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ORIGINAL ARTICLE

The Use of a Spring-Loaded Silo for Gastroschisis


Impact on Practice Patterns and Outcomes
Aaron R. Jensen, MD; John H. T. Waldhausen, MD; Stephen S. Kim, MD

Objective: To evaluate the impact of the use of a bedside- teral feeds, time of hyperalimentation requirement, and
placed spring-loaded silo (SLS) on practice patterns and length of hospital stay.
on outcomes for infants with gastroschisis.
Results: The rate of immediate fascial closure was lower
Design: Retrospective review comparing neonates with in the postimplementation group (58% before vs 20% af-
gastroschisis treated before and after the implementa- ter implementation, P⬍.001). Overall length of stay, time
tion of selective SLS placement. to enteral feeding, and infection rates were not signifi-
cantly different between the 2 groups.
Setting: Tertiary referral center.
Conclusions: The use of an SLS placed at the bedside
has resulted in lower immediate fascial closure rates for
Patients: Of 91 consecutive neonates admitted for ini- infants with gastroschisis without significant detrimen-
tial treatment of gastroschisis between January 1998 and tal clinical outcome. The main benefit of using the bedside-
August 2007, 45 were admitted before and 46 were ad- placed SLS is the avoidance of urgent surgical interven-
mitted after implementation of the SLS. tion. For patients undergoing delayed fascial closure, use
of the bedside SLS resulted in shorter times to definitive
Main Outcome Measures: Immediate fascial closure fascial closure.
rate, infection rate, time to fascial closure, time to ini-
tiation of enteral feeding, time to achievement of full en- Arch Surg. 2009;144(6):516-519

G
ASTROSCHISIS IS A CONGEN- son of selected cases of intermittent SLS
ital anomaly of the ab- placement3,4 or routine SLS placement2,5 vs
dominal wall that has his- urgent surgical treatment.
torically been treated on The choice of immediate surgical
an emergency basis by therapy or bedside-placed SLS in our in-
primary closure or, in the case of abdomi- stitution has been determined in most cases
novisceral disproportion, by surgical silo by surgeon discretion. Therefore, direct
placement. Ongoing controversy exists re- comparison of SLS with traditional treat-
garding the optimal surgical treatment of ment is subject to selection bias, and the
this anomaly. Bedside placement of a impact of the SLS is most appropriately
spring-loaded silo (SLS) (Ventral Wall De- evaluated within the context of overall pa-
fect Silo Bags; Bentec Medical, Woodland, tient outcomes with selective use. To our
California; Figure 1) was first described knowledge, there are no data regarding the
in 1995 and was implemented at our insti-
impact of the availability of this device on
tution in January 2004.1 Proposed ben-
practice patterns or on patient outcomes be-
efits of this device have included fewer days
in need of ventilatory support, decreased cause previous study designs do not ac-
incidence of pulmonary barotrauma, count for potential selection bias in treat-
shorter time to enteral feeding, improved ment modality. The objective of this study
Author Affiliations: tissue perfusion, improved cosmetic out- was to investigate changes in practice pat-
Department of Surgery, come, decreased incidence of infectious terns and potential changes in patient
University of Washington outcomes related to the availability and se-
complications, avoidance of emergency sur-
School of Medicine, Seattle
gical intervention, and lowered hospital lective use of the SLS in our institution.
(Drs Jensen, Waldhausen, and
Kim); and Division of General charges owing to shorter stay and fewer Therefore, comparisons are made between
and Thoracic Surgery, Seattle complications.1-5 Several studies have de- overall patient outcomes, regardless of treat-
Children’s Hospital, Seattle scribed an initial experience with this de- ment modality, before and after selective
(Drs Waldhausen and Kim). vice,1,6 including a retrospective compari- implementation of the SLS.

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METHODS

PATIENT POPULATION

Medical records were reviewed for all patients admitted to Se-


attle Children’s Hospital for initial treatment of gastroschisis
between January 1998 and August 2007. Patients were identi-
fied on the basis of an operating room scheduling database
and by International Classification of Diseases, Ninth Revision,
diagnostic codes.7 Patients were excluded if they underwent
surgical repair at an outside facility before presentation to our
institution.

