J Gastrointest Surg (2017) 21:1428– 1

DOI 10.1007/s11605-017-3459-1
ORIGINAL ARTICLE

Implementation and Evaluation of a Clinical Pathway

for Pancreaticoduodenectomy Procedures:
a Prospective Cohort Study
Marion van der Kolk1,2 • Mark van den Boogaard2 • Femke Becking-Verhaar1 •
Hettie Custers 3 • Hans van der Hoeven2 • Peter Pickkers2 • Kees van Laarhoven1

Received: 23 March 2017 / Accepted: 16 May 2017 / Published online: 6 June 2017
Ⓒ 2017 The Author(s). This article is an open access publication

Abstract
Introduction Medical and nursing protocols in perioperative care for pancreaticoduodenectomy are mainly mono-
disciplinary, limiting their integration and transparency in a continuous health care system. The aims of this study were to
evaluate adherence to a multidisciplinary clinical pathway for all pancreaticoduodenectomy patients during their entire hospital
stay and to determine if the use of this clinical pathway is associated with beneficial effects on clinical end points.
Materials and Methods A prospective cohort study was conducted in 95 pancreaticoduodenectomy patients treated according
to a clinical pathway, including a variance report, compared to a historical control group (n = 52) with a traditional treatment
regime. Results Process evaluation of the clinical pathway group revealed that protocol adherence throughout all units was
above 80%. Major complications according to Clavien-Dindo classification grade ≥3 decreased from 27 to 13%; p = 0.02.
Hospital length of stay was significantly shorter in the clinical pathway group, median 10 days [IQR 8–15], compared with
the control group, median 13 days [IQR 10–18]; p = 0.02.
Conclusion The use of a clinical pathway in pancreaticoduodenectomy patients was associated with high protocol
adherence, improved outcome and shorter hospital length of stay. Variance report analysis and protocol adherence with a
Prepare-Act- Reflect Cycle are essential in surveillance of outcome.

Keywords Pancreaticoduodenectomy . Clinical pathway .

is associated with high morbidity (30–70%) and a mortality
Protocol adherence . Perioperative care
of 1–5% in specialized centres.1, 2 Centralization of pancreas
surgery and advances in surgical techniques resulted in
more patients being operated for advanced-staged
Introduction tumours.3, 4 Patients with more comorbidity receiving pre-
operative che- motherapy and/or vascular reconstructions
Pancreaticoduodenectomy for pancreas tumours and in advanced dis- ease, need more complex perioperative
periampullary tumours is considered high-risk surgery and care. Currently this is facilitated by multiple guidelines and
medical and nursing protocols. This complexity demands an
overall multidisciplin- ary approach and clear
communication.
Marion van der Kolk
Marion.vanderKolk@radboudumc.nl Different departments are involved in the treatment
during the patients’ journey through the surgical ward,
operation the- atre, post-anaesthesia care unit (PACU) and
1
Department of Surgery, Radboud University Medical Center, intensive care unit (ICU). However, large differences in the
P.O. Box 9101, 6500HB Nijmegen, The Netherlands
actual use of these protocols are present between the
2
Department of Intensive Care Medicine, Radboud different units and medical and nursing staff members.5, 6
University Medical Center, Nijmegen, The Netherlands
Moreover, while multidisci- plinary teamwork for these
3
Department of Anesthesiology, Radboud University Medical Center, patients is essential, the develop- ment and implementation
Nijmegen, The Netherlands
of a clinical pathway (CP) involve many aspects of the total
patient care and should therefore be multidisciplinary by
J Gastrointest Surg (2017) 21:1428–1441
doctors and nurses as well.
 J Gastrointest Surg (2017) 21:1428– 3

A CP may facilitate the care for this group of high-risk 2012 of pancreas surgery in the Netherlands, approximately
sur- gery patients by unifying different protocols into one 80 pancreas operations (60
multidis- ciplinary protocol for all units during the hospital
stay of the patients. This may result in an increased protocol
adherence, less morbidity and improved outcome. Key
elements of a CP are guidelines, evidence-based clinical
protocols and best practice rules, together with a coordinated
sequence of activities of the multidisciplinary team.7
Registration, monitoring and evaluation of adherences,
variances and outcomes are part of a CP and can be part of a
process-driven pathway.8 A multidisciplinary CP has therefore
many evaluation moments and scheduled actions. To keep
the patient on the ‘pathway’, the CP mandates a registered
response of the nurse or doctor if results are outside the range
of the prescribed boundaries.
Many CPs have been developed for high volume with
low- risk and with average-risk health care procedures in
order to reduce complications.9–12 The post-operative phase
of the pa- tient spent in the ICU or PACU, however, is a
seldom part of a CP.13 A CP including the PACU/ICU stay
mandates an hour- to-hour care plan during the post-
operative stay in the ICU/ PACU.14 Many standardized
care plans related to a pancreaticoduodenectomy have
been published, focussing on the use of an enhanced
recovery program after surgery (ERAS) with elements like
early mobilization, early enteral feeding, pain treatment
and reduction of iv fluid administra- tions to shorten the
length of hospital stay.15–19 In these care plans, a reduction
of hospital length of stay (LOS), morbidity or mortality was
not always observed. Crucially, the ICU pe- riod of these
patients was not integrated in these protocols.
The aim of this study was first to determine the
feasibility to develop and implement a multidisciplinary CP
including a variance report for all pancreaticoduodenectomy
patients dur- ing their entire hospital stay and second to
determine if the use of this CP is associated with an
improvement of patient’s morbidity and outcome.

