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YJPSU-59406; No of Pages 5

Journal of Pediatric Surgery xxx (xxxx) xxx

Contents lists available at ScienceDirect

Journal of Pediatric Surgery


journal homepage: www.elsevier.com/locate/jpedsurg

ERAS Protocol for Pediatric Laparoscopic Cholecystectomy Promotes Safe


and Early Discharge☆,☆☆,☆☆☆
Andrew Yeh a, Gabriella Butler b, Stephen Strotmeyer b, Kelly Austin b, Mihaela Visoiu c,
Franklyn Cladis c, Marcus Malek b,⁎
a
Department of Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, PA
b
Division of Pediatric General and Thoracic Surgery, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, PA
c
Department of Anesthesiology, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, PA

a r t i c l e i n f o a b s t r a c t

Article history: Purpose: Elective laparoscopic cholecystectomy (LC) pediatric patients in our institution have historically been
Received 15 September 2019 admitted for an overnight hospital stay (OHS). The purpose of this study was to implement an ERAS protocol
Accepted 29 September 2019 for elective LC in pediatric patients to promote same-day discharge (SDD) while maintaining excellent outcomes.
Available online xxxx Methods: An ERAS protocol for elective LC was implemented encompassing pre-, peri-, and postoperative man-
agement. A retrospective review of prospectively collected data from patients before (BI) and after implementa-
Key words:
tion (AI) of the protocol was performed.
ERAS
Laparoscopic cholecystectomy
Results: A total of 250 patients (BI 105, AI 145) were included in the study. The AI group had significantly higher
rate of SDD compared to BI (77.2% vs. 1.9%, p b b 0.01) and significantly decreased opioid use (morphine equiv-
alents mg/kg AI 0.36 vs. BI 0.46, p b b 0.001). There were also no significant differences in the rate of total 30-day
emergency department visits (BI 11.4% vs. AI 9.7%, p = 0.52) or surgery-related 30-day emergency department
visits (BI 7.6% vs. AI 8.3%, p = 0.53). Factors that predisposed patients to an OHS after LC included higher ASA,
later surgery start times, and longer operative times.
Conclusions: The ERAS protocol significantly increased the rate of SDD after elective LC in pediatric patients with-
out an associated increase in emergency department visits or readmissions.
Level of evidence: III.
© 2019 Published by Elsevier Inc.

The laparoscopic approach to cholecystectomy was first performed no differences in mortality, adverse events, or readmission rates [2].
in adults in the 1980s and has now clearly supplanted the open proce- Furthermore, no differences in the degree of postoperative symptoms
dure as the standard approach to cholecystectomy. The laparoscopic ap- (pain, nausea, anxiety) have been shown when comparing SDD or
proach offers several advantages over the open technique, including OHS patients [2].
decreased length of stay, smaller incisions, and reduced postoperative In the pediatric population, there are limited data evaluating the role
pain [1]. The dramatic reduction in postoperative pain has allowed elec- of SDD after LC. A study by Mendez et al. retrospectively reviewed 35
tive laparoscopic cholecystectomy (LC) to become a largely outpatient pediatric patients that underwent either SDD or OHS after an LC and
procedure in adults. Several adult studies comparing same-day dis- found that SDD was safe and effective when comparing these small
charge (SDD) versus an overnight hospital stay (OHS) after LC show groups [3]. Dalton et al. and Gould et al. have also demonstrated safe
SDD in larger patient series, and interestingly found the ability to do
so was correlated with an early start time for surgery [4,5].
☆ Financial Support: None. Enhanced Recovery After Surgery (ERAS) protocols have become
☆☆ Conflicts of Interest: None.
more prevalent over the past decade, and have helped improve postop-
☆☆☆ How this paper will improve care: Implementation of an ERAS protocol for perioper-
ative management of laparoscopic cholecystectomy promotes reduced perioperative opi- erative management strategies. ERAS protocols have demonstrated that
oid usage and an increased rate of same-day discharge while maintaining excellent a multidisciplinary approach to perioperative care of surgical patients,
outcomes. Input from surgery, anesthesia, and nursing were critical for the success of this with early diet advancement and ambulation, limitation of narcotics,
protocol. and aggressive prevention of postoperative nausea and vomiting
⁎ Corresponding author at: Division of Pediatric General and Thoracic Surgery, UPMC
Children's Hospital of Pittsburgh, 4401 Penn Avenue, 7th floor Faculty Pavilion, Pittsburgh,
(PONV) can accelerate recovery, and lead to earlier discharge from the
PA 15244. Tel.: +1 4126 928 735; fax.:+1 412 6928 299. hospital, while maintaining patient safety. These protocols were initially
E-mail address: marcus.malek@chp.edu (M. Malek). developed for colorectal surgery patients, but have since extended to

