ERAS. Presented by Timothy L. Beard MD, FACS, CPI Bend Memorial Clinic

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1 ERAS Presented by Timothy L. Beard MD, FACS, CPI Bend Memorial Clinic

2 Outline Definition Justification Ileus Pain

3 Outline Specifics Data BMC Data Worldwide Data Implementation

4 What is ERAS? AKA Fast-track or ERP Developed by Kehlet in Denmark in colonic surgery Gradually has gained world-wide acceptance Originally described in Open Surgery but same advantages seem to apply for Laparoscopy Gustafsson/Scott

7 Goal of ERAS Implement a standardized, patient centered protocol. Integrate the pre-operative, intra-operative, post-operative and post-discharges phases of care to reduce LOS. Improve patient experience and satisfaction and decrease variability.

8 Getting Popular

9 Why Me?

10 Studies as PI A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of IV Ulimorelin Administered Post-Operatively to Accelerate GI Motility in Subjects Who Have Undergone a Partial Bowel Resection. 2010

11 Studies as PI Phase IIA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Post-Operative Ileus after Bowel Resections and Ventral Hernia Repairs 2007

12 Studies as PI Phase III Protocol #14CL314, Multicenter, Double- Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Post- Operative Ileus 2005

13 Studies as PI A Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing a Radical Cystectomy 2010

21 Cystectomy Trial

25 Great Article

32 Survey

33 Pain

41 Elements of ERAS Pre-OP Intra-OP Post-OP

42 Develop Clinical Specifics and Standardization of Care Clinic Prep Inpatient and ICU unit PACU (pain control and mobilization) Post-op pain control plan

43 Factors Influencing Patient Recovery

44 Benefits 44

45 Example of Enhanced Recovery Elements Referral from Primary Care Optimised health / medical condition Informed decision making Pre operative health & risk assessment PT information and expectation managed DX planning (EDD) Pre-operative therapy instruction as appropriate Optimising pre operative haemoglobin levels Managing pre existing co morbidities e.g. diabetes Pre- Operativ e Admissio n Minimally invasive surgery Use of transverse incisions (abdominal) No NG tube (bowel surgery) Use of regional / LA with sedation Epidural management (inc thoracic) Optimised fluid management Individualised goal directed fluid therapy Admission on day Optimised Fluid Hydration CHO Loading Reduced starvation No / reduced oral bowel preparation ( bowel surgery) Intra- Operative DX when criteria met Therapy support (stoma, physio) 24hr telephone follow up Planned mobilisation Rapid hydration & nourishment Appropriate IV therapy No wound drains No NG (bowel surgery) Catheters removed early Regular oral analgesia Paracetamol and NSAIDS Avoidance of systemic opiate-based analgesia where possible or administered topically Post- Operativ e Follow Up 45

46 The Bible

47 Pre-Op Preadmission counseling Fluid and Carbohydrate Loading No Prolonged Fasting No/Selective Bowel Prep

48 Pre-Op Antibiotic Prophylaxis Thromboprophylaxis No Pre-Meds

49 Intra-Op Short-acting anesthetic agents Epidural or other regional block PONV prophylaxis Limit Fluids

50 Intra-Op No NGT No Drains Lap Approach if Possible Normothermia

51 Post-Op Early Removal of Foley Early Feeding Early Ambulation Limit IVF

52 Post-Op Multi-Modal pain management Epidural Non-Opioids

53 Complete Guidelines

54 ERAS Results Type of Operation Carotid endarterectomy Lung lobectomy Prostatectomy Colectomy Aortic Aneurysm Duration of stay 1-2 days 1-2 days 1-2 days 1-3 days 3-4 days

55 Incorporation of Alvimopan (Entereg ) as Part of Perioperative Management of Patients Undergoing Colectomy: 1 Surgeon s Experience Timothy L. Beard, MD; Bob Cutter, PharmD; Emily Meeks; Karla Lichter, RN, CCRC Bend Memorial Clinic, Bend, Oregon

56 Study Design Independent study of patients undergoing open colectomy All patient data from same surgeon Conducted at Bend Memorial Clinic Multispecialty medical clinic with 85 physicians and 600 staff members Patients in 2 of 3 arms received a standardized accelerated postoperative care pathway (post-pathway or alvimopan + pathway) Based on alvimopan phase III clinical trials 1-4 Removal of NGT at the end of surgery or morning before first postoperative dose of alvimopan Early ambulation (initiated POD 1) Early diet advancement (liquids offered POD 1, solids offered POD 2) Abbreviations: NGT, nasogastric tube; POD, postoperative day. 1. Wolff BG, et al. Ann Surg. 2004;240: Delaney CR, et al. Dis Colon Rectum. 2005;48: Viscusi ER, et al. Surg Endosc. 2006;20: Ludwig K, et al. Arch Surg. 2008;143(11):