Methods

Setting and Patients

The Radboud University Medical Center in Nijmegen is a

1000-bed university hospital, including a 32-bed closed-format
ICU, a 5-bed PACU and a 30-bed gastrointestinal (GI)
oncol- ogy surgical ward. An anaesthesiologist with a
resident are supervising the PACU. The ICU is supervised
by the intensivists, with intensivists-in-training and
residents. They all work in close relation with the surgical
team. On the surgical ward, nurses, physician assistants and
young residents are car- ing for patients undergoing a
pancreaticoduodenectomy, under daily supervision of the
senior GI-oncology medical staff. Since the centralization in
J Gastrointest Surg (2017) 21:1428–1441
malignant cases) are operated annually in the (MUST) score above 2 need an active feeding intervention
Radboudumc. As a result, the logistics and perioperative according to the quality system of health care in the
care of our pancreatic surgical program needed reflection Netherlands. We decided that patients with a MUST above 2
and rescheduling. should start with total par- enteral nutrition (TPN) within 24 h
after surgery. Publications on
Development of the CP

The development of the multidisciplinary CP for

pancreatico- duodenectomy was a multistep procedure
with the use of les- sons learned from the development and
implementation of the cardiac and oesophageal CPs,
previously developed in Radboudumc, and started in
2013.
The first step was redefining and searching for evidence
un- derneath the surgical, anaesthesiology and ICU protocols
in the perioperative period. This was a multidisciplinary
procedure, un- dertaken by the physician assistants, senior
nurses, ‘key’ nurses and medical staff.20–27 Instead of a
traditional ‘day-to-day-care’ plan for the surgical ward, an
‘hour-to-hour’ care plan had to be developed, including the
PACU and ICU care. It was important to identify potential
barriers and facilitators in these settings, in order to tailor
the implementation strategy.28–31 An evidence- based
implementation strategy according to Grol was used.32
Second, a unique variance report (‘Radboud variance
report’; Appendix 1) had to be incorporated and developed
together with the CP.33 This Radboud model of variance
report enables nurses, physician assistants and young
residents to execute predefined actions in accordance with
and within the preset boundaries of a variance protocol,
without having to wait for approval of the responsible
physician first (Dutch law and order for health care
professionals BWBR0006251 chapter IV, article 35).
Until 2012, a surgical pancreas matrix for
(peri)operative care was used at the surgical ward. The
historical control group was treated according to this
matrix including the sur- gical medical and nursing
protocols without the variance re- port. In the PACU and
ICU, these patients were treated ac- cording to different
PACU and ICU protocols. This pancreas matrix was used
as backbone for further multidisciplinary de- velopment of
the CP. As part of the development and imple- mentation
strategy, a small group of key nurses responsible for other
CPs reflected on the concepts of the pancreas CP and
variance report as part of a Prepare-Act-Reflect (PAR)
Cycle. The pancreas CP had to be a continuum from
admission to discharge from the hospital. Essential
elements included re- strictive intra-operative fluid use,
strict pain control, early mo- bilization, early drain and tube
removal and early enteral feed- ing. Post-operatively, early
warning scores (EWS) are mea- sured at least once during
every 8-h shift or more frequent, whenever indicated by
the nurses, with strict directives for
action by nurses according to the variance report.34
Patients with a malnutrition universal screening tool
 14 J Gastrointest Surg (2017) 21:1428–

calorie deficit and enteral feeding or TPN after surgery in actions were needed. Deviations from the CP had to be
ICU patients often do not take into account malnutrition and described in the variance report or patient record.
MUST score >2. Our protocol prescribes that if the gastric
tube can be removed, the patients need to start with
oral/enteral feeding, and TPN needs to stop as soon as the
oral intake of the patients is above 1000 kcal.22, 23, 35–37 TPN
should be started on day 3 if patients had a MUST score of 1
and enteral feeding had not been started on day 3. All patients
with a gastroparesis without signs of sepsis or ileus on day 7
will be given a naso-jejunal tube by the gastroenterologist
through the gastrojejunostomy and start enteral feeding. 38 In
contrast to ERAS-based protocols, devia- tions from the CP
had to lead into prompt actions according to the variance
report.