https://doi.org/10.1016/j.jpedsurg.2019.09.053
0022-3468/© 2019 Published by Elsevier Inc.

Please cite this article as: A. Yeh, G. Butler, S. Strotmeyer, et al., ERAS Protocol for Pediatric Laparoscopic Cholecystectomy Promotes Safe and Early
Discharge, Journal of Pediatric Surgery, https://doi.org/10.1016/j.jpedsurg.2019.09.053
2 A. Yeh et al. / Journal of Pediatric Surgery xxx (xxxx) xxx

adult patients undergoing hepatobiliary, cardiac, and urologic proce- were counseled on early postoperative mobilization, diet advancement,
dures. In pediatric surgery, ERAS implementation has certainly lagged and PONV management. Patients were then scheduled with an early op-
behind, but some groups are starting to present data on their early expe- erating room start time.
rience [6]. The perioperative component was initiated in the preoperative
Understanding there was an opportunity to streamline the care of holding area. Patients deemed to be at high risk for PONV based on an
pediatric patients following LC, we used what we have learned from Apfel score of 4 were administered a transdermal 1.5 mg extended re-
ERAS to design and implement a multidisciplinary protocol for elective lease scopolamine patch [7]. Pain management included the use of
pediatric LC. We performed a retrospective review of prospectively col- scheduled acetaminophen and ketorolac IV (at the surgeon's discretion)
lected data of pediatric patients undergoing LC before and after imple- and fentanyl IV as needed. Emphasis was made on limiting the use of
mentation of the ERAS protocol over a 4-year period. We hypothesize narcotics and intravenous fluids. PONV was managed with scheduled
that standardization of perioperative care with aggressive pain and dexamethasone IV at the start of the case and scheduled ondansetron
PONV management would lead to increased rates of SDD while main- IV at the conclusion of surgery.
taining excellent outcomes. The postoperative component was initiated in the postanesthesia
care unit (PACU) and involved pain management (hydromorphone IV,
1. Material and methods oxycodone PO, acetaminophen IV, and ketorolac IV), early mobilization,
and early diet advancement. Postoperative nausea was managed with
1.1. Patient population ondansetron IV as needed. Nurses and the anesthesia team in the
PACU were given discretion on when the patient was adequately alert
Patients undergoing an elective LC between January 2014 and 2018 to begin ambulation and diet advancement. If the patient was ambulat-
were included in the study. This time period included patients prior to ing, tolerating a diet, and their pain was under control, they were
implementation of the ERAS protocol when the standard of care was discharged from the PACU with prescriptions for a short course of oxy-
for an OHS. This study was approved by the Institutional Review Board. codone (5 mg tablets), acetaminophen, ibuprofen, and senna.
Following discharge, postoperative monitoring for emergency de-
1.2. Pre-ERAS patient management partment and readmissions was completed.

Prior to implementation of the ERAS protocol, patients generally had


an OHS at the discretion of the surgeon. Diet advancement and PONV 1.4. Data collection
management were at the discretion of the surgeon and/or
anesthesiologist. Prospective collection of patient demographic and clinical data from
the electronic medical record was performed on a monthly basis for all
1.3. ERAS protocol patients undergoing an elective LC.

The design of the ERAS protocol was a collaborative effort with sur-
geons, anesthesiologists, nursing staff, and quality officers. The protocol 1.5. Statistics
is summarized in Fig. 1 and contains preoperative, perioperative, and
postoperative components. Univariate and multivariate logistic regression was performed to as-
The preoperative clinic component was initiated in patients once certain the effects of age, gender, ethnicity, BMI, ASA, indication for pro-
they were scheduled to undergo an elective LC. Patients and their fam- cedure, surgery start time, and operative time on the likelihood of SDD
ilies were counseled on the ERAS protocol and the aim for a SDD. They after implementation of the ERAS protocol.

