ENHANCED RECOVERY AFTER SURGERY GUIDELINE	2







Enhanced Recovery After Surgery 
Evidence-Based Practice Perioperative Guideline Implementation for Hepatectomy
Camille Petraitis
East Carolina University




Running head: ENHANCED RECOVERY AFTER SURGERY GUIDELINE	1

ENHANCED RECOVERY AFTER SURGERY GUIDELINE	47





Abstract
Liver cancer is the 10th most common cancer in the United States and the fifth most common cause of cancer-related deaths (American Society of Clinical Oncology [ASCO], 2016).  Partial hepatectomy continues to remain the most frequently used curative treatment for liver cancer (Ni et al., 2013).  The Enhanced Recovery After Surgery (ERAS) protocol is a standardized, interdisciplinary, coordinated perioperative care plan that integrates evidence-based interventions to improve surgical outcomes through minimizing the metabolic stress response (Huang, 2016; Ni et al, 2013; Melloul et al., 2016).  Variation in surgical care for hepatectomy can be reduced through ERAS guideline implementation that ultimately leads to improvement in postoperative outcomes (Hughes, Chong, Harrison, & Wigmore, 2016).  The primary purpose of this project was to implement and evaluate compliance of the ERAS guideline for the three phases of perioperative care in patients undergoing hepatectomy.  Secondary aims were to evaluate morbidity, hospital length of stay (HLOS), readmission within 30 days, and 30-day mortality.  The ERAS protocol was implemented and data was collected from September 14, 2017 to November 24, 2017.  A total of 20 patients were included in this project.  The guideline was effectively implemented with a mean overall compliance of 77.7%.  Secondary aims showed favorable outcomes when compared with other studies within this institution and will be further discussed within this paper.   









Acknowledgments
Several people have played an important role throughout the process of completing this quality improvement project.  I would like to express gratitude to my DNP project committee and champion for the guidance and encouragement to pursue this project.  Next, a special thank you to my mother, father, sister, grandparents, and friends for their generous support as well as motivation to finish.  Last but certainly not least, many thanks to my wonderful boyfriend for the continued support and love through the countless hours of work necessary to complete school and this project.  I appreciate the support all of you have given me and am truly blessed to have each one of you in my life.
















Table of Contents
Abstract	2
Acknowledgments	3
Problem Statement	7
Justification of Study	7
Conceptual Framework	8
Lewin’s Change Management Theory	8
Assumptions	9
Problem Question	10
Summary	10
Research Based Evidence	11
Overview of ERAS Guidelines	11
ERAS in Hepatectomy	12
Lewin’s Change Management Theory	18
Summary	20
Methodology	21
Study Design	21
Sample	21
Setting	22
Methods	22
Protection of Human Subjects	24
Data Collection	25
Data Analysis	25
Limitations	26
Results	27
Sample Characteristics	27
Major Findings	27
References	29
Appendix A	34
Appendix B	37
Appendix C	38
Appendix D	45
Appendix E	55
Appendix F	57
Appendix G	59
Appendix H	60
Appendix I	63
Appendix J	64
Appendix K	65







Enhanced Recovery After Surgery 
Evidence-Based Practice Perioperative Guideline Implementation for Hepatectomy
Liver cancer is the 10th most common cancer in the United States and the fifth most common cause of cancer-related deaths (American Society of Clinical Oncology [ASCO], 2016).  According to the American Cancer Society (2017), there will be 40,710 new predicted cases of liver cancer in 2017.  Liver resection is the first-line option for patients with resectable disease (Jelic & Sotiropoulos, 2010).  Hepatectomies are challenging for surgeons and patients with morbidity rates ranging from 17% to 45% and a mortality risk up to five percent (Hughes, Chong, Harrison, & Wigmore, 2016; Melloul et al., 2016).  In recent studies, Enhanced Recovery After Surgery (ERAS) perioperative guidelines have decreased overall morbidity rates compared with traditional practice (Hughes, McNally, & Wigmore, 2014; Jones et al., 2013; Wu et al., 2015).  ERAS is a concept that consists of a multidisciplinary team working together throughout the three phases of perioperative care using a multimodal approach to prevent issues that delay recovery and ultimately cause complications (Llungqvist, Scott, & Fearon, 2017).  Randomized controlled trials implementing ERAS protocols for liver surgery have also been shown to reduce morbidity rates after resection (Hughes et al., 2016; Jones et al., 2013). 
Problem Statement
Partial hepatectomy continues to remain the most frequently used curative treatment for liver cancer (Ni et al., 2013).  Hepatectomy can cause a considerable stress reaction and disturbance in metabolic function within the body and complications associated with this surgery can be fatal (Ahmed et al., 2016).  Standardization of perioperative care can help to improve the variability that can potentially lead to the negative outcomes associated with major abdominal surgery (Hughes et al., 2016; Ahmed, Khan, Lim, Chandrasekaran, & MacFie, 2011).  Consequently, compliance is a key factor in improving outcomes associated with the perioperative ERAS protocol implementation (Pedziwaitr et al., 2015).  The purpose of this project is to implement the ERAS protocol in hepatectomies and evaluate compliance in the three phases of the ERAS guideline for hepatectomy to reduce variability in perioperative care.  Potential decreased patient morbidity, decreased hospital length of stay (HLOS), readmission within 30 days, and 30-day mortality may be observed. 
Justification of Study 
Cancer survivors are living much longer lives due to advancements in healthcare (Llungqvist et al., 2017).  Survival rate at one year for patients with a primary liver cancer is 44% and 17% at five-years (ASCO, 2016).  With improved survival, quality healthcare needs to be delivered through a multidisciplinary approach within the oncologic population.  At this large urban healthcare system located in the southeastern United States (U.S.), approximately 180 hepatectomies were completed in 2016 without a uniform perioperative process.  Improvements in current surgical and perioperative management for liver resections at other organizations have led to mortality rates under five percent (Hughes et al., 2014).  Yet, morbidity rates remain greater than 30% (Wang et al., 2017).  The site can improve morbidity and mortality by standardization and compliance with hepatectomy perioperative care. These numbers could be improved at this facility with standardization, completeness, and compliance in perioperative care for hepatectomies.
Conceptual Framework
The concept of change management is a familiar term to many organizations but there is a great amount of variability on how institutions manage change.  Change is an inevitable occurrence, yet literature has identified numerous barriers or failures associated with the transformation of an idea or plan into action (Mitchell, 2013).  It is estimated that more than two thirds of organizational change projects fail (Mitchell, 2013).  Planned change in any setting is very challenging; in healthcare, the difficulties arise from attitudes of staff, availability of resources, and generalized resistance to change (Mitchell, 2013).  Enhanced communication and purposeful planning will assist with the process of change (Mitchell, 2013).  Thus, a structured approach with implementation will help to overcome foreseeable obstacles.  Accordingly, an identified change theory for this quality improvement (QI) project was essential in implementing, managing and evaluating the planned guideline transformation (Mitchell, 2013).
Lewin’s Change Management Theory
Lewin’s change management theory aimed to help others understand human behavior and change as well as the patterns of resistance associated with change (Sutherland, 2013).  Change in this model was described as a dynamic force within an organization that moved in opposite directions (Butts & Rich, 2015).  The two types of forces consisted of driving and restraining forces.  The driving forces expedited change by pushing employees in the preferred direction.  In contrast, the restraining force hindered change by pushing employees in the opposite direction (Mitchell, 2013).  The balance of these forces happened when the change occurred in this model (Butts & Rich, 2015).  The shift of the balance needed to be initiated in the direction of the planned change that promoted the desired outcome using three steps: unfreezing, moving, and refreezing.  These three steps provided a framework for managing organizational change for this QI project.
Three stages. There are three steps to Lewin’s change management theory.  In the first step, unfreezing, this institution identified the problem of focus (Sutherland, 2013).  Once the problem or variability of perioperative care was established, communication about planned change to create recognition of the updated protocol was completed (Mitchell, 2013).  In the moving stage, attitudes were developed with the planning and implementation of the QI project that allowed for the assessment of consequences of these changes (Mitchell, 2013; Sutherland, 2013).  Then, in the refreezing or final stage, the change was consolidated and reinforced through policies and organizational norms (Manchester et al., 2014).  Additional support and encouragement of the updated guideline were encouraged from the ERAS team in this phase as well.  The unfreezing, moving, and refreezing stages helped to strengthen the thought process throughout the application of this QI project.  This theory created a solid foundation for the implementation of ERAS guidelines in hepatectomy within this facility.  The stages provided a framework for following this conceptual model throughout the implementation of this project.
Assumptions 
	There has been an abundant amount of research conducted on ERAS guidelines within multiple specialties (Hughes, McNally, & Wigmore, 2014; Ni et al., 2013; Lau & Chamberlain, 2016; Melloul et al., 2016).  While there are numerous studies with recommended ERAS items pertinent to hepatectomies, discrepancies occur between institutions (Ni et al., 2013; Wong-Lun-Hing et al., 2014).  Therefore, assumptions were made about ERAS implementation at this institution prior to the execution.  The first hypothesis suggested that compliance was variable throughout the initial implementation of ERAS guidelines. Variability can occur with new protocols due to medically justified circumstances or may be related to existing attitudes and beliefs in healthcare (Roulin et al., 2017).  Therefore, it is important to document the rationale for deviations in guideline adherence (Roulin et al., 2017).  Variability in compliance may not reveal the true benefits of ERAS.  The second assumption believed there would be resistance from all staff involved with the application of the perioperative guideline that needed to be overcome through audits.  The final assumption stated the results of this QI project would unlikely display much difference in improvements of secondary aims due to a short implementation period.  Future studies need to be implemented once compliance percentages are met and more cases were available for comparison.
Problem Question
	Liver surgery requires a multidisciplinary team specific to each perioperative phase that work together to improve patient outcomes.  Standardization of perioperative care can improve variable mortality rates associated with hepatectomy cases (Melloul et al., 2016).  Consequently, the following statement was identified throughout the search for evidence on this topic: With the implementation of the three phases of the perioperative ERAS guideline for hepatectomy through staff education and electronic medical record (EMR) powerplan, will compliance of the protocol reduce variability in perioperative care with possible decreases noted in patient morbidity, HLOS, 30-day readmission, and 30-day mortality? 

