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Enhanced ColectomyRecovery:Impact of Postoperative Ileus

Anthony J. Senagore, MD, MS, MBAVP Research & Education

Spectrum HealthProfessor of Surgery

Michigan State UniversityGrand Rapids, MI

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Disclosure

Ethicon Endosurgery, Advisory Board Deltex Medical, Research Support Tranzyme Pharmaceutical, Advisory Board Adolor Corporation, Advisory Board and

Research Support Life Cell, Research Support

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Schilling et al. Prioritizing Quality Improvement in General Surgery. J Am Coll Surg. 2008;207:698–704.

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International Mean LOS

Kehlet et al. J Am Coll Surg 2006;202:45–54.

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NSQIP LOS Analysis

Cohen Ann Surg 2009;250: 901–907)

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Why the Outliers?

Cohen Ann Surg 2009;250: 901–907)

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In the UK Too (NBOCAP data)

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Clinical and Financial Significance

HCFA data (Medicare): 1999-2000 161,000 major intestinal / colorectal resections

mean post-op stay =11.3 days

1.8 million hospital bed-days

$1.75 billion per annum

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There Are Numerous Risk Factors for POI

POI Is Expected to Affect Almost

Every Patient Who Undergoes

Abdominal Surgery

Surgical Site

Extent ofBowel

Manipulation

Operation Time

PatientHealth

Systemic Infections

Amount of Opioids

PatientAge,

Gender, Race

Resnick J, et al. Am J Gastroenterol. 1997;92:751-762.Resnick J, et al. Am J Gastroenterol. 1997;92:934-940.Senagore AJ. Am J Health-Syst Pharm. 2007;64(suppl 13):S3-S7. Senagore AJ, et al. Surgery. 2007;142:478-486. Woods MS. Perspect Colon Rectal Surg. 2000;12:57-76.

♦ Ghrelin: Impacts multiple

mechanisms involved in POI Accelerates gastric

emptying Induces Migrating

Motor Complexes (MMCs)

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How Long Can POI Last?

Figure from Steinbrook RA. Contemp Surg. 2005; March(suppl):4; based on data from Wolff BC. Ann Surg. 2004; 240:728.

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Inhibitory Effects of Opioids on Bowel Function

Endogenous opioids

Released in response to surgical trauma/ manipulationHigher degrees of surgical

trauma/manipulation→ greater inflammation→ greater gut paralysis

Exogenous opioids

Commonly administered for postoperative pain Relationship between

amount of opioid administered and time to return of bowel function

Yoshida S, et al. Surg Endosc. 2000; 14:137–140; ff JC, et al. Ann Surg. 1998; 228:652–663; Cali, et al. Dis Colon Rectum. 2000; 43:163–168.

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Impact of Technique: Endogenous Morphine

Madbouly et al. British Journal of Surgery 2010; 97: 759–764

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Average Length of Stay: Technique matters

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Clinical Impact of POI1-4

1Woods MS. Perspect Colon Rectal Surg. 2000;12:57.3Behm B, Stollman N. Clin Gastroenterol Hepatol. 2003;1:71.

Increased postoperative pain Increased nausea and vomiting Increased risk of aspiration

Prolonged time to regular diet Delayed wound healing Increased risk of malnutrition/catabolism

Prolonged time to mobilization Increased pulmonary complications

Prolonged hospitalization Increased healthcare costs

Delayed recovery

2Kehlet H, Holte K. Am J Surg. 2001;182(5A suppl):3S.4Leslie JB. Ann Pharmacother. 2005; 39:1502.

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Hospital LOS and Total Costs

5.4

10.6

0

5

10

15 No coded POICoded POI

Mea

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n of

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ays

*P < 0.01 for patients with coded POI versus patients with no coded POI.

** **

9.9

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25No coded POICoded POI

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Primary POI (N=41)

Secondary POI (N=10)

Non POI (140)

Admission $ 31,629 $ 32,499 *$ 17,626Hospital $ 9,276 $ 8,891 *$ 3,672Pharmacy $ 47,118 $ 7,578 *$ 2,389Radiology $ 1,135 $ 1,954 *$ 189OR $ 11,389 $ 10,961 $ 10,391Labs $ 1,217 $ 556 *$ 556Other $ 1,514 $ 429 *$ 429

Cost data I.Index admission: SH colectomy

* p<0.05 ANOVA

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Cost data II.Readmission: SH colectomy

Delayed POI (N=11)

Other (N=17)

