Seminar 11.6.09

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Supervisors

A/Prof Shahjahan Khan

Dept of Mathematics and Computing, USQ

Prof M Ashraf Memon Dept of Surgery, Ipswich Hospital

Dept of Surgery, School of Medicine, UQ

Acknowledgement

Rossita Yunus

Dept of Mathematics and Computing, USQ

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Setting the scene

Newly diagnosedpancreatic cancer

Has had 6 months ofprogressive weight loss 80kg to 60kg

25% body weight loss

Poor appetite, vomitingafter meals, painassociated with eating =reduced nutritional intake

for >6 months Physically deconditioned

Evidence of moderatemuscle loss, mild fat loss

Early vs Traditional Postoperative Feeding

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Nutritional issues with Gastrointestinal

surgery patients

Common reasons forrequiring GIT surgery

Cancer of the GIT

Inflammatory boweldisease (Crohns Disease,

UC) Diverticular disease

Commonly at risk ofmalnutriton due to symptoms

Poor appetite, poor oralintake

Significant weight loss

Physically deconditioned

Malabsorption of nutrients

Nausea/Vomiting and/or

diarrhoea

Malnutrition is associated withsignificantly poorerpostoperative outcomes

Increased postoperativemortality

Increased risk ofpostoperativecomplications including

Infection

Wound breakdown

Anastomotic breakdown

Malnutrition may increaselength of hospital stay due toincreased complications andtherefore increase cost ofhealth care in these cases


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Postoperative Nutritional

Philosophies

Traditional practice

NBM prior to surgery

NBM and gastricdecompression until

bowel function resumedpost surgery

Diet progression oncegut working Clear fluids

free fluids soft/light diet

full diet

Rationale

Initially adopted to combatpost operative vomitingand subsequent concerns

Aspiration pneumonia Increase abdominal

pressureanastomoticrupture

Also thought to protectthe anastomosis byallowing gut rest andavoiding food passing thesurgical site


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Postoperative Nutritional

Philosophies

Early post-op feeding

Clear fluids to 3-4hrs pre-anaesthetic

Fluids or diet from firstpostoperative day

irrespective of resumptionof bowel function No NGT post op Often in the context of

multimodal approachincluding earlier mobilisation,

non-opioid analgesia, key-hole surgery

Rationale Gut secretes and reabsorbs

~7L fluid/d irrespective of oralintake, so protecting theanastomosis is based on a

false premise Many patients already

malnourishedmorepostoperative complications

Nausea/vomiting is much lessof a problem with new

anaesthetic agents Some evidence that early

feeding reduces the bodysstress response tosurgery/trauma


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The research

Increasing numbers of studies investigating thistopic dating from 1978 Tube feedingearly liquids early solids

Individual studies do not demonstrate major

adverse outcomes with early feeding Some suggestion of organisational benefits May decrease length of hospital stay and cost of

treatment

Reported adverse outcomes Nausea, vomiting, NG reinsertion (common)

? Respiratory complications1 study in thoracotomypatients stopped early


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Previously conducted meta-

analyses

Nutritional issues

Inclusion of immune-modulating EN products

Inclusion of studies feeding both proximal and distal toanastomoses

Nutrition provided at 24hrs post op may have includedclear fluidslittle nutritional value

Statistical issues

Fixed effects model of meta-analysis used in all (2008

publication also includes Random Effects Modelresults)

General issues

Appears to contain inconsistencies in inclusion criteriaof studies included

new RCTs published on this topic since 2006 not


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Objectives of the current work

To conduct a meta-analysis investigating the

benefit and harm of early vs traditional

postoperative feeding in gastrointestinal

resectional surgery patientsUtilising stricter nutritional parameters for

inclusion

Proximal feeding (ie nutrition must come in contact

with the surgical site)

Nutritionally significant provision in early stages

postop

More thorough literature review

Random effects model of meta-analysis


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Inclusion Criteria

Randomised controlled trials

Primary comparisons made between early (within24h) and traditional (NBM until bowel functionresumed) nutritional management followinggastrointestinal resectional surgery

