Enhanced Recovery After Surgery (ERAS®) Society Consensus Guidelines for Emergency Laparotomy Part 3: Organizational Aspects and General Considerations for Management of the Emergency Laparotomy Patient.

BACKGROUND: This is Part 3 of the first consensus guidelines for optimal care of patients undergoing emergency laparotomy using an enhanced recovery after surgery (ERAS) approach. This paper addresses organizational aspects of care. METHODS: Experts in management of the high-risk and emergency general surgical patient were invited to contribute by the International ERAS® Society. PubMed, Cochrane, Embase, and MEDLINE database searches were performed for ERAS elements and relevant specific topics. Studies were selected with particular attention to randomized clinical trials, systematic reviews, meta-analyses and large cohort studies, and reviewed and graded using the Grading of Recommendations, Assessment, Development and Evaluation system. Recommendations were made on the best level of evidence, or extrapolation from studies on elective patients when appropriate. A modified Delphi method was used to validate final recommendations. RESULTS: Components of organizational aspects of care were considered. Consensus was reached after three rounds of a modified Delphi process. CONCLUSIONS: These guidelines are based on best current available evidence for organizational aspects of an ERAS® approach to patients undergoing emergency laparotomy and include discussion of less common aspects of care for the surgical patient, including end-of-life issues. These guidelines are not exhaustive but pull together evidence on important components of care for this high-risk patient population. As much of the evidence is extrapolated from elective surgery or emergency general surgery (not specifically laparotomy), many of the components need further evaluation in future studies.

Consensus Guidelines for Perioperative Care for Emergency Laparotomy Enhanced Recovery After Surgery (ERAS®) Society Recommendations Part 2-Emergency Laparotomy: Intra- and Postoperative Care.

BACKGROUND: This is Part 2 of the first consensus guidelines for optimal care of patients undergoing emergency laparotomy (EL) using an Enhanced Recovery After Surgery (ERAS) approach. This paper addresses intra- and postoperative aspects of care. METHODS: Experts in aspects of management of high-risk and emergency general surgical patients were invited to contribute by the International ERAS® Society. PubMed, Cochrane, Embase, and Medline database searches were performed for ERAS elements and relevant specific topics. Studies on each item were selected with particular attention to randomized clinical trials, systematic reviews, meta-analyses, and large cohort studies and reviewed and graded using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system. Recommendations were made on the best level of evidence, or extrapolation from studies on elective patients when appropriate. A modified Delphi method was used to validate final recommendations. Some ERAS® components covered in other guideline papers are outlined only briefly, with the bulk of the text focusing on key areas pertaining specifically to EL. RESULTS: Twenty-three components of intraoperative and postoperative care were defined. Consensus was reached after three rounds of a modified Delphi Process. CONCLUSIONS: These guidelines are based on best available evidence for an ERAS® approach to patients undergoing EL. These guidelines are not exhaustive but pull together evidence on important components of care for this high-risk patient population. As much of the evidence is extrapolated from elective surgery or emergency general surgery (not specifically laparotomy), many of the components need further evaluation in future studies.

Guidelines for Perioperative Care for Emergency Laparotomy Enhanced Recovery After Surgery (ERAS) Society Recommendations: Part 1-Preoperative: Diagnosis, Rapid Assessment and Optimization.

BACKGROUND: Enhanced Recovery After Surgery (ERAS) protocols reduce length of stay, complications and costs for a large number of elective surgical procedures. A similar, structured approach appears to improve outcomes, including mortality, for patients undergoing high-risk emergency general surgery, and specifically emergency laparotomy. These are the first consensus guidelines for optimal care of these patients using an ERAS approach. METHODS: Experts in aspects of management of the high-risk and emergency general surgical patient were invited to contribute by the International ERAS® Society. Pubmed, Cochrane, Embase, and MEDLINE database searches on English language publications were performed for ERAS elements and relevant specific topics. Studies on each item were selected with particular attention to randomized controlled trials, systematic reviews, meta-analyses and large cohort studies, and reviewed and graded using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system. Recommendations were made on the best level of evidence, or extrapolation from studies on non-emergency patients when appropriate. The Delphi method was used to validate final recommendations. The guideline has been divided into two parts: Part 1-Preoperative Care and Part 2-Intraoperative and Postoperative management. This paper provides guidelines for Part 1. RESULTS: Twelve components of preoperative care were considered. Consensus was reached after three rounds. CONCLUSIONS: These guidelines are based on the best available evidence for an ERAS approach to patients undergoing emergency laparotomy. Initial management is particularly important for patients with sepsis and physiological derangement. These guidelines should be used to improve outcomes for these high-risk patients.

