Sutureless vs Sutured Gastroschisis Closure

Trial ID or NCT#

NCT01094587

Status

not recruiting iconNOT RECRUITING

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.

Official Title

Sutureless vs Sutured Gastroschisis Closure

Eligibility Criteria

Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. Inclusion criteria are the diagnosis of gastroschisis, birth weight of 1500 grams or greater, and gestational age of 34 weeks or more.
Exclusion Criteria:
  1. 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.

Contact us to find out if this trial is right for you.

Contact

Sanjeev Dutta, MD
650-723-6439