Implementation of the CP

After informative meetings for medical and nursing staffs,

including reflections on the positive aspects of previous
CPs, bedside training started on the surgical ward and
PACU/ICU in 2014. Implementation of the pancreas CP
would introduce an essential change in daily practice for
most nurses, physician assistants and medical staff. The first
step in teaching was getting acquainted to the CP vision
that would result to one continuous multidisciplinary
protocol.32 In nursing and med- ical staff meetings, updates
of the project were discussed, and feedback was welcomed
by the CP developers. During this teaching period,
especially new PACU-specific aspects arose for the
pancreas CP, including new variance report criteria, and as
an interactive process of PAR cycles, these criteria were
incorporated in the pancreas CP during the development.
In this try-out period, feedback was asked and given
every 4 weeks during the multidisciplinary team meetings
of the project. After 4 months of teaching and try-out
period, it was concluded that it was feasible and safe to use
the pancreas CP with the Radboud model variance report
for patients during their entire clinical stay, including the
PACU/ICU. With the completion of this implementation
step, the pancreas CP was considered being implemented
and our study on the use of the CP and variance report for
all pancreaticoduodenectomy pa- tients started on the first
of September 2014, 18 months after the start of the
development of the CP, including many PAR cycles.
Patients treated for other pancreas procedures than
pancreaticoduodenectomy were considered candidates to
have the benefits of the pancreas CP during their stay in
PACU/ICU and ward, but were not included in this study.
Protocol adherence was measured per pathway action. We
considered protocol adherence if a deviation from the CP
re- sulted in the correct action, according to the CP, or if no
action was needed and no action was started. No protocol
adherence was defined as wrong actions or no actions if
 J Gastrointest Surg (2017) 21:1428– 14
Design report).
For the analysis of the developmental process, we
This is a pre-post design study. After the implementation of evaluated barriers and facilitators for protocol adherence.
the pancreas CP, patients treated according to the CP For this,
were com- pared with a historical control group of
patients treated with standard perioperative care for
pancreaticoduodenectomy ac- cording to the original
pancreas matrix and monodisciplinary protocols and
operated on between 2009 and 2012.

End Points

Primary endpoint was to determine the feasibility and

safety, including incidence of post-operative complications,
according to Clavien-Dindo classification, of the use the
CP. Secondary endpoints were in length of stay (LOS) in-
hospital, post- operative fluid balance, gastroparesis, protocol
adherence to mo- bilization, drain removal, radiologic and
surgical re-interven- tions, ICU readmission, hospital
readmission and mortality rate.

Statistics

Continuous variables were described as median and

interquartile range [IQR] and tested with the Mann-
Whitney U test. Differences in dichotomous variables were
analyzed using the chi-squared test. Due to the exploratory
nature of this study, and to increase the sensitivity to detect
differences between groups, no correction for multiple testing
was performed. With our con- venience sample size of 95
patients in the CP group and 52 patients in the control
group, our study had 80% power to dem- onstrate a 7%
absolute reduction of post-operative complica- tions. All
statistical analyses were performed using SPSS version
20.01 for Windows (IBM, SPSS statistics, Chicago, IL, USA).

Results

Development Results of the CP

Nurses, physiotherapists, dieticians and medical staff

special- ized in pancreas surgery contributed to the
development of the pancreas CP and the variance report.
This resulted in a set-up of clear and safe boundaries in
taking clinical treatment deci- sions and an upscaling
system to consultation with a key nurse or senior staff
members, if actions according to the variance report did
not seem right.
First, the pancreas CP for medical and nursing
decisions was written according to existing evidence-
based protocols, best practices and guidelines. Finally, a
multidisciplinary var- iance report was incorporated
(Appendix Table 4: summary of the differences between
CP and control surgery and Appendices 2 and 3: variance
 14 J Gastrointest Surg (2017) 21:1428–

interviews and questionnaires were used, focussing on possible colorectal tumour) were no part of the study. A cohort of 52
barriers and facilitators for protocol adherence to the new CP. consecutive elective pancreaticoduodenectomy patients treated
An important facilitator was the motivation of nursing and before the CP implementation period between 2009 and 2012
medical staff to ask for guidance and training in the use of this was identified as historical control group. Their
protocol. The most important barrier was that using the
protocols was experienced as a time consuming processes of
getting acquainted with the system, resulting in feelings of
loss of autonomy for doctors and nurses. Key nurses together
with medical leadership were essential for awareness,
feedback and motivation during development,
implementation and the use of the CP.