Summary
The dissemination of ERAS in hepatectomy appeared advantageous with studies noting reduced morbidity, hospital length of stay (HLOS), and cost with no change in mortality or readmission rates (Ahmed et al., 2016; Hughes et al., 2014; Ni, Yang, Zhang, Meng, & Li, 2015; Wang et al., 2017; Wong-Lun-Hing et al., 2014).  It is important to note that documentation of compliance in each perioperative phase with the guideline implementation for liver resections was a crucial part for future trials to complete for benchmarking purposes (Melloul et al., 2016).  Thus, more prospective studies need to augment existing literature on the clinical use of the ERAS guidelines in liver resections (Ahmed et al., 2016; Melloul et al., 2016; Wang et al., 2017).  Admittedly, with new guidelines come many changes and challenges for all the staff involved with the executed protocol.  New protocols in healthcare are gradual processes that require time, restructuring, and persistence to achieve optimal results (Mitchell, 2013).  Improved outcomes with ERAS will continue to depend on evidence-based projects to strategically guide institutions to create and sustain these protocols.
Research Based Evidence
Overview of ERAS Guidelines
	Perioperative care was changed worldwide for all patients with the introduction of multimodal enhanced recovery programs (Wong-Lun-Hing et al., 2014).  Several studies within the surgical community have studied the enhanced recovery concept (Ni et al., 2013; Melloul et al., 2016; Wong-Lun-Hing et al., 2014).  This approach combined numerous evidence-based practices in perioperative protocols and transformed them into a structured care pathway; this pathway permitted accelerated postoperative recovery (Ansari, Gianotti, Schroder, & Anderson, 2013; Llungqvist, Scott, & Fearon, 2017; Wong-Lun-Hing et al., 2014).  The coordinated perioperative approach aims to reduce several physiological responses in the body, termed the stress response (Melloul et al., 2016).  With a reduction in the body’s stress response, a reduction in medical complications can be seen (Huang, 2016; Ni et al., 2013; Lau & Chamberlain, 2016; Melloul et al., 2016).  
 A literature review was completed to review ERAS and hepatectomies.  PubMed was the database primarily used for this search.  Ovid and Medline were also utilized to enhance this review.  Keywords associated with this search included: Enhanced recovery after surgery, ERAS, fast-track surgery, perioperative care, hepatecomy, liver resection, liver surgery, primary liver cancer, hepatocellular carcinoma, HCC, liver lesion, benign liver lesion, and liver metastases.  For this literature review, all patients undergoing hepatectomy were included in this search regardless of pathology.  The word “and” was included in all searches to encompass as much data as possible.  Approximately 250 articles pertaining to the various elements of ERAS and hepatectomy were obtained. Predominantly, articles published within the last five years were used for this paper. The oldest article out of the research pertaining to ERAS protocol was a guideline published in 2010; there were no updated versions of this article available.  Data on non-liver surgery were generally excluded from this paper.  If non-liver topics were included, valuable data on ERAS utilization were included in articles non-specific to surgical procedure. Ultimately, there were 27 articles used in this paper on ERAS data and hepatectomy.  Other articles and websites pertained to statistics and theory. 
Adoption of ERAS programs have been slow despite documented benefits (Lau & Chamberlain, 2016; Llungqvist et al., 2017).  Multiple articles revealed decreased HLOS, morbidity, and cost with ERAS in liver resections; yet, future studies and additional research was recommended (Ahmed et al., 2016; Hughes et al., 2014; Jones et al., 2013; Ni et al., 2013).  The purpose of this QI project was to complement existing data on compliance with the implementation of ERAS in hepatectomies through EMR powerplan and education.  In the process of execution, data has been collected to further discuss deviations from the protocol to improve barriers and variability with compliance in ERAS implementation. 
ERAS in Hepatectomy
	 Since the creation of ERAS, many elements of this concept have been informally introduced to perioperative care (Wong-Lun-Hing et al., 2014).  For example, many institutions partially implement ERAS guidelines by initiating some but not all the recommended ERAS items (Wong-Lun-Hing et al., 2014).  Without every element or documented compliance, the benefits of ERAS may not be identifiable (see Appendix A for ERAS items) (Ahmed et al., 2011; Pedziwaitr et al., 2015).  Fortunately, several groups within the surgical community have started to properly execute and document the concept of ERAS within different specialties (Wong-Lun-Hing et al., 2014).  The positive outcomes associated with ERAS and colorectal surgeries have created a new standard of perioperative care (Llungqvist et al., 2017; Melloul et al., 2016; Wong-Lun-Hing et al., 2014).  Accordingly, additional dissemination of ERAS in hepatectomy appeared beneficial with studies noting reduced morbidity, HLOS, and cost with no change in mortality or readmission rates (Ahmed et al., 2016; Hughes et al., 2014; Ni et al., 2015; Wang et al., 2017; Wong-Lun-Hing et al., 2014).  
Morbidity. Hepatectomies have been steadily associated with major morbidity due to the complexity of these surgeries (Hughes et al., 2014).  With advancements in perioperative care such as enhanced recovery pathways, morbidity rates have declined but remain above 30% (Ni et al., 2015; Hughes et al., 2014; Lau & Chamberlain, 2016).  Common complications associated with hepatectomy included: nausea, vomiting, wound infection, pleural effusion, intraperitoneal abscess, bile leak, postoperative hemorrhage, and liver failure (Ahmed et al., 2016; Hughes et al., 2016; Ni et al., 2013).  Reduction of inflammatory reactions, decreased surgical stress, and maintenance of physiologic function of vital organs are a few of the aims of ERAS in hepatectomy to reduce the complications associated with surgery (Wu et al., 2015). Two meta-analyses were reviewed that evaluated ERAS with traditional care for hepactomies.  Wu et al. (2015) merged complication rates of 14 studies with 1,400 patients and found the enhanced recovery group to have a total complication rate of 19% compared to a 27% complication rate in the conventional surgery group.  Hughes et al. (2014) revealed similar findings through their meta-analysis including 522 patients with a median overall complication rate of 25% in the ERAS group versus 31% in the conventional group.  
HLOS.  Enhanced recovery pathways for major abdominal surgeries have resulted in shorter HLOS by 30-50% according to a review of ERAS (Llungqvist et al., 2017).  One of the main components used to evaluate ERAS is HLOS.  Decreased HLOS justified the additional benefits of ERAS such as perceived quality of life and decreased hospital costs (Fawcett, Mythen, & Scott, 2012; Llungqvist et al., 2017).  Compliance to ERAS protocol could prevent unnecessary prolonged hospital stays (Ansari et al., 2013; Fawcett et al., 2012).  
ERAS programs in hepatectomy have been shown to significantly reduce HLOS (Jones et al., 2013; Kailbori et al., 2017; Ni et al., 2015; Wu et al., 2015).  On average, ERAS reduces HLOS by 2 days in patients that underwent hepatectomy for any type of liver lesion (Joliat et al., 2016; Stone et al., 2016).  In contrast, a study by Liang, Jun, Xiao, Jun, & Jian, (2014) revealed a 4-day reduction in HLOS in patients with hepatocellular carcinoma in the enhanced pathway group compared with conventional care.  The results of this specific study may have been skewed since the study took place in one facility and had relatively small sample sizes (Liang et al., 2014).  Regardless, with any reduction in HLOS, hospital costs were reduced (Ansari et al., 2013; Lau & Chamberlain, 2016; Llungqvist et al., 2017; Wu et al., 2015).
Cost.  As healthcare costs continue to rise, ERAS guidelines are becoming increasingly attractive with their economic benefit and improved medical outcomes (Gani et al., 2016).  These programs decrease postoperative complication risk and accelerate recovery, which ultimately decreases hospital LOS and cost per patient (Gani et al., 2016; Joliat et al., 2016).  Postoperative complication from hepatectomy in one study showed prolonged hospital stay and services which resulted in a total hospital cost one and a half times higher than a benign postoperative course (Joliat et al., 2016).  Another study by Volanthen et al. (2011) revealed a statistically significant increase in costs associated with postoperative complications.  Costs reached up to five times more compared to a similar operation without complication (Volanthen et al., 2011). 
At this hospital located in the southeastern U.S. the total cost for partial hepatectomy was $13,740 and hepatic lobectomy totaled $16,529 (K. Tezber, personal communication, December 2016); In brief, one can conclude that the reduction in LOS alone associated with the implementation of ERAS guidelines could potentially decrease hospital costs on average by $3,000 per person.  Although the implementation of these guidelines has not yet shown a specific reduction in readmission rates, it should be noted that the general cost of readmission at this facility is $6,000 per case (K. Tezber, personal communication, December 2016).  With the clinical improvements recognized through ERAS, assumptions could state reduction in complication rates will also decrease readmission rates in the future.  
It is important to recognize that the implementation of ERAS guidelines is an expensive endeavor.  Stone et al. (2016) completed a study that discussed implementation costs and compared these with hospital savings from ERAS guidelines within one academic medical center.  A total cost of $552,783 was associated with implementation and was offset by a savings in the first year of $948,500; making a net savings of $395,717 (Stone et al., 2016).  To maximize cost-effectiveness while simultaneously minimizing unnecessary use of hospital and financial resources, ERAS guidelines have been steadily implemented worldwide (Stone et al., 2016).  
Mortality and Readmission.  The positive outcomes that are associated with the ERAS guidelines in hepatectomy that previously were noted required further investigation to ensure that a quicker recovery did not equal increased mortality or readmission rates.  The same studies that have demonstrated decreased morbidity, HLOS, and cost also revealed no significant difference in 30-day readmission or mortality rates (Ahmed et al., 2016; Lau & Chamberlain, 2016; Ni et al., 2015; Wu et al., 2015).  While these guidelines do not necessarily improve mortality or readmission rates, they do improve other aspects of patient care to improve overall evidence-based quality healthcare (Ni et al., 2015; Wu et al., 2015).  This data further supports that enhanced recovery pathways are favorable to traditional surgical approaches (Wang et al., 2017; Wu et al., 2015).  It was significant to note if compliance was measured throughout implementation of the guideline to address the maximal benefits of ERAS with implementation.
Compliance.  Optimal outcomes are yet to be established in hepatectomies due to variation in the components of ERAS protocols as well as compliance in everyday practice (Huang, 2016).  Perioperative care can vary substantially even with ERAS protocols in place (Wong-Lun-Hing et al., 2014).  Increased compliance to ERAS items in the perioperative phases can improve the outcomes previously discussed (Pedziwaitr et al., 2015).  ERAS teams that tracked compliance could better identify barriers and problems with execution to increase adherence (Wong-Lun-Hing et al., 2014).  In general, adherence to preoperative and intra-operative modalities have been noted with a distinguishable decrease in adherence within the postoperative period (Roulin et al., 2017).  This may be due to appropriate medical decision making to deviate from the guideline or previous training and resistance to postoperative guideline change (Roulin et al., 2017).  
The introduction of ERAS is a gradual process and compliance rates should increase with time (Pedziwaitr et al., 2015).  Full compliance in most studies was noted to be at least 70% or above in each phase of the guideline (Gustafsson et al., 2011; Pedziwaitr et al., 2015).  Higher compliance is congruent with improved clinical outcomes (Gustafsson et al., 2011).  In short, current discrepancies in results from previous studies or ongoing studies may be due to issues with compliance that should eventually subside (Ahmed et al., 2011).  Protocol adherence needs to be documented as part of further trials to improve future guideline application (Melloul et al., 2016).  
