- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01094587
Sutureless vs Sutured Gastroschisis Closure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. The parameters of this trial were determined using our retrospective study as pilot data. Primary outcome measures will be time on ventilator and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death.
In comparing these techniques of gastroschisis closure, we can further evaluate which is the safer and more efficacious method, thereby improving patient care while decreasing hospital cost.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:Inclusion criteria are the diagnosis of gastroschisis, birth weight of 1500 grams or greater, and gestational age of 34 weeks or more.
Exclusion Criteria:Exclusion criteria are infants with other major abnormalities or medical conditions, grade IV intraventricular hemorrhage, inability to obtain informed consent, and the presence of a closed-type gastroschisis defect.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sutured closure
|
|
Active Comparator: Sutureless closure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time on ventilator
Time Frame: Up to 1 week
|
Up to 1 week
|
Time to initiating enteral feeds
Time Frame: Up to 4 weeks
|
Up to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of hospital stay
Time Frame: Up to 6 weeks
|
Up to 6 weeks
|
Cosmesis
Time Frame: 6 months after hospital discharge
|
6 months after hospital discharge
|
Complications including bowel resection, sepsis, and death.
Time Frame: Up to 45 days
|
Up to 45 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sanjeev Dutta, Stanford University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-10142009-4180
- IRB Protocol: 16918
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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