Implementation Results of the CP

First, the medical aspects of the CP were implemented on

the ward followed by the nursing aspects. Because of the
lack of experience with CPs, the care providers working on
the PACU received more time for training and bedside
teaching and started later with implementation. Key nurses at
the surgical ward gave guidance and were partner for the
key nurses of the PACU.
Evaluation after the implementation process was per-
formed every 2 months during the first 6 months and after
this period whenever needed. These evaluations resulted
mostly in questions or new ideas for a change in the CP from
the units or when less compliance was observed. The
variance report was an important tool for evaluating
compliance. When compli- ance of one of the CP domains
was below 80%, feedback was given by the key nurse or
surgeon through focussed teaching sessions for nurses and
residents.
After a period of 18 months, the pancreas CP was
implement- ed and evaluation of protocol adherence was
80% for PACU/ICU periods and 60% for the surgical ward.
The latter was mainly influenced by a low compliance to
drain removal (<50%). According to the pancreas CP, drain
removal was allowed if amylase level in the drain was
below 500 U/l and volume below 200 ml/day. Deviations
turned out to be primarily a system problem of postponing
drain removal during weekends. After recognition of this
system problem, an active policy started and protocol
adherence on this item improved to above 80%.
Following the implementation, in September 2014, the
out- come study of the pancreas CP was started (Fig. 1
implemen- tation flowchart).

Clinical Outcomes

Between September 2014 and September 2016, in total, 95

elec- tive consecutive pancreaticoduodenectomy patients were
treated within the pancreas CP. Semi-acute
pancreaticoduodenectomies (for bleeding tumours) and other
types of resections (e.g. total pancreatic resections or
pancreaticoduodenectomies with resec- tion of a secondary
 J Gastrointest Surg (2017) 21:1428– 14
perioperative treatment had been according to the >6 on day 7 and hemorrhagic bleeding on day 14 in the CP
underlying matrix protocol that was used as base for the group. This complication was successfully treated by
development of the CP. Three surgeons in the pre-CP radiologic coiling of the gastroduode- nal artery and splenic
period operated on the pancreaticoduodenectomy patients. artery.
Results between these sur- geons did not differ, and
perioperative care was regulated by protocols. These
surgeons were also responsible for pancreas surgery in the
CP period.
Baseline characteristics between the two groups were
not significantly different, apart from a higher number of
CP pa- tients receiving portal vein resection or celiac
trunk/superior mesenteric artery (SMA) vessel
exploration (Table 1).

Intra-operative Data

The median intra-operative amount of fluids administered

was 3900 ml [IQR 3000–4600] in the CP patients versus
5200 ml [IQR 4000–6000] in the control group (p <
0.001). Post- operative fluid balance and fluid balance on
day 1 post- operative were also significantly lower in the
CP group versus the control group (p < 0.001; Table 2).
Although more portal vein resections and celiac trunk and
explorations along the SMA were performed, blood loss was
less in the CP patients: 755 ml [IQR 500–1100] versus 1303
ml [IQR 656–2402] (p < 0.001, Table 2).

Post-operative Data

Adherence of pain and hemodynamic interventions according

to the variance report was 100% at the PACU/ICU, and a
step-up approach regarding pain control was adequately used
according to CP protocol. Hemodynamic interventions in
accordance with the variance report were not needed and not
started in 17% of the CP patients, and 57% of the CP patients
needed an extra hemo- dynamic intervention which was
subsequently started according to the CP protocol. In total,
26% of the patients were treated with vasopressors on
arrival in the PACU/ICU, which could be re- duced during
their stay. Significantly more CP patients were swing
mobilized within 24 h compared with the control group,
respectively, 83 versus 19%, p = 0.001. Especially poor
pain control and patients’ feelings of weakness, early after
the oper- ation, were recorded as reasons not to start swing or
mobilization at the surgical ward. Trigger for complications
was the EWS; in 32% of the patients in the CP group, the
EWS was above 3. Interventions on a high EWS were
adequate and according to the variance report >95% of the
patients.
Considering clinical outcome, major complications
accord- ing to the Clavien-Dindo classification grade 3 or
more oc- curred less frequently (13 vs 27%, p = 0.02) in
the CP group, compared to the control group.39 One
patient had a Clavien- Dindo 4b complication as a result
of pancreatic leakage com- plicated by sepsis with EWS
 14 J Gastrointest Surg (2017) 21:1428–

Short Cycle Act and Reflect meetings

input and feed back in 2-4monthly meetings and close e-mail contact

Building
multidisciplinary Teaching
Multi- Variance report ward CP
disciplina Buildi by ‘key’nurses nurses, Exclusion: non-
161 patients Pancreatico-
iry ng on the surgical PACU pancreatico-
duodenectomy
search medica ward and nurses duodenectomy
inclusion 95 pts
for l PACU, and patients
EBM matrix dietrician,fysio physicia
and EBP CP and medical ns