DEFINITIONS

Initial surgical treatment was considered in 3 distinct catego-


ries: (1) immediate fascial closure, (2) sutured silo with de-
layed fascial closure, and (3) SLS with delayed fascial closure.
Immediate fascial closure referred to definitive fascial closure
performed within the first 6 hours of life without prior treat-
ment with SLS or sutured silo. Sutured silo with delayed fascial
closure referred to primary placement of a formal silicone rub-
ber (Silastic; Dow Corning, Midland, Michigan) silo by sutur-
ing it to the fascia through an extended midline incision. And Figure 1. A spring-loaded silo can be placed at the bedside for coverage and
SLS with delayed fascial closure referred to the placement of an gradual reduction of visceral contents in patients with gastroschisis.
SLS at the bedside or in the operating room within the first 6
hours of life. Delayed fascial closure was then attempted 2 to 5 tents were allowed to reduce under gravity, and delayed fas-
days later. All patients were classified according to the first cial closure was performed in the operating room under gen-
method of treatment (ie, SLS with subsequent conversion to eral anesthesia with IAP monitoring. Spring-loaded silo treatment
sutured silo due to increased intra-abdominal pressures (IAPs) was generally allowed to proceed for up to 5 days before sur-
at the time of attempted fascial closure was classified as SLS gical intervention (attempted fascial closure or formal sutured
with delayed fascial closure). Definitive fascial closure was de- silo placement depending on the IAP). Because treatment with
fined as fascial closure by suture or by tension-free methods, the SLS has been subjectively successful over time, practice pat-
including the use of prosthetic mesh or patch. terns have evolved to routine use of the device.

BEFORE IMPLEMENTATION STUDY DESIGN


OF SURGICAL TREATMENT This was a retrospective study. Approval from the Seattle Chil-
dren’s Hospital institutional review board was obtained before
Before implementation of the SLS, all patients were treated with review of the patient records. Patients who were seen through
urgent surgical intervention. All neonates arrived at our insti- December 31, 2003 (45 neonates) were considered a preimple-
tution via transfer from a referring hospital, because our free- mentation (historical) control group, whereas patients seen be-
standing children’s hospital does not have a labor and delivery tween January 1, 2004, and August 2007 (46 neonates) were
ward. Because of the delay in treatment due to transfer, surgi- considered the postimplementation group. Practice pattern out-
cal treatment was attempted as soon as possible after arrival. comes included immediate fascial closure rates. Patient out-
Immediate fascial closure was attempted in all patients with real- comes included infection rate, time to fascial closure, time to
time IAP measurement as determined by intragastric pressure initiation of enteral feeding, time to achievement of full en-
monitoring. Neonates with IAPs greater than 20 mm Hg were teral feeds, time of hyperalimentation requirement, and length
treated with a midline incision and a reinforced silicone rub- of hospital stay. Patients were excluded from length of stay and
ber silo sutured to the fascia. Patients were then transferred to time to enteral feeding analysis if they had a confounding con-
the intensive care unit and continued to receive mechanical ven- dition including atresia, short gut syndrome at the time of dis-
tilation. Silo reduction with the use of a wringer clamp was per- charge, stricture, web, perforation, severe gastroesophageal re-
formed once or twice daily as previously described.8 Once the flux, or an associated congenital anomaly that prolonged care
visceral contents were reduced to the skin level, patients were (1 infant with total anomalous pulmonary venous return)
taken to the operating room for definitive fascial closure. (Table 1) or if they underwent regional transfer to an outside
facility before cessation of hyperalimentation (3 infants).
AFTER IMPLEMENTATION
OF SURGICAL TREATMENT STATISTICAL ANALYSIS
Initially after the implementation of the bedside-placed SLS, Outcome data were significantly nonnormal and therefore were
patients either underwent urgent surgical treatment or re- analyzed according to nonparametric methods (Mann-
ceived a bedside-placed silo, per surgeon preference. Some pa- Whitney test for continuous data and ␹2 test of independence
tients with confounding factors such as skin bridges or om- for frequency data). To control for experiment-wide type I er-
phalomesenteric bands were taken to the operating room for ror (␣=.05), a Bonferroni correction for 17 comparisons was
SLS placement.9 Patients treated with SLS did not receive me- used with P⬍.003 per comparison considered statistically sig-
chanical ventilation unless indicated for unrelated causes (eg, nificant. For ␹2 analysis involving frequency counts of less than
acute respiratory distress syndrome, aspiration). Visceral con- 5, a conservative Yates correction was used.

