perioperative nutritional management · perioperative nutritional management federico bozzetti...
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PERIOPERATIVE NUTRITIONAL
MANAGEMENT
Federico Bozzetti
Faculty of Medicine, University of Milan, Italy
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TOPICS
● A historical perspective
● Lessons from RCT and meta-analyses
PN vs no specialised support (SS)
EN vs no specialised support (SS)
PN vs EN
IEEN vs EN
● The Milan experience
● Conclusions
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TOPIC
● A historical perspective
● Lessons from RCT and meta-analyses
PN vs no specialised support (SS)
EN vs no specialised support (SS)
PN vs EN
IEEN vs EN
● The Milan experience
● Conclusions
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A historical perspective
RATIONALE
• Malnutrition increases
postop complications
• Starvation of the gut
is deleterious
• Complications are
related to immune
suppression
CLINICAL APPROACH
• TPN in malnourished
pts (Holter&Fischer 1977)
• EN in surgical
patients (Bower et al 1986)
• Use of immune-
enriched EN formulae
(Daly et al 1992)
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TOPIC
● A historical perspective
● Lessons from RCT and meta-analyses
PN vs no specialised support (SS)
EN vs no specialised support (SS)
PN vs EN
IEEN vs EN
● The Milan experience
● Conclusions
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AUTHOR YEAR PREOPERATIVE POSTOPERATIVE
# n # n
Klein et al 1997 13 (1358) 9 (754)
Torosian 1999 14 (1245) 8 (710)
Braunschweig
et al 2001 2 (181)
Heyland et al 2001 11 (1165) 16 (1742)
Koretz et al 2001 25 (2164) 18 (482)
Preop PN vs no-SS (#:studies, n:patients)
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Preop PN vs no-SS
Results from meta-analyses
• No reduction of mortality
• 4 out of 5 showed a decrease of serious complications from 40% (control) to 30% (PN)
• >5 days of preop PN necessary to get a benefit
• >7 days of preop PN necessary in severely malnourished patients
• Preop PN is indicated only in the 5% of elective surgical patients who are severely malnourished
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Postop PN vs no-SS
• 9 studies (>700 patients, well and malnourished)
have compared PN to simple intravenous fluids
• 3 meta-analyses (Braunschweig et al 2001, Heyland et al 2001,
Koretz et al 2001)
• PN increased morbidity by 10%, mostly because
of septic complications
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Preop standard EN vs no-SS
• Four RCT (Shukla 1988, Foschi 1986, Fynn&Leighhty 1987,
von Meyenfeldt 1992)
• Few studies because this approach
became quickly obsolete
• Reduction of surgical complications
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Postop EN vs no-SS (from Koretz et al 2007)
• 13 RCTs, 1032 patients
• EN associated with fewer infections and a
tendency for fewer intra-abdominal or
intrathoracic complications
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Postop early vs later EN ( from Lewis et al 2009)
• 13 RCTs (7 TF, 6 ONS) , 1173 patients
• Lower mortality and shorter length of
stayIncrease
• Increase of vomiting in EEN
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PN vs EN
• 4 meta-analyses (Braunschweig et al 2001, Heyland et al
2001, Koretz et al 2001, Elia et al 2006)
• ~ 20 RCTs, ~1033 patients
• EN associated with fewer infections (RR
0.66), shorter hospital stay, no effect on
mortality
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Postop PN vs EN
Meta-analysis of Mazaki and Ebisawa (2008)
(29 RCTs, 2552 patients)
EN beneficial in the reduction of
• any complication (RR 0.85)
• any infectious complication (RR 0.69)
• anastomotic leaks (RR 0.67)
• intrabdominal abscesses (RR 0.63)
• duration of hospital stay (RR -0.81)
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IEEN vs EN (Marik and Zaloga 2010, Cerantola et al* 2010)
Meta-analysis* (21 RCTs, 2730 pts)
• IEEN; Arg, n-3FA, RNA (but 2 with Gln and n-3FA)
• Control: 9 isocal-isoN, 4 isocal
• Preop, postop, peri IEEN ↓ complications (OR: 0.48, 0.54, 0.39) ↓ infections (OR;0.36, 0.53, 0.41)
• IEEN reduced hospital stay by 2 days
• No difference in mortality
• 3 RCTs reported mean saving of 52%, 13% and 18%
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TOPIC
● A historical perspective
● Lessons from RCT and meta-analyses
PN vs no specialised support (SS)
EN vs no specialised support (SS)
PN vs EN
IEEN vs EN
● The Milan experience
● Conclusions
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The Milan experience
A wide literature supports the concept that
malnutrition adversely affects surgical outcome.