Fig. 1. Overview of ERAS protocol.

Please cite this article as: A. Yeh, G. Butler, S. Strotmeyer, et al., ERAS Protocol for Pediatric Laparoscopic Cholecystectomy Promotes Safe and Early
Discharge, Journal of Pediatric Surgery, https://doi.org/10.1016/j.jpedsurg.2019.09.053
A. Yeh et al. / Journal of Pediatric Surgery xxx (xxxx) xxx 3

Table 1
Patient demographics and surgical indications before and after ERAS implementation.

Before Implementation (BI; n = 105) Full Implementation (AI; n = 145) p-value

Age 13.5 (0 to 20) 14.6 (3 to 31) 0.08


Female 78 118
Gender 0.58
Male 27 27
White 94 132
Black 8 10
Ethnicity Asian 0 0 0.43
Pacific Islander 1 0
Not specified 2 3
Body Mass Index 24.2 (13.9 to 46.0) 26.6 (13.3 to 57.6) bb0.01
Abdominal pain 21 15
Biliary dyskinesia 37 38
Cholelithiasis / biliary colic 8 13
Indication for Surgery 0.17
Chronic acalculous cholecystitis 8 30
Chronic calculous cholecystitis 27 42
Other 4 7

Age and body mass index are shown as means with the range in brackets.

2. Results patients). The rate of 30-day readmissions were also not significantly
different between groups (BI 5.7% vs. AI 2.1%, p = 0.37).
2.1. Patient population
2.3. SDD vs OHS after ERAS implementation
A total of 250 pediatric patients undergoing an elective LC between
2014 and 2018 were included in the study. There were 105 patients in
We sought to determine what patient and/or clinical factors after
the group before implementation of the protocol (BI) and 145 patients
implementation of the ERAS protocol may predict an OHS. On univariate
in the group after full implementation of the protocol (AI). Patient char-
analysis, we found that patients in the AI group that were more likely to
acteristics are shown in Table 1. Age, gender, ethnicity, and ASA were
be admitted overnight had a higher ASA class (p b b 0.001), were more
not different between BI and AI. BMI was slightly greater in the AI
likely to have a later surgery start time (SDD 10:12 AM vs OHS
group compared to BI (24.2 vs 26.2, p = 0.0004). Indications for surgery
11:53 AM, p = 0.006) and had longer operative times (SDD 1.11 h vs.
between the BI and AI groups were not statistically different. However,
OHS 1.46 h, p = 0.004) compared to patients that underwent SDD. Mul-
there was a trend toward a greater proportion of acalculous chronic
tivariate logistic regression confirmed these findings with a lower ASA
cholecystitis and lesser proportion of biliary dyskinesia and abdominal
(p = 0.01), earlier surgery start time (p = 0.002), and shorter operative
pain not otherwise specified in the AI group compared to BI.
time (p = 0.005) associated with SDD.

2.2. BI vs AI 3. Discussion

The AI group had a significantly greater rate of SDD (77.2%) com- The goal of this study was to implement an ERAS protocol that stan-
pared to the BI group (1.9%) (Table 2). In regards to length of stay dardized the postoperative care of pediatric LC patients and actively
(LOS) in hours, AI had an average LOS of 13.6 h compared to BI with promoted SDD. After implementation of our protocol, we saw a signifi-
27.5 h (p b b 0.001). When comparing surgery start time, patients in cant increase in the rate of SDD from 1.9% to 77.2%. The simple act of
the AI group had an earlier average surgery start time of 10:37 AM com- creating a standardized protocol and the associated awareness of the
pared to BI with an average surgery start time of 12:22 PM (p b b0.001). protocol, likely played a major role in the dramatic increase in SDD
Operative time, type of surgery (laparoscopic vs. robotic), and estimated and decrease in opioid administration on the day of surgery. Preopera-
blood loss were not significantly different between groups. Opioid use tive patient and family education regarding ERAS and SDD, as well as
was significantly reduced on the day of surgery in the AI group com- changes in analgesic strategy and aggressive management of PONV,
pared to BI (morphine equivalents/kg AI 0.36 vs. BI 0.46, p b b0.001, was likely also important contributing factors.
Fig. 2). There were also no significant differences in the rate of total In adults, several studies have demonstrated that SDD after LC is safe,
30-day emergency department visits (BI 11.4% vs. AI 9.7%, p = 0.52) well tolerated by patients, and does not result in increased rates of failed
or surgery-related 30-day emergency department visits (BI 7.6% vs. AI discharges [2]. There are published studies that show patients undergo
8.3%, p = 0.53). Most common reasons for surgery-related visits to SDD after elective LC but do not evaluate its effect on failed discharges
the emergency department included nausea/vomiting (BI 5 of 8 [8,9]. Dalton et al. and Gould et al. compared SDD to OHS and found
patients, AI 6 of 12 patients) and pain (BI 3 of 8 patients, AI 2 of 12 no increased rates of complications [4,5]. Our study is the largest cohort