Limitations in Previous Projects.  Although all the literature included within this review was high quality, there were still a few consistent limitations documented.  To start, in a few of the studies conducted, double-blinding was impractical to complete due to the nature of the intervention (Jones et al., 2013; Kailbori et al., 2017).  Bias could therefore be an issue because researchers wanted to produce positive outcomes with ERAS groups (Jones et al., 2013).  Bias was also noted in other studies due to incomplete charts, which could create reporter bias in analysis sections (Hughes et al., 2016).  If complications were not charted, there is a possibility a complication was missed and not accurately included in the study (Hughes et al., 2016).  Additionally, comorbidities may have been omitted, which also can skew data (Hughes et al., 2016).  
Another common limitation was the baseline differences in patient characteristics noted between groups (Jones et al., 2013; Wang et al., 2017).  For example, in the study completed by Jones et al. (2013), a significantly greater number of patients in one group had neoadjuvant chemotherapy.  This could increase morbidity or influence postoperative outcomes (Jones et al., 2013).  
The final limitation noted a lack of consensus in published guidelines worldwide in ERAS items for hepatectomy (Wang et al., 2017).  Thus, compliance also varied within studies; both of which could have reduced or enlarged the effects of ERAS within studies (Wang et al., 2017).  Variability in guidelines as well as terminology within the protocol can lead to misrepresentations.  For example, some studies use HLOS as an outcome of interest while other studies would prefer to use functional recovery (Hughes et al., 2014).  Hence, standardization is needed to decrease future limitations.
Gaps in Literature.  Enhanced recovery pathways have demonstrated their value in many different specialties including liver resections; still, a need remains for high-quality studies to enhance the data for hepatectomy (Melloul et al., 2016).  Research conducted on ERAS in hepatectomy has proven to be feasible and safe (Jones et al., 2013; Kailbori et al., 2017; Ni et al., 2015; Wang et al., 2017).  However, there is a lack of standardization of ERAS guidelines in hepatectomy that need to be further investigated (Melloul et al., 2016; Wang et al., 2017).  The major gaps in literature noted in ERAS items for hepatectomy included prophylactic abdominal drainage and analgesia.
 	Many institutions use prophylactic abdominal drains to detect early complications of surgery such as leaks, hemorrhage, or abscess (Kailbori et al., 2017).  Prophylactic abdominal drains in major abdominal surgery were studied in a meta-analysis conducted in 2004 with the recommendation of omission of routine prophylactic abdominal drainage; but only three of the selected RCT’s were focused on liver resections (Melloul et al., 2016).  Other studies have looked at prophylactic abdominal drainage revealing some positives and negatives (Kailbori et al., 2017; Melloul et al., 2016).  The positives of prophylactic abdominal drainage in liver resections included reduced frequency of subphrenic abscess and biliary fistula formation, as well as other excess fluid in the abdominal cavity decreasing the need for paracentesis (Kailbori et al., 2017; Melloul et al., 2016).  The disadvantages in another study regarding prophylactic abdominal drains proved higher rates of infected collections and impediment to achieving early mobilization (Kailbori et al., 2017).  The existing research is inconclusive and no recommendation could be made for or against abdominal drainage (Melloul et al., 2016).  
	Analgesia also lacks consistency in the ERAS guideline for hepatectomy.  Thoracic epidural analgesia (TEA), local anesthetic wound infusion catheters, and pain-controlled analgesia (PCA) have all been used within the protocol (Melloul et al., 2016).  A concern with TEA is the prolongation of prothrombin time after hepatectomy, which may delay removal of the catheter and increase the rate of corrective blood product usage (Melloul et al., 2016).  Local anesthetics have shown a decrease in HLOS but provide less pain control compared with epidural analgesia (Melloul et al., 2016).  Pain-controlled analgesia can always be used as an alternative but opioid usage can delay gastric motility and cause a prolonged postoperative hospital stay (Melloul et al., 2016).  Given these points, there is a push to decrease opioid usage postoperatively.  The standardization of postoperative pain control needs to be addressed to unify the ERAS hepatectomy guidelines to better results.
	Enhanced recovery pathways need to continually be conducted to confirm their benefit and justify their use.  Prolonged studies would benefit ERAS guidelines in hepatectomy to better investigate the long-term effects of these guidelines such as quality of life, readmissions, or mortality.  For example, readmission rates were almost doubled in a study with the use of ERAS programs in upper gastrointestinal surgeries (Lau & Chamberlain, 2016).  
Future trials, including this project, have continued to develop the enhanced recovery pathways for hepatectomy.  Compliance and strategies for creating and sustaining ERAS programs need to be better stated in studies to complete the gap of the unknown information that comes with implementation.  Theoretical frameworks can assist novice institutions with this process to ensure completion of the different elements found within the ERAS protocol.
Lewin’s Change Management Theory
Lewin’s change management theory used a traditional approach to change within organizational structure through driving and resisting forces (Butts & Rich, 2015).  This approach alters the conventional method to a clinical path (unfreezing), refines provider and staff behaviors (movement), and then reinforces new organizational change (refreezing) to assist in the inevitable transformation within healthcare settings (Manchester et al., 2014).  Lewin’s change management theory will provide a framework for managing organizational change with this QI project through three stages of change: unfreezing, movement, and refreezing.
Unfreezing stage.  The first step of this theory involved the identification of the initial problem or change focus (Sutherland, 2013).  In the case of this QI project, the variation in surgical management for hepatectomy was the change focus.  Thus, the implementation of ERAS guidelines within this institution aimed to reduce the variation in perioperative care.  In this stage, communication was key with all stakeholders including ERAS specialists, nursing staff, operating room (OR) staff, managers, and administration.  The lines of communication needed to remain open and honest for feedback as this creates a sense of trust and security with the proposed change (Sutherland, 2013).  The inclusion of the staff with the planning and decision making in the unfreezing stage helped key players to feel empowered with the change.  
In this phase, many discussions needed to take place with the intent to identify driving and restraining forces to overcome barriers in the future with implementation (Manchester et al., 2014). For this institution, the driving forces included: financial investment, support from surgeons as well as higher management, standardization in perioperative care for staff, education to all staff involved with the guideline implementation, and most importantly positive patient outcomes.  The restraining forces that would inhibit the acceptance of the ERAS guidelines consisted of: habits of experienced surgeons and OR staff, nursing staff not following postoperative guidelines on the floor, lack of trust in the guideline, inability to see the overall benefit or value of the project, and aversion to a new perioperative guideline as it added more work initially (Manchester et al., 2014).  The important point from this stage was to promote driving forces while diminishing restraining forces that promoted successful adoption of ERAS guidelines through active engagement for all involved.
Moving stage.  The moving stage signified the period where ideas or attitudes were developed with the planning and implementation of this QI project (Sutherland, 2013).  Obtaining data, action planning, execution, follow-up and assessment of implementation were all part of this process.  Putting the ERAS guidelines for hepatectomy into practice required active involvement and sustained effort from staff across each phase of the perioperative recommendation set.  A project this large involving so many departments needed an effective roll out with inclusion of all stakeholders and champions as well as assistance from key players.  Considerations throughout this phase included: timelines, educational or training needs, effects on workflow, organizational leadership, and reliability of data collectors for compliance accuracy (Sutherland, 2013).  A project leader was important to oversee and monitor progress through all phases of the implementation. With time, the guidelines will become the new norm and attitudes will be favorable toward these new practices as resistance declined (Manchester et al., 2014).  
Refreezing stage. The final stage of Lewin’s theory was the refreezing stage.  Consolidating the change and reinforcement through support mechanisms, policies, and organizational norms were part of this phase (Manchester et al., 2014).  Praise, rewards, and encouragement were needed on the individual level, and performance recognition was necessary on an organizational level to increase sustainability (Manchester et al., 2014).  Booster sessions were also encouraged to continue troubleshooting problems with the guidelines (Manchester et al., 2014). 
 	At this hospital, all the above needed to happen for effective implementation of ERAS guidelines.  Two key meetings were planned during the unfreezing phase completed within a month of implementation; monthly meetings were completed thereafter.  Based on the evidence, compliance levels should be targeted to remain above 70% to generate notable differences in outcomes with ERAS (Gustafsson et al., 2011; Pedziwaitr et al., 2015).  At the end of this phase, a summary of problems and challenges encountered as well as accomplishments were noted for future reference and will be further explored in the discussion (Sutherland, 2013).  
Summary
	Enhanced recovery pathways for hepatectomy are systematically developed statements that facilitate decision-making by healthcare personnel to decrease inappropriate variations in perioperative care to promote high-quality patient care (Wu et al., 2015).  The shift in perioperative care with ERAS guidelines has verified improvements in surgical outcomes with major abdominal surgery (Ahmed et al., 2011; Hughes et al., 2016).  Outcomes in recent studies with ERAS in hepatectomies have demonstrated reductions in HLOS, morbidity, and cost without increasing readmission or mortality rates (Huang, 2016; Lau & Chamberlain, 2016; Melloul et al., 2016; Ni et al., 2015; Wang et al., 2017).  Nevertheless, completeness and compliance remain an issue to fully comprehend the significant effects of ERAS on perioperative care.
The adoption of a new perioperative guideline can be a very difficult task (Sutherland, 2013).  The healthcare environment has created a complex culture for surgical care that can be resistant to change.  Successful introduction of ERAS guidelines through a shared vision of collaboration for patient-centered care that involves a multidisciplinary approach has been completed in the past within this institution.  Dedication and motivation of the staff to continue to change daily practice and sustain this guideline is essential.  The change management theory was vital to help overcome the difficulties of implementation and capturing compliance.
Methodology
Study Design 
		This QI project used a prospective design to evaluate compliance of staff to each of the perioperative phase of the guideline during the implementation of the ERAS protocol.  Clinical outcomes after implementation of the ERAS guideline were also reviewed.  Secondary outcomes that were observed included: morbidity, HLOS, readmission after 30 days, and 30-day mortality.  In the future, the results of this QI project could be compared to historical data to evaluate potential decreases in secondary outcomes.
Sample
		The project included a purposive sample of adults with resectable liver lesions.  Inclusion criteria was comprised of men or women over 18 years of age and older diagnosed with a resectable liver lesion.  The liver lesion may be a primary liver cancer, metastatic disease, or a benign lesion. There were no exclusion criteria for this project.
Setting
		The ERAS protocol was implemented at an 875-bed surgery center in the Southeast U.S.  The surgery program performs benign and malignant surgical management of patients with liver conditions.  The ERAS guideline encompasses multiple sites within this institution.  The preoperative phase of the ERAS guideline was completed on site at the cancer institute.  The intraoperative phase was implemented in the preoperative area and the operating room.  The postoperative phase took place in a specialized surgical unit for hepatobiliary patients or the intensive care unit if needed.  
Methods