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Table 1. Patient Demographics Table 2. Infectious Complications

1998-2003 2004-2007 No. (%) of Patients


Characteristic (n=45) (n = 46)
Infectious 1998-2003 2004-2007 P
EGA, wk, mean 36.1 36.1 Complication (n = 45) (n = 46) Value a
Birth weight, g, mean 2492 2449
Confounding condition, No. (%) 16 (36) 16 (35) Wound infection 1 (2) 4 (9) .37
Atresia 4 (9) 7 (15) Bacteremia 18 (40) 16 (35) .61
Short gut syndrome at discharge 1 (2) 2 (4) Fungemia 4 (9) 1 (2) .34
Stricture 0 1 (2) Urinary tract infection 4 (9) 5 (11) .97
Web 1 (2) 0 Pneumonia 3 (7) 2 (4) .97
Perforation 1 (2) 1 (2) Any infection b 23 (51) 17 (37) .17
Severe GER 2 (4) 0
a ␹2 Test of independence with Yates correction for frequency counts of
TAPVR 1 (2) 0
Necrotizing enterocolitis 6 (13) 5 (11) less than 5.
b Some patients had multiple infections.

Abbreviations: EGA, estimated gestational age (at time of birth); GER,


gastroesophageal reflux (requiring fundoplication); TAPVR, total anomalous
pulmonary venous return. Table 3. Time to Enteral Feeding and Time to Discharge

Median No. of Days


20 (Range) a
Bedside placement of spring-loaded silo
18 Surgical placement of silo 1998-2003 2004-2007 P
Primary closure
16 Period (n = 34) (n = 37) Value b
14 Length of stay 39.5 (19-120) 39 (21-87) .57
Time to initiation of 14 (2-33) 14 (7-42) .68
No. of Patients

12
enteral feeding
10 Time to achievement of 37.5 (16-120) 34 (19-87) .53
8 full enteral feeds
Time to advance enteral 21.5 (4-110) 16 (9-62) .40
6
feeding to goal rate
4 Time of hyperalimentation 32 (13-114) 29 (11-76) .58
2 requirement
0 a Summary data and comparisons exclude patients with significant
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
Year confounding factors (see “Study Design” subsection of the “Methods”
section).
b Mann-Whitney test.
Figure 2. Initial surgical treatment of patients with gastroschisis by year
(1998-2007).
Infectious complications were not significantly dif-
ferent between groups, but a possible trend was noted
RESULTS for decreased overall infectious complications in the
postimplementation group (Table 2). No significant dif-
Baseline patient characteristics were similar in the 2 groups ferences were seen in length of stay, time to initiation of
(Table 1). Overall mortality was 1%. One neonate in the enteral feeding, time to achievement of full enteral feeds,
postimplementation group died of sepsis at 4 days of life time to advance enteral feeding to goal rate (as calcu-
and was excluded from all analyses. Primary closure rates lated by the interval between initiation of enteral feed-
weresignificantlylowerafterimplementationoftheSLS(58% ing and achievement of full feeds), or time of hyperali-
vs 20%, P⬍.001) (Figure 2). Abdominal compartment mentation requirement (Table 3).
syndromewasnotobservedineithergroup.Intra-abdominal
pressure at time of closure was similar in the 2 groups (mean, COMMENT
10 vs 11 mm Hg for the preimplementation group vs the
postimplementation group; P=.37). Time to fascial closure This study is the first to our knowledge to demonstrate
was not significantly different between groups (mean, 5.3 the impact of the selective implementation of an SLS on
vs 5.7 days; P=.30). Among patients treated with bedside- practice patterns and subsequent clinical outcomes. A sig-
placed SLS, successful fascial closure was achieved in 90% nificant decrease was seen in immediate fascial closure
(19 of 21) of patients on the first attempt. Two patients re- rate, but clinical outcomes, including length of stay and
quired conversion to a formal sutured silo owing to persis- time to enteral feeding, were not negatively affected. It
tent abdominovisceral disproportion; 1 of the 2 eventually is difficult to make a definitive statement about infec-
required closure with bioprosthetic mesh. Among patients tious complications other than that the demonstrated
undergoing SLS placement in the operating room, closure postimplementation wound infection rate is consistent
was successful in 75% (6 of 8) of the subsequent operating with that reported in the literature. The lack of signifi-
room trips. Reasons for failure to achieve fascial closure in- cance in overall infection rate may represent a type II er-
cluded elevated IAP and perforated atresia. ror due to small numbers or may be due to difficulty in