Hospital Costs and Long-term Survival of Patients Enrolled in an Enhanced Recovery Program for Open Liver Resection: Prospective Randomized Controlled Trial.

BACKGROUND: The clinical benefits of enhanced recovery programs (ERPs) have been extensively researched, but few studies have evaluated their cost-effectiveness. Our ERP for open liver resection is based closely on the guidelines produced by the Enhanced Recovery After Surgery Society (2016). This study follows on from a previous randomized controlled trial. We also undertook a long-term follow-up of the patients enrolled in the original trial alongside an analysis of the associated health economics. OBJECTIVE: We aimed to undertake a health economic and long-term survival analysis as part of a trial investigating the implementation of an ERP for open liver resection. METHODS: The enhanced recovery elements utilized included extra preoperative education, carbohydrate loading, oral nutritional supplements, postresection goal-directed fluid therapy (LiDCOrapid), early mobilization, and physiotherapy (twice a day compared with once per day in the standard care group). A decision-analytic model was used to compare the study endpoints for ERP versus standard care provided to patients undergoing open liver resection. Outcomes obtained included costs per life-years gained. Resource use and costs were estimated from the perspective of the National Health Service of the United Kingdom. A decision tree and Markov model were constructed using results from our earlier trial and augmented by external data from other published clinical trials. Long-term follow-up was also undertaken for up to 5 years after the surgery, and data were analyzed to ascertain if the ERP conferred any benefit on long-term survival. RESULTS: Patients receiving ERP had an average life expectancy of 6.9 years versus 6.1 years in the standard care group. The overall costs were £9538.279 (£1=US $1.60) for ERP and £14,793.05 for standard treatment. This results in a cost-effectiveness ratio of -£6748.33/QALY. Patients receiving ERP required fewer visits to their general practitioner (P=.006) and required lesser help at home with day-to-day activities (P=.04) than patients in the standard care group. Survival was significantly improved at 2 years at 91% (42/46) for patients receiving ERP versus 73% (33/45) for the standard care group (P=.03). There was no statistically significant difference at 5 years after the surgery. CONCLUSIONS: ERPs for patients undergoing open liver resection can improve their medium-term survival and are cost-effective for both hospital and community settings.

Early Postoperative Death in Patients Undergoing Emergency High-Risk Surgery: Towards a Better Understanding of Patients for Whom Surgery May Not Be Beneficial.

The timing, causes, and quality of care for patients who die after emergency laparotomy have not been extensively reported. A large database of 13,953 patients undergoing emergency laparotomy, between July 2014 and March 2017, from 28 hospitals in England was studied. Anonymized data was extracted on day of death, patient demographics, operative details, compliance with standards of care, and 30-day and in-patient mortality. Thirty-day mortality was 8.9%, and overall inpatient mortality was 9.8%. Almost 40% of postoperative deaths occurred within three days of surgery, and 70% of these early deaths occurred on the day of surgery or the first postoperative day. Such early deaths could be considered nonbeneficial surgery. Patients who died within three days of surgery had a significantly higher preoperative lactate, American Society of Anesthesiologists Physical Status (ASA-PS) grade, and Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM). Compliance with perioperative standards of care based on the Emergency Laparotomy Collaborative care bundle was high overall and better for those patients who died within three days of surgery. Multidisciplinary team involvement from intensive care, care of the elderly physicians, and palliative care may help both the communication and the burden of responsibility in deciding on the risk-benefit of operative versus nonoperative approaches to care.

Understanding the influences on successful quality improvement in emergency general surgery: learning from the RCS Chole-QuIC project.