Development of the Radboud

variance report and CP for training in use of CP and
Study
pancreaticoduodenectomy variance report
period

strategy development

12 months 6 months 24 months

Fig. 1 Implementation of pancreas CP and study flowchart

Less patients suffered from gastroparesis grades B and

Discussion
C in the CP group compared to the control group, 9 ver-
sus 62%, p < 0.001, as were radiologic interventions: 11
This study illustrates that development of a CP for
versus 27%, p = 0.04. In the control group, the gastric
pancreaticoduodenectomy is an iterative multidisciplinary
tube was not removed when production was reduced but
pro- cess, starting with a dynamic protocol with
was left in place and blocked and could be removed if
improvements through PAR cycle evaluation and change
after measurement of retention after 8 and 16 h, it was
moments. Implementation of the pancreas CP in all units
less than 100 ml per 8 h. Pancreatic leakage and chylus
involved in the entire (peri-) operative process (OR,
leakage, readmission to ICU and readmission to hospital
PACU/ICU/surgical ward) took 18 months. Process evaluation
did not significantly differ between the CP group and
of the prospective CP group revealed that protocol adherence
control group. Median times to drain removal were also
was successfully achieved in
not influenced. The mortality rate was low and not differ-
>80% for most of the criteria throughout the clinical stay.
ent between groups (Table 3).
Comparison of both cohort groups on main clinical
outcomes showed that major complications according to
the Clavien-

Table 1 Baseline characteristics

of pancreas CP and control Clinical pathway, N = 95 Control, N = 52 P
groups of
pancreaticoduodenectomy Age, median (IQR) 66 (57–72) 66 (58–72) 0.98
Male, n (%) 56 (58.9) 35 (67.3) 0.26
Stent/(PTC) percutaneous drainage, n (%) 59 (61.5) 28 (53.8) 0.34
Pulmonary comorbidity, n (%) 13 (13.7) 4 (7.7) 0.52
Cardial comorbidity, n (%) 13 (13.7) 10 (19.2) 0.62
Vascular comorbidity, n (%) 29 (30.5) 16 (30.8) 0.80
Diabetes, n (%) 21 (22.1) 16 (31.4) 0.4
Preoperative chemotherapy, n (%) 4 (4.2) 0
Portal vein resection, n (%) 20 (21.1) 1 (1.9) <0.001
Celiac trunk/SMA exploration, n (%) 6 (6.3) 0

IQR first and third interquartile range, PTC percutaneous transhepatic cholangiography, SMA superior mesenteric
J Gastrointest Surg (2017) 21:1428– 14
artery
 14 J Gastrointest Surg (2017) 21:1428–

Table 2 Intra-operative results of pancreas CP and control groups of pancreaticoduodenectomy

Fluid and vasopressor management Clinical pathway, N = 95 Control, N = 52 P

Intra-operative fluids (ml), median (IQR) 3900 (3000–4600) 5200 (4000–6000) <0.001
Fluid balance, at the end of the procedure, median (IQR) 405 (−107 to 833) 1926 (1253–2818) <0.001
Intra-operative blood loss, median (IQR) 755 (500–1100) 1303 (656–2402) <0.001
Intra-operative vasopressor use, n (%) 94 (99) 48 (92) 0.22

