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

This is Part 3 of a three-part guideline. Part 1[1] dealt with background and preoperative care including rapid assessment and diagnosis, simultaneous resuscitation and optimization, and Part 2 (Scott et al. 2023 WJS in press) covered intraoperative and postoperative care. This section covers organizational aspects of management and includes end-of-life issues. The latter important aspect of care was included as the mortality of emergency laparotomy (EL) remains high, and patients may present with low likelihood of survival [1]. Due to the diverse underlying conditions and varying presentations of this group of patients, not all pathway components will always be applicable; however, we believe the organizational aspects of care are relevant to all teams, hospitals and systems seeking to implement an enhanced recovery after surgery (ERAS) EL pathway.

This project was initiated by the ERAS® Society. Lead authors (MS and CP) were invited by the society to establish a guideline development group (GDG) of health-care professionals with diverse clinical or academic expertise in the management of patients undergoing EL. The GDG consisted of surgeons, anesthesiologists, a nurse, a geriatrician, and a PhD who supported the organization of the literature. Several of the authors were also accredited in intensive care, and the group was selected to ensure international representation. There was equal author representation from the USA and the UK (lead authors MS and CP are both US and UK experienced), with more surgical representatives from the USA, and more anesthetic representatives from the UK reflecting National Emergency Laparotomy (NELA) audit involvement. There were five European authors and two from the rest of the world. We recognize with regret in retrospect that Asia and Africa were not included and will correct this on the next iteration of these guidelines. A list of topics was generated, and groups of physicians with different backgrounds and from different countries were assigned to each topic, based on their expertise, to perform a literature review of English language publications and then to generate recommendations using the GRADE structure [2] and a modified Delphi process. Once the topic groups had drafted recommendations, these were collated and sent to the whole group for feedback. There was then significant review, editing, and response to comments, as well as extensive discussion of appropriate inclusion or modification of the recommendation list. The paper and recommendation list were then circulated again using a modified Delphi approach to rank the strength of the recommendation and seek further comment. A final Delphi was then undertaken highlighting areas where, prior to modification, there had been less than 80% agreement, on this final round more than 80% consensus was reached. The period searched was from 2005 until September 2021, with greater emphasis on recent publications, randomized clinical trials (RCTs), systematic reviews, meta-analyses and large cohort studies. With delays in reconvening the group due to the COVID-19 pandemic, an updated search was performed in the Spring of 2022. Retrospective studies were considered where no other higher level of evidence was available, and there was particular relevance to EL. The final guidelines were then circulated to all authors for review and identification of further relevant papers. All authors had access to papers reviewed using a reference library. The guideline development process used to reach consensus on recommendations was based on the guidance published by the ERAS® Society [3, 4]. Key components of the organization of care were agreed on and assessed with three circulations of the paper. A reviewer from the International ERAS® Society (OL) was appointed to provide internal review of the guideline as it developed, on his suggestion and the need for ERAS recommendations to be measurable for compliance and actionable; the paper was re-ordered prior to the final Delhi round to place all intra and postoperative components into Part 2 (WJS in press 2023), and other components perhaps less amenable to change by clinicians, such as delivery system structure, into this paper. We would suggest that monitoring of these organizational components should occur at a hospital or system level, consider culture and context, and be separate from the clinical components in the pre-, intra- and postoperative pathways. Discussion of implementation and delivery of the whole consensus guidelines pathway is discussed in this paper.

A summary of the ERAS elements for organizational aspects of care and general management considerations and grading of recommendations with their respective level of evidence is described in Table 1.

Outcomes from patients undergoing emergency general surgery (EGS) and specifically EL have been shown to vary widely, with variation attributed to both patient factors and system factors [7]. Modifiable system factors include availability of intensive care beds, access to high-quality radiological services and involvement of senior health-care professionals in the delivery of all stages of care [8‐12]. Improved delivery of evidence-based processes of care [13, 14] and provision of structural metrics [15] improve outcomes. Organization of services to ensure key care components delivered reliably, by highly skilled personnel, to all patients regardless of location and type of presentation, is one of the main challenges to improving care for these high-risk patients [8, 10, 15‐17].

Compared with standards of care for elective major surgical procedures, such as colorectal cancer, standards for EGS have been sparse. Over the last decade, awareness of organizational needs has increased [18]. Some countries have defined standards for the organization of emergency surgical services including the separation of elective and emergency surgical workload with the provision of separate teams and identification of key resources and facilities including the provision of postoperative intensive care beds [19‐21]. Many health-care systems are seeing a steady yearly increase in emergency surgical cases, especially in the older population [22]. The centralization of EGS services and number of surgeries performed per annum by the surgeon has been shown to improve outcomes [23], especially in the geriatric population [22]. Different models of care have been shown to provide better outcomes for EGS, with one US study showing a 31% reduction in mortality with an acute care surgery service model compared with a general surgical service [24].

