NCT01094587

Sutureless vs Sutured Gastroschisis Closure

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroschisis

Interventions

Type	Name	Description
PROCEDURE	Gastroschisis closure with suture
PROCEDURE	Gastroschisis closure without suture

Timeline

• Start date: 2009-11-01
• Primary completion: 2015-06-24
• Completion: 2015-06-24
• First posted: 2010-03-29
• Last updated: 2017-10-13

Locations

1 site across 1 country: United States