Sutureless vs Sutured Gastroschisis Closure

• Sponsor: Stanford University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01094587
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arms: 2
• Actual Duration (Months): 67.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroschisis	Procedure: Gastroschisis closure with suture; Procedure: Gastroschisis closure without suture	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sutureless vs Sutured Gastroschisis Closure
• Actual Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Jun 24, 2015
• Actual Study Completion Date: Jun 24, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sutured closure	Procedure: Gastroschisis closure with suture
Active Comparator: Sutureless closure	Procedure: Gastroschisis closure without suture

Outcome Measures

Primary Outcome Measures

1. Time on ventilator [Up to 1 week]

2. Time to initiating enteral feeds [Up to 4 weeks]

Secondary Outcome Measures

1. Cosmesis [6 months after hospital discharge]

2. Length of hospital stay [Up to 6 weeks]

3. Complications including bowel resection, sepsis, and death. [Up to 45 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Sanjeev Dutta, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matias Bruzoni, Principal Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT01094587
• Other Study ID Numbers: SU-10142009-4180; IRB Protocol: 16918
• First Posted: Mar 29, 2010
• Last Update Posted: Oct 13, 2017
• Last Verified: Oct 1, 2017

• Additional relevant MeSH terms: Gastroschisis

Study Results

No Results Posted as of Oct 13, 2017