Patients undergoing EL are at high risk of morbidity and mortality. There is minimal margin for error, and there is some evidence to show that outcomes improve with experienced surgical and anesthesia teams. A study of the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database showed that surgery led by trainee surgeons was independently associated with increased intra- and postoperative events, wound, pulmonary, venous thromboembolic complications, and urinary tract infections [25]. However, 40% of the cases were appendectomy and 15% labeled as “other” [25]. Other studies have shown an association with the presence of a senior surgeon and anesthesiologist in the operating room and improved outcomes [14, 26, 27]. English National Health Service (NHS) organizations are now incentivized to provide a senior surgeon and senior anesthesiologist for high-risk EL cases, including all cases in frail patients, by being paid a higher tariff for such a pathway. Such an approach has been shown to be effective in improving outcomes in other emergency surgical conditions such as patients with fractured neck of femur [28]. In the USA, the ACS and the American Association for Surgery of Trauma (AAST) have recently introduced new resources and standards, including training requirements for surgeons at verified trauma/EGS centers [21].

A recent large observational study from the UK National Emergency Laparotomy Audit (NELA) database comparing trainees with consultant surgeon outcomes showed no detrimental influence on mortality or return to theater—although the level of experience of the operating surgeon was not specified [29] nor the level of supervision. However, the need for trainee exposure and management of complex pathology and emergency situations should not be understated. The specialist expertise of the operating surgeon appears to be important. Recent large studies report an increase in mortality in patients operated on by surgeons whose area of expertise was not in the area of the pathology, and for colorectal patients not operated on by specialist colorectal surgeons there were lower rates of laparoscopy and an increase in return to the operating room [30], although these results must be interpreted with caution as factors such as the urgency of the procedure may not have been fully accounted for. Another study shows lower mortality and stoma formation if an emergency colorectal resection is done by a colorectal subspecialist [31]. Solutions may include partnering across specialties in the management of complex emergency surgical patients [32, 33]. However, the authors acknowledge the availability of expertise will be dependent on the local health-care system.

The impact of age and frailty on outcomes after EL was also discussed in Part 1 of these guidelines [1]. Age alone is significantly associated with poor outcomes for EL [27, 65], and many older patients are also frail, resulting in a lack of resilience in the face of a physiological insult [66‐70]. Patients over 65 years of age should be screened for frailty using a validated tool [71]. Frailty is also strongly associated with an increased risk of delirium [72]. In a study of outcomes at 12 months in older patients after EL, the strongest predictors of mortality were frailty and increased ASA status [73]. A study using the NSQIP database showed a dose-dependent effect of frailty on FTR, as well as postoperative complications, reoperation, and all-cause mortality in older EGS patients [74]. An ERAS approach improved outcomes and reduced mortality in patients over the age of 70 years [14, 75, 76]. Although mortality is improving for older patients undergoing EGS, for those that survive large numbers do not return to their previous level of independence [77].

Involvement of a physician specialized in the care of older adults to co-manage these patients, and/or the use of targeted interventions should occur as soon as possible after surgery (if not before) [70]. Recent studies and guidelines provide evidence that proactive screening for frailty and comprehensive geriatric assessment (CGA) and management, improves outcomes in EGS [70, 78‐81], and specifically for patients over 65 years of age who have undergone EL [15, 82]. One major study [81] used a proactive approach for EGS patients over 65 years including integration of a geriatric assessment team, promotion of patient-oriented rehabilitation, and early discharge planning, and found a significant reduction in mortality, LOS and discharge to a higher level of care [81]. Proactive management of frail patients may also decrease overall costs of care [83, 84]. At present, the evidence indicates that older EL patients are not reliably assessed for frailty nor co-managed with a care of the older-adult team [27].

A key theme in successful implementation of ERAS pathways is the importance of the multidisciplinary team. Although the role of the nurse is always mentioned, there is little data examining the impact of the nursing role within an ERAS context, and of nursing care of the emergency patient group using an ERAS pathway [17]. Changes to nursing workload have been described in relation to elective ERAS [85], and nursing workload is likely to increase when applying ERAS to emergency patients [86]. Nursing care of this patient group is complicated by factors associated with EL such as increased frailty, pre-existing medical conditions [68] and cardiovascular concerns including orthostatic intolerance in addition to the lack of pre-habilitation due to the nature of presentation of these patients [17]. Nursing staff require a robust education program to ensure understanding of the rationale behind ERAS, including the need for early mobilization [87]. Nursing ratios decrease as the patient recovers and moves through different levels of postoperative care. One study [88] illustrated patients’ perspectives around step-down from critical care, interviews confirmed that the transition could be difficult, and patients felt insecure due to greater nursing workload and a perception of busier areas with fewer staff. In the UK specialist nursing roles focused on EL have evolved. NELA highlighted a need for continuity through transitions from critical care to general surgical areas, and for an outreach program [89].

