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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