Agoes Wibisono

INTRODUCTION
Gastroschisis 1 in 4000 live births
A higher risk of infection and complication
Purpose : identify risk factors for infectious
complication strategies to prevent
Primary outcome of interest development of inhospital infectious / antibiotic complications ( 60 days
of a life )

SUBJECTS AND METHODS

Retrospective and descriptive analysis
155 patients were cared for with gastroschisis ( August
2001 June 2013) 129 remained for analysis
The study was conducted in Childrens Hospital and
Medical Center and The University of Nebraska Medical
Center (Omaha)
Included in the study were patients gastroschisis
( complicated gastroschisis excluded ) the first 60
days of life

Database variables collected :

gestational age,
mode of delivery,
method of gastroschisis closure,
length of silo usage,
number of days with a CVL/PICC,
days on TPN,
length of stay,
birth weights

Additional data :
infectious complications,
antibiotic duration,
complications of antibiotic usage,
antibiotic blood levels

recorded for the first 60 days of life

Operative management
A primary closure a silo ( If the bowel did not reduce
easily )
Type of closure (sutured or sutureless) was determined
by the surgeon.

Eliminated from the study were :

Complicated gastroschisis (patients with intes- tinal
atresia, necrotic bowel, or perforation )

Results were expressed as mean SD or proportions as

appropriate as well as ranges where appropriate
using the MannWhitney test for continuous data and
the Fishers exact test for categorical data.
P-value of less than 0.05 significant.

RESULTS
N =155

N = 129

Database demographic
Organism identified
Infection-free survival

N = 26
(excluded)

RESULTS

24 % (31) acquired one or more infections during the

first 60 days of life
Sepsis (12)
SSI (11)
CLABSI (8)

Organism :
SSI Candida albicans + Staphylococcus aureus
CLABSI Staphylococcus aureus
Sepsis Staphylococcus aureus

Antibiotic complication 6,2 % (8)

Gentamicin oral thrush (2), candidal rash (5)

Patients who developed infections were born at a lower

gestational age (35 weeks vs. 36.35 weeks, P = 0.01)
Low birth weight was also as- sociated with an increased
risk of infectious complications (P = 0.01)
atients who had primary closure of their gastroschisis
defect were less likely to acquire an infection than were
patients who required the use of a silo (Primary: 8/70,
Silo: 23/59, P = 0.01)

Gastroschisis patients who received a sutureless repair

of their gastroschisis defect were less likely to acquire
an infection during their first 60 days of life compared
to patients who had their defect closed with sutures
(0/21 vs. 31/108, P = 0.01)

DISCUSSION
no statistically significant difference in the risk of sepsis
or NEC infection based on mode of delivery (Snyder et
al. )
gastroschisis patients delivered prior to 37 weeks
gestation had a 14 times higher risk of morbidities than
patients carried to term (Maramreddy )
gastroschisis pregnancies carried to term lead to earlier
defect clo- sures, and shorter times to full feeds
(Huang)

Infants born at a lower gestational age were at an

increased risk of acquiring an infection within the first
60 days of life (p=0.01)
Better outcomes for patients with a primary
gastroschisis closure
The sutureless repair of gastroschisis (2007)
the ability to avoid intubation,
decreased OR costs,
potentially improved cosmetics

Limitations of this study include the small sample size

and the retrospective nature
Many of these patients were electively delivered at 36
weeks because of concerns by the perinatologists for
ongoing injury to the bowel or the risk of fetal demise
late in pregnancy with gastroschisis.
Antibiotics started at birth were continued at the
discretion of the surgeon

Strategies :
delivery of gastroschisis patients as late in pregnancy as
possible.
primary closure is attempted on all patients born with
gastroschisis
recommend consideration of the sutureless repair technique.
antibiotic usage has been standardized to an empiric course
of ampicillin and gentamicin for the first 48 hours of life,
regardless of method of closure.
A 24-hour course of Ancef is prescribed at the time of silo
closure.

Conclusion
Infectious complications following gastroschisis repair are
common.
Gastroschisis patients at higher risk of acquiring an infection :
secondary closure,
preterm delivery,
low birth weight.

utilizing a sutureless repair decrease the risk of infection.

Mode of delivery was not found to affect patients risk of
infection.
recommendations are to carry gastroschisis patients to term if
possible, to avoid routine silo use, and to consider a
sutureless repair.

25

THE NEWCASTLE CRITICAL APPRAISAL

WORKSHEET
A format for examining journal articles*
*(Based on Medical Journal of Australia 1992;157:389-94)
Presented by Dick Heller, Professor of Public Health, The University of
Manchester, UK <Dick.Heller@man.ac.uk

>

26

1. What is the research question?

What is the strategies to decrease
infectious complication in patient
with gastroschisis ?

