Sanjeev Dutta, MD MA FRCSC FACS
Sutureless vs Sutured Gastroschisis Closure
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
Not yet recruitingStanford Recruiting Status:
Not yet recruitingCondition(s):
Intervention(s):
- Procedure: Sutureless gastroschisis closure
Phase:
N/AEligibility
Ages Eligible for Study:
Any Age to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Inclusion criteria are the diagnosis of gastroschisis, birth weight of 1500 grams or greater, and gestational age of 34 weeks or more.
Key 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 gastroschsis defect.
Additional Study Details
Official Title:
Sutureless vs Sutured Gastroschisis ClosureAnticipated start date:
11/16/2009Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
Assignment:
ParallelEndpoints:
EfficacyPrimary Outcomes:
- Time on ventilator
- Time to initiating enteral feeds
Secondary Outcomes:
- Cosmesis
- Length of hospital stay
- Complications including bowel resection, sepsis, and death.
Total Number to be Enrolled:
54Total Number to be Enrolled at Stanford:
54More Information
Secondary ID(s):
- IRB Protocol: 16918
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
10/26/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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