Enhanced recovery after surgery program for elective abdominal surgery at three Victorian hospitals.
Clinical pathways have been developed to enhance the quality of patient care by optimising available resources, improving patient satisfaction, promoting patient safety and improving outcomes (4-7). Such pathways include multiple interventions in routine practice and ideally these should be evidence-based (3-12). The key challenge relates to organisational change rather than specific surgical or anaesthesia-related interventions (3-6) the acceptance and integration of a mindset of protocol-directed care. It is recognised however, that changes to traditional practice are not delivered easily. For example, there is reluctance to discharge patients from hospital earlier than is currently practised despite clinical evidence of sufficient functional recovery (3). Over the past decade a growing body of literature, mostly from Europe, has provided an evidence base to support clinical pathways for enhanced recovery after surgery (ERAS). These studies have demonstrated that ERAS can enhance efficiency of care without adversely affecting outcome, even after major abdominal surgery (9-13).
In 2009, The Australian Safety and Efficacy Register of New Interventional Procedures--Surgical reported on the likely potential of the safety and efficacy of 'fast-track' surgery programs in Australia (14). They concluded fast-track surgery was as cost-effective, efficient and could result in beneficial outcomes for patients. The Victorian Department of Human Services (now Department of Health) sought a collaboration to investigate this further. A perioperative collaboration was formed between the Alfred, Geelong and Box Hill Hospitals (Ethics Committee approval numbers 275/09, 09/97 and LR43/0910 respectively) to investigate current practice, the feasibility of establishing a fast-track surgical program for abdominal surgical patients and to establish a set of measures of successful implementation of such a program. This paper reports on the uptake, feasibility and outcome of this ERAS program following abdominal surgery in three major hospitals in Victoria.
MATERIALS AND METHODS
We used a before-and-after study design. The baseline (pre-implementation) phase was for five months in 2009. During this time, a team of trained project officers collected existing perioperative practices and outcome data from eligible patients undergoing surgery. Following this baseline collection, an education and introductory phase occurred for the subsequent two months, with a change team consisting of a senior anaesthetist, surgeon, perioperative (nursing) care co-ordinator and project officer, along with representatives from surgical nursing and allied health. The evidence-based background of ERAS was sent to all surgical, anaesthetic and nursing staff by the team, and local meetings were held. After the two-month educational phase the change team monitored patient management for ERAS bundle compliance with the aim of maximally incorporating it into routine practice for the remainder of the project. The post-ERAS intervention phase occurred for five months following the completed implementation phase, during which identical perioperative data were collected.
The study was approved by the Ethics Committee of each hospital, with endorsement of the waiver for patient consent in view of this being a quality improvement project. Adult patients undergoing elective abdominal surgery involving a laparotomy incision or laparoscopic colorectal surgery were included. Patients were excluded if they were undergoing vascular, inguinal hernia, gynaecological or urological surgery.
An ERAS treatment bundle derived from systematic reviews (5,6,9) and published recommendations (7,11) was defined before commencing the study (Table 1). A clinical pathway was designed aiming for hospital discharge by postoperative day 5.
We used recommended indicators to characterise the ERAS program (6,12). Indicators influenced by the ERAS program included: 1) Financial (hospital stay); 2) Clinical processes (intravenous fluid volume; pain and nausea scores and intensive care unit stay) and outcomes (complications, hospital readmission, mortality); and 3) Service (global quality of recovery).
The primary endpoint of the study was adherence to the ERAS treatment bundle, using the median number of successfully implemented ERAS items. Secondary endpoints included hospital stay and each of the outcome measures. We initially identified 13 items from the ERAS bundle that could be readily quantified on our database, but later amended this to 14 to include use of any local anaesthetic technique (Table 1) and a score of 1 was given to each. We chose a score of 8 or more to define successful program implementation.
Patient and surgery characteristics
Patients' demographic, co-morbidity, usual medication, surgical and anaesthetic data were collected. The risk of postoperative morbidity and mortality, and thus casemix, was defined by using the American Society of Anesthesiologists (ASA) physical status classification and the Portsmouth modification of the Physiologic and Operative Severity Score for Enumeration of Mortality and Morbidity (P-POSSUM) system (1,15). Physical functioning was determined by the Duke Activity Status Index (16). Surgery was classified as minor, moderate, major or complex major, according to the degree of and expected duration of surgery, as well as the expected postoperative inflammatory response (1,15).