Table 2
Surgical parameters and outcomes of patients before and after ERAS implementation.

Before Implementation (BI; n = 105) Full Implementation (AI; n = 145) p-value

Surgery Start Time 12:22 PM (7:40 AM–7:03 PM) 10:37 AM (7:45 AM–6:19 PM) bb0.01
Operative Time (h) 1.17 (0.43–2.97) 1.22 (0.33–2.90) 0.78
Length of Stay (h) 27.5 (10.5–48.6) 13.6 (0.4–52.9) bb0.01
Same Day Discharge 2 (1.9%) 112 (77.2%) bb0.01
Total Visits 12 (11.4%) 14 (9.7%) 0.52
ED Return Visits
Surgery-Related Visits 8 (7.6%) 12 (8.3%) 1
30 day Readmissions 6 (5.7%) 3 (2.1%) 0.17

Values display either means or total number of patients. Brackets denote either ranges or percentage of patients.

Please cite this article as: A. Yeh, G. Butler, S. Strotmeyer, et al., ERAS Protocol for Pediatric Laparoscopic Cholecystectomy Promotes Safe and Early
Discharge, Journal of Pediatric Surgery, https://doi.org/10.1016/j.jpedsurg.2019.09.053
4 A. Yeh et al. / Journal of Pediatric Surgery xxx (xxxx) xxx

without increasing the rate of postoperative emergency department


visits or readmissions. Patients that required an OHS after imple-
mentation of the ERAS protocol were more likely to be sicker (higher
ASA class), have more complicated operations (longer operative
time), or had cases that started later in the day making SDD less
likely.

Appendix A. Discussion: ERAS Protocol for Pediatric Laparoscopic


Cholecystectomy Promotes Safe and Early Discharge

Presenter: Andrew Yeh.

Male Did you want to show anything from the toolkit?


