PI Name | Protocol Number | Protocol Title | Status | Approval Date |
Mary L. Brandt, MD |
H-16773 | Gastroschisis: a prospective cohort outcome study |
Background Info |
Gastroschisis occurs in approximately 1 in 5000 live births. All infants with gastroschisis require reduction of the herniated intestine and closure of the abdominal wall defect. Traditional treatment is primary closure where the bowel is reduced into the abdomen and the abdominal wall defect closed in the operating room. If reduction is not possible, a silo can be placed so the bowel may reduce by gravity, time, and gentle pressure. Regardless of how the bowel is reduced, infants with gastroschisis are at risk for a number of poor outcomes including necrotizing enterocolitis, bowel ischemia, prolonged ileus, sepsis, liver injury, prolonged intubation, and death. |
Hypothesis |
To prospectively review the outcome of children with gastroschisis that receive either primary closure or silo treatment. Specific outcomes will include total time in hospital, time until feedings tolerated, need for additional surgery, and development of complications such as necrotizing enterocolitis or central line infections. |
Design |
Multi-center, observational, prospective cohort study |
Sample size | 100 |
Entry criteria |
All patients with gastroschisis treated at Texas Children's Hospital, Ben Taub Hospital, and Memorial Herman Hospital System. |
Results/conclusions to date |
We have currently enrolled 18 patients at TCH. There have been 2 deaths. |