Intraoperative data were recorded in real-time by the anaesthetist. During the daily audits by the local project officer, current surgical and perioperative practices were recorded from hospital paper and electronic sources. An 11-point (0=no pain, to 10=worst pain ever) verbal rating scale was used to measure pain at rest and on movement. Opioid usage was reported in morphine equivalents, with oral oxycodone dosage conversion using a ratio of 2:3. Wound infection and other complications were classified according to established criteria (17-20).
Definition of complications
1. Reoperation--a return to theatre within 30 days.
2. Hospital readmission--patient readmitted to hospital within 30 days.
3. Thromboembolism--symptomatic deep vein thrombosis or pulmonary embolism confirmed by medical imaging or autopsy.
4. Myocardial infarction--confirmed by electrocardiography and/or troponin rise.
5. Respiratory--pneumothorax, atelectasis, or pneumonia--confirmed by chest X-ray; for pneumonia: also two or more of temperatures >38[degrees]C, white cell count >12 x [10.sup.9]/l, positive sputum culture.
6. Urinary tract infection--The presence of >105 bacteria/ml with the presence of white cells in the urine in previously clear urine.
7. Acute kidney injury as defined by the Acute Kidney Injury Network criteria (21). Absolute increase in serum creatinine of [greater than or equal to] 26.4 [micro]mol/l ([greater than or equal to] 0.3 mg/dl) or a relative increase in serum creatinine of 50% or more.
8. Ileus--documented cessation of bowel function with a variable reduction in motility.
9. Intra-abdominal collection--documented clinically or radiologically.
10. Wound infection--purulent discharge or a positive microbial culture.
11. 30-day mortality--death at 30 days postoperatively due to any cause.
A required sample size of 450 (225 per group) was calculated based on a change in ERAS bundle uptake from 50 to 65% (A=0.05, B=0.2). Inferential statistics were calculated by the Student's t-test if normally distributed or otherwise with the Mann-Whitney U test. Hospital length of stay was expected to be skewed and so we did a logarithmic transformation to calculate geometric mean in order to compare groups with a t-test (22). Intergroup frequencies were compared with the chi-square test. Continuous data are reported as mean (SD) and/or median (interquartile range [IQR]). Linear regression analysis was used to adjust for P-POSSUM scores and extent of surgery to account for imbalance in casemix in the comparison of the geometric mean hospital stay. A P value <0.05 was considered significant.
We recruited 323 subjects in the 12 month period for which we were funded. The pre--and post-ERAS cohorts had comparable demographic and perioperative characteristics, as well as P-POSSUM scores (Table 2). Post-ERAS patients tended to be older with higher rates of hypertension and coronary heart disease, and at higher risk of postoperative nausea and vomiting (PONV). Patients in the post-ERAS cohort underwent more colorectal and hepatobiliary surgery, but underwent less extensive surgery.
Characteristics of anaesthesia and perioperative care
The use of ERAS-recommended items was significantly higher in the post-implementation phase (Table 3 and Figure 1). The use of preoperative oral nutritional supplementation, nausea prophylaxis, less opioid administration in the 48 to 72 hour postoperative period, earlier oral fluid and solids intake, and earlier ambulation after surgery were all significantly improved. Intravenous fluid administration was substantially reduced intra--and postoperatively. The post-implementation cohort had higher rates of successful ERAS treatment bundle adherence, 68 vs 83%, P=0.001.
Recovery profile and hospital stay
The post-ERAS cohort had higher rates of postoperative oral nutritional supplementation (Table 4). Markers of comfort and restoration of normal function, including pain scores and nausea scores, were significantly improved.
ERAS patients had significantly shorter hospital stay, geometric mean (SD) 5.7 (2.5) vs 7.4 (2.1) days, P=0.006; median (IQR) 6.2 (4 to 10) vs 7.0 (5 to 11) days, P=0.026. When the effect of ERAS was adjusted for differences in P-POSSUM scores and extent of surgery, the reduction in length of stay remained significant (P=0.012). Those who had successfully achieved at least 8 ERAS items had a shorter hospital stay when compared with those who did not, geometric mean 6.0 (2.4) vs 7.8 (2.2) days, P=0.029.