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defining and determining a true infectious complica- suggests that neonates with gastroschisis can be safely
tion. The definition of infectious complication that was used treated initially with an SLS placed at the bedside, thereby
for data abstraction was documented erythema requir- not requiring an urgent surgical intervention. The avoid-
ing the initiation of antibiotics at any point after fascial ance of urgent surgical intervention may allow for medi-
closure. In the control group, however, patients rou- cal optimization, including hemodynamic stabilization,
tinely had abdominal wall erythema immediately after diuresis, and resolution of intestinal edema before de-
initial primary closure and were frequently treated with finitive closure. A randomized longitudinal study is war-
an extended course of antibiotics, making subsequent de- ranted to validate these hypotheses.
termination of infection difficult. Therefore, the rate of
infection is likely underreported in the preintervention Accepted for Publication: April 7, 2008.
group because most of these children could not be char- Correspondence: Stephen S. Kim, MD, Division of Gen-
acterized by the definition used. eral and Thoracic Surgery, Seattle Children’s Hospital,
Previous studies have shown a mixed impact on time 4800 Sand Point Way, Mailstop W7729, Seattle, WA
to achievement of full enteral feeds and time to hospital 98105 (stephen.kim@seattlechildrens.org).
discharge, possibly related to patient selection criteria. Our Author Contributions: Drs Jensen, Waldhausen, and Kim
data suggest that these 2 outcomes are not detrimentally had full access to all of the data in the study and take re-
affected by the selective implementation of the SLS. In ad- sponsibility for the integrity of the data and the accuracy
dition, outcomes of infections have demonstrated mixed of the data analysis. Study concept and design: Jensen and
results, likely due to small sample sizes and the previ- Kim. Acquisition of data: Jensen. Analysis and interpreta-
ously mentioned difficulty in defining wound infections. tion of data: Jensen, Waldhausen, and Kim. Drafting of the
The retrospective nature of this study limits the defini- manuscript: Jensen. Critical revision of the manuscript for
tive conclusions of this study, but at this point, it repre- important intellectual content: Waldhausen and Kim. Sta-
sents the best available evidence for the implementation tistical analysis: Jensen. Study supervision: Waldhausen, Kim.
of the SLS. Other factors, such as hand washing, antibi- Financial Disclosure: None reported.
otic use, and central venous access procedures, have Previous Presentation: This study was presented at the
changed with time and may affect outcomes. The small Annual Meeting of the Pacific Coast Surgical Associa-
number of patients in this single-institution study limits tion; February 16, 2008; San Diego, California.
the generalizability of these findings, and further multi-
center prospective study is warranted to reinforce these
findings. One of the major proposed benefits of the bedside- REFERENCES
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