However, it is not clearly known whether a
perioperative nutritional support (and which one) has
a protective effect against complications when other
independent risk factors are accounted for.
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AIMS OF THE STUDY
To investigate the potential joint prognostic role upon the
occurrence of postoperative complications in GI surgery for
cancer of:
• baseline demographic, clinical and nutritional parameters
• type of nutritional support
• intraoperative factors
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PATIENTS & METHODS
We reanalysed databases of 1410 pts with GI cancer
included in 7 previous RCTs* on perioperative
nutritional support and receiving:
• standard intravenous fluid (SIF), n 149
• total parenteral nutrition (TPN), n 368
• enteral nutrition (EN), n 399
• immune-enhancing enteral nutrition (IEEN), n 500
* Gianotti (Arch Surg 1997), Braga (Arch Surg 1999), Bozzetti (JPEN 2000), Bozzetti (Lancet
2001), Braga (Crit Care Med 2001), Braga (Arch Surg 2002), Gianotti (Gastroenterology 2002)
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NUTRITIONAL REGIMEN per day
• SIF 400 to 900 kcal
• TPN 25 to 34 kcal/kg + 0.25g N/kg
• EN,IEEN 25 to 28 kcal/kg + 0.25g N/kg
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Definition of complications Wound infection Any redness/ tenderness of surgical wound with discharge of pus
Abdominal abscess Deep collection of pus
Pulmonary tract infection Abnormal chest X-ray with fever (>38° C) and WBC > 12.000 cells/mm3
and positive sputum or bronco-alveolar lavage.
Urinary tract infection More than 107 microorganisms per mL of urine
Bacteremia Two consecutive positive blood cultures without shock
Wound dehiscence Any dehiscence of the fascia longer than 3 cm.
Bleeding Necessity of blood transfusion ( 2 units)
Anastomotic leak Any dehiscence with clinical and radiologic evidence
Respiratory failure Presence of dyspnea and respiratory rate > 35/min or PaO2 < 70 mm Hg.
Circulatory insufficiency Unstable blood pressure requiring use of extra fluids and/or cardiac
stimulants
Renal dysfunction Increased serum urea and/or creatinine level (50% above baseline)
Renal failure Necessity of hemodialysis
Hepatic dysfunction Increased serum bilirubin level (50% above baseline)
Pancreatic fistula Daily output of fluid > 10 mL from surgical drainage with amylase level 5
times higher than serum concentration
Delayed gastric emptying Necessity of naso-gastric suction for more than 8 days after surgery
Multiple Organ Dysfunction
Syndrome (MODS)
A state of physiological derangement in which organ function is not
capable of maintaining homeostasis
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MAJOR COMPLICATIONS
• lethal
• requiring relaparotomy
• requiring transfer to ICU
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Statistical Methods
• Univariate analysis (Pearson’s 2 test)
• Multivariate analysis (logistic models)
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Main series characteristics (1) SIF TPN EN IEEN TOT P
% % % % % §
Sex 0.161
Male 53.7 59.8 60.1 54.0 57.2
Age (years) 0.333
22.8 23.6 21.9 22.2 22.6
56-65 33.6 32.6 34.9 30.6 32.6
66-75 33.6 36.1 33.3 33.4 34.1
> 75 10.1 7.6 9.9 13.8 10.7
Tumor site <0.000
Colon-rectum 35.6 33.4 38.2 40.4 37.4
Stomach 45.6 46.2 42.0 36.4 41.5
Pancreas 18.8 20.4 19.8 23.2 21.1
Weight loss <0.000
10% 31.5 83.7 69.0 36.0 57.2
Duration of surgery
(hrs)
<0.000
20.8 15.2 6.8 7.6 10.7
2.1-5.0 66.4 67.8 73.4 70.8 72.7
> 5 12.8 17.0 19.8 21.6 19.0