Feeding proximal to the anastomosis

Elective surgery patients

Adults (>18yrs) English language publication

Reporting clinically relevant outcomes


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Exclusion criteria

Duplicate publications

Abstracts from conferences where full papers

were not accessible

Use of immune-modulating enteral feeding

products

Studies that utilised IV feeding in any

interventional arm


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Literature search

Electronic databases Medline

Pubmed

EMBASE

CINAHL Cochrane Register of

Systematic Reviews

Science Citation Index

Google Scholar

All availabletimeframes

LimitsRCTs, 19-80+

Search terms Early feeding

Colorectal

Gastric

Gastrointesintal Upper GI

Postoperative

Randomiz/sed

Prospective Oral

Enteral

Surgery


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Data extraction

Used QUOROM recommendations

21 point checklist devised by quality reporting inmeta-analysis group

QUOROM statement Data extraction form devised and used

Jadad score of methodological quality

0 = poor quality; 5 = high quality

Data extracted into Excel spreadsheet on allclinically relevant outcomes

Additional data requested from authors ifrequired


E l T di i l P i F di

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Statistical AnalysisSummary

stats

Odds Ratios for binary outcomes

OR = odds of event in intervention group/odds ofevent in control group ad/bc where a=event in intervention group, b=no event

in intervention group, c=event in control group, d= noevent in intervention group. cf RR = risk in intervention/risk in control or

[a/(a+b)]/[c/(c+d)]

Amended estimator of OR used to avoid recipricalzeros 0.5 added to each cell of 2x2 table

Where no events occur cannot compute an OR


E l T diti l P t ti F di

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Statistical AnalysisSummary

stats

Weighted Mean Differences for continuous

outcomes

Mean difference is assigned a weight. These weightings

determine the relative importance of each quantity on theaverage, based on sample size.

To calculate a weighted average: 1. Multiply each value by its weight.

2. Add up the products of value times weight to get the total value.

3. Add the weight themselves to get the total weight.

4. Divide the total value by the total weight.

If only median and range were reported, estimates of mean

and SD were made using Hozo et al formulas



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Statistical Analysis

Random effects model

utilised

Inverse weighted

approach

Assessment of

heterogeneity

Qstatistic

I2

index andconfidence intervals

Subgroup analysis

based on year of

publication (pre-, post-

2000)

Funnel plots synthesized

Log OR or WMD vs

Precision (1/SE)

Standard Error Sample size

Estimates obtained by R

Plots obtained by rmeta

package



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Results

87 abstracts of potential relevance

5 non-English abstracts located (despite limits)

2 potentially relevant but full articles could not be

obtained 15 studies eligible for inclusion

1240 patients in total

n=617 traditional management

n=623 early postoperative management

Studies spanning 1979 to 2007



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Potentially relevant papers identified

and retrieved (n=87)Papers excluded, with reasons:

N= 41, Not RCTs (correspondence, reviews, true

observational studies, meta-analyses, editorials)RCTs reviewed for more detailed

evaluation (n=46)RCTs excluded (n=15), with reasons:N=8, not GI resectional surgery (n=6 gynae (incl 3 abstracts), n=1

H&N, n=1 ICU)

N=2, Non-English publications

N=2, surgical technique (lap vs open)

N=2 intestinal repair under emergency conditions

N=1, Enteral vs ParenteralPotentially appropriate RCTs to beconsidered for the meta-analysis

(n=31) RCTs excluded (n=7), with reasons:N = 2, nutrition not primary outcome (ie part of fast track program)

N= 4, early nutrition provided >24hrs post operatively or timeframe

not stated

N=1, traditional group provided with jejunal feeds

RCTs comparing early vs traditional NBMfeeding practices as 1variable (N=24)

RCTs excluded (n=9), with reasons:

N= 5, feeding distal to the anastomosis (including n=3 with

immunonutrition utilised)

N= 2, nutrition provided within Day 1 post op not nutritionally

significant

N=1 clinically relevant outcomes not reported

N=1 published abstract of included study

RCTs comparing early vs traditional

feeding practices with minimal loss to

follow-up reporting clinically meaning

outcomes (n= 15)