57 Study Design Treatment arms Type of analysis Enrollment dates Patients (n) Pre-pathway Retrospective 10/04-10/05 19 Post-pathway Retrospective 3/07-9/08 26 Alvimopan + pathway Prospective 7/08-5/09 25

Baseline Demographics and Surgery Characteristics Prepathway (n = 19) Postpathway (n = 26) Alvimopan + pathway (n = 25) Male, n (%) NA 14 (53.8) 10 (40.0) Mean age, years NA 67.1 73.

58 Baseline Demographics and Surgery Characteristics Prepathway (n = 19) Postpathway (n = 26) Alvimopan + pathway (n = 25) Male, n (%) NA 14 (53.8) 10 (40.0) Mean age, years NA Type of BR surgery, a % Low anterior resection Right colectomy Transverse colectomy Other Mean length of surgery, min NA Abbreviations: BR, bowel resection; NA, not available. a All BRs performed via laparotomy.

59 Mean LOS, days Alvimopan Reduced Length of Stay (LOS) P = P = P = Pre-pathway Post-pathway Alvimopan + pathway LOS > 5 days was observed in 84%, 77%, and 32% of patients in the pre-pathway, post-pathway, and alvimopan + pathway groups, respectively Unpaired 2-tailed P values were calculated using a t-test.

60 Mean time to first postoperative BM, days Alvimopan Reduced Time to First Postoperative Bowel Movement P = Post-pathway Alvimopan + pathway Note: Time to first bowel movement (BM) was not collected for patients in the pre-pathway group. Unpaired 2-tailed P values were calculated using a t-test.

61 Patients requiring NGT, % Patients requiring readmission, % Alvimopan Reduced the Need for Nasogastric Tube (NGT) Reinsertion and Readmission a Postpathway 0 Alvimopan + pathway 0 Postpathway 0 Alvimopan + pathway a There was 1 death in the alvimopan + pathway group; this was attributed to sepsis. Proportion of patients requiring NGT insertion or readmission was not collected for patients in the prepathway group.

62 Mean total adjusted hospital costs, US $ Alvimopan Appeared to Reduce Total Adjusted Hospital Costs a 30,000 $29,860 $25,725 20,000 10, Post-pathway Alvimopan + pathway a Cost data corrected for a specific fee increase that occurred 1/09; changes in billing practices occurred between the post-pathway and pathway + alvimopan groups. Total adjusted hospital costs were not calculated for patients in the prepathway group.

63 Alvimopan Use in Laparoscopic Bowel Resections Byron Holloway MS 4 WesternU/COMP Timothy L. Beard MD, FACS Bend Memorial Clinic

64 Bend Memorial Clinic Study Retrospective Review BMC is a multi-specialty clinic with over 80 providers and 5 general surgeons Data collected from early 2012 Extensive chart review

65 Data 37 pts in Entereg group 44 pts in control group No hand assisted cases All done by board certified surgeons Mix of right and left colon resections

66 Alvimopan Group N=37 Average age 61.5 range Ave length of stay 4.24 days range 3-6 Ave time to first BM 2.62 days range 1-5 No SAEs in this group

67 Control Group N=44 Ave. age range Ave. length of stay 4.84 days range 3-8 Ave. time to first BM 3.57 days range 2 to 6 No SAEs in this group One pt. excluded from this group.

68 Length of Stay Length of stay decreased 4.81 to 4.25 P value is Statistically significant difference

69 BMC Outcomes with Laparoscopic Colon Resections

70 Length of hospital stay (days) Experimental group= Enhanced Recovery After Surgery (ERAS) Control = Traditional Care (TC)

71 Complications Experimental group= Enhanced Recovery After Surgery (ERAS) Control = Traditional Care (TC)

72 Readmissions (days) Experimental group= Enhanced Recovery After Surgery (ERAS) Control = Traditional Care (TC)

73 Mortality Experimental group= Enhanced Recovery After Surgery (ERAS) Control = Traditional Care (TC)

74 Results

77 Website

78 Can we do this at SCMC? Barriers Cost Physicians Admin

79 We Can Do IT ERAS website ERAS Society help Well Rounded Team

80 Questions?

If you reduce variability in volume administration, HOW. you can reduce post-surgical complications, LOS and associated costs 1-4

A large body of clinical evidence* demonstrates If you reduce variability in volume administration, you can reduce post-surgical complications, LOS and associated costs 1-4 Complications Too Dry Too Wet