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Main series characteristics (2) SIF TPN EN IEEN TOT P
% % % % % §
Blood loss (mL) 0.274
> 500 26.0 36.7 34.6 34.6 34.4
Transfusions 0.109
Done 28.9 39.9 34.9 36.6 36.2
Haemoglobin (g/dL) 0.049
13.1 14.8 9.5 13.4 12.5
10.1-12.0 16.2 31.5 25.5 28.5 26.7
> 12.0 70.7 53.7 65.0 58.1 60.8
Lymphocytes
(x 1000/mmc)
17.2 26.1 23.5 25.9 23.8
1201-1500 22.8 30.3 30.1 20.1 25.1
> 1500 60.0 43.6 46.4 54.0 51.1
Albumin (g/dL) <0.000
3.4 20.3 15.6 4.5 10.4
3.1-3.5 24.0 32.8 32.1 19.5 26.2
> 3.5 72.6 46.9 52.3 76.0 63.4
0.016
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RESULTS
COMPLICATIONS
• Minor 32%
• Major 7%
• Mortality 2.1%
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Postoperative complications VARIABLE % pts with
complications
p
NUTRITION 0.000
SIF 50
TPN 43
EN 37
IEEN 33
AGE (yrs) 0.001
< 56 30
56-65 42
66-75 60
TUMOUR SITE <0.000
Colon-rectum 31
Stomach 40
Pancreas 51
WEIGHT LOSS <0.013
10% 42
< 10% 35
DURATION of SURGERY (hrs) 0.001
31
2.1-5.0 38
> 5.0 49
BLOOD LOSS (mL) 0.002
35
> 500 44
ALBUMIN (g/dL) 0.000
44
50
> 3.5 46
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Postoperative infectious complications
VARIABLE %pts with
complications P
NUTRITION * 0.000
SIF 40
TPN 26
EN 20
IEEN 13
AGE (yrs) 0.046
< 56 17
56-65 20
66-75 21
< 75 28
TUMOUR SITE 0.011
Colon-rectum 17
Stomach 21
Pancreas 26
WEIGHT LOSS* 0.009
10% 23
< 10% 17
TRANSFUSIONS 0.040
yes 24
no 19
ALBUMIN (g/dL) 0.000
25
3.1-3.5 26
> 3.5 18
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Multivariate analysis of risk factors for major complications OR P
§
Nutrition 0.002
TPN vs. SIF 0.39 0.19 - 0.80
EN vs. SIF 0.27 0.13 - 0.57
IEEN vs. SIF 0.32 0.16 - 0.63
Age (years) 0.050
56-65 vs. 55 1.48 0.72 - 3.05
66-75 vs. 55 1.55 0.77 - 3.12
> 75 vs. 55 3.05 1.35 - 6.86
Tumour site 0.004
Stomach vs. Colon-rectum 2.82 1.48 - 5.37
Pancreas vs. Colon-rectum 2.87 1.38 - 5.98
Weight loss ¶ -- 0.029
95% CI
--
§ Wald’s P for testing the overall association between the occurrence of complications
and main series characteristics
¶ OR and CI estimates are given only for categorical factors
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Weight Loss (%)
0 5 10 15 20 25 30 35
Pro
bab
ility
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
Standard
Parenteral
Enteral
Immune
Pro
ba
bilit
y o
f c
om
pli
ca
tio
ns
SIF
TPN
EN
IEEN
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CONCLUSIONS (I)
● Preop (→postop)PN
- rarely recommended (only in elective surgery)
- useful in malnourished hospitalized pts,with non
working gut, fed >7days *
● Postop PN
- recommended in pts with complications, unable to
be fed enterally for at least 7 days *
* Grade A by the ESPEN GL 2009
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CONCLUSIONS (II)
● Preop standard EN
- recommended in severely malnourished pts for 10-
14 d prior to major surgery *
● Postop (early) EN (TF or standard ONS)
- recommended after GI surgery *
● IEEN (preop, postop, peri) better than standard EN *
* GRADE A by ESPEN GL 2006
GRADE A by ESPEN GL
*
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CONCLUSIONS (III)
Future challenges
• Gln-enriched solutions in malnourished patients
• Comparison/integration with preop CHO load
• Restrictive fluids
• Fast track/ERAS protocols
• Anti-ileus agents (lidocaine, methylnaltrexone,
alvimopan, laxatives, opioid-sparing analgesia….)
• Probiotics
• …………..
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…knowledge is the enemy of
disease…