QUOROM statementEarly vs Traditional Postoperative Feeding

Earl s Traditional Postoperati e Feeding
http://d/userdata/OslandEJ/temp/XPGrpWise/search%20breakdown%20for%20flow%20chart%20for%20article%20updated%2023.6.08.xlshttp://d/userdata/OslandEJ/temp/XPGrpWise/search%20breakdown%20for%20flow%20chart%20for%20article%20updated%2023.6.08.xls

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Results

Median Jadad score of 2 (range 1-3)

6 studies described randomisation method

6 studies reported withdrawals

1 study reported blinding

Sufficient data for analysis on 8 (of 24

reported) clinical outcomes

Some clarification/data requested of authors inattempt to assist



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ResultsPostoperative

Complications

Study

pre 2000

Sagar

Ryan

Schroeder

Binderow

Beier-Holgersen

CarrOrtiz

Hartsell

Nessim

Stewart

subtotal

post 2000

Han-Geurts

DelaneyLucha

Zhou

Han-Geurts

subtotal

POOLED

Early

3 of 15

2 of 7

4 of 16

0 of 32

8 of 30

0 of 1417 of 93

1 of 29

3 of 27

10 of 40

48 of 303

12 of 56

7 of 311 of 26

23 of 161

22 of 46

65 of 320

113 of 623

Traditional

5 of 15

7 of 7

7 of 16

0 of 32

19 of 30

4 of 1418 of 95

1 of 29

4 of 27

12 of 40

77 of 305

13 of 49

10 of 331 of 25

70 of 155

20 of 50

114 of 312

191 of 617

OR

0.53

0.03

0.46

1

0.22

0.080.96

1

0.75

0.78

0.55

0.76

0.690.96

0.21

1.37

0.62

0.55

L

0.08

0

0.07

0.02

0.05

00.24

0.07

0.11

0.17

0.34

0.18

0.140.07

0.06

0.33

0.26

0.35

U

3.78

0.94

2.91

61.41

1.08

2.063.77

13.42

5.01

3.56

0.9

3.27

3.3812.99

0.74

5.61

1.51

0.87

0.1 2.0 4.0 6.0

favour Early favour Traditional



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ResultsPostoperative

Complications

Total (n=1240; N=15) OR 0.55; 95% CI 0.35, 0.87; p=0.01

Q = 29.07, p=0.01

I2Index 51.8%, 95% CI 13.15, 73.25%

Pre-2000 subgroup (n=608; N=10) OR 0.55; 95% CI 0.34, 0.90; p=0.01

Q = 10.61, p= 0.3

I2Index 15%, 95% CI, 0, 45.47%

Post-2000 subgroup (n=632; N=5) OR 0.62; 95% CI 0.26, 1.51; p=0.29

Q = 17.78, p=0.001

I2Index 77.5%, 95% CI 45, 90.68%



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Results - Mortality

Study

pre 2000

Sagar

Ryan

Schroeder

Binderow

Beier-Holgersen

Carr

Ortiz

Hartsell

Nessim

Stewartsubtotal

post 2000

Han-Geurts

Delaney

Lucha

Zhou

Han-Geurts

subtotal

POOLED

Early

0 of 15

0 of 7

0 of 16

0 of 32

2 of 30

0 of 14

0 of 93

0 of 29

0 of 27

0 of 402 of 303

0 of 56

0 of 31

0 of 26

0 of 161

3 of 46

3 of 320

5 of 623

Traditional

0 of 15

0 of 7

0 of 16

0 of 32

4 of 30

1 of 14

0 of 95

1 of 29

0 of 27

1 of 407 of 305

3 of 49

0 of 33

0 of 25

0 of 155

1 of 50

4 of 312

11 of 617

OR

1

1

1

1

0.52

0.31

1.02

0.32

1

0.330.58

0.12

1.06

0.96

0.96

2.66

1.03

0.71

L

0.02

0.02

0.02

0.02

0.1

0.01

0.02

0.01

0.02

0.010.22

0.01

0.02

0.02

0.02

0.38

0.27

0.32

U

53.66

57.31

53.46

51.94

2.65

8.29

52.01

8.24

52.22

8.221.54

2.33

55.24

50.35

48.83

18.77

3.88