Admission $ 9,862 $11,978

Hospital $5,558 $5,988

Pharmacy $2,780 $3,257

Radiology $1,019 $946

OR $668

Labs $381 $592

Other $35 $528No statistical significance ANOVA

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Cost Data III.Total cost of care for entire cohort

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GI2* Recovery Following Bowel Resection

StudyPlacebo (Mean h)

ENTEREG (alvimopan)

12 mg(Mean h)

Difference(Mean h)

Hazard Ratio (95% CI)

1 111.8 92.0 19.8 1.533 (1.293, 1.816)

2 132.0 105.9 26.1 1.625 (1.256, 2.102)

3 130.3 116.4 14.0 1.365 (1.057, 1.764)

4 119.9 106.7 13.2 1.400 (1.035, 1.894)

5 109.5 98.8 10.7 1.299 (1.070, 1.575)

*GI2=time to toleration of solid food and first bowel movement.CI=confidence interval.

ENTEREG [prescribing information]. Exton, PA: Adolor Corporation; 2008.

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GI2 Recovery: 5 Alvimopan StudiesEs

timat

ed P

roba

bilit

y of

A

chie

ving

GI2

Rec

over

y

Hours After End of Surgery

1.00.90.80.70.60.50.40.30.20.10.0

0 24 48 72 96 120 144 168 192 216 240 264

ENTEREGPlacebo

ENTEREG [prescribing information]. Exton, PA: Adolor Corporation; 2008.

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Prospective Evaluation of Entereg

Post-Operative Ileus

HALS / Open LAP

AlvimopanControl

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Impact of POI with Entereg

Days

Open/No POI Open/POI Lap/No POI Lap/POI

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TZP-101 480µg/kg: Time to BM (Survival Analysis)

0 24 48 72 96 120 144 168

0

10

20

30

40

50

60

70

80

90

100

TZP-101 CL-005 POI TrialEnd of Surgery to First Bowel Movement

Hours After End of Surgery

Per

cent

of S

ubje

cts

Ach

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ndpo

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0 24 48 72 96 120 144 168

0

10

20

30

40

50

60

70

80

90

100

TZP-101 CL-005 POI TrialEnd of Surgery to First Bowel Movement

Hours After End of Surgery

Per

cent

of S

ubje

cts

Ach

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ndpo

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Placebo480 ug/kg

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Clinical pathway for planned 48hr stay

•• 60 patients60 patients•• colonic (not rectal) resectioncolonic (not rectal) resection•• multimodal pathway: multimodal pathway:

•• transverse and oblique incisionstransverse and oblique incisions•• epiduralepidural•• catharticcathartic•• prokineticprokinetic

•• median stay 2 days (mean = 4.1, median stay 2 days (mean = 4.1, 2828 failedfailed))•• 9 readmissions (15%), 2 deaths, 2 anastomotic leaks9 readmissions (15%), 2 deaths, 2 anastomotic leaks•• Did they go home??Did they go home??

(Basse (Basse et alet al, Ann Surg 2000), Ann Surg 2000)

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Enhanced Recovery Protocol

•• prepre--operative information and educationoperative information and education

•• no NG or epidurals usedno NG or epidurals used

•• PCA analgesia, supplementary i.v. toredolPCA analgesia, supplementary i.v. toredol

•• encouraged to ambulate x 5 per dayencouraged to ambulate x 5 per day

•• liquids liquids ad libad lib after surgeryafter surgery

•• diet from evening postdiet from evening post--op day 1op day 1

•• oral analgesia day 2 if tolerating dietoral analgesia day 2 if tolerating diet

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NG tube usage

Kehlet et al. J Am Coll Surg 2006;202:45–54.

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Time to general diet

Kehlet et al. J Am Coll Surg 2006;202:45–54.

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RCT of epidural in Lx colectomy (CCF) 42 randomized cases, three month period Pre-emptive thoracic epidural (marcain + fentanyl)

LAC+epi LAC+PCA p _

Nausea / vomiting 29% 29% nsPruritus 14% 5%VAS pain6h 2.2 6.6 <0.05

18h 2.2 4.0 <0.0536h 1.7 2.1 ns

LOS (d) 2.4 2.3 ns

Senagore, Delaney et al, Br J Surg 2003Senagore, Delaney et al, Br J Surg 2003

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Can it Work?