		Once this QI project was approved by the institution as well as East Carolina University Institutional Review Boards, a multidisciplinary ERAS team was gathered.  This ERAS team consisted of: an ERAS program director, department head, ERAS nurse, anesthesiologists and surgeons, as well as a data analyst.  The role of this QI project leader within the ERAS team was to collaborate with the team, gather data, create an EMR ERAS powerplan, fill out patient packets, as well as educate the staff on the powerplan and ERAS protocol.  Next, the foundational groundwork needed to be addressed.  Fundamental factors in this step included: identifying a motived leader, creating a realistic timeline, and identification of current resources. Fortunately, this institution already had these three key concepts from a previous implementation.  Funding had already been addressed for this enhanced recovery pathway and this project was added into the preexisting budget. 
		The initial phase of the implementation of the ERAS protocol started with extensive education to the unit nursing staff, physicians, and residents currently on service that was divided into two sessions one month prior to the formal execution of the guideline (see Appendix B). The education sessions were conducted during work hours by this author.  If a team member could not make one of these sessions, it was expected that they would catch up through their peers for updates in ERAS.  A call in option was available as well.  For those that could not call in or attend, the minutes from the meeting were emailed on the information covered during these two sessions to all preoperative, intraoperative, and postoperative staff that may be involved with ERAS patients.  Minutes were sent to all staff members after completion of the meeting.  There was no log to track attendance of these meetings.  Notable system-level changes were designed and completed prior to formal implementation to facilitate compliance with each perioperative stage of the ERAS guideline checklist (Appendix C).  These system-level changes included: creation of an electronic standardized powerplan for hepatectomy that was created by the Doctor of Nursing Practice (DNP) project leader and EMR technologist as well as a weekly email of upcoming hepatectomies from the clinic to notify the ERAS team and DNP project leader for data collection.   
		Since ERAS guidelines were already implemented within this institution for a different surgical site within the same specialty, a pilot test was not indicated or completed.  Once the formal implementation began, the preoperative, intraoperative, and postoperative phases were strictly monitored for quality data.  Monthly meetings that discussed barriers, compliance rates, and additional restructuring of the execution continued throughout this project as well as after to maintain sustainability.  
		Phase one.  Preoperative care was completed in phase one of the ERAS guideline.  Each patient received one hour of preoperative counseling on the same day as their physical conducted by the anesthesia department.  One ERAS nurse completed all the ERAS educational sessions to ensure consistency. These educational sessions involved discussions of preoperative learning and how to prepare for surgery for patients and families undergoing hepatectomy.  Counseling topics included: smoking and/or alcohol cessation, preoperative nutrition, preoperative carbohydrate loading, complications of surgery, drain and pain management concepts, immediate postoperative expectations, as well as discharge and homecare expectations.  The ERAS nurse gave the patients a tour of the postoperative surgical unit.  The point of educational teaching in the preoperative setting was to provide a procedure-specific education course to help patients understand and familiarize themselves with details pertaining to the surgery.  Patients presented to the hospital the morning of surgery to begin phase two.
		Phase two.  Phase two was initiated when patients presented to the preoperative area and continued in the operating room.  Anti-thrombotic prophylaxis and methylprednisolone 30 mg/kg were given to patients unless diabetic or other contraindications applied.  Sequential compression devices were placed.  Skin preparation with chlorhexidine 2% scrub, and anti-microbial prophylaxis were completed in the operating room prior to the start time of surgery.  Patients received goal-directed therapy by utilization of stroke volume variance technology.  Glycemic control was maintained through insulin therapy.  Appropriate body temperature was maintained during surgery with a forced-air garment system.  The use of a nasogastric tube was not routinely indicated.  Again, completion of items on the checklist were documented for compliance purposes of the ERAS protocol.  At the completion of surgery, phase three was initiated.
			Phase three. Postoperatively, patients were admitted to the hospital to the hepatobiliary surgical unit or intensive care unit if appropriate.  A PCA pump was started on most postoperative hepatectomy cases depending on surgeon preference per each individual case.  Anti-thrombotic prophylaxis was continued throughout hospitalization.  Normoglycemia was maintained with insulin therapy if indicated.  Nausea prophylaxis was made available on an as needed basis.  Early mobilization was encouraged.  Diets were advanced as tolerated on postoperative day one.  If adequately tolerating oral intake, pain pumps were discontinued.  Fluids are discontinued once a diet was started in effort to maintain a near-zero fluid balance.  Foleys were removed on postoperative day one.  Once patients were tolerating a diet, urinating, had bowel function, and pain was controlled, discharge was considered.  A unique addition to this guideline was the referral to a medical oncologist after discharge in addition to the surgeon.  After all the above was completed, audits were accomplished (see Appendix D). 
Protection of Human Subjects
		All patients received evidence-based standardized perioperative care.  Patient privacy was maintained throughout this project.  Review by the Nursing Scientific Advisory Committee (NSAC) and Institutional Review Board (IRB) at this institution as well at East Carolina University were completed. Once permission was obtained and the project was deemed a QI project rather than subject research, patients were assigned a unique QI number when their data was collected and recorded.  All data collected from this project was maintained on a single spreadsheet that was linked to the unique code separate from the spreadsheet to any patient-identifying information.  This information was stored in a locked desk within a locked office that accessible by only the QI project leader.  Primary and secondary aims were then placed into ERAS Interactive Audit Systems (EIAS).  The EIAS is an international internet based data entry and analysis system used to monitor compliance. The EIAS permits official ERAS institutions to gain access to this database. The key element to this system is that patient data is de-identified with the main goal of assisting the perioperative team improve compliance to the ERAS protocol.  Once a subscription is cancelled, the subscriber has three months to download data of preference then all the information is deleted.  All the information collected throughout this study was shredded after data collection and analysis.   
Data Collection
		Outcome measures were collected and managed by the DNP project leader.  Data was extracted from the EMR during the intervention period daily in real-time and was recorded with a compliance checklist from September 14, 2017 through November 24, 2017 (see Appendix C).  Real-time data collection attempted observation of daily compliance and barriers that inhibited adherence to the protocol.  The DNP project leader then gave the data to ERAS nurse for proper entry into the EIAS.  This system ensured compliance was maintained and provided immediate feedback regarding deviation from best practice noted within the ERAS guideline.  Furthermore, the EIAS had the capability to continually monitor audit progress and clinical outcomes to make identifiable improvements.  
Data Analysis
		Outcome measures were collected and managed by the DNP project leader and appropriately entered into the EIAS by the ERAS nurse.  The primary outcome of interest was the implementation of the ERAS protocol for this QI project.  This was measured by percent completion and compliance to the preoperative, intraoperative, and postoperative phases of the guideline.  A data analyst assisted the DNP project leader with the statistical analyses of this study.  Secondary outcomes were also evaluated that included: morbidity, HLOS, readmission within 30 days, or 30-day mortality.  Patient complications in this project were graded using the Clavien Classification System.  This is a system commonly used to determine the severity of surgical complications.  In brief, classification of surgical complications are as follows: Grade one refers to any deviation from the postoperative course without a need for pharmacological treatment outside of the usual medications to treat postoperative pain or nausea, grade two complication requires pharmacologic treatment with drugs other than such allowed for grade one complications and also includes blood transfusions as well as total parental nutrition, grade three necessitates a need for surgical, endoscopic, or radiological intervention, grade four is a life-threatening complication requiring intensive care unit management, and grade five refers to death of a patient (Dindo, Demartines, & Clavien, 2004).  
Results
Sample Characteristics
At the conclusion of this QI project, 20 patients underwent liver procedures performed by the hepatobiliary surgical team between September 14, 2017 through November 24, 2017.  There were a few population variables that were important to note for this project sample.  Out of the 20 patients, seven were male (35%), the average age was 51.7 years old with a standard deviation (SD) of 14.5, and the mean body mass index was 32.9 with a SD of 8.1.  An additional important variable noted was the American Society of Anesthesiologists (ASA) physical status classification system that measures patient fitness prior to surgery.  The lower the score, the healthier the patient.  Four patients or 20% of patients fell into categories one or two.  The other 80% or 16 patients were rated a three or four demonstrating the fact that most operative candidates had severe systemic disease (see Appendix E).  There were 13 patients that were excluded from the ERAS protocol as their procedures were aborted due to ablative procedures not requiring resection or extensive disease.  Procedure types for the participants included: left hepatectomy, extended left hemihepatectomy, right hemihepatectomy, extended right hemihepatectomy, other segmentectomies, as well as a wedge or minor resection (see Appendix E).
Major Findings
  The purpose of this project was to implement the ERAS protocol in hepatectomies and evaluate compliance in the three phases of the ERAS guideline for hepatectomy to ultimately reduce variability in perioperative care.  Preadmission and preoperative compliance are one phase of the guideline but given the complexity of the preoperative phase due to extensive patient teaching, it was divided in the next section to better evaluate compliance needs.  Compliance was recorded for each individual ERAS item that can be reviewed in Appendix F.  To summarize, out of 31 measured items, compliance over 70% was met in 19 areas.  The four generalized areas that scored below 70% compliance pertained to mobilization, postoperative epidural analgesia, and resection-site drainage (see Appendix F).  These areas may be lower due to appropriate variations in perioperative care or lack of documentation. 
Overall, preadmission, preoperative, and intraoperative compliance were above 80 %.  The mean preadmission compliance totaled 81.3% with a SD of 21.3.  Preoperative compliance had the highest mean of 87.5 % with an 8.1 SD.  Intraoperative compliance mean totaled 80% with a SD of 9.9.  Lastly, postoperative mean was the lowest compliance mean of 77.1% and a SD of 8.3.  The total overall compliance mean equaled 77.7 with a SD of 7.2 (see Appendix F).  This remained above the recommended 70% to see positive outcomes with the ERAS protocol (Gustafsson et al., 2011).   The potential secondary outcomes of continued compliance with the ERAS protocol in hepatectomy procedures included decreased patient morbidity, HLOS, readmission within 30 days, and 30-day mortality.
Morbidity.  The Clavien Classification System was used to categorize the severity of surgical complication.  In total, out of the 20 cases, there was a single grade one complication (8.3%), four grade two complications (33.3%), four grade three complications (33.3%), one grade four complication (8.3%), and one grade five complication (8.3%).  A breakdown of the most common complications can be reviewed in appendix G including two intraoperative bleeds, one reoperation, two cases of ascites, and one postoperative wound infection.
Secondary Outcome Measures.  Hospital length of stay is a key measurement used to determine efficiency of ERAS in hepatectomies.  The mean HLOS for all months was 5 days with a SD of 5.6 days.  Hospital length of stay ranged from 3.2 to 6 days.  Monthly means and SD can be viewed in Table 1 below. 
Thirty-day readmission and survival were also evaluated for this project.  There were two readmissions recorded within the two-and-a-half-month period equating to a 10% readmission rate.   The survival rate at 30 days was 95% with one documented patient death.  
	Table 1

