Sutureless vs Sutured Gastroschisis Closure

Not Applicable

Terminated

• Conditions: Gastroschisis
• Interventions: Procedure: Gastroschisis closure without suture; Procedure: Gastroschisis closure with suture

• Registration Number: NCT01094587
• Lead Sponsor: Stanford University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-29
• Primary Completion: 2015-06-24
• Study Completion: 2015-06-24
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-12
• Last Update Posted: 2017-10-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Inclusion criteria are the diagnosis of gastroschisis, birth weight of 1500 grams or greater, and gestational age of 34 weeks or more.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sutureless closure	Gastroschisis closure without suture	-
Sutured closure	Gastroschisis closure with suture	-

Primary Outcome Measures

Name	Time	Method
Time on ventilator	Up to 1 week
Time to initiating enteral feeds	Up to 4 weeks

Secondary Outcome Measures

Name	Time	Method
Cosmesis	6 months after hospital discharge
Length of hospital stay	Up to 6 weeks
Complications including bowel resection, sepsis, and death.	Up to 45 days

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States