There were no significant differences in the rates of complications after surgery, including rates of hospital re-admission (Table 5). The overall rates of complications (excluding PONV, re-operation and readmission) were comparable, 31 vs 32% (P=0.78).
[FIGURE 1 OMITTED]
Implementation of a comprehensive ERAS program into three Victorian hospitals with a two-month education and implementation phase has been demonstrated. we have shown an increase in delivery of ERAS bundle of care principles from 68 to 83%. This was associated with improvement in postoperative recovery as defined by lower pain and nausea scores, earlier feeding and mobilisation. There was also an associated reduction in hospital stay with no risk of additional complications. Our reoperation and hospital readmission rates were not increased, and were lower than that reported by others (310,23,24).
Despite these positive findings, variation and poor uptake was noted in some of the key ERAS items across the three hospitals and few patients achieved high (>80%) compliance. The amount of intravenous fluid administered during and after surgery was higher than that recommended by others (9). we observed only a small increase in the number of implemented ERAS items, from a median of 8 to 9 items. Our defined successful ERAS implementation, increasing from 68 to 83%, could have been achieved with only one additional item because we started close to 8 ERAS items in the pre-implementation phase.
Despite a study design that aimed to eliminate bias, it is acknowledged that the pre--and post-ERAS group are not well matched in the type of surgery performed. Because this was a non-blinded study it is acknowledged an element of Hawthorne effect cannot be excluded. The pre--and post-ERAS patient numbers were 164 and 159 respectively; the total number of 225 patients per group was not achieved. Despite the post-ERAS group being at higher risk as assessed by the P-POSSUM score, a higher proportion of major cases were in the pre-ERAS group; the latter would be expected to have a longer expected hospital stay and, because it is not a contemporaneous control group, caution should be used in interpreting the results and fully attributing improvements to the use of the ERAS protocol. One of the ERAS principles is to minimise the size of surgical incisions and thus consider laparoscopic rather than open approaches to surgery--this may be one explanation for the reduced extent of surgery in the post-ERAS group. Future data acquisition under an ERAS protocol may allow comparisons within individual craft groups. The study was not powered to reliably detect possible complications of an ERAS program. The large number of statistical comparisons will increase the chances of type I errors.
The existence of an ERAS project co-ordinator was considered an important constituent for successful ERAS implementation. Regular communication between disciplines including presentations, 'in-service' training and email-based circulation of information took place. Specific attention was given at junior medical staff changeover throughout the year to ensure awareness of the program and assist with compliance.
Anecdotally, each of the three hospitals reported very positive feedback from ERAS patients regarding their care before and after surgery. Many patients commented on the special value of receiving the personalised phone call from the hospital in the weeks after their surgery that was part of the ERAS package. The purpose of this follow-up was to monitor and ensure that enhanced recovery was not associated with increased morbidity or need for readmission. Improved relationships across the various disciplines caring for surgical patients throughout the hospital were also reported. Improved co-ordination in patient follow-up after surgery was found to greatly improve staff, patient and family satisfaction with the care delivered.
Although increased uptake rates of ERAS principles in the anaesthesia care of patients having major abdominal surgery have been demonstrated, there remain opportunities to further improve and implement these principles into care. Sustained change is likely to require ongoing active processes to monitor and correct reversion to old habits and practices. Smoking cessation was not improved prior to surgery, but most patients were reviewed only one to two weeks before their admission. Nevertheless this opportunity for health promotion and reduced perioperative risk should not be missed (25). Doctors are notoriously resistant to the use of protocols (5), but non-adherence to clinical guidelines or pathways is most often related to either a lack of awareness of their existence or busy work schedules. More extensive pre-admission and surgical nursing education and support could lead to further improvements.
we gratefully acknowledge the expert clinical care and cooperation of numerous clinicians at each of the hospitals, including: i) Anaesthetist: Michele Joseph; ii) Surgeons: Peter Nottle, Roger Wale, David watters, Simon Crowley, Darrin Goodall wilson, Mal Steele, Michael Grigg; iii) Nurses: Anne Spranklin, Ross O'Brien, Vanessa Cuthbert; Vicki wall, wendy Brack, Sarah Burns, Lauren Savage; iv) Dieticians: Ibolya Nyulasi, Sarah Jukes, Michelle McPhee, Anna Boltong; v) Physiotherapists: Jim Sayer, Gemma Taylor, Val Bulmer, Pratichi Vasavada; vi) Occupational Therapist: Kristen Payne; vii) Stomal therapist: Stefan Demur.
