JR Gastroschisis.pptx

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 in-hospital 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 Children’s 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 Mann–Whitney test for continuous data and the Fisher’s exact test for categorical data.

P-value of less than 0.05 significant.

RESULTS

N =155

N = 129

Database demographicOrganism 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 aureusCLABSI Staphylococcus aureusSepsis 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.

ConclusionInfectious 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.

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 <[email protected]>

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1. What is the research

question?

What is the strategies to decrease

infectious complication in patient

with gastroschisis ?

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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 )

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4. 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

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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)

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7. Are statistical tests considered?

Yes, using the Mann–Whitney test for continuous data and the Fisher’s exact test for categorical data.

P-value of less than 0.05 significant

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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 Center–Joint Pediatric Institutional Review Board

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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.

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CAT(Critical Appraisal of the Topics)

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Screen for Initial Validity and Relevance1. 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

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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

Screen for Initial Validity and Relevance

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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

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Clinical category

Description Preferred Study Design

Therapy Tests the effectiveness of a treatment, such as a drug, surgical procedure, or other intervention

Randomized, double-blinded, placebo- controlled 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

disease Longitudinal cohort

study

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Evaluate the Validity of the Article Based on Its Intent

Therapy

Diagnosis

Causation

Prognosis

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Level 1 of EvidenceLevel Therapy/Prevention,

Aetiology/HarmPrognosis 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††

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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 good†††reference standards;

CDR† after derivation, or validated only on split-

sample§§§ or databases

2c "Outcomes" Research; Ecological studies

"Outcomes" Research  

Level 2 of Evidence42

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

5 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"

Level 3,4,5 of Evidence43

Grades of RecommendationA consistent level 1 studies

B consistent level 2 or 3 studies or extrapolations from level 1 studies

C level 4 studies or extrapolations from level 2 or 3 studies

D level 5 evidence or troublingly inconsistent or inconclusive studies of any level

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Thank You

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