Hospital Length of Stay

	Month 
	Mean
	SD

	September
	5.3
	3.1

	October
	6
	7.3

	November
	3.2
	2.7



Discussion
The ERAS guidelines have been well established in a few surgical specialties, but need continued data collection and support for hepatectomies.  This QI project implemented ERAS guidelines for hepatectomy procedures within a single institution over a two-and-a-half-month period timeframe.  This project aimed to implement the three phases of ERAS in hepatectomies while monitoring compliance in real time to reduce variability in perioperative care.  Secondary outcomes including morbidity, HLOS, 30-day readmissions and 30-day mortality were collected as well to monitor outcomes.  In brief, 20 patients were included in this QI project.  Preadmission, preoperative and intraoperative mean compliance remained above 80% while the postoperative mean compliance was documented at 77.1%.  There were 12 patients that had complications (Appendix G).  The mean HLOS for hepatectomies at this institution was 5 days.  There was one death as well as two noted readmissions within the 30-day time frame.  
Implications of Findings
The main objective of this project was to evaluate and increase compliance in each perioperative phase of the ERAS guideline with the goal of improving morbidity, HLOS, mortality and readmissions in liver resection cases over time. Compliance has a central influence in the improvement of outcomes associated with perioperative ERAS protocol implementation (Pedziwaitr et al., 2015).  Full compliance in this study as well as most other studies is noted to be at last 70 % or above in each perioperative phase (Gustafsson et al., 2011; Pedziwaitr et al., 2015).  The mean compliance in each phase of the perioperative guideline exceeded 70% compliance in this QI project.  This is somewhat atypical as implementation and standardization is a gradual process that can take a period of about six months or 30 patients to attain such compliance rates (Gustafsson et al., 2011; Pedziwaitr et al., 2015).  However, this institution was practicing ERAS with other surgical procedures within the same unit possibly prompting higher acceptance rates of this protocol among staff.  It is important to exceed the 70% compliance rates as this percentage has been found to correspond with improved clinical outcomes (Gustafsson et al., 2011).  While each phase of the guideline remained above 70%, another interesting similarity to prior research is the lowest compliance rate noted within the postoperative period.  Roulin et al. (2017) revealed that this may be due to appropriate decision making or resistance to postoperative guideline change from staff.  Lower compliance rates in the postoperative phase found within this institution were speculated to be due to difficult surgeries, medically unstable patients, and necessary medical deviations due to postoperative complications.  	
Postoperative complications occurred in 12 patients accounting for 60% of patients undergoing hepatectomies for this QI project.  This is higher than the national morbidity rate of up to 45% (Hughes et al., 2016; Melloul et al., 2016).  This is important data to record and benchmark for future studies as well as for comparison of ERAS patients within this facility undergoing hepatectomies in the future.  A decline in postoperative complications may be noted with increased compliance and usage of ERAS with hepatectomies (Hughes et al., 2014; Wu et al., 2015).    
Prolonged hospital stays could be prevented through increased compliance with ERAS guidelines (Ansari et al., 2013; Fawcett et al., 2012).  Typically, ERAS reduces HLOS by 2 days in patients undergoing hepatectomy (Joliat et al., 2016; Stone et al., 2016).  A meta-analysis of randomized control trials of ERAS programs in liver surgery was completed to better evaluate ERAS outcomes.  On average, HLOS for hepatectomy procedures could range from 3 to 13 days (Song, Wawng, Zhang, Dai, & Zou, 2016).  Song et al. (2016) found mean HLOS for ERAS groups was 6.05 days versus 8.9 days in the conventional groups within this study.  The ERAS group mean stay of 6.05 is comparable to the mean HLOS of 5 days found within this QI project.  Differences in HLOS could be due to high acuity patients, severity of surgical procedures, and surgeon preferences on early discharge.  Readmission and mortality rates were also included within this project for benchmarking purposes but were not able to be compared with other studies given lack of data on this topic.  
Compliance as well as postoperative outcomes needs to be tracked to better identify barriers and problems within the execution of ERAS protocols (Wong-Lun-Hing et al., 2014).  Lewin’s change management theory assisted this QI project to understand behaviors and patterns of resistance associated with change (Sutherland, 2013).  The unfreezing, moving, and refreezing stages provided a framework to better implement the ERAS protocol and avoid or address barriers as well as improve compliance. 
 In the unfreezing stage, specific planned measures were accomplished to facilitate a smooth implementation phase.  For example, two educational ERAS meetings for staff prior to the QI start date were completed to provide appropriate educational material to encourage usage of the ERAS guidelines as well as guidance on navigation through the hepatectomy powerplan.  These meetings addressed any questions staff had about the protocol and created a new standard of perioperative care within this facility for hepatectomy patients.  All of which were intended to improve compliance within this stage.  
In the moving phase, monthly meetings to address compliance issues with individual ERAS items helped to disclose many questions and barriers to adherence.  For example, urinary foley removal had a compliance rate of 66.7% in the month of September.  Therefore, charts were reviewed for rationale for late foley removal and education was provided to the ERAS staff for poor compliance rates.  If there was question as to why a foley was not removed on time, the attending and nurse responsible for this patient were asked to explain prolonged foley usage.  Compliance rates increased to 77.8% and 80% the next two months indicating this educational exercise was helpful to enhance appropriate perioperative care and awareness of guidelines.  
In the refreezing stage, consolidation of the change and reinforcement were required for sustainability.  Results of compliance and positive outcomes associated with ERAS and hepatectomy procedures were reviewed with the team at the end of this project.  Given that ERAS already was an institutional desire and previously funded within this facility, the project has continued after the termination of this QI project.  Dissemination of the project via PowerPoint presentation was completed to nursing staff as well as advanced care providers in the surgical oncology department to review the QI project results and praise the hard work that was completed by all staff on the implementation of this project.  Additionally, monthly meetings with EIAS compliance data will continue to identify areas of improvement with individual ERAS items and validate ERAS usage within this institution.  
Successful introduction of ERAS and sustained usage in a complex health care environment can be a challenging task.  A lot of time and education are needed to successfully implement ERAS in any setting involving a large multidisciplinary team.  Recognition of an appropriate theoretical framework is essential to implementation and evaluation of ERAS in hepatectomy. 
Limitations
This QI project was limited due to the relatively short study period, which resulted in a smaller number of patients for of data collection.  The next limitation noted was the inclusion of all liver resections in this project.  This gave the project increased numbers for more meaningful results but did not pertain exclusively to oncology patients; which primarily would be a topic of interest to this institution.  An additional limitation was the timing of the data collection.  Due to time constraints, data was collected at the end of the day resulting in shift change or difficulty finding sources of noncompliance.  Similarly, locating the staff that entered the data into the EMR within different areas of the hospital proved to be very difficult to further discuss rationale for non-compliance.  On this same topic, residents and fellows completing their surgical oncology rotations were an unexpected limitation to this QI project.  Many different residents and fellows rotated through the hepatobiliary service that did not have education on ERAS.  In the future, rotation of new personnel on and off the service may need to be considered to appropriately educate staff for consistency and compliance of the ERAS guideline.  The last limitation included the fact that this study was completed in a single center.  Accordingly, future studies need to be completed to replicate values and prove further significance.
Recommendations
The ERAS guideline for hepatectomy was safely and successfully implemented within this facility throughout this QI project.  Morbidity, HLOS, readmission and mortality rates would need to continue to be monitored for a longer period and compared with other institutions utilizing ERAS to confirm conclusions with statistical significance for recommended changes in practice.  While the implementation of this QI project was a challenging endeavor, sustaining this project in practice could be quite difficult.  In fact, less than 40 percent of health improvement initiatives or projects effectively transition from adoption to sustained implementation (Health Quality Ontario, 2013).  Therefore, sustainability needs to be addressed at the beginning of a project through engagement of staff, open communication, formalization as well as standardization of changes, appropriate training, as well as formal measurements of intended change (Health Quality Ontario, 2013).  Future studies need a larger group of patients to correlate relationships between outcomes and individualized elements of the ERAS guidelines.  Additionally, studies need to be completed within multiple institutions to validate transferability of the ERAS guideline for patients undergoing hepatectomy.
Conclusion
Doctor of Nursing Practice key essentials were used throughout the execution and dissemination of this QI project.  These essentials laid the groundwork for this specific project.  Utilization of Essentials I through VIII within this QI project will be further clarified in the following paragraphs.  This project should serve as a foundation for future scholarly practice and projects (American Association of Colleges of Nursing, 2006).  
Essential I: Scientific Underpinning for Practice was completed through extensive research to appreciate the benefits of ERAS in surgical procedures, especially hepatectomies.  This research elaborated on and supported the need for a standardized compliant guideline for hepatectomy care across this system.  This aided to promote quality evidence-based improvements in surgical patient care (American Association of Colleges of Nursing, 2006).  Theory was applied to this project and used as a concept to guide this QI project.  Essential I continued to be utilized throughout the progression of this QI project.
Essential II: Organizational and Systems Leadership for Quality Improvement and Systems Thinking was a critical component of this QI project to improve patient and healthcare outcomes (American Association of Colleges of Nursing, 2006).  Projected healthcare reductions were considered within this essential.  System-wide practice initiatives were also introduced throughout this project as ERAS is now being implemented within other specialties and institutions through advanced communication and processes (American Association of Colleges of Nursing, 2006).  
Essential III: Clinical Scholarship and Analytical methods for Evidence-Based Practice was utilized throughout this QI project through the usage of ERAS within hepatectomies to replace traditional practices with evidence based protocols (American Association of Colleges of Nursing, 2006).  This project focused on patient-centered care through the identification of gaps in existing literature regarding hepatectomies and perioperative care prompting further investigation of this institutions current practice and patient outcomes.
Essential IV: Information Systems/Technology and Patient Care Technology for the Improvement and Transformation of Health Care guided the creation of the hepatectomy powerplan.  This powerplan was developed as a technologic improvement for staff to properly follow the ERAS protocol.  Additionally, unidentified patient data was kept in the EIAS to monitor compliance and compare our institutions with others across the world.  This will assist with monitoring patient outcomes, which is a key part of Essential IV (American Association of Colleges of Nursing, 2006).  
Essential V: Health Care Policy for Advocacy in Health Care influenced the ERAS protocol in hepatectomies to impact policy makers to formally adopt this QI project.  Education of staff and policy makers on the positive inferences of ERAS such as decreased postoperative complications, HLOS, as well as hospital cost were an important portion of this essential. 
Essential VI: Interprofessional Collaboration for Improving Patient and Population Health Outcomes was applied throughout the entire QI project.  Multidisciplinary collaboration was executed to implement this guideline across various teams and departments within this institution.  Monthly meetings continue to happen to monitor compliance and discuss barriers of the ERAS protocol for hepatectomies (American Association of Colleges of Nursing, 2006).  
Essential VII: Clinical Prevention and Population Health for Improving the Nation’s Health was intertwined throughout this process as ERAS attempts to minimize unnecessary use of medications, fluids, and prolonged hospital stays through optimization of surgical care.  These concepts are applicable to clinical prevention and improving patient health through evidence based information.  This essential was used throughout the entire QI project from brain storming about implementation to the completion of the project.
Essential VIII: Advanced Practice Nursing was completed during the design, implementation, and evaluation of this QI project.  The project conducted an inclusive and systematic evaluation of the complexity of surgical care (American Association of Colleges of Nursing, 2006).  At the finish of this project, all the data was synthesized and interpreted with the intention of improving perioperative patient care (American Association of Colleges of Nursing, 2006).  
In conclusion, this QI project demonstrated successful implementation of perioperative ERAS guidelines for hepatectomy procedures within a single institution.  Compliance rates above 70% are attainable in a relatively short period of time if staff is already oriented to the concept of ERAS prior to implementation.  If ERAS is a new concept to an institution, 30 patients or a six-month period should be expected to achieve over 70% compliance rates.  A strong theoretical framework should be utilized to help facilitate implementation and promote dissemination of ERAS projects.  The project underlines the importance of improved compliance rates for better postoperative outcomes.  Future research may conclude that morbidity, HLOS, 30-day mortality and 30-day readmission rates may be reduced with increased compliance of the ERAS guideline over an extended period.  If ERAS is effective in decreasing surgical complications in oncology patients undergoing liver resections, time to chemotherapy may be reduced; which, may promote prolonged survival rates within these populations.  Forthcoming studies on ERAS protocols will need be completed to augment existing data to validate its usage within oncologic populations. 
 




