Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis

Study Overview
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Brief Summary
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This study seeks to evaluate whether the routine, primary use of the spring-loaded silo (SLS) to treat infants with gastroschisis will result in improved outcomes, faster recovery times and fewer post-surgical complications than the standard selective use of the silo.

Detailed Description
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Standard treatment of the infant with gastroschisis consists of , the bowel being reduced into the abdomen, when possible,and the abdominal wall defect being closed in the operating room. When complete reduction of the eviscerated contents is not possible, a silastic  silo is sewn on the abdominal wall and its contents are gradually reduced into the abdomen over several days. Once reduction is obtained, the silo is removed and the abdominal defect is closed. Current methods of treatment are associated with significant morbidity, prolonged hospitalization, and high costs. Gastroschisis closure continues to be accompanied by a number of complications ranging from ileus, sepsis, TPN-related liver damage, necrotizing enterocolitis, respiratory insufficiency, and death. The optimal timing and method of closure, including primary versus secondary closure, continues to be debated. No prospective randomized studies to date have examined the routine use of the spring-loaded silo.

Official Title
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A Multi-Centre, Prospective Randomized Trial to Evaluate Routine Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis

Conditions
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Gastroschisis

Intervention / Treatment
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* Procedure: Primary placement of a spring-loaded silo
* Procedure: Primary Closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Gastroschisis Birth Weight ≥ 1500 grams Gestational Age ≥ 34 weeks Exclusion Criteria: Birth Weight < 1500 grams Gestational Age < 34 weeks Presence of Bowel Ischemia or Necrosis Abdominal wall defect too small Major associated anomalies or medical condition Presence of Intracranial Hemorrhage (grade IV) Parent Refusal for Randomization

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Silastic Spring-Loaded Silo | Procedure: Primary placement of a spring-loaded silo<br> <br> |
| Active Comparator: 2<br>Primary Closure of Abdomen | Procedure: Primary Closure<br>* primary closure of abdomen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of time on the ventilator |  | days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| return to bowel function as measured by serum lactate and intragastric pressure |  | preop and 2 hours postop on day of definitive closure, then daily; intragastric pressure at time of closure; | 
| urine output |  | 5 days post closure | 
| tpn |  | days | 
| time to full enteral feeding |  | days | 
| length of hospital stay |  | days | 
| complications during hospitalization (e.g., NEC, sepsis) |  | post-surgery to hospital discharge | 
| height and weight |  | post-discharge | 
| urine output |  | for 5 days after definitive closure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, gastroschisis, silastic spring-loaded silo