Sutureless vs Sutured Gastroschisis Closure
Overview
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.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: June 24, 2015
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.
Interventions
- Procedure: Gastroschisis closure with suture
- Procedure: Gastroschisis closure without suture
Arms, Groups and Cohorts
- Active Comparator: Sutured closure
- Active Comparator: Sutureless closure
Clinical Trial Outcome Measures
Primary Measures
- Time on ventilator
- Time Frame: Up to 1 week
- Time to initiating enteral feeds
- Time Frame: Up to 4 weeks
Secondary Measures
- Cosmesis
- Time Frame: 6 months after hospital discharge
- Length of hospital stay
- Time Frame: Up to 6 weeks
- Complications including bowel resection, sepsis, and death.
- Time Frame: Up to 45 days
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Stanford University
- Provider of Information About this Clinical Study
- Principal Investigator: Matias Bruzoni, Principal Investigator – Stanford University
- Overall Official(s)
- Sanjeev Dutta, Principal Investigator, Stanford University
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