Back to resultsSilo Versus Primary Closure for Gastroschisis
Primary Purpose
Gastroschisis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
silo for gastroschisis
Primary closure of gastroschisis
Sponsored by
About this trial
This is an interventional treatment trial for Gastroschisis focused on measuring gastroschisis, silo, primary closure
Eligibility Criteria
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.
Sites / Locations
- Children's Mercy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
primary closure of gastroschisis
silo for gastroschisis
Arm Description
Attempt primary skin closure of gastroschisis shortly after birth
Surgical placement of silo over gastroschisis shortly after birth
Outcomes
Primary Outcome Measures
Length of hospitalization
The length of time required for meeting discharge criteria
Secondary Outcome Measures
Full Information
NCT ID
NCT01506531
First Posted
January 2, 2012
Last Updated
January 8, 2019
Sponsor
Children's Mercy Hospital Kansas City
1. Study Identification
Unique Protocol Identification Number
NCT01506531
Brief Title
Silo Versus Primary Closure for Gastroschisis
Official Title
Bedside Silo Versus Attempted Operative Closure for Gastroschisis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 2011 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroschisis
Keywords
gastroschisis, silo, primary closure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
primary closure of gastroschisis
Arm Type
Active Comparator
Arm Description
Attempt primary skin closure of gastroschisis shortly after birth
Arm Title
silo for gastroschisis
Arm Type
Active Comparator
Arm Description
Surgical placement of silo over gastroschisis shortly after birth
Intervention Type
Procedure
Intervention Name(s)
silo for gastroschisis
Intervention Description
silo placed around abdominal contents in gastroschisis patients
Intervention Type
Procedure
Intervention Name(s)
Primary closure of gastroschisis
Intervention Description
Primary closure of gastroschisis, if possible
Primary Outcome Measure Information:
Title
Length of hospitalization
Description
The length of time required for meeting discharge criteria
Time Frame
1-6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Minutes
Maximum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn D St. Peter, MD
Organizational Affiliation
Children's Mercy Hospital and Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Silo Versus Primary Closure for Gastroschisis
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