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

The Hospital for Sick Children

Status and phase: Terminated; Phase 2

Conditions: Gastroschisis

Treatments: Procedure: Primary placement of a spring-loaded silo; Procedure: Primary Closure

Study type: Interventional

Funder types: Other

Identifiers

NCT00539292

0020010078

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 88 patients

Sex: All

Ages: 1 to 30 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

1

Experimental group

Description:

Silastic Spring-Loaded Silo

Treatment:

Procedure: Primary placement of a spring-loaded silo

2

Active Comparator group

Description:

Primary Closure of Abdomen

Treatment:

Procedure: Primary Closure