A Commonwealth grant from the Department of Health was provided to undertake the ERAS program at the three Victorian Hospitals.
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E. G. E. THOMPSON *, S. T. GOWER ([dagger]), D. S. BEILBY ([double dagger]), S. SOPHIE ([section]), S. TOMLINSON **, G. D. GUEST ([dagger]) ([dagger]), R. RICHARD ([double dagger])([double dagger]), J. S. SERPELL ([section]) ([section]), P. S. MYLES ***
Department of Anaesthesia and Perioperative Medicine, Alfred Hospital, Melbourne; Department of Anaesthesia, Geelong Hospital, Geelong and Department of Anaesthesia, Box Hill Hospital, Melbourne, Victoria, Australia
* MB, ChB, FRCA, FANZCA, Grad Cert Clin Res Meth, Consultant Anaesthetist, Department of Anaesthesia and Perioperative Medicine.
([dagger]) MB, BS, FANZCA, Consultant Anaesthetist, Department of Anaesthesia, Geelong Hospital.
([double dagger]) MB, BS, FANZCA, Director and Senior Lecturer, Department of Anaesthesia, Box Hill Hospital and Monash University.
([section]) BSc, MPH, Research Manager, Department of Anaesthesia and Perioperative Medicine.
** MB, ChB, FANZCA, Director, Department of Anaesthesia, Geelong Hospital.
([dagger]) ([dagger]) MB, BS, FRACS, Senior Lecturer, Department of Anaesthesia, Geelong Hospital and University of Melbourne.
([double dagger]) ([double dagger]) MB, BS, FRACS, Associate Professor and Director, Department of Hepatic-Pancreatic-Biliary/Upper Gastrointestinal Surgery, Box Hill Hospital and Monash University.
([section])([section]) MB, BS, MD, FRACS, FACS, Professor and Director, Department of General Surgery, Alfred Hospital and Monash University.
*** MB, BS, MPH, MD, FCARCSI, FANZCA, Director, Department of Anaesthesia and Perioperative Medicine.
Address for correspondence: Dr G. Thompson, email: g.thompson@ alfred.org.au
Accepted for publication on January 10, 2012.
Table 1 Anaesthesia roles within an ERAS treatment bundle (derived from references (5,6,7,9,11) Anaesthetist role ERAS team roles 1. Preoperative Patient education and counselling Patient education and counselling Counselling on expectations and Printed information patient's personal role for recovery after surgery Minimum fasting: 2 h for fluids, Avoidance of bowel preparation * 6 h for solids * Carbohydrate loading on morning of surgery * 2. Intraoperative Antimicrobial prophylaxis within Avoid drain tubes * 60 min of skin incision * Local anaesthesia techniques Any local anaesthesia technique recommended included * Avoid nasogastric tube * Avoid nasogastric tube * IV fluid therapy and blood pressure management * Restrict crystalloid maintenance to 5 ml/kg/h Equivolume colloid in event of excessive bleeding Use vasopressors in preference to more fluid to maintain BP Avoid hypothermia * Monitor patient temperature Forced air body warmer Warmed intravenous fluids Thromboprophylaxis as per local protocol * Double-therapy for postoperative nausea vomiting prophylaxis in those with 2 risk factors * Postoperative analgesia plan Multimodal including a non- steroidal anti-inflammatory drug (unless contraindicated) Paracetamol for