BACKGROUND: Acute gallstone disease is the highest volume Emergency General Surgical presentation in the UK. Recent data indicate wide variations in the quality of care provided across the country, with national guidance for care delivery not implemented in most UK hospitals. Against this backdrop, the Royal College of Surgeons of England set up a 13-hospital quality improvement collaborative (Chole-QuIC) to support clinical teams to reduce time to surgery for patients with acute gallstone disease requiring emergency cholecystectomy. METHODS: Prospective, mixed-methods process evaluation to answer the following: (1) how was the collaborative delivered by the faculty and received, understood and enacted by the participants; (2) what influenced teams' ability to improve care for patients requiring emergency cholecystectomy? We collected and analysed a range of data including field notes, ethnographic observations of meetings, and project documentation. Analysis was based on the framework approach, informed by Normalisation Process Theory, and involved the creation of comparative case studies based on hospital performance during the project. RESULTS: Chole-QuIC was delivered as planned and was well received and understood by participants. Four hospitals were identified as highly successful, based upon a substantial increase in the number of patients having surgery in line with national guidance. Conversely, four hospitals were identified as challenged, achieving no significant improvement. The comparative analysis indicate that six inter-related influences appeared most associated with improvement: (1) achieving clarity of purpose amongst site leads and key stakeholders; (2) capacity to lead and effective project support; (3) ideas to action; (4) learning from own and others' experience; (5) creating additional capacity to do emergency cholecystectomies; and (6) coordinating/managing the patient pathway. CONCLUSION: Collaborative-based quality improvement is a viable strategy for emergency surgery but success requires the deployment of effective clinical strategies in conjunction with improvement strategies. In particular, achieving clarity of purpose about proposed changes amongst key stakeholders was a vital precursor to improvement, enabling the creation of additional surgical capacity and new pathways to be implemented effectively. Protected time, testing ideas, and the ability to learn quickly from data and experience were associated with greater impact within this cohort.

Evaluation of the Collaborative Use of an Evidence-Based Care Bundle in Emergency Laparotomy.

Importance: Patients undergoing emergency laparotomy have high mortality, but few studies exist to improve outcomes for these patients. Objective: To assess whether a collaborative approach to implement a 6-point care bundle is associated with reduction in mortality and length of stay and improvement in the delivery of standards of care across a group of hospitals. Design, Setting, and Participants: The Emergency Laparotomy Collaborative (ELC) was a UK-based prospective quality improvement study of the implementation of a care bundle provided to patients requiring emergency laparotomy between October 1, 2015, and September 30, 2017. Participants were 28 National Health Service hospitals and emergency surgical patients who were treated at these hospitals and whose data were entered into the National Emergency Laparotomy Audit (NELA) database. Post-ELC implementation outcomes were compared with baseline data from July 1, 2014, to September 30, 2015. Data entry and collection were performed through the NELA. Interventions: A 6-point, evidence-based care bundle was used. The bundle included prompt measurement of blood lactate levels, early review and treatment for sepsis, transfer to the operating room within defined time goals after the decision to operate, use of goal-directed fluid therapy, postoperative admission to an intensive care unit, and multidisciplinary involvement of senior clinicians in the decision and delivery of perioperative care. Change management and leadership coaching were provided to ELC leadership teams. Main Outcome and Measures: Primary outcomes were in-hospital mortality, both crude and Portsmouth Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM) risk-adjusted, and length of stay. Secondary outcomes were the changes after implementation of the separate metrics in the care bundle. Results: A total of 28 hospitals participated in the ELC and completed the project. The baseline group included 5562 patients (2937 female [52.8%] and a mean [range] age of 65.3 [18.0-114.0] years), whereas the post-ELC group had 9247 patients (4911 female [53.1%] and a mean [range] age of 65.0 [18.0-99.0] years). Unadjusted mortality rate decreased from 9.8% at baseline to 8.3% in year 2 of the project, and so did risk-adjusted mortality from a baseline of 5.3% to 4.5% post-ELC. Mean length of stay decreased from 20.1 days during year 1 to 18.9 days during year 2. Significant changes in 5 of the 6 metrics in the care bundle were achieved. Conclusions and Relevance: A collaborative approach using a quality improvement methodology and a care bundle appeared to be effective in reducing mortality and length of stay in emergency laparotomy, suggesting that hospitals should adopt such an approach to see better patient outcomes and care delivery performance.

Does the Implementation of a Quality Improvement Care Bundle Reduce the Incidence of Acute Kidney Injury in Patients Undergoing Emergency Laparotomy?