Dindo classification grade 3 or more and hospital LOS in the to prevent discomfort for the awake patient while reposi-
CP group were significantly lower compared to the control tioning the tube, even if early removal is according to
group. In addition, implementation of the CP was associated proto- col. The action was a team reflection on the
with a reduc- tion of gastroparesis, an improved post-operative discomfort of a needless gastric tube for too long and, as a
fluid balance, and patients in the CP group were more likely result, delay in starting early oral nutrition and well-being.
to receive early mobilization and adequate actions on EWS Postponing early mobilization because of patients’ pain
above 3. These data illustrate that implementation of a CP in or weakness did occur. In all situations, the iterative
this specific group of patients is feasible, safe and likely to be process of repeated and specific education was important
beneficial for the patient. Analyzing reasons not to follow to explain the reasons behind the CP and guidance.
the variance report was part of this study. Human factors Considering the diverse landscape of CPs and surgical care
were often reasons for devi- ation from the report, for plans, it is difficult to compare the different studies. In
example, insecurity of young pro- fessionals on decisions studies, related to implementation of CPs, not all hospital
leading to postponing gastric tube re- moval. The prevention wards in- volved in the clinical process (like PACU/ICU)
of gastroparesis is part of a very active PAR cycle in the CP. were included, which negatively influences the continuous
Nurses, young doctors and patients want care process for the patient. Also different treatment
regimes make reliable comparison and evaluation of
Table 3 Post-operative data of pancreas CP and control groups of different CPs difficult. Regarding the available studies, we
pancreaticoduodenectomy found only studies not
covering the whole clinical stay, excluding parts of the post-
Clinical Control,
pathway,
operative period. In these studies usually some specific aspects
N = 95 P N = 52 like ERAS, drain and gastric tube removal were addressed.18
Post-operative PACU, n (%) 81 (85) 29 (55) 0.002 A standardized care plan for pancreaticoduodenectomy pa-
Mobilization swing, 78 (83) 10 (19) 0.02 tients was retrospectively studied in another study focussing
according to protocol on predictors of LOS in-hospital.15 Specific ERAS
(within 24 h) n (%) pathways, without PACU/ICU periods involved, focussed on
Mobilization out of bed in 2 (1–2) 2 (2–3.3) 0.001 in-hospital LOS, outcome mortality and morbidity. While
days, median (IQR)
Gastroparesis (ISGPS): n (%) these were un- changed, measurement of protocol adherence
• Type A 20 (21) 15 (29) <0.001 was not part of the study.16 Braga et al. evaluated the
• Type B 7 (7) 18 (35) compliance to the en- hanced recovery protocol and
• Type C 2 (2) 14 (27) concluded that patients with low compliance had a higher
Pancreas leakage, n (%) 12 (13) 5 (10) 0.82 incidence of complications.40
Drain in situ (days), median (IQR) 6 (4–10) 7 (5–12) ns Our results are in pursuance of previous studies that
Clavien-Dindo classification n (%) showed that a CP or standardized care plan for
3a 9 (10) 9 (19) 0.02 pancreatico- duodenectomy patients resulted in an earlier
3b 1 (1) 4 (8) start of solid en- teral feeding and a shorter hospital LOS and
4b 1 (1) 0 less readmissions. Importantly, protocol adherence to
5 1(1) 0 predefined targets has not been part of these studies as was
Radiologic reintervention, n (%) 10 (11) 14 (27) 0.04 analysis of the reasons not following the protocol and its
Relaparotomy, n (%) 3 (3) 4 (8) 0.01 association to outcome.
Readmission ICU, n (%) 7 (7) 7 (14) ns Comparing our study to these studies, a similar effect on
Readmission hospital, n (%) 12 (13) 9 (18) ns reduction of complications, hospital LOS, readmissions,
LOS in-hospital (days), 10 (8–15) 13 (10–18) 0.02 gastroparesis, time to enteral feeding and time to mobilization
median (IQR) was found. Our present study also illustrates that it is
30-day mortality, n (%) 1 (1) 0 ns
feasible to implement a CP that covers the entire clinical
90-day mortality, n (%) 2 (2) 1 (2)
admission, applying different targets of the various
J Gastrointest Surg (2017) 21:1428– 14
involved units (e.g. focus on hemodynamic and respiratory
vital parameters at the PACU/ICU, versus focus on EWS
and ERAS criteria at the
 14 J Gastrointest Surg (2017) 21:1428–

surgical ward). Nurses were also able to start adequate This study shows us, in line with the implementation of our
therapy in accordance with the variance rapport when EWS cardiac surgery CP and oesophageal surgery CP,41 that it is
deviated from the target. Moreover, new to the other studies
is that this study, via the variance report method, exposed the
barriers and facilitators of CP adherence. In addition, these
two monthly formal meetings to evaluate variance report
deviations and their barriers and facilitators enabled us to
discriminate the difference of loss of compliance to a
protocol due to compli- cated discourse of operations,
versus loss of professional ad- herence to the CP protocol.
The current study has several limitations. Most
importantly, this is a single-centre pre-post-intervention study.
The intensity and duration to develop the CP, as well as the
implementation process, limit the feasibility of using other
study designs. In addition, the historical group was not
formally matched, which, together with the fact that no
randomization was carried out, induces a higher risk of
confounding factors. No relevant differ- ences in patient
characteristics between the different study pe- riods were
observed. However, the case load per surgeon in- creased,
which could be considered as a possible confounding factor.
We considered the development of a CP as the most
appropriate intervention to re-schedule the process. Prospective
complication registration was part of the daily supervised
peri- operative care as well as the discharge procedure in both
groups. Moreover the prospective database on outcome and
complica- tions of the control group (2009–2012) served as a
document to identify barriers and facilitators for building the
CP. Furthermore, no relevant changes in other procedures,
staffing levels, technical infrastructure or other major changes
that could influence patient management occurred, and during
the whole study period, there were no changes in
interventions that are known to influence morbidity or
mortality in the ICU such as strict glucose regula- tion, early
goal-directed therapy, use of corticosteroids, prone
positioning and low tidal volume ventilation. Second, no a
priori power calculation was carried out, implying that the
risk for a type 1 or 2 error has not been overcome. Using our
convenience sample, we did calculate that our study has 80%
power to dem- onstrate a 7% change in complication rate,
while we observed that the complication rate halved.
Nevertheless, the sample size of the study and the discussed
design issues should make us aware of the possible
overestimation of the outcome differences. In contrast, this does
not necessarily apply for the process anal- ysis part. As no
comparison of the CP group was made to the control group,
the conclusions of the process analysis merely indicate that
CP development, implementation and high level of
adherence to such a CP, throughout all units involved in the
perioperative process, are feasible within a relative short period
and up toa high standard.

