Sutureless vs Sutured Gastroschisis Closure

Gastroschisis Clinical Trial

Official title:

Sutureless vs Sutured Gastroschisis Closure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01094587
• Other study ID #: SU-10142009-4180
• Secondary ID: IRB Protocol: 16
• Status: Terminated
• Phase: N/A
• First received: March 25, 2010
• Last updated: October 12, 2017
• Start date: November 2009
• Est. completion date: June 24, 2015

Study information

• Verified date: October 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: June 24, 2015
• Est. primary completion date: June 24, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastroschisis

Intervention

Procedure:
• Gastroschisis closure with suture

• Gastroschisis closure without suture

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time on ventilator		Up to 1 week
Primary	Time to initiating enteral feeds		Up to 4 weeks
Secondary	Cosmesis		6 months after hospital discharge
Secondary	Length of hospital stay		Up to 6 weeks
Secondary	Complications including bowel resection, sepsis, and death.		Up to 45 days