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Pre-operative Education

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ERP Standardized Order Set

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1

2

3

4

5

6

48 Hour VAS Score (Graded 1-10)

ERPFailed ERP

Results

Visual Analog Pain Scale Scores were significantly lower for the

ERP group

Graded on 1-10 severity scale with 10 as the most amount of possible

perceived pain

ERP: 3.57 +/- 2.73

Failed: 5.60 +/- 2.93

P < 0.05

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Results

0

10

20

30

40

50

60

Percent with Complications (All Kinds)

ERPFailed ERP

Total percent of patients with any medical or

surgical complication was lower in the ERP

group.

ERP: 14.51%

Failed: 47.94%

P < 0.05

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0

2

4

6

8

10

12

Percent with Anastamotic Leak

ERPFailed ERP

Results

Total percent of patients with an anastamotic leak was lower in the

ERP group.

ERP: 0.81%

Failed: 9.59%

P < 0.05

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Results

0

1

2

3

4

5

6

7

8

Length of Stay (Average Number ofDays)

ERPFailed ERP Hospital Length of Stay

in days was lower in the ERP group.

ERP: 3.41 +/- 1.2

Failed: 7.22 +/- 5.47

P < 0.05

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Departmental length of stay19911991--19991999 19991999 33--6/20006/2000

nn LOSLOS nn LOSLOS nn LOSLOS

DRG 148DRG 148study team study team 17841784 9.59.5 185185 8.68.6 6262 5.75.7 **other CR teamsother CR teams 64596459 9.89.8 824824 8.88.8 162162 10.110.1LaparoscopicLaparoscopic 2424 3.23.2 **

DRG 149DRG 149study teamstudy team 742742 6.46.4 6969 5.25.2 4444 3.53.5 ††other CR teamsother CR teams 22562256 6.46.4 327327 5.15.1 111111 4.54.5LaparoscopicLaparoscopic 1818 2.52.5 **

DRG 148 & 149DRG 148 & 149study teamstudy team 25262526 8.68.6 254254 7.77.7 106106 4.74.7 §§other CR teamsother CR teams 87158715 8.98.9 11511151 7.77.7 273273 7.77.7LaparoscopicLaparoscopic 4242 2.92.9 **

* * pp<0.0001; <0.0001; †† pp=0.002; =0.002; §§ pp<0.001, Student<0.001, Student’’s t tests t test

Delaney, Fazio, Senagore et al, Br J Surg, 2001

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Outcomes

N BMI OR Time

EBL Conv LOS (mean/med)

Right 314 29.2 88 95 9% 3.5/3.0Left 435 28.9 110 110 12% 3.8/2.0Total 61 25.7 189 185 11% 4.1/3.0Other 190 28.1 115 120 10% 3.9/2.0All 1000 28.3 112 135 11% 3.7/2.0

Senagore et al 2006 Am J Surg

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Does it work elsewhere?

20 Lap/fast track vs 20 Open/std OR time 109 min v 250 min Complications 25% v 45% LOS 3.6d v 8.3d Cost $4993 v $11383

Bosio R, Senagore AJ. Am J Surg 2007; 193(3):413-5

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“The 48 Hour Colectomy”

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“The 23 Hour Colectomy”

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DRG 148 assignment

0%

20%

40%

60%

80%

100%

Laparoscopy Open

BothPostopPreop

Patient Patient no.no.

** p<0.03p<0.03

**

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Professional Cut to Close Ratio

0

100

200

300

400

500

600

0 50 100 150 200 250 300 350 400

Prof CM per Day/OR Hour per Case

Prof

CM

per

Day

Professional Margin: Fee v OR time

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Is There a Down-side?

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Outcome of unplanned readmission (UR)

553 resections in 6 months; 56 UR (10%) No predictors (complications, WBC, Hb, antibiotics, co-

morbidity, fever, urgency, stoma, length of stay) Matched non-readmitted cases had shorter primary LOS (6 vs 5

days, p=0.04) UR had more periop. steroids (32 vs 17%, p=0.03) No adverse event related to delayed diagnosis

Conclusion: UR is unpredictable, not related to LOS, doesn’t affect overall outcome

Kiran, Delaney, Senagore et al, Ann SurgKiran, Delaney, Senagore et al, Ann Surg

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Why it works Fastrack pathways are a win-win

situation (reduction of POI and cardiopulmonary complications)

Include all groups nurses, residents, pharmacists, ET nurses

Evidence based Decisions not Compromise and consensus

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“… a new idea will not win by the strength of is arguments; it will only win when the old generation dies out and the new generation accepts it as fact.”

Max Planck