PURPOSE: Previous work has demonstrated a survival improvement following the introduction of an enhanced recovery protocol in patients undergoing emergency laparotomy (the emergency laparotomy pathway quality improvement care (ELPQuiC) bundle). Implementation of this bundle increased the use of intra-operative goal directed fluid therapy and ICU admission, both evidence-based strategies recommended to improve kidney outcomes. The aim of this study was to determine if the observed mortality benefit could be explained by a difference in the incidence of AKI pre- and post-implementation of the protocol. METHOD: The primary outcome was the incidence of AKI in the pre- and post-ELPQuiC bundle patient population in four acute trusts in the United Kingdom. Secondary outcomes included the KDIGO stage specific incidence of AKI. Serum creatinine values were obtained retrospectively at baseline, in the post-operative period and the maximum recorded creatinine between day 1 and day 30 were obtained. RESULTS: A total of 303 patients pre-ELPQuiC bundle and 426 patients post-ELPQuiC bundle implementation were identified across the four centres. The overall AKI incidence was 18.4% in the pre-bundle group versus 19.8% in the post bundle group p = 0.653. No significant differences were observed between the groups. CONCLUSIONS: Despite this multi-centre cohort study demonstrating an overall survival benefit, implementation of the quality improvement care bundle did not affect the incidence of AKI.

Perioperative management of liver resection surgery.

Advances in liver resection surgery have lead to reductions in both mortality and morbidity. However morbidity remains high so effective multidisciplinary teamwork is essential to optimise the perioperative care of this patient group. In this article we review the current literature on the perioperative management of patients undergoing liver resection surgery.

Operative mortality, blood loss and the use of Pringle manoeuvres in 526 consecutive liver resections.

INTRODUCTION: Centres with high volumes of high-risk surgery have significantly better outcomes than low-volume centres for pancreatic resection, oesophagectomy and pelvic exenteration. However, this has not to date been conclusively demonstrated for hepatic resection. With increased experience, operative practice can change. The use of the Pringle manoeuvre reduced substantially over a 12-year period in a single centre as it was felt anecdotally that its use increased the incidence of hepatic insufficiency and operative mortality. This study was designed to review 12 years of experience in a single hepatobiliary centre. PATIENTS AND METHODS: Data regarding 526 consecutive liver resections were prospectively recorded and retrospectively analysed in a high-volume referral unit over a 12-year period. Patients' demographics, operative mortality and morbidity were analysed on an annual basis. RESULTS: Overall peri-operative mortality was 1.9%. Operative mortality in the first 6 years compared to the latter 6 years was 4.1% and 1.2%, respectively (P = 0.13). The morbidity rate was 26.8% and 20.3% in the first and second halves of the study, respectively (P = 0.15). With increased experience, intra-operative blood loss and patients receiving blood transfusions decreased (P = 0.047 and 0.03, respectively) while the number of intra-operative Pringle manoeuvres also decreased (P < 0.0001). Hospital stay decreased significantly over the 12 years (P = 0.049). CONCLUSIONS: High-volume centres are the safest environment for hepatic resection. With increased experience, it may be possible to reduce the intra-operative use of the Pringle manoeuvre without increasing the intra-operative blood loss. This may be associated with a decrease in hepatic insufficiency and peri-operative mortality.

Early postoperative outcomes following hepatic resection for benign liver disease in 79 consecutive patients.

BACKGROUND: Liver resection is an accepted treatment modality for malignant disease of the liver. However, because of its potential morbidity and mortality, the practice of liver resection in benign disease is more controversial. This study was designed to assess the early outcomes of 79 consecutive liver resections for benign disease over a 12-year period and compare these with early outcomes of 390 consecutive liver resections for metastatic colorectal cancer (MCRC) during the same period. METHODS: Consecutive liver resections were carried out in a single hepatopancreatobiliary (HPB) centre between 1996 and 2008. Patient demographics and early outcomes were recorded. Statistical analyses were performed using spss (Version 15). P < 0.05 was considered to be significant. RESULTS: There was no difference in median age between the benign group vs. the MCRC group (P = 0.181). However, there was a significant trend towards a lower ASA grade in the benign group (P < 0.001). There was no difference in median blood loss (P = 0.139) or hospital stay (P = 0.262). Morbidity rates were 8.9% in the benign group and 20.5% in the MCRC group (P = 0.002). The rate of serious complications was 1.3% in the benign group compared with 4.4% in the MCRC group (P = 0.041). There were no postoperative deaths in the benign group and eight (2%) in the MCRC group (P = 0.004). CONCLUSIONS: Liver resection for benign liver tumours can be undertaken with a mortality rate approaching zero and minimal morbidity in specialist HPB units.