Sutureless vs Sutured Gastroschisis Closure
Primary Purpose
Gastroschisis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gastroschisis closure with suture
Gastroschisis closure without suture
Sponsored by
About this trial
This is an interventional treatment trial for Gastroschisis
Eligibility Criteria
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.
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sutured closure
Sutureless closure
Arm Description
Outcomes
Primary Outcome Measures
Time on ventilator
Time to initiating enteral feeds
Secondary Outcome Measures
Cosmesis
Length of hospital stay
Complications including bowel resection, sepsis, and death.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01094587
Brief Title
Sutureless vs Sutured Gastroschisis Closure
Official Title
Sutureless vs Sutured Gastroschisis Closure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Enrollment difficulty
Study Start Date
November 2009 (Actual)
Primary Completion Date
June 24, 2015 (Actual)
Study Completion Date
June 24, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroschisis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sutured closure
Arm Type
Active Comparator
Arm Title
Sutureless closure
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Gastroschisis closure with suture
Intervention Type
Procedure
Intervention Name(s)
Gastroschisis closure without suture
Primary Outcome Measure Information:
Title
Time on ventilator
Time Frame
Up to 1 week
Title
Time to initiating enteral feeds
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Cosmesis
Time Frame
6 months after hospital discharge
Title
Length of hospital stay
Time Frame
Up to 6 weeks
Title
Complications including bowel resection, sepsis, and death.
Time Frame
Up to 45 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjeev Dutta
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sutureless vs Sutured Gastroschisis Closure
We'll reach out to this number within 24 hrs