Lessons Learned
 J Gastrointest Surg (2017) 21:1428– 14
feasible to develop and implement a CP for pancreatico- of interest.
duodenectomy procedures for all involved units like the
PACU/ICU and surgical ward through the entire clinical
perioperative period. In all units, the CP targets need to
be aligned and the use of a variance report discriminates
complication-related to failure of professional adherence.
Implementation is an iterative process that takes time to
become comfortable in use for all involved units. Key
nurses together with medical leadership were essential for
aware- ness, feedback and motivation during
development, imple- mentation and the use of the CP.

Future Perspectives

In order to overcome the methodological drawbacks of

this study and to validate the CP methods, a multicenter
stepped- wedged cluster randomized controlled trial
would be ideal. However, due to the complexity of the
implementation and intervention with barrier and
facilitator analysis in different hospitals and units,
interpretation of the results will be diffi- cult. Exploring
the validity of similar CPs is in line with the need for
quality assurance of standardized treatment regimes with
high protocol adherences.
For the near future, continuous monitoring, wearables
and electronic medical data recording with pop-up
facilities warn- ing medical and nursing staff for
deviations from the CP will likely be of help in building
more complex pathways. Possibly, patients with high
comorbidity will be able to follow their personalized
clinical pathway (pCP) with the help of dedicated staff.

Conclusion

The use of the CP was associated with a reduction of

periop- erative morbidity. Essential new tools include a
variance re- port analysis, scheduled barrier and facilitator
analyses and the iterative PAR cycle protocol
development, performed by a multidisciplinary team.
Development, implementation and use of a CP throughout
the hospital stay for patients undergo- ing
pancreaticoduodenectomy are a multistep procedure in
which we showed that this is feasible and safe.

Acknowledgements This study was conceived and designed by

MvdK, FB-V, HC, MvdB, HvdH and PP. MvdK and MvdB
performed the data collection. Data analysis and discussion, together
with the inter- pretation of the results, were a mutual effort of all
authors. MvdK, MvdB, PP and KvL drafted the manuscript, and all
authors contributed substan- tially to its revision. All authors take
responsibility for the paper as a whole and agree to be accountable
for all aspects of the work.

Compliance with Ethical Standards

Conflict of Interest The authors declare that they have no conflict

 14 J Gastrointest Surg (2017) 21:1428–

Appendix 1

Table 4 Similarities and differences between clinical pathway and control period

Clinical pathway Control

Outpatient Tumour board treatment advice (PACON) Tumour board treatment advice (PACON)
clinic Oral and written patient information Oral patient information
Dietician contact: MUST screening tool, nutrition advice and if Dietician contact if needed supplemental feeding oral or enteral
needed supplemental feeding oral or enteral
Frailty screening tool
Medication verification
Training advice: home trainer use, 1-h walking per day
Surgical Use of ERAS protocol Use of ERAS protocol
ward
Preoperative lanreotide® Preoperative lanreotide®
Thrombosis prophylaxis nadroparine® 5700 E Thrombosis prophylaxis nadroparine® 2850 E
6:00 day of operation: last preop or clear liquid intake, anti-thrombosis
compression stockings.
Pain management and control according to protocol together with Pain management together with pain service team
pain service team
Early warning score once per 8 h and whenever indicated together Early warning score once per 8 h and whenever indicated action
with actions by nurses by resident
Patient communication between doctors, nurses and handover situations Patient communication between doctors, nurses and handover
according to Reason, Story, Vital Signs and Plan (RSVP) situations not specified
Mobilization after surgery: swing and out of bed within 24 h Mobilization after surgery: swing and out of bed within 24
h Gastric tube: if production <200 ml in 12 h, remove tube Gastric tube: if production is reduced, start clamp tube and
remove if retention is <100 ml in 8 h (after two
consecutive periods of 8 h)
Drain removal if production <200 ml and amylase <500 U/l per day Drain removal if amylase <500 U/l per day and operating
surgeon agrees
Nutrition: MUST >2, start TPN on day 1 post-operative Nutrition: enteral feeding will start on day 1 if the patient has a
jejunostomy. Oral fluids according to ERAS
MUST = 1: if gastric tube has not been removed on day 3, start TPN If no enteral intake is possible on day 6, TPN has to start on
day 7 All patients: if the gastric tube cannot be removed because of
gastroparesis on day 7 without signs of sepsis or ileus: placement of
a jejunal tube through the gastrojejunostomy by the
gastroenterologist and start enteral feeding
Glucose control Glucose control
Discharge criteria Discharge criteria not specified
Use of the variance report if actions are not according to protocol.
Operating Use of ERAS protocol Use of ERAS protocol
room Pain control by epidural catheter Pain control by epidural
catheter Central venous line in the vena jugularis, if indicated PiCCO
Antibiotic prophylaxis 15–60-min pre-incision. Cefazoline® and Antibiotic prophylaxis 15–60-min pre-incision. Cefazoline® and
metronidazole®. If a stent or percutaneous transhepatic drain has metronidazole®. Otherwise if indicated by the surgeon
been placed in the ductus choledochus, use
piperacillin/tazobactam® as prophylaxis.
Target post-operative fluid balance between 0 and 500 ml Post-operative fluid balance not specified but according to ERAS
Handover to PACU team members by surgeon and anaesthesiologist Handover to PACU team members by anaesthesiologist
according to RSVP
PACU/ICU Entrance in PACU: every 15 min: RR and heart rate control until Entrance in PACU: every 15 min: RR and pulse control until
stable, than every 30 min RR and pulse stable than every 30 min RR and pulse
Continuation of antibiotics will be part of the sign-out procedure after Continuation of antibiotics at the decision of the surgeon
surgery
Normothermia (>36.0 °C), Bair Hugger or heating system if necessary Normothermia (>36.0 °C), Bair Hugger or heating system
if
necessary
Every hour (1st until 24th hour): Every hour (1st until 24th hour):
Respiratory status after extubation: saturation, respiratory frequency, Respiratory status after extubation: saturation, respiratory
coughing and deep breathing exercises frequency, coughing and deep breathing exercises
 14 J Gastrointest Surg (2017) 21:1428–