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Song, W., Wang, K., Zhang, R., Dai, Q., & Zou, S. (2016). The enhanced recovery after surgery (ERAS) program in liver surgery: A meta-analysis of randomized controlled trials. Singer Plus, 5, 1-10. doi: 10.1186/s40064-016-1793-5
Stone, A., Grant, M., Roda, C., Hobson, D., Pawlik, T., Wu, C., & Wick, E. (2016). Implementation costs of an enhanced recovery after surgery program in the United States: A financial model and sensitivity analysis based on experiences at a quaternary academic medical center. Journal of the American College of Surgeons, 2016, 219-225. http://dx.doi.org/http://dx.doi.org/10.10.16/j.jamcollsurg.2015.11.021
Sutherland, K. (2013). Applying Lewin’s change management theory to the implementation of bar-coded medication administration. Canadian Journal of Nursing Informatics, 8, 1-6. Retrieved from http://cjni.net/journal/?p=2888
Volanthen, R., Slankamenac, K., Breitenstein, S., Puhan, M., Muller, M., Hahnloser, D., ... Clavien, P. (2011). The impact of complications on costs of major surgical procedures. Annals of Surgery, 254, 907-913. http://dx.doi.org/10.1097/SLA.0b013e31821d4a43
Wang, C., Zheng, G., Zhang, W., Lv, S., Wang, A., & Fang, Z. (2017). Enhanced recovery after surgery programs for liver resection: A meta-analysis. Journal of Gastrointestinal Surgery, 1-15. http://dx.doi.org/10.1007/s11605-017-3360-y
Wong-Lun-Hing, M., Van Dam, R., Heijnen, L., Busch, O., Terkivatan, T., Van Hillegersberg, R., ... Dejong, C. (2014). Is current perioperative practice in hepatic surgery based on enhanced recovery after surgery (ERAS) principles? World Journal of Surgery, 38, 1127-1140. http://dx.doi.org/10.1007/s00268-013-2398-6
Wu, S., Xiong, X., Lu, J., Cheng, Y., Lin, Y., Zhou, R., & Cheng, N. (2015). Fast-track programs for liver surgery: A meta-analysis. Journal of Gastrointestinal Surgery, 19, 1640-1652. http://dx.doi.org/10.1007/s11605-015-2879-z

Appendix A
Melloul et al. (2016) Summary of ERAS Recommendations for Liver Surgery
	ERAS items
	Summary
	Evidence level
	Grade of Recommendation

	Preoperative counseling
	Patients should receive routine dedicated preoperative counseling and education before liver surgery
	Moderate
	Strong

	Perioperative nutrition
	Patients at risk (weight loss >10-15% within 6 months, BMI < 18.5 kg/m2 and serum albumin <30 g/l in the absence of liver or renal dysfunction) should receive oral nutritional supplements for 7 days prior to surgery. For severely malnourished patients (>10% WL), surgery should be postponed for at least 2 weeks to improve nutritional status and allow patients to gain weight
	High
	Strong

	Perioperative oral immunonutrition
	There is limited evidence for the use of immunonutrition in liver surgery 
	Low
	Weak

	Preoperative fasting
	Preoperative fasting does not need to exceed 6 h for solids and 2 for liquids.
	Moderate
	Strong

	Preoperative carbohydrate load
	Carbohydrate loading is recommended the evening before liver surgery and 2 before induction of anesthesia 
	Low
	Weak

	Oral bowel preparation
	Oral MBP is not indicated before liver surgery
	Low
	Weak

	Pre-anesthetic medication
	Long-acting anxiolytic drugs should be avoided. Short-acting anxiolytics may be used to perform regional analgesia prior to the induction of anesthesia.
	Moderate
	Strong

	Anti-thrombotic prophylaxis
	LMWH or unfragmented heparin reduces the risk of thromboembolic complications and should be started 2-12 h before surgery, particularly in major hepatectomy. 
	Moderate
	Strong

	Intermittent pneumatic compression stockings
	Intermittent pneumatic compression stockings should be added to further decrease the risk.
	Low
	Weak

	Perioperative steroid administration
	Steroids (methylprednisolone) may be used before hepatectomy in normal liver parenchyma, since it decreases liver injury or intraoperative stress, without increasing the risk of complications. Steroids should not be given in diabetic patients
	Moderate
	Weak

	Antimicrobial prophylaxis 
	Single dose intravenous antibiotics should be administered before skin incision and less than 1 hour before hepatectomy. Postoperative “prophylactic” antibiotics are not recommended.
	Moderate
	Strong

	Skin preparation
	Skin preparation with chlorhexidine 2% is superior to povidone-iodine solution
	Moderate
	Strong

	Incision
	The choice of incision is at the surgeon’s discretion. It depends on the patient’s abdominal shape and location in the liver of the lesion to be resected. Mercedes-type incision should be avoided due to higher incisional hernia risk.
	Moderate
	Strong

	Minimally invasive approach
	LLR can be performed by HPB surgeons experienced in laparoscopic surgery, in particular left lateral sectionectomy and resections of lesions located in anterior segments.
	Moderate
	Strong

	Robotic approach
	There is currently no proven advantage of robotic liver resection in ERAS. Its use should be reserved for clinical trials
	Low
	Weak

	Prophylactic nasogastric intubation
	Prophylactic nasogastric intubation increases the risk of pulmonary complications after hepatectomy. Its routine use is not indicated.
	High
	Strong

	Prophylactic abdominal drainage
	The available evidence is non-conclusive and no recommendation can be given for the use of prophylactic drainage or against it after hepatectomy.
	Low
	Weak

	Preventing intraoperative hypothermia
	Perioperative normothermia should be maintained during liver resection
	Moderate
	Strong