Patients recovering from EL may experience issues with fatigue as well as pain [68] and consideration should be given to highlighting pathway goals such as mobilization targets [90]. To facilitate ERAS goal attainment multidisciplinary collaboration particularly between physiotherapy and nursing teams, and staff availability over weekends and out-of-hours, should be considered [17, 91]. Patients have reported [92] that weekends can be a challenging time during their recovery. Many emergency patients needing a stoma will not see a stoma nurse preoperatively and may go several days before seeing one postoperatively. The absence of preoperative stoma site marking, and emergency surgery have been identified as risk factors for development of a problematic stoma [93]. Much stoma specialist nursing is a weekday, office hours service.

Audit is a central component of ERAS [124]. Having a pathway with defined measurable components facilitates improvement and allows comparison of processes and outcomes between different practitioners and centers. Outcomes from EL and EGS have shown widespread variation ascribed to differences in patients, and variations in individual hospital performance [10, 125, 126]. There is a lack of data on the impact of patient triage for surgery, and relatively little data on variation of patient selection, and assessment of non-beneficial surgery [97, 106]. Variations in patients who undergo surgery can be accounted for to a certain extent with risk adjustment, but collection of all relevant data such as frailty and cognitive status is required. Variations in hospital performance are better addressed through quality improvement methodology.

An important component for improving care is mortality review which is a standard part of any audit and quality improvement program. Regular multidisciplinary meetings should be held, including not only surgeons and anesthesiologists but other relevant specialties such as radiologists, emergency department clinicians and geriatricians. Hospital executives should on occasion be involved, as any required system change may not be within the remit of clinicians [127]. Using a structured approach to review all laparotomy deaths can provide thematic insights into system, teamwork and communication issues and enable sharing and categorization of harm events, and development of areas for improvement. Such an approach to mortality review was mandated in the UK by the National Quality Board [128] and the use of standard nomenclature so that thematic analysis can be performed and lessons learnt across multiple specialties has also been promoted by the ACS [129].

National data collection and reporting of performance of key metrics has been shown to be effective by NELA in the UK [130], and other countries have started similar projects [131, 132]. The way performance data are used, particularly timely and frequent feedback, has been associated with the effectiveness of the quality improvement program [133]. Attempts to implement too many ERAS components at once may be challenging, especially in the setting of emergency surgery, and when time to work on improvement is limited [134]. Approaching implementation of a smaller number of high impact components, such as in an EL care bundle or pathway [14, 45, 75, 135] may be more effective, especially when standard ERAS elements are already established (See Fig. 2 for an example of an ERAS pathway Emergency Laparotomy Bundle). One study showed that good compliance with a specific EL care bundle decreased mortality, but when compliance fell mortality increased [13]. When the bundle was re-applied with high compliance, mortality decreased again. Therefore, consideration of how improvements will be sustained should occur at the planning phase [13]. Increased use of quality improvement principles has been shown to aid improvement of process delivery for EL [136]. Guidance to help quality improvement and implementation is available [130, 137]. Changing care delivery is challenging, a protocol is not enough [138], real change needs not only clinical will and hard work, but cultural change and management support [13, 127, 134, 139]. Program success is associated with the adoption of evidence-based practices, assuring adequate resources are allocated for implementation and long-term sustainability.

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These guidelines present a summary of the current evidence base and recommendations for key components of the organizational aspects of an ERAS pathway for EL. The quality of evidence is low in certain areas and much has been extrapolated from elective ERAS guidelines and elective intra-abdominal surgery; therefore, many components may require further prospective validation. We have addressed some components of care outside of the usual remit of an elective ERAS pathway, such as aspects of management of the patient who may be at their end-of-life, as we believe these issues must be addressed to provide a comprehensive and holistic patient-centered EL pathway. It is hoped that these organizational guidelines, paired with the preoperative and intraoperative guidelines, will provide a framework for improved management of patients undergoing EL. While there will be benefit in implementing certain components of the pathway, the greatest gain should be expected when organizational aspects of care are addressed, and the whole pathway is considered, implemented, and audited for compliance. Excitingly, the literature continues to grow in this area, and these guidelines will be reviewed and updated when appropriate.