Andrew Yeh I have it uploaded online.
Male While we take a question, we could switch to the online
website. That would be great.
Q. Kurt Heiss, Atlanta Nice presentation. Can you tell us a little bit about
important steps you made in implementation of this in your
team in your institution? Every time you start a new semi-
enhanced recovery type thing, it requires some adjustments.
What were the inflection points as you worked with your
team to make this happen?
Andrew Yeh I think the most important thing as with all these QI pro-
jects I'm sure, is gathering all the stakeholders, getting every-
Fig. 2. Opioid administration on the day of surgery. Morphine equivalents normalized to
patient weight (mg/kg) on the day of surgery before and after implementation of the
body on the same page, and working toward the same goal.
protocol. There was a significant decrease in AI compared to BI (0.36 vs. BI 0.46, This includes not only just the anesthesia staff, which is obvi-
p b b0.001). Error bars denote standard deviation ously very important, but also the nursing staff and the EMR
people that helped us make a very easy to use power plan
to our knowledge showing that SDD did not result in an increase in that residents that rotate in and out of the service can use
these balancing measures. quite easily and follow the protocol.
This is also the first study to our knowledge to publish results from Q. Female Cincinnati. Quick question. The patients that you had, were
implementation of an ERAS protocol for pediatric LC in a large cohort they actually discharged from the PACU, or did they actually
of patients. Only a handful of studies have evaluated the role of ERAS get admitted to the floor? Because for us in our institution,
in pediatric surgery in general. Surgical procedures that have been stud- there's a significant cost difference for patients who are actu-
ied include appendectomies, hypospadias repairs, nephrectomies, ally admitted to the floor as a 22 h admit. And you don't utilize
pyloromyotomies, fundoplications, ileocecectomies, and bowel surger- that same cost savings if you have to admit them to the floor.
ies requiring anastomoses [10–14]. Most of these studies did demon- Andrew They were discharged from the PACU.
strate a reduction in hospital length of stay when the ERAS protocol Q. Male Nice protocol. Thank you. It says you're admitting the average
was implemented. Jawaheer et al. implemented an ERAS protocol for start time was 10:30 in the morning. But then your average
LC that is similar to what we present here. Although they were able to length of stay was 13 h. So, are you discharging them at 11
show an increase in SDD, the study was limited to evaluation of only o'clock or midnight?
13 patients in the ERAS arm and 25 patients total [6]. Andrew Yeh Usually no. I think that's a result of the statistical analysis.
This study has also demonstrated that, after implementation of the And I think they usually go home early evening around six
ERAS protocol, factors associated with an OHS included a higher ASA o'clock at the latest.
class, longer operative times, and later surgery start times, similar to Q. Male Andrew, I had two questions while you pull up the toolkit
what was found in the studies by Dalton et al. and Gould et al. [4,5]. there. One is, did you guys stagger the Tylenol and Toradol
These factors make intuitive sense in that more medically complex pa- that you used intraoperatively such that in the postoperative
tients (higher ASA class) or difficult cases (longer operative times) setting, in the PACU, they weren't waiting a full six hours be-
result in overnight observation. Additionally, later surgery start times fore they could get additional doses of those medications.
most likely resulted in an increased rate of OHS because of insufficient That's something we're struggling with when we're doing a
time remaining in the day to recover adequately in the PACU and thus similar same day discharge for appendicitis protocol. And
led to an OHS. that's one of the things that we've been very thoughtful
One weakness of this study is that it is a retrospective review com- about. Did you have to do anything along those lines?
paring patients before and after ERAS implementation. Whether the ob- Andrew Yeh We didn't, but it think that would be a great addition to
served increase in SDD is because of protocol awareness, the changes in the QI project, and probably it would reduce opioid use
perioperative management initiated by the protocol, or a combination even further if we could actually stagger out the doses of
of these factors cannot be elucidated by the current study, but we do Tylenol and Toradol.
clearly show that creation of the protocol led to a dramatic increase in Q. Male And then the second question was for your sickle cell pa-
SDD, without an increase in balancing measures. Future work will deter- tients. Were any of these patients sickle cell patients with
mine the cost benefit of this ERAS protocol and whether it can be prior opioid exposure and higher pain requirements? Were
adopted for other elective surgical procedures. you able to successfully get those patients home the same
day?
4. Conclusions Andrew Yeh That's a great question. I think there were a couple of
sickle cell patients in the implementation group, but I would
The implementation of an ERAS protocol for pediatric patients have to go back and look at that. But they were included in
undergoing an elective LC dramatically increased the rate of SDD the study.

Please cite this article as: A. Yeh, G. Butler, S. Strotmeyer, et al., ERAS Protocol for Pediatric Laparoscopic Cholecystectomy Promotes Safe and Early
Discharge, Journal of Pediatric Surgery, https://doi.org/10.1016/j.jpedsurg.2019.09.053
A. Yeh et al. / Journal of Pediatric Surgery xxx (xxxx) xxx 5

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Andrew Yeh They are given a very short course of narcotics, but they're erative nausea and vomiting: conclusions from cross-validations between two cen-
ters. Anesthesiology 1999;91:693–700.
also given a script of Ibuprofen and Tylenol and instructed to [8] Cairo SB, Ventro G, Meyers HA, et al. Influence of discharge timing and diagnosis on
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https://doi.org/10.1016/j.surg.2017.07.029.
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Please cite this article as: A. Yeh, G. Butler, S. Strotmeyer, et al., ERAS Protocol for Pediatric Laparoscopic Cholecystectomy Promotes Safe and Early
Discharge, Journal of Pediatric Surgery, https://doi.org/10.1016/j.jpedsurg.2019.09.053

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