Clinical Trial: Sutureless vs Sutured Gastroschisis Closure
Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Sutureless vs Sutured Gastroschisis Closure
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 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.
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.
Sponsor: Stanford University
Current Primary Outcome:
- Time on ventilator
- Time to initiating enteral feeds
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Cosmesis [ Time Frame: 6 months after hospital discharge ]
- Length of hospital stay
- Complications including bowel resection, sepsis, and death.
Original Secondary Outcome: Same as current
Information By: Stanford University
Dates:
Date Received: March 25, 2010
Date Started: November 2009
Date Completion: March 2014
Last Updated: June 21, 2013
Last Verified: June 2013