Table 4 (continued)

Clinical pathway Control

Hemodynamics: heart rhythm, heart frequency, RR, ScvO2 Hemodynamics: heart rhythm, heart frequency, RR, ScvO2 (if
(if indicated). indicated).
Excretions: urine, drain, gastric tube Excretions: urine, drain, gastric tube
Temperature Temperature
Pain and sedation: NRS pain score Pain and sedation: NRS pain score
RASS and CAM ICU RASS
Mean arterial pressure (MAP) between 70 and 100 mmHg and Mean arterial pressure (MAP) targets need approval of the
heart frequency between 60 and 90 per minute. Different targets supervising anaesthesiologist.
than the CP prescribe possible after approval of the supervising
anaesthesiologist .
MAP should be above 70 mmHg: if below, start norepinephrine.
iv fluids: ERAS protocol
Balance between 0 and +500 ml/24 h
Urine production has to be above 0.5 ml/kg/h. Protocol ‘oliguria PACU’ Urine production has to be above 0.5 ml/kg/h. Protocol ‘oliguria
PACU’
First choice of inotropics: dobutamine® First choice of inotropics: supervising
anaesthesiologist Stress ulcer prophylaxis pantoprazole® 1 dd 40 mg iv/po Stress ulcer prophylaxis pantoprazole® 1 dd
40 mg iv/po
Nausea and vomiting: Nausea and vomiting:
3/day 4 mg ondansetron® iv (maximum until 36 h after surgery) If indicated: 3/day 4 mg ondansetron® iv
3/day metoclopromide® 3/day 10 mg iv (3/day 5 mg iv when If indicated: 3/day metoclopromide® 3 day 10 mg iv
kidney (3/day 5 mg iv when kidney function reduced) (cave
function reduced) (cave QT time) QT time)
Anti-thrombosis prophylaxis nadroparine® 5700IE Anti-thrombosis prophylaxis nadroparine® 2850 IE
Mobilization according to protocol: starts within 24 h
Gastric tube: see CP surgical ward Gastric tube
Drain: 2 abdominal drains Drain: 2 abdominal drains
Drain production control every hour: aspect and volume, 100–200 Drain production control every hour: aspect and volume, 100–
ml/h. If production >200 ml/h or >400 ml/4 h, contact surgeon 200 ml/h. If production >200 ml/h or >400 ml/4 h, contact
surgeon
Electrolyte control and interventions Electrolyte control and interventions
Glucose regulation: normoglycaemia (glucose 5.0–10.0 mmol/l) Glucose regulation: normoglycaemia (glucose 5.0–10.0 mmol/l)
Discharge criteria: handover procedure according to RSVP, vital Discharge criteria according to PACU
signs accepted by the surgical ward.
Use of the variance report if actions are not according to protocol.
J Gastrointest Surg (2017) 21:1428– 14

Appendix 2
14 J Gastrointest Surg (2017) 21:1428–

Appendix 3
J Gastrointest Surg (2017) 21:1428– 14
 14 J Gastrointest Surg (2017) 21:1428–

Open Access This article is distributed under the terms of the Ronellenfitsch U. Perioperative quality of care is modulated by
Creative Commons Attribution 4 .0 International License process management with clinical pathways for fast-track surgery
(http:// creativecommons.org/licenses/by/4.0/), which permits of the colon. International Journal of Colorectal Disease.
unrestricted use, distribution, and reproduction in any medium, 2011;26(12):1567–75.
provided you give appro- priate credit to the original author(s) and the
source, provide a link to the Creative Commons license, and indicate
if changes were made.

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