Sutureless vs Sutured Gastroschisis Closure
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Gastroschisis |
Procedure: Sutureless gastroschisis closure |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Sutureless vs Sutured Gastroschisis Closure |
- Time on ventilator [ Designated as safety issue: No ]
- Time to initiating enteral feeds [ Designated as safety issue: No ]
- Cosmesis [ Time Frame: 6 months after hospital discharge ] [ Designated as safety issue: No ]
- Length of hospital stay [ Designated as safety issue: No ]
- Complications including bowel resection, sepsis, and death. [ Designated as safety issue: No ]
| Estimated Enrollment: | 54 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| 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 gastroschsis defect.
Contacts and Locations| Contact: Sanjeev Dutta, MD | (650) 723-6439 | sdutta1@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Sanjeev Dutta, MD 650-723-6439 sdutta1@stanford.edu | |
| Contact: Susan Hintz, MD (650) 497-8800 srhintz@stanford.edu | |
| Principal Investigator: Sanjeev Dutta | |
| Sub-Investigator: Susan Hintz | |
| Principal Investigator: | Sanjeev Dutta | Stanford University |
More Information
No publications provided
| Responsible Party: | Sanjeev Dutta, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01094587 History of Changes |
| Other Study ID Numbers: | SU-10142009-4180, IRB Protocol: 16918 |
| Study First Received: | March 25, 2010 |
| Last Updated: | March 25, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Gastroschisis Musculoskeletal Abnormalities Musculoskeletal Diseases Congenital Abnormalities |
Hernia, Abdominal Hernia Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 19, 2013