Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Silastic Spring-Loaded Silo |
Procedure: Primary placement of a spring-loaded silo
|
| Active Comparator: 2 Primary Closure of Abdomen |
Procedure: Primary Closure
primary closure of abdomen
|
Outcome Measures
Primary Outcome Measures
- length of time on the ventilator [days]
Secondary Outcome Measures
- return to bowel function as measured by serum lactate and intragastric pressure [preop and 2 hours postop on day of definitive closure, then daily; intragastric pressure at time of closure;]
- urine output [5 days post closure]
- tpn [days]
- time to full enteral feeding [days]
- length of hospital stay [days]
- complications during hospitalization (e