Silo Versus Primary Closure for Gastroschisis

Children's Mercy Hospital Kansas City

Status: Completed

Conditions: Gastroschisis

Treatments: Procedure: Primary closure of gastroschisis; Procedure: silo for gastroschisis

Study type: Interventional

Funder types: Other

Identifiers

NCT01506531

11 09-156

Details and patient eligibility

About

The objective of this study is to scientifically evaluate two different closure strategies for gastroschisis to determine if there is a difference in the two approaches.

Full description

The hypothesis is that there is no difference between bedside silo placement and operative closure in return of bowel function, ventilator dependence, or length of stay.

The primary outcome variable between the two techniques will be length of hospitalization. The likely variables will be length of time to meet discharge criteria, length of hospitalization, time to full feedings, time on mechanical ventilation and total hospital charges.

Enrollment: 38 patients

Sex: All

Ages: 5 minutes to 2 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants with gastroschisis

Exclusion criteria

• Born prior to 34 weeks estimated gestational age
• Another congenital anomaly influencing the respiratory status, gastrointestinal status, or the length of hospitalization and recovery.
• Inability to get parental permission before treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

primary closure of gastroschisis

Active Comparator group

Description:

Attempt primary skin closure of gastroschisis shortly after birth

Treatment:

Procedure: Primary closure of gastroschisis

silo for gastroschisis

Active Comparator group

Description:

Surgical placement of silo over gastroschisis shortly after birth

Treatment:

Procedure: silo for gastroschisis