Clinical trial NCT00539292: Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis
Official title: A Multi-Centre, Prospective Randomized Trial to Evaluate Routine Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gastroschisis
Keywords: pediatrics
gastroschisis
silastic spring-loaded silo
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2007-10-04
Enrollment: 88
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study seeks to evaluate whether the routine, primary use of the spring-loaded silo (SLS) to treat infants with gastroschisis will result in improved outcomes, faster recovery times and fewer post-surgical complications than the standard selective use of the silo.

Detailed description: Standard treatment of the infant with gastroschisis consists of , the bowel being reduced into the abdomen, when possible,and the abdominal wall defect being closed in the operating room. When complete reduction of the eviscerated contents is not possible, a silastic " silo" is sewn on the abdominal wall and its contents are gradually reduced into the abdomen over several days. Once reduction is obtained, the silo is removed and the abdominal defect is closed.

Current methods of treatment are associated with significant morbidity, prolonged hospitalization, and high costs. Gastroschisis closure continues to be accompanied by a number of complications ranging from ileus, sepsis, TPN-related liver damage, necrotizing enterocolitis, respiratory insufficiency, and death. The optimal timing and method of closure, including primary versus secondary closure, continues to be debated. No prospective randomized studies to date have examined the routine use of the spring-loaded silo.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Gastroschisis
* Birth Weight ≥ 1500 grams
* Gestational Age ≥ 34 weeks

Exclusion Criteria:

* Birth Weight \< 1500 grams
* Gestational Age \< 34 weeks
* Presence of Bowel Ischemia or Necrosis
* Abdominal wall defect too small
* Major associated anomalies or medical condition
* Presence of Intracranial Hemorrhage (grade IV)
* Parent Refusal for Randomization

Primary outcomes:
measure: Ventilation Status
timeFrame: Data collected daily during the first 14 days after the abdominal wall closure (measured in days)
Secondary outcomes:
measure: Intraabdominal Pressure (IAP) as Reflected by Intragastric Pressure
timeFrame: intraabdominal pressure at the time of definitive closure
measure: TPN
timeFrame: Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days)
measure: Length of Hospital Stay
timeFrame: Data collected daily during the first 14 days after the abdominal wall closure (measured in days), then monthly for 3 months until discharge.
measure: Complications During Hospitalization (e.g., Sepsis)
timeFrame: post-surgery to hospital discharge; Data collected daily during the first 14 days after the abdominal wall closure (measured in days), then monthly for 3 months until discharge.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Jacob Langer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pastor AC, Phillips JD, Fenton SJ, Meyers RL, Lamm AW, Raval MV, Lehman E, Karp TB, Wales PW, Langer JC. Routine use of a SILASTIC spring-loaded silo for infants with gastroschisis: a multicenter randomized controlled trial. J Pediatr Surg. 2008 Oct;43(10):1807-12. doi: 10.1016/j.jpedsurg.2008.04.003.