oral bowel preparation and preoperative fasting/media/grandroundsmedia/2016/cme... · goal of eras...

ERAS

Presented by

Timothy L. Beard MD, FACS, CPI

Bend Memorial Clinic

Outline

• Definition

• Justification

• Ileus

• Pain

Outline

• Specifics

• Data

• BMC Data

• Worldwide Data

• Implementation

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

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.

Getting Popular

Why Me?

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

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

Studies as PI

Phase III Protocol #14CL314, Multicenter, Double-

Blind, Placebo-Controlled, Parallel Study of

Alvimopan for the Management of Post-

Operative Ileus 2005

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

Cystectomy Trial

Great Article

Survey

Pain

Elements of ERAS

• Pre-OP

• Intra-OP

• Post-OP

Develop Clinical Specifics

and Standardization of Care

Clinic

Prep

Inpatient and ICU unit

PACU (pain control and mobilization)

Post-op pain control plan

Factors Influencing Patient Recovery

Benefits

44

Example of Enhanced Recovery Elements

45

Referral from

Primary Care

Pre-

Operativ

e

Admissio

n

Intra-

Operative

Post-

Operativ

e

Follow

Up

• 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

• 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

• 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

• Admission on day

• Optimised Fluid

Hydration

• CHO Loading

• Reduced starvation

• No / reduced oral bowel

preparation ( bowel

surgery)

• DX when criteria met

• Therapy support (stoma,

physio)

• 24hr telephone follow up

• Optimising pre operative

haemoglobin levels

• Managing pre existing co

morbidities e.g. diabetes

The Bible

Pre-Op

• Preadmission counseling

• Fluid and Carbohydrate Loading

• No Prolonged Fasting

• No/Selective Bowel Prep

Pre-Op

• Antibiotic Prophylaxis

• Thromboprophylaxis

• No Pre-Meds

Intra-Op

• Short-acting anesthetic agents

• Epidural or other regional block

• PONV prophylaxis

• Limit Fluids

Intra-Op

• No NGT

• No Drains

• Lap Approach if Possible

• Normothermia

Post-Op

• Early Removal of Foley

• Early Feeding

• Early Ambulation

• Limit IVF

Post-Op

• Multi-Modal pain management

• Epidural

• Non-Opioids

Complete Guidelines

ERAS Results

Type of Operation Duration of stay

Carotid endarterectomy 1-2 days

Lung lobectomy 1-2 days

Prostatectomy 1-2 days

Colectomy 1-3 days

Aortic Aneurysm 3-4 days

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

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 trials1-4

•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;240:728-734.

2. Delaney CR, et al. Dis Colon Rectum. 2005;48:1114-1125.

3. Viscusi ER, et al. Surg Endosc. 2006;20:64-70.

4. Ludwig K, et al. Arch Surg. 2008;143(11):1098-1105

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

Pre-

pathway

(n = 19)

Post-

pathway

(n = 26)

Alvimopan +

pathway

(n = 25)

Male, n (%) NA 14 (53.8) 10 (40.0)

Mean age, years NA 67.1 73.9

Type of BR surgery,a %

Low anterior resection

Right colectomy

Transverse colectomy

Other

36.8

42.1

0

21.1

19.2

46.2

15.4

19.2

24.0

48.0

0

28.0

Mean length of surgery, min NA 81.0 65.7

Abbreviations: BR, bowel resection; NA, not available. aAll BRs performed via laparotomy.

Alvimopan Reduced Length

of Stay (LOS)

7.57.1

5.3

0

1

2

3

4

5

6

7

8

9

10

Pre-pathway Post-pathway Alvimopan +

pathway

Mean

LO

S,

days

• LOS > 5 days was observed in 84%, 77%, and 32% of patients in the pre-pathway, post-pathway, and alvimopan + pathway groups, respectively

P = 0.5724 P = 0.0040

P = 0.0005

Unpaired 2-tailed P values were calculated using a t-test.

Alvimopan Reduced Time to First

Postoperative Bowel Movement

4.6

3.6

0

1

2

3

4

5

Post-pathway Alvimopan + pathway

Mean

tim

e t

o f

irst

po

sto

pera

tive B

M,

days

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.

P = 0.0084

Alvimopan Reduced the Need for

Nasogastric Tube (NGT) Reinsertion

and Readmissiona

0

19.2

0

5

10

15

20

Pa

tie

nts

re

qu

irin

g N

GT

, %

0

7.7

0

2

4

6

8

10

Pa

tie

nts

re

qu

irin

g r

ea

dm

iss

ion

, %

Post-

pathway

Alvimopan

+ pathway

Post-

pathway

Alvimopan

+ pathway

aThere 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 pre-

pathway group.

Alvimopan Appeared to Reduce Total

Adjusted Hospital Costsa

$29,860

$25,725

-

10,000

20,000

30,000

Post-pathway Alvimopan + pathway

Mean

to

tal

ad

juste

d h

osp

ital

co

sts

, U

S $

aCost 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 pre-

pathway group.

0

Byron Holloway MS 4

WesternU/COMP

Timothy L. Beard MD, FACS

Bend Memorial Clinic

Alvimopan Use in

Laparoscopic Bowel

Resections

Retrospective Review

BMC is a multi-specialty clinic with over 80

providers and 5 general surgeons

Data collected from 2009 - early 2012

Extensive chart review

Bend Memorial Clinic Study

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

Data

N=37

Average age 61.5 range 33-93

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

Alvimopan Group

N=44

Ave. age 64.02 range 33-85

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.

Control Group

Length of stay decreased 4.81 to 4.25

P value is 0.0075

Statistically significant difference

Length of Stay

BMC Outcomes with

Laparoscopic Colon Resections

Length of hospital stay (days)

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

Complications

Experimental group= Enhanced Recovery After Surgery (ERAS)

Control = Traditional Care (TC)

Readmissions (days)

Experimental group= Enhanced Recovery After Surgery (ERAS)

Control = Traditional Care (TC)

Mortality

Experimental group= Enhanced Recovery After Surgery (ERAS)

Control = Traditional Care (TC)

Results

Website

Can we do this at SCMC?

• Barriers

• Cost

• Physicians

• Admin

We Can Do IT

• ERAS website

• ERAS Society help

Well Rounded Team

Questions?