	Early oral intake 


	Most patients can eat normal food at day one or after liver surgery.
	Moderate
	Strong

	Nutritional Supplements
	-
	Moderate
	Weak

	Artificial nutrition
	Postoperative enteral or parenteral feeding should be reserved for malnourished patients or those with prolonged fasting due to complications (e.g., ileus>5 days, DGE)
	High
	Strong

	Postoperative glycemic control
	Insulin therapy to maintain normoglycemia is recommended
	Moderate
	Strong

	Prevention of delayed gastric emptying (DGE)
	An omentum flap to cover the cut surface of the liver reduces the risk of DGE after left-sided hepatectomy
	High
	Strong

	Stimulation of bowel movement
	Stimulation of bowel movement after liver surgery is not indicated
	High
	Strong

	Early mobilization
	Early mobilization after hepatectomy should be encouraged from the morning after the operation until hospital discharge
	Low
	Weak

	Analgesia
	Routine TEA cannot be recommended in open liver surgery for ERAS patients. Wound infusion catheter or intrathecal opiates can be good alternatives combined with multimodal analgesia
	Moderate
	Strong

	Preventing postoperative nausea and vomiting (PONV)
	Multimodal approach to PONV should be used. Patients should receive PONV prophylaxis with 2 anti-emetic drugs
	Moderate
	Strong

	Fluid management
	The maintenance of low CVP (below 5 cmH20) with close monitoring during hepatic surgery is advocated. Balanced crystalloid should be preferred over 0.9% saline or colloids to maintain intravascular volume and avoid hyperchloremic acidosis or renal dysfunction, respectively.
	Moderate
	Strong

	Audit
	Systematic audit improves compliance and clinical outcome in healthcare practice
	Moderate
	Strong
























Appendix B
Meeting Agenda
Meeting # 1 (8/3/17)
· Discussed start date with staff (8/28/17)
· Educated staff on the 23 items for the ERAS guideline for hepatectomy
· Reviewed the P.O.L.A.R.I.S (pre-operative learning and readiness in surgery) preoperative teaching
· Provided handouts reviewing ERAS items 
· Discussed compliance sheets. Reviewed completeness and compliance of each perioperative phase
· Reviewed the importance of documentation if deviation from the guideline occurs and why
Meeting # 2 (8/17/17)
· Reviewed and educated staff on hepatectomy powerplan 
· Directed staff on how to access / locate order set
· Went over each perioperative phase within powerplan and timing of initiation within each phase
· Reviewed for questions
· Made staff aware of monthly meetings to go over compliance, concerns, and issues that arise with implementation












Appendix C
Compliance Checklist
C1.   Preoperative Checklist
	
n

	Item
	Applied Practice
	Initiation
	Compliance
	Reason for    Non-
Compliance

	1
	Preoperative counseling

	Patient should receive pre-operative counseling
	30 PreOD
	☐
	

	2
	Smoking / ETOH Cessation
	Patient should have one-month abstinence before surgery
	30 PreOD
	☐
	

	3
	Perioperative nutrition
	Routine nutritional screening should be mandatory for all patients undergoing major abdominal surgery.  

*Patients at risk: weight loss > 10-15% within 6 months, BMI < 18.5 or serum albumin <30 g/l in absence of liver or renal dysfunction should receive oral nutrition for 7 days prior to surgery
*Severely malnourished patients (>10% WL) should have surgery postponed for at least 2 weeks to improve NS.
	30 PreOD
	☐
	

	4
	Preoperative fasting
	Preoperative fasting does not exceed 6 hours for solids and 2 hours for liquids
	Solids: 6 PreO Hrs
Liquids: 2 PreO Hrs
	☐
☐
	

	5
	Preoperative Carbohydrate Loading
	Carbohydrate loading is recommended the evening before liver surgery and 2 hours before anesthesia induction
	2 PreO Hrs
	☐
	

	6
	Oral Bowel Preparation
	Patient should not receive mechanical bowel preparation before liver surgery
	-
	☐
	





























C2. Intraoperative Checklist

	
n

	Item
	Applied Practice
	Initiation
	Compliance
	Reason for Non-Compliance

	1
	Pre-Anesthetic Medication

	Patient should not receive long-acting sedatives as pre-induction
	-
	☐
	

	2
	Anti-Thrombotic prophylaxis (LMWH)
	Patient should receive LMWH 2 – 12 hrs before surgery

*Should be administered 12 hours prior to insertion of epidural catheter
	12 PreO Hrs
	☐


☐
	

	3
	Anti-Thrombotic prophylaxis (SCD)
	Patient should receive SCD from the time of surgery 
	1 PreO Hrs
	☐
	

	4
	Anti-microbial prophylaxis
	Patient should receive initial antibiotic dose < 1 hr before incision. 
	1 PreO Hrs
	☐
	

	5
	Perioperative Steroid Administration
	Methylprednisolone 30 mg/kg 30 minutes to 2 hrs prior to surgery unless diabetic
	2 PreO Hrs
	☐
	

	7
	Skin Preparation
	Chlorhexidine 2% scrub AM prior to surgery
	0 Hrs


	☐

	

	8
	Incision
	Choice of incision is at surgeon’s discretion
	-
	☐
	

	9
	Preventing Intraoperative Hypothermia
	Perioperative normothermia should be maintained during liver surgery
	-
	☐
	

	10
	Minimally Invasive Approach

	Laparoscopic Liver Resection (LLR) can be performed by HPB surgeons experienced in laparoscopic surgery.
	-
	☐
	

	11
	Prophylactic Nasogastric Intubation
	Routine use not indicated
	-
	☐
	

	12
	Prophylactic Abdominal Drainage
	Available evidence is non-conclusive and no recommendation can be given for the use of prophylactic drainage or against it.
	-
	☐ Did complete

☐ Did not complete
	

	13
	Prevention of Delayed Gastric Emptying
	Usage of omental flap to cover the cut surface after left-sided hepatectomy will reduce incidence of DGE
	-
	☐
	

	14
	Glycemic Control
	Insulin therapy to maintain normoglycemia is recommended.

*Insulin therapy should be initiated early during liver surgery to maintain normoglycemia (80-120 mg/dL). Programmed infusion of insulin is superior than manual injection with sliding-scale method.
	-
	☐
	

	15
	Fluid Management
	Maintenance of low CVP (below 5 cmH20) with close monitoring during hepatic surgery is advocated.

Balance crystalloid should be preferred over 0.9% saline or colloids to maintain intravascular volume
	-LR @ 75 cc/hr in orders
-250cc IVP q8h x 3 doses
	☐



☐
	




























C3. Postoperative Checklist

	
n

	Item
	Applied Practice
	Initiation
	Compliance
	Reason for Non-Compliance

	1
	Early Oral Intake
	CLD->Consistent carbohydrate diet
	1 POD->2 POD
	☐
	

	2
	Postoperative Nutrition
	Postoperative enteral or parenteral feeding should be reserved for malnourished patients or those with prolonged fasting due to complications.
	-
	☐
	

	3
	Anti-thrombotic prophylaxis (LMWH)
	Patient should receive LMWH during hospitalization
	1 POD
	☐
	

	4
	Anti-thrombotic prophylaxis (SCD)
	Patient should receive SCD until ambulating without assistance
	1 POD
	☐
	

	5
	Glycemic Control

	Insulin therapy to maintain normoglycemia
	0 POD
	☐
	

	6
	Stimulation of Bowel Movement 
	Not indicated
	-
	☐
	

	7
	Postoperative Nausea and Vomiting
	Patients should receive 2 antiemetic drugs.
-4 mg ondansetron IVP q6h prn
-12.5 mg promethazine IVP once prn if unrelieved by ondansetron
-4 mg dexamethasone IVP once prn if unrelieved by above
	0 POD
	☐
	

	8
	Analgesia
	Patient-Controlled Analgesia
	0 POD
	☐

	

	9
	Early Mobilization
	Early mobilization should be encouraged from the morning after surgery until discharge
	1 POD
	☐


	

	10
	Fluid utilization on the floor

	Patient should be maintained in a near-zero fluid balance, until bowel function returns and tolerates diet (KVO).  
	1 POD
	☐
	

	11
	Urinary catheter duration

	Patient’s urinary catheter should be no later than POD #1, unless otherwise indicated.
	1 POD
	☐
	

	12
	Intra-abdominal drain 
	Do not flush; empty q4h and record. 
	1 POD
	☐
	

	13
	Dressing
	Should be clean and dry. Change prn.
	0 POD
	☐
	

	14
	Medical oncology appointment
	Referral to medical oncologist at discharge.
	-
	☐
	

	15
	Audit
	First case audit for ERAS compliance and immediate post-operative results should be performed at discharge
	-
	☐
	


*The gray items represent the ERAS society recommendations	
*The green items represent additional recommendations from this institution
Appendix D
Applied Practices in Hepatectomy
D1.   Preoperative Module
	
n

	Item
	Applied Practice
	ERAS 
LOE
	Grade
Of
Recommendation
	
Evidence

	1
	Preoperative Counseling

	Patients should receive routine dedicated preoperative counseling and education before liver surgery.
	Moderate

	Strong
	Lassen, K. (2012). Clin Nutr 31: 817

	2
	Smoking / ETOH Cessation
	Alcohol abusers: 1-month of abstinence before surgery.
Daily Smokers: 1-month abstinence before surgery
	Alcohol: Low

Smoking: Moderate
	Strong



	Tonnesen, H. (1999). 
Br J Surg 86: 869

Lindstrom, D. (2008) 
Ann Surg 248: 739

	3
	Perioperative Nutrition
	Routine nutritional screening should be mandatory for all patients undergoing major abdominal surgery.

