enhanced colectomyrecovery: impact of postoperative ileus · enhanced colectomyrecovery: impact of...
TRANSCRIPT
Spectrum Health
1
Enhanced ColectomyRecovery:Impact of Postoperative Ileus
Anthony J. Senagore, MD, MS, MBAVP Research & Education
Spectrum HealthProfessor of Surgery
Michigan State UniversityGrand Rapids, MI
Spectrum Health
Disclosure
Ethicon Endosurgery, Advisory Board Deltex Medical, Research Support Tranzyme Pharmaceutical, Advisory Board Adolor Corporation, Advisory Board and
Research Support Life Cell, Research Support
Spectrum Health
Schilling et al. Prioritizing Quality Improvement in General Surgery. J Am Coll Surg. 2008;207:698–704.
Spectrum Health
Spectrum Health
International Mean LOS
Kehlet et al. J Am Coll Surg 2006;202:45–54.
Spectrum Health
NSQIP LOS Analysis
Cohen Ann Surg 2009;250: 901–907)
Spectrum Health
Why the Outliers?
Cohen Ann Surg 2009;250: 901–907)
Spectrum Health
In the UK Too (NBOCAP data)
Spectrum Health
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
Spectrum Health
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)
Spectrum Health
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.
Spectrum Health
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.
Spectrum Health
Impact of Technique: Endogenous Morphine
Madbouly et al. British Journal of Surgery 2010; 97: 759–764
Spectrum Health
Average Length of Stay: Technique matters
02468
1012141618
Fles
hman
,99
Schl
acta
,99
Bocc
asan
ta,9
9Ca
nin-
Endr
e...
Nels
on,0
0He
ah,0
0Se
nago
re T
...
LapOpen
Spectrum Health
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.
Spectrum Health
Hospital LOS and Total Costs
5.4
10.6
0
5
10
15 No coded POICoded POI
Mea
n du
ratio
n of
hos
pita
l sta
y, d
ays
*P < 0.01 for patients with coded POI versus patients with no coded POI.
** **
9.9
16.3
0
5
10
15
20
25No coded POICoded POI
Mea
n ho
spita
l cos
ts p
er p
atie
nt, ×
$1,0
00
Spectrum Health
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
Spectrum Health
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
Spectrum Health
Cost Data III.Total cost of care for entire cohort
Spectrum Health202020
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.
Spectrum Health212121
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.
Spectrum Health
Prospective Evaluation of Entereg
Post-Operative Ileus
HALS / Open LAP
AlvimopanControl
Spectrum Health
Impact of POI with Entereg
Days
Open/No POI Open/POI Lap/No POI Lap/POI
Spectrum Health
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
ievi
ng E
ndpo
int
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
ievi
ng E
ndpo
int
Placebo480 ug/kg
Spectrum Health
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)
Spectrum Health
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
Spectrum Health
NG tube usage
Kehlet et al. J Am Coll Surg 2006;202:45–54.
Spectrum Health
Time to general diet
Kehlet et al. J Am Coll Surg 2006;202:45–54.
Spectrum Health
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
Spectrum Health
30
Can it Work?
Spectrum Health
Pre-operative Education
Spectrum Health
ERP Standardized Order Set
Spectrum Health
0
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
Spectrum Health
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
Spectrum Health
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
Spectrum Health
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
Spectrum Health
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
Spectrum Health
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
Spectrum Health
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
Spectrum Health
“The 48 Hour Colectomy”
Spectrum Health
“The 23 Hour Colectomy”
Spectrum Health
DRG 148 assignment
0%
20%
40%
60%
80%
100%
Laparoscopy Open
BothPostopPreop
Patient Patient no.no.
** p<0.03p<0.03
**
Spectrum Health
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
Spectrum Health
44
Is There a Down-side?
Spectrum Health
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
Spectrum Health
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
Spectrum Health
“… 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