laparoscopic surgery only 3. Postoperative Fluid therapy * Oral fluids 2-4 h post surgery; target [less than or equal to] 2000 ml * IV fluid restricted to 4 ml/kg/h Urinary catheter (if used) removed morning after surgery (unless epidural in situ) * Oral analgesia Early ([less than or equal to] 24 h) change to include oral analgesia * Transition made to oral analgesia at earliest opportunity (day 2 or 3) Regular oral non-steroidal anti- inflammatory drug and paracetamol; oxycodone for breakthrough pain 4. Enhanced postoperative recovery Nutrition * Aim to commence oral nutritional supplement 4 h after surgery, and continue until normal level of food intake achieved Early mobilisation * Early ([less than or equal to] 24 h) mobilisation * Adequate analgesia Nurse in environment that encourages independence and mobilisation Adequate nausea, vomiting Physiotherapy and breathing propyhlaxis and treatment exercises recommended 5. Expedited discharge Discharge planning commences in surgeons' rooms and preadmission clinic Follow-up and adequate continuity of care Clinic-based review service established in view of greater likelihood of readmission (e.g. anastomotic leak or other major complication) * Items quantified to measure adherence to the ERAS treatment bundle. ERAS=enhanced recovery after surgery. Table 2 Study population: casemix Variables Pre-ERAS, ERAS, P value n = 154 n = 169 Male gender 82 (53%) 85 (50%) 0.60 Age, y 59 (16) 63 (15) 0.045 Height, cm 166 (12) 167 (10) 0.76 Weight, kg 79.7 (22) 76 (16) 0.14 BMI, kg/[m.sup.2] 29 (9) 0.056 Systolic BP, mmHg 131 (19) 133 (19) 0.32 Diastolic BP, mmHg 77 (11) 76 (11) 0.32 Resting pulse rate, b/min 76 (11) 75 (14) 0.36 Past medical history Current smoker 29 (19%) 28 (17%) 0.59 cigarettess/day in 10 (5-20) 13 (5-25) 0.48 last 6 weeks Hypertension 56 (37%) 88 (52%) 0.005 Coronary artery disease 16 (10%) 36 (21%) 0.008 Heart failure 5 (3.2%) 8 (4.7%) 0.50 Cardiomyopathy 2 (1.3%) 5 (3%) 0.45 Myocardial infarction 11 (7%) 19 (11%) 0.2 Peripheral vascular 3 (1.9%) 9 (5.4%) 0.1 disease Diabetes 28 (18%) 31 (18%) 0.97 Chronic liver disease 4 (2.6%) 4 (2.4%) >0.99 Peripheral oedema 4 (3%) 9 (5%) 0.21 Previous laparotomy 68 (44%) 91 (54%) 0.08 Chronic pain 22 (14%) 16 (10%) 0.18 Lives alone 36 (23%) 34 (20%) 0.48 Duke Activity Status 29.7 (16) 30 (13.2) 0.92 Index (16) P-POSSUM physiological score 17 (14-22) 17 (14-23) 0.14 operative severity score 11 (10-13) 11 (9-14) 0.69 predicted mortality, % 1.3 (0.7-3.1) 1.6 (0.8-4.2) 0.16 Type of surgery <0.0001 Colorectal 71 (46%) 94 (56%) Gastric 24 (16%) 7 (4%) Small bowel 20 (13%) 19 (11%) Hepatobiliary 17 (11%) 43 (25%) Oesophageal 6 (4%) 6 (4%) Other 16 (10%) 0 Extent of surgery 0.001 Minor 4 (3%) 11 (7%) Moderate 38 (25%) 74 (44%) Major 100 (65%) 70 (41%) Complex major 12 (8%) 14 (8%) Surgery technique 0.13 Laparoscopic 36 (23%) 33 (20%) Laparoscopic-assisted 8 (5%) 19 (11%) Open 110 (71%) 117 (69%) Mean (SD), median (IQR) or n (%). ERAS=enhanced recovery after surgery, BMI=body mass index, BP=blood pressure, P-POSSUM=Portsmouth modification of the Physiologic and Operative Severity Score