1.56

0.1 2.0 4.0 6.0




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Results - Mortality

Total (n=1240; N=15) OR 0.71; 95% CI 0.32, 1.56; p=0.39

Q = 4.24, p=0.99

I2Index 0%, 95% CI 0, 0%


Q = 0.85, p= 0.99

I2Index 0%; 95% CI 0,0%


Q = 2.93, p=0.56

I2Index 0%, 95% CI 0, 71.6%



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ResultsAnastomotic

DehiscenceStudy

pre 2000

Sagar

SchroederBeier-Holgersen

Carr

Ortiz

HartsellNessimStewart

subtotal

post 2000Han-Geurts

Delaney

Lucha

ZhouHan-Geurts

subtotal

POOLED

Early

0 of 15

0 of 162 of 30

0 of 14

2 of 93

0 of 290 of 271 of 40

5 of 264

2 of 18

0 of 31

1 of 26

2 of 1612 of 42

7 of 278

12 of 542

Traditional

1 of 15

0 of 164 of 30

0 of 14

4 of 95

1 of 290 of 270 of 40

10 of 266

1 of 19

0 of 33

0 of 25

4 of 1552 of 35

7 of 267

17 of 533

OR

0.31

10.52

1

0.56

0.321

3.08

0.62

1.87

1.06

3

0.530.83

0.93

0.75

L

0.01

0.020.1

0.02

0.12

0.010.020.12

0.25

0.22

0.02

0.12

0.110.14

0.36

0.39

U

8.29

53.462.65

53.89

2.68

8.2452.22

77.8

1.52

15.73

55.24

77.17

2.525.06

2.43

1.45

0.1 2.0 4.0 6.0



R l A iEarly vs Traditional Postoperative Feeding

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ResultsAnastomotic

Dehiscence Total (n=1075; N=13)

OR 0.75; 95% CI 0.39, 1.4; p=0.39

Q = 3.31, p=0.99

I2Index 0%, 95% CI 0,0%


Q = 1.50, p=0.98

I2Index 0%, 95% CI 0,0%


Q =0.98, p=0.83

I2Index 0%; 95% CI 0,42.23%



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ResultsNasogastric Tube

Reinsertion

Study

pre 2000

Binderow

Hartsell

Stewart

subtotal

post 2000

Han-Geurts

Delaney

Lucha

Zhou

Han-Geurts

subtotal

POOLED

Early

6 of 32

8 of 27

4 of 92

18 of 151

9 of 56

2 of 31

5 of 26

3 of 161

12 of 61

30 of 320

48 of 471

Traditional

4 of 32

5 of 27

3 of 103

12 of 162

9 of 49

3 of 33

3 of 25

1 of 155

7 of 67

21 of 312

33 of 474

OR

1.55

1.78

1.46

1.61

0.85

0.74

1.64

2.27

2.68

1.41

1.48

L

0.42

0.52

0.35

0.75

0.32

0.13

0.38

0.33

0.89

0.78

0.93

U

5.78

6.11

6.08

3.44

2.3

4.04

7.11

15.6

8.11

2.52

2.35

0.5 1.0 1.5 2.02.5 3.5




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ResultsNasogastric Tube

Reinsertion

Total (n=945; N=8) OR 1.48; 95% CI 0.93, 2.35; p=0.09

Q = 3.24, p=0.86

I2Index 0%, 95% CI 0, 29.95%


Q = 0.05, p= 0.97

I2Index 0%; 95% CI 0,0%


Q = 3.12, p=0.53

I2Index 0%, 95% CI 0, 73.77%



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ResultsNausea and Vomiting


Study

pre 2000

BinderowBeier-Holgersen

Carr

Ortiz

Hartsell

Nessim

Stewart

POOLED

Early

14 of 3219 of 30

1 of 14

13 of 93

16 of 29

3 of 27

14 of 40

80 of 265

Traditional

8 of 3222 of 30

7 of 14

8 of 95

15 of 29

7 of 27

14 of 40

186 of 267

OR

2.260.64

0.11

1.73

1.14

0.39

1.00

0.93

L

0.80.22

0.02

0.69

0.41

0.1

0.4

0.53

U

6.391.88

0.79

4.29

3.15

1.58

2.47

1.65

0.1 2.0 4.0 6.0



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ResultsNausea and Vomiting

Post-2000 subgroup (n=532; N=7)

