Silo Versus Primary Closure for Gastroschisis
Not Applicable
Completed
- Conditions
- Gastroschisis
- Interventions
- Procedure: Primary closure of gastroschisisProcedure: silo for gastroschisis
- Registration Number
- NCT01506531
- Lead Sponsor
- Children's Mercy Hospital Kansas City
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description primary closure of gastroschisis Primary closure of gastroschisis Attempt primary skin closure of gastroschisis shortly after birth silo for gastroschisis silo for gastroschisis Surgical placement of silo over gastroschisis shortly after birth
- Primary Outcome Measures
Name Time Method Length of hospitalization 1-6 weeks The length of time required for meeting discharge criteria
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States