27

2. What is the study type?

retrospective and descriptive study

3. What are the outcome factors?

development of in-hospital infectious / antibiotic
complications ( 60 days of a life )

28

. What are the study factors?

gestational age,
mode of delivery,
method of gastroschisis closure,
length of silo usage,
number of days with a CVL/PICC,
days on TPN,
length of stay,
birth weights
infectious complications,
antibiotic duration,
complications of antibiotic usage

29

5. What important potential confounders are considered?

No confounders

6. What are the sampling frame and sampling method?

performed a retrospective and descriptive analysis in which
129 patients were cared for with gastroschisis ( August 2001
June 2013)

30

7. Are statistical tests considered?

Yes, using the MannWhitney test for continuous data and the
Fishers exact test for categorical data.
P-value of less than 0.05 significant

31

8. Are the results clinically/socially

significant?
Yes clinically significant
9. Are ethical issues considered?
Yes, This study was approved by the University
of Nebraska Medical CenterJoint Pediatric
Institutional Review Board

9. What conclusions did the authors reach

about the study question ?
Infectious complications following gastroschisis repair are
common.
Gastroschisis patients at higher risk of acquiring an
infection :
secondary closure,
preterm delivery,
low birth weight.

utilizing a sutureless repair decrease the risk of infection.

Mode of delivery was not found to affect patients risk of
infection.

32

33

34

35

CAT
(Critical Appraisal of the Topics)

Screen for Initial Validity and

Relevance
1. Is the article from a peer-reviewed journal ? Yes
2. Is the location of the study similar to mine so
that the results, if valid, would apply to my
practice ? Yes
3. Is the study sponsored by an organization that
might influence the study design or results ? no
4. Will this information, if true, have a direct
impact on the health of my patients, and is it
something they will care about ?Yes

36

Screen for Initial Validity and

Relevance
5. Is the problem addressed one that is
common to my practice, and is the
intervention or test feasible and available
to me ? Yes
6. Will this information, if true, require me
to change my current practice ?Yes

37

Determine the Intent of the

Article
Why the study was performed?
Identifying strategies to decrease infectious
complications of gastroschisis repair

Four major clinical categories

Therapy
Diagnosis
Causation
Prognosis

38

Clinical
category

Description

Preferred Study
Design

39

Therapy

Tests the effectiveness of a

treatment, such as a drug, surgical
procedure, or other intervention

Randomized, doubleblinded, placebocontrolled trial

Diagnosis

Measures the validity (is it

dependable?) and reliability (will the
same results be obtained every
time?) of a diagnostic test, or
evaluates the effectiveness of a test
in detecting disease at a pre
symptomatic stage when applied to
a large population

Cross-sectional survey
(comparing the new test
with a reference
standard)

Causation

Assesses whether a substance is

related to the development of an
illness or condition

Cohort or case-control

Prognosis

Determines the outcome of a

Longitudinal cohort

disease

study

40

Evaluate the Validity of the Article Based on Its Intent

Therapy
Diagnosis
Causation
Prognosis

41

Level 1 of Evidence
Level

Therapy/Prevention,
Aetiology/Harm

Prognosis

Diagnosis

1a

SR (with homogeneity*)
of RCTs

SR (with homogeneity*)
of inception cohort
studies; CDR
validated in different
populations

SR (with homogeneity*) of
Level 1 diagnostic
studies; CDR with 1b
studies from different
clinical centres

1b

Individual RCT (with

narrow Confidence
Interval)

Individual inception
cohort study with >
80% follow-up;
CDR validated in a
single population

Validating** cohort study

with good reference
standards; or CDR
tested within one
clinical centre

1c

All or none

All or none case-series

Absolute SpPins and

SnNouts

Level 2 of Evidence

42

Level

Therapy/Prevention,
Aetiology/Harm

Prognosis

Diagnosis

2a

SR (with homogeneity* ) of
cohort studies

SR (with homogeneity*) of
either retrospective cohort
studies or untreated
control groups in RCTs

SR (with homogeneity*) of
Level >2 diagnostic studies

2b

Individual cohort study

(including low quality RCT;
e.g., <80% follow-up

Retrospective cohort
study or follow-up of
untreated control patients
in an RCT; Derivation of
CDR or validated on
split-sample only

Exploratory** cohort study with

goodreference standards;
CDR after derivation, or
validated only on splitsample or databases

2c

Outcomes" Research;"
Ecological studies

Outcomes" Research"

Level 3,4,5 of Evidence

43

Level

Therapy/Prevention,
Aetiology/Harm

Prognosis

Diagnosis

3a

SR (with homogeneity*) of
case-control studies

SR (with homogeneity*) of 3b
and better studies

3b

Individual Case-Control
Study

Non-consecutive study; or
without consistently applied
reference standards

4 Case-series (and poor quality

cohort and case-control
studies )

Case-series (and poor

quality prognostic cohort
studies***)

Case-control study, poor or

non-independent reference
standard

Expert opinion without

explicit critical appraisal,
or based on physiology,
bench research or "first
"principles

Expert opinion without explicit

critical appraisal, or based on
physiology, bench research or
""first principles

Expert opinion without

explicit critical appraisal, or
based on physiology, bench
"research or "first principles

44

Grades of Recommendation
A

consistent level 1 studies

consistent level 2 or 3 studies or

extrapolations from level 1 studies

level 4 studies or extrapolations from level

2 or 3 studies

level 5 evidence or troublingly inconsistent

or inconclusive studies of any level

45

Thank You