OR 0.93; 95% CI 0.53, 1.65; p=0.8

Q =10.99, p=0.08

I2Index 45%, 95% CI 0, 77.01%


R lt L th f H it lEarly vs Traditional Postoperative Feeding

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ResultsLength of Hospital

Stay

Study

pre 2000

Sagar

Schroeder

Binderow

Carr

Hartsell

Stewart

subtotal

post 2000

Han-Geurts

Delaney

Zhou

Han-Geurtssubtotal

POOLED

N

15

16

32

14

29

40

146

56

31

161

46294

440

Early

16.1(5.27)

10.0(4.00)

6.70(3.25)

9.80(6.60)

7.20(3.30)

12.8(7.25)

24.5(21.92)

5.20(2.50)

8.40(3.40)

12.0(1.80)

N

15

16

32

14

29

40

146

49

33

155

49286

432

Traditional

23.8(11.86)

15.0(10.0)

8.00(3.75)

9.30(2.80)

8.10(2.30)

11.5(3.61)

15.6(8.76)

5.80(3.00)

9.60(5.00)

17.5(4.20)

WMD

-7.67

-5

-1.3

0.5

-0.9

1.33

-1.05

8.9

-0.6

-1.2

-5.5-0.93

-1.28

L

-15.57

-11.86

-6.01

-5.27

-5.52

-3.72

-2.66

1.27

-5.19

-5.68

-10.07-3.95

-2.94

U

0.23

1.86

3.41

6.27

3.72

6.38

0.56

16.53

3.99

3.28

-0.932.09

0.38

-15 -10 -5 0 5 10 15



R lt L th f H it lEarly vs Traditional Postoperative Feeding

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ResultsLength of Hospital

Stay Total (n=872; N=10)

WMD -1.28; 95% CI -2.94, 0.38; p=0.13

Q = 61.19, p

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ResultsPassage of Flatus

Study

pre 2000

Schroeder

Stewartsubtotal

post 2000

Zhou

Han-Geurts

subtotal

POOLED

N

16

4056

161

43

204

260

Early

2.41(1.33)

3.00(1.20)

3.00(0.90)

1.70(0.20)

N

16

4056

155

49

204

260

Traditional

2.91(1.29)

4.00(1.20)

3.60(1.20)

1.40(0.10)

WMD

-0.5

-1-0.87

-0.6

0.3

-0.14

-0.42

L

-2.09

-2.41-1.33

-1.93

-1.01

-1.02

-1.12

U

1.09

0.41-0.42

0.73

1.61

0.74

0.28

-2 -1 0 1

favour Earl favour Traditional



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ResultsPassage of Flatus

Total (n=520; N=4) WMD -0.42 days; 95% CI -1.12, 0.28; p=0.23

Q = 75.63, p

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ResultsPassage of Bowel

Motion

Study

pre 2000

Schroeder

Stewartsubtotal

post 2000

Zhou

Han-Geurts

subtotal

POOLED

N

16

4056

161

43

204

260

Early

3.21(1.50)

4.77(2.15)

4.10(1.10)

4.30(0.30)

N

16

4056

155

49

204

260

Traditional

4.16(1.33)

5.00(1.80)

4.80(1.40)

3.70(0.30)

WMD

-0.95

-0.23-0.55

-0.7

0.6

-0.04

-0.28

L

-2.93

-2.16-1.25

-2.45

-1.13

-1.32

-1.2

U

1.03

1.70.15

1.05

2.33

1.23

0.64

-2 -1 0 1 2


y p g

R lt P f B lEarly vs Traditional Postoperative Feeding

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ResultsPassage of Bowel

Motion Total (n=520; N=4)

WMD -0.28 days; 95% CI -1.20, 0.68; p=0.55

Q = 78.99, p

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Funnel plots

y p g

0.02 0.10 0.50 2.00 10.00

1.

5

1.

0

0.

5

0.

0

Log odds ratio

Standard

error

Complication rate

0.02 0.10 0.50 2.00 10.00

1.

5

1.

0

0.

5

0.

0

Log odds ratio

Standard

error

Mortality rate

0.02 0.10 0.50 2.00 10.00

1.

5

1.

0

0.5

0.