*Patients at risk: weight loss > 10-15% within 6 months, BMI < 18.5 or serum albumin <30 g/l in absence of liver or renal dysfunction should receive oral nutrition for 7 days prior to surgery
*Severely malnourished patients (>10% WL) should have surgery postponed for at least 2 weeks to improve NS.
	High
	Strong
	Weimann, A. (2006). 
Clin Nutr 25: 224

Schindler, K. (2010). 
Clin Nutr 29: 552

Weimann, A. (2014).
Chirurg 85: 320

	4
	Perioperative Oral Immunonutrition
	Limited evidence exists for use of immunonutrition in liver surgery.
	Low
	Weak
	Mikagi, K. (2011). 
Kurume Med J 58: 1

	5
	Preoperative Fasting
	Preoperative fasting does not exceed 6 hours for solids and 2 hours for liquids
	Moderate
	Strong
	Gustafsson, UO. (2013). 
World J Surg 37: 259

	6
	Preoperative Carbohydrate Loading
	Carbohydrate loading is recommended the evening before liver surgery and 2 hours before anesthesia induction
	Low
	
Weak
	Nygren, J. (2013).
World J Surgery 37: 285

Beyer, T. (2008).
Cell Cycle 7: 874

	7
	Oral bowel preparation
	Patient should not receive mechanical bowel preparation before liver surgery
	Low
	Weak
	Holte, K. (2004).
Dis Colon Rectum 47:1397




D2.   Intraoperative Module
	n
	Item
	Applied Practice
	ERAS
LOE
	Grade
Of 
Recommendation
	Evidence

	1
	Pre-Anesthetic Medication

	Long-acting anxiolytic drugs should be avoided. Short-acting anxiolytics may be used to perform regional analgesia prior to anesthesia induction.
	Moderate
	Strong
	Walker, K. (2009). Cochrane Database

	2
	Anti-Thrombotic prophylaxis (LMWH)
	Patient should receive LMWH 2 – 12 hrs before surgery

*Should be administered 12 hours prior to insertion of epidural catheter
	Moderate
	Strong
	Lassen, K. (2012). Clin Nutr 31: 817

	3
	Anti-Thrombotic prophylaxis (SCD)
	Patient should have SCDs in place in OR
	Low
	Weak
	Nygren, J. (2013).
World J Surgery 37: 285


	4
	Perioperative Steroid Administration
	Steroid (methylprednisolone) may be used before hepatectomy in normal liver parenchyma. Steroids should not be given in diabetic patients.

*Dosage 30 mg/kg 30 min to 2 hours prior to surgery
	Moderate
	Weak
	Richardson, A. (2014). HPB 12: 12

	5
	Antimicrobial Prophylaxis
	Single dose antibiotics should be administered less than 1 hour before incision
*Postoperative prophylactic antibiotics are not recommended 
	Moderate
	Strong
	Bratzler, D. (2004). 
Clin Infect Dis 38: 1706

	6
	Skin Preparation
	Skin preparation with chlorhexidine 2% is superior to povidone-iodine solution
	Moderate
	
Strong
	Darouiche, R. (2010).
N Engl J Med 362: 18

	7
	Type of incision
	Choice of incision is at surgeon’s discretion. 

*Mercedes-type incision should be avoided due to higher incisional hernia risk
	Moderate
	Strong
	D’ Angelica, M. (2006). 
World J Surg 30: 410

	8
	Minimally Invasive Approach
	Laparoscopic Liver Resection (LLR) can be performed by HPB surgeons experienced in laparoscopic surgery. 
	Moderate
	Strong

	Stoot, H. (2009). 
HPB 11: 140

	9

	Prophylactic Nasogastric Intubation
	Prophylactic nasogastric intubation increases the risk of pulmonary complications after hepatectomy. Routine use not indicated.
	High
	Strong
	Pessaux, P. (2007). 
Br J Surg 94: 297

	10
	Prophylactic Abdominal Drainage 
	Available evidence is non-conclusive and no recommendation can be given for the use of prophylactic drainage or against it. 
	Low
	Weak
	Petrowsky, H. (2004). 
Ann Surg 240: 1074

	11
	Preventing Intraoperative Hypothermia

	Perioperative normothermia should be maintained during liver surgery
	Moderate
	Strong
	Wong, P. (2007).
Br J Surg 94: 421

	12
	Prevention of Delayed Gastric Emptying 
	Usage of omental flap to cover the cut surface after left-sided hepatectomy will reduce incidence of DGE
	High
	Strong
	Igami, T. (2011).
J Hepatobiliary Pancreat Sci 18: 176

	13
	Glycemic Control
	Insulin therapy to maintain normoglycemia is recommended.

*Insulin therapy should be initiated early during liver surgery to maintain normoglycemia (80-120 mg/dL). Programmed infusion of insulin is superior than manual injection with sliding-scale method.
	Moderate
	Strong
	Frisch, A. (2010). Diabetes Care 33: 1783

Lipshitz, A. (2009).
Anesthesiology 110: 408


Blixt, C. (2012). 
Clin Nutr 31: 676

	14
	Fluid management
	Maintenance of low CVP (below 5 cmH20) with close monitoring during hepatic surgery is advocated.

Balance crystalloid should be preferred over 0.9% saline or colloids to maintain intravascular volume
	Moderate
	Strong
	Dunki-Jacobs E. (2014).
Ann Surg Oncol 21: 473


Shaw, A. (2012).
Ann Surg 255: 821





























D3.   Postoperative Module
	n
	Item
	
Applied Practice
	ERAS LOE
	Grade
Of
Recommendation
	Evidence

	1
	Early Oral Intake
	
Eat normal food at day one after liver surgery.
	Moderate
	
Strong
	Lassen, K. (2008).
Ann Surg 247: 721

	2
	Postoperative nutrition
	
Postoperative enteral or parenteral feeding should be reserved for malnourished patients or those with prolonged fasting due to complications.
	Oral nutritional supps: Moderate

No routine postoperative artificial nutrition: High
	Oral nutritional supps: Weak

No routine postoperative artificial nutrition: Strong
	Richter, B. (2006).
Dig Surg 23: 139

Guenter, P. (2012). 
JPEN 36: 399

	3
	Anti-Thrombotic prophylaxis (LMWH)
	Should continue while in hospital. Could be continued for 4 weeks after hospital discharge; especially in oncology population.
	Moderate
	Strong
	Rasmussen, M. (2009). Cochrane Database System Review

	4
	Anti-Thrombotic prophylaxis (SCD)
	Compression stockings should be in place until mobile to further decrease risk.
	Low
	Weak
	Nygren, J. (2013).
World J Surgery 37: 285


	5
	Glycemic Control
	Insulin therapy to maintain normoglycemia is recommended.

*Programmed infusion of insulin is superior than manual injection with sliding-scale method.
	Moderate
	Strong
	Okabayashi, T. (2009). Diabetes Care 32: 1425

	6
	Stimulation of Bowel Movement
	Stimulation of bowel movement with laxative or chewing gum is not indicated.
	High
	Strong
	Ni, C. (2013).
Eur J Surg Oncol 39: 542

Melloul, E. (2012).
J Hepatol 57: 1268

	7
	Early Mobilization
	Early mobilization after hepatectomy should be encouraged from the morning after the operation until discharge
	Low
	Weak
	Brower, R. (2009). 
Crit Care Med 37: S422

	8
	Analgesia
	Routine thoracic epidural analgesia (TEA) cannot be recommended in open liver surgery for ERAS patients. 

*Wound infusion catheter or intrathecal opiates can be good alternatives when combined with multimodal analgesia. 
	Moderate
	Strong

	Roy, J. (2006).
Anesth Analg 103: 990



Revie, E. (2012).
HPB 13: 611

	9
	Postoperative Nausea and Vomiting
	Multimodal approach to PONV should be used. Patients should receive PONV prophylaxis with 2 antiemetic drugs. 

*5HT3 antagonists remain the first-line therapy due to their good side effect profile. Secondary drugs: Low-dose dexamethasone improves liver regeneration; use in caution with diabetics, antihistamines, butyrophenones and phenothiazines.
	Moderate
	Strong
	Carlisle, J. (2006).
Cochrane Database Syst Rev

	10
	Urinary Catheter Duration
	Removed not later than POD #1 after major abdominal surgery, unless otherwise indicated
	High
	
Strong
	Zaouter, C. (2009). 
Anesth Pain Med 34: 542

Wald, H. (2008).
Arch Surg 143: 551

	11
	Medical Oncology Referral
	At discharge from the hospital, patient will need a referral to medical oncologist to promote a multidisciplinary approach to care.
	-
	-
	Stein, S. (2013). 
J Clin Gastroentreology 47: 47

Jelic, S. (2010).
Annals of Oncology: 21: 59

	12
	Audit 
	Systematic audit improves compliance and clinical outcomes in healthcare practice
	Moderate
	Strong
	Gustafsson, U. (2011).
Arch Surg 146: 571.


*The gray items represent the ERAS society recommendations	
*The green items represent additional recommendations from this institution























Appendix E
Population and Procedure Variables 
E1. Population Characteristics
	All Liver Procedures Performed by HPB Surgery Between 9/14/17 – 11/24/2017 
n=20

	Population Variables 

	Sex, male n (%)
	7 (35)

	Age, years, mean (SD)
	51.7 (14.5)

	BMI, mean (SD)
	32.9 (8.1)

	ASA Group n (%)
	

	1-2
	4 (20)

	3-4
	16 (80)


















E2. Liver Procedures
	Liver Procedures 

	Procedure Type n (%)
	

	Left hepatectomy
	6 (30)

	Extended left hemihepatectomy
	3 (15)

	Right hemihepatectomy
	6 (30)

	Extended right hemihepatectomy
	3 (15)

	Other segmentectomies
	2 (10)

	Wedge or minor resection
	1 (5)





















Appendix F
Compliance Variables
F1. Compliance SD by Module
	Compliance Variables

	Compliance by module
	

	Preadmission compliance, mean (SD)
	81.3 (21.3)

	Preoperative compliance, mean (SD)
	87.5 (8.1)

	Intraoperative compliance, mean (SD)
	80 (9.9)

	Postoperative compliance, mean (SD)
	77.1 (8.3)

	Total/Overall compliance, mean (SD)
	77.7 (7.2)




















F2. Compliance by Item and Month








Appendix G
30-Day Complications 
	30-Day Complications
Any n (%)
	12 (60)

	Intraoperative bleeding or hemorrhage n (%)
	2 (10)

	30-day reoperation n (%)
	1 (5)

	30-day ascites n (%)
	2 (10)

	30-day wound infection n (%)
	1 (5)

	30-day postoperative bleeding or hemorrhage n (%)
	0





















Appendix H
Project Evaluation Form






Appendix I
Letter of Support



Appendix J
East Carolina University IRB Waiver

Appendix K
Organization IRB Waiver









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