome and may provide additional information [56].
A summary of the findings and grading of the evidence for each outcome is pre-
sented in Table 43.4.
Recommendations Based on the Data
“Patients undergoing open colectomy should be managed by a standardized
Enhanced Recovery Pathway designed to preserve preoperative function, minimize
surgical stress, and hasten return to normal activities.”
Strength of recommendation: strong
Table 43.4 Summary of the evidence evaluating enhanced recovery pathways vs. traditional care
for colectomy
Outcome Summary
Quality of
evidence Comment
Complications Consistently decreased with
ERP in multiple meta-
analyses of randomized trials
Low Inconsistency
Small magnitude of
effect
Readmission No increase with ERP in
multiple meta-analyses of
randomized trials
Moderate Study quality
Publication bias
Length of Stay Consistently decreased with
ERP in multiple meta-
analyses of randomized trials
High Imprecision
Cost Consistently decreased with
ERP in all available studies
Low Study quality
Inconsistency
Imprecision
Publication bias
Quality of Life/Patient
Satisfaction
No decrease with ERP in any
study; similar or slightly
improved in most studies
Low Study quality
Inconsistency
Small magnitude of
effect
43 Quality Improvement: Enhanced Recovery Pathways for Open Surgery
496
Quality of the evidence: low
The strength of this recommendation reflects our confidence that the desirable
effects of ERP outweigh the undesirable effects, as influenced by the magnitude of
the treatment effect, the quality of the evidence, and the value placed on the out-
comes of interest, in accordance with the GRADE approach to developing guide-
lines [57]. We placed a high value on the avoidance of complications and readmission.
While the quality of the evidence regarding complications is low, based on signifi-
cant heterogeneity and a modest treatment effect, there is no data to suggest that
ERP are unsafe or associated with any increase in harm. The safety of ERP is further
supported by numerous trials demonstrating a lack of difference in readmission
when patients are managed by ERP. This is a consistent finding with low heteroge-
neity, though there is a risk for observational error.
If there is no undesirable effect of ERP on patient safety, the question becomes if
there is any improvement in either resource utilization or patient quality of life.
There is abundant evidence that implementation of ERP leads to shorter LOS after
colorectal surgery. Hospital LOS is a reliable, objective, and easy to measure out-
come and the quality of the evidence supporting the positive effect of ERP is high.
Whether this reduction in hospital stay is associated with a reliable decrease in
resource utilization and healthcare system costs is less clear, for the reasons stated
above. The quality of the evidence in this regard is poor, but no studies have sug-
gested that overall expense is increased by the use of ERP, even when costs of
implementing the program are considered [27]. The available literature suggests
that there is no negative effect on QoL or patient satisfaction when patients are man-
aged by ERP.
A Personal View of the Data
Despite the shortcomings of the available evidence, there is ample data that the
institution of ERP is associated with a decrease in some postoperative complica-
tions and a reduction in hospital stay, without an increase in readmissions. There is
no data to suggest that patients managed by ERP are dissatisfied with being fed
earlier or allowed to return to their homes sooner. In fact, the limited evidence (and
common sense) would suggest that QoL improves when complications are avoided
and patients are able to return to their normal activities. While health system costs
may be of minimal importance to individual patients, the impact on the practice of
medicine and healthcare economics cannot be overlooked. In an era of diminishing
resources, clinician efforts to be cost-effective are paramount to sustainability.
The concept of “enhanced recovery” and the specific components constituting a
pathway is a moving target. It is frequently assumed that individual interventions,
shown to be beneficial on their own, will have an additive effect when combined
into multidimensional pathways. The inherent problem with this approach however
is that it becomes very difficult to weigh the individual merits of a particular
W.C. Mustain and C.P. Delaney
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intervention when multiple variables are instituted at once. This problem is further
compounded by the fact that the literature on ERP rarely includes the degree of
compliance to specific measures within pathways and infrequently uses blinded
data collectors. Furthermore, the natural course of medicine is such that treatments
or interventions which seem radical at first, such as avoiding NG tubes after colec-
tomy, eventually become part of standard practice, thereby altering “traditional
care” and blurring the lines between ERPs and modern surgical management.
We and others believe that a critical part of a successful ERP is the audit of one’s
own data and the willingness to adapt. For various reasons certain components of an
ERP may cease to become efficient or cost-effective in a given setting. A perfect
example in our practice is that of intravenous acetaminophen, which we abandoned
in favor of the oral form when the price of the drug more than doubled. If epidurals
are slow to be placed and poorly managed in a particular hospital, they are unlikely
to have a benefit. Proper education of the staff and adherence to the protocol is para-
mount to success, and deviations from the pathway should be analyzed
periodically.
How We Do It
Since 2000, we have managed patients according to a standardized ERP which has
been modified and refined over time [58–62]. We use a similar protocol for open and
laparoscopic colectomy, except where noted below. In the preoperative phase we
focus on patient education, medical optimization, and avoiding physiologic derange-
ments. Patients are counseled in the office about the details of their procedure and
their anticipated post-operative course. They are provided with printed instructions
for the days leading up to surgery as well as the expected course of recovery and
rehabilitation. Patients with an anticipated need for a stoma are referred to a sepa-
rate appointment with our certified enterostomal therapists for marking and educa-
tion. Pre-anesthesia evaluation and testing is ordered based on the results of a
standardized risk assessment form.
We prescribe gabapentin 300 mg 3 times daily for 3 days prior to surgery and
100 mg of diclofenac for the night before surgery. On the day of surgery patients are
encouraged to drink clear liquids until 2 h before surgery. They are provided with a
high carbohydrate beverage to be consumed on the way to the hospital. We use
mechanical bowel preps selectively. We order mechanical and antibiotic bowel prep
on all rectal cancer patients and in settings where a diverting ostomy is deemed
likely. This is consistent with recommendations from the ERAS Group on rectal and
pelvic surgery [63]. We avoid mechanical bowel prep for right colectomy when
there is no anticipated need for intraoperative colonoscopy. We make a point to
inform our anesthesiologists whether the patient has had mechanical bowel prep to
help them gauge preoperative volume status.
In the preoperative holding area patients are ordered an additional 300 mg gaba-
pentin, appropriate antibiotic and thromboembolic prophylaxis, and alvimopan
43 Quality Improvement: Enhanced Recovery Pathways for Open Surgery