0

Log odds ratio

Standard

error

Anastomotic leak rate

0.2 0.5 2.0 5.0

1.

2

0.

8

0.

4

0.

0

Log odds ratio

Standard

error

NG reinsertion rate

-1.0 -0.5 0.0 0.5 1.0

0.

4

0.

3

0.

2

0.

1

0.0

Mean difference

Standard

error

Days to pass ing flatus

-1.0 -0.5 0.0 0.5 1.0

0.5

0.

4

0.

3

0.

2

0.

1

0.0

Mean difference

Standard

error

Days to first bowel motion

-5 0 5

3.0

2.

0

1.0

0.

0

Mean difference

Standard

error

Length of stay (days)

-5.5 -4.5 -3.5 -2.5

0.

6

0.4

0.

2

0.

0

Mean difference

Standard

error

Days to solid diet

Considerations in interpretationEarly vs Traditional Postoperative Feeding

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Considerations in interpretation-

Heterogeneity

A lot of variability between outcomes assessed

Little/none detected for

Mortality,

Anastomotic dehiscence, NGT reinsertion and

Pre-2000 measures of bowel function

Extremely large detected for

Complications (but not pre-2000)

LOS (less so for pre-2000)

Pooled and post-2000 measures of bowel function

y p g


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Heterogeneity

Possible explanations for heterogeneity, and

closer agreement with pre-2000 study

subgroup analysis

Changes to nutritional provision Early feeding via NG feeding ~30% of pts pre-2000 =

more consistent nutritional provision than oral intake

better outcomes from better nutrition?

Changes to perioperative practices over 28 yearsHans-Geurts et al studies (2001, 2007) appear to

show quite different results than all others

Related to statistical power (N=10 in pre-2000;

N=5 in post-2000 subgroup analysis)

y p g


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Publication Bias

Visually asymmetric irrespective of choice of

vertical axis

Limitations of assessment of publication bias

Visual assessment subjective, especially withsmall number of studies

Random effects model known to amplify the

presence of publication bias in funnel plots

Exclusion of non-English publications bias,

abstracts without full articles available

Heterogeneity detected

Comparison of outcomes withEarly vs Traditional Postoperative Feeding

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Comparison of outcomes with

previous meta-analyses

Possible explanations for differences

Different studies included

7 different studies in current work

Inclusion of Han-Geurts (2001, 2007) studies Differences in inclusion criteria

Immune nutrition provided to up to 21% of patients

included

Clear fluids allowed as early feeding

Feeding distal to the anastomosis


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Limitations of the current work

Reporting in included studies

No quantitative data on oral intake of early

feeding interventions!!!

Assumptions made From data unable to clarified or obtained

Methodological quality generally poor

Bias in subgroup analysisSmall numbers

Changes in feeding practices

Changes in perioperative practices

Future Directions ClinicalEarly vs Traditional Postoperative Feeding

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Future DirectionsClinical

Research

Future RCTs investigating this topic need to

quantify nutritional intake and anthropometric

measures

Allow determination if early feeding is providingnutritional intake different to traditional group.

Multidisciplinary research

Quantifiable relationship between nutritional

intake and postoperative outcomes Is there a specific level of nutritional/caloric/protein intake required to

reduce LOS or complications?

Does the texture of diet provided affect rates of anastomotic

dehiscence?

What effect does early vs traditional feeding have on weight and lean

Future Directions StatisticsEarly vs Traditional Postoperative Feeding

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Future DirectionsStatistics

Modelling

Development of meta-analysis methods to

better deal with situations posed by medical

research

Detection of publication bias in REM, smallnumbers

More sensitive methods of detecting between

study heterogeneity in cases of small numbers

Investigation re effect of assuming normaldistribution in REM

Guidance on investigation of heterogeneity

?Temper promotion of meta-analysis in many


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Conclusions

Early feeding after GI surgery appears to be

safe and should be part of standard practice

This meta-analysis supports the results of those

previously conducted despite limitations of all! Need for multidisciplinary research in this area

Clinicians should receive better education in

statistics

Critical approach to practice based on a thorough

understanding of the recommendations being

implemented

Seminar 11.6.09

Documents

Transcript of Seminar 11.6.09