for Enumeration of Mortality and Morbidity. Table 3 Perioperative care Pre-ERAS, ERAS, P value n = 154 n = 169 Intraoperative IV fluid warmer 120 (78%) 115 (68%) 0.046 Forced air warmer 150 (97%) 166 (98%) 0.71 Thromboprophylaxis 123 (80%) 142 (84%) 0.33 Local anaesthetic techniques Epidural 18 (12%) 18 (11%) 0.77 Spinal 0 4 (2.4%) 0.12 Transversus abdominis plane 32 (21%) 36 (21%) 0.91 block Nerve block 4 (2.6%) 1 (0.6%) 0.20 Wound infusion catheter 10 (7%) 6 (4%) 0.22 Local infiltration 83 (54%) 114 (68%) 0.012 Morphine, mg 10 (1.5-15) 10 (0-10) 0.077 Antiemetic prophylaxis Antiemetic 123 (80%) 153 (91%) 0.004 Lowest body temperature, 36.3 (0.6) 36.4 (0.5) 0.23 [degrees]C Intraoperative IV fluid therapy Crystalloid + colloid, ml 2269 (1284) 1590 (1073) <0.0001 Total infusion rate, ml/kg/h 12 (6.6) 9.0 (5.1) <0.0001 Cumulative IV fluid Recovery room, ml 2802 (1570) 1950 (1281) <0.0001 At 24 h, ml 5315 (1973) 4225 (2295) <0.0001 At 48 h, ml 7248 (2475) 5510 (3222) <0.0001 At 72 h, ml 8603 (2992) 6434 (3986) <0.0001 ERAS No. of items achieved 8 (7-9) 9 (8-10) <0.0001 ERAS ([greater than or equal to] 104 (68%) 141 (83%) 0.001 8 items) implemented Mean (SD), median (IQR) or n (%). ERAS=enhanced recovery after surgery, IV=intravenous. Table 4 Recovery measures Pre-ERAS, ERAS, P value n = 154 n = 169 Recovery room Body temperature on arrival, 36.5 (4.2) 36.9 (0.4) 0.38 [degrees]C Pain score at rest 3.5 (3) 2.6 (2.8) 0.008 Pain score on movement 5.4 (9) 3.2 (3.1) 0.01 Morphine, mg 5.4 (6.8) 4.6 (6.3) 0.25 Postoperative PONV score at 24 h 1 (0-2) 1 (0-1) 0.012 at 48 h 0.7 (0-1) 0 (0-1) 0.016 Time to oral fluids, h 16 (6-28) 6.0 (3.7-19) <0.0001 Time to oral solids, h 68 (27-120) 25 (17-52) <0.0001 Time to defaecation, h 80 (48-130) 73 (44-117) 0.23 Time to ambulation, h 23 (19-45) 19 (8.3-25) <0.0001 Morphine consumption, mg 0-24 h 33 (10-58) 27 (11-49) 0.29 0-72 h 58 (21-117) 40 (17-97) 0.10 Pain score on movement at 24 h 4.4 (2.7) 4.6 (3) 0.61 Length of stay, days median (IQR) 7.0 (5.0-11) 6.2 (4.0-10) 0.026 geometric mean (SD) 7.4 (2.1) 5.7 (2.5) 0.006 Mean (SD), median (IQR) or n (%). ERAS=enhanced recovery after surgery, PONV= postoperative nausea and vomiting, IQR=interquartile range. Table 5 Postoperative complications * Complications Pre-ERAS, ERAS, P value n = 154 n = 169 Reoperation 9 (5.8%) 9 (5.3%) 0.84 Hospital readmission 24 (16%) 19 (11%) 0.25 Thromboembolism 0 3 (1.8%) 0.25 Myocardial infarction 2 (1.3%) 3 (1.8%) >0.99 Respiratory 3 (1.9%) 6 (3.6%) 0.51 Urinary tract infection 5 (3.2%) 12 (7.1%) 0.12 Acute kidney injury 10 (6.5%) 15 (8.9%) 0.42 Ileus 10 (6.5%) 14 (8.3%) 0.54 Intra-abdominal collection 8 (5.2%) 3 (1.8%) 0.091 Wound infection 24 (16%) 24 (14%) 0.73 30-day mortality 2 (1.3%) 2 (1.2%) >0.99 N (%). * See text for details. ERAS=enhanced recovery after surgery.
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|Author:||Thompson, E.G.E.; Gower, S.T.; Beilby, D.S.; Sophie, S.; Tomlinson, S.; Guest, G.D.; Richard, R.; Se|
|Publication:||Anaesthesia and Intensive Care|
|Date:||May 1, 2012|
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