Clinical Trials Directory

Trials / Completed

CompletedNCT01506531

Silo Versus Primary Closure for Gastroschisis

Bedside Silo Versus Attempted Operative Closure for Gastroschisis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
38 (actual)
Sponsor
Children's Mercy Hospital Kansas City · Academic / Other
Sex
All
Age
5 Minutes – 2 Days
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREsilo for gastroschisissilo placed around abdominal contents in gastroschisis patients
PROCEDUREPrimary closure of gastroschisisPrimary closure of gastroschisis, if possible

Timeline

Start date
2011-08-01
Primary completion
2018-01-01
Completion
2018-04-01
First posted
2012-01-10
Last updated
2019-01-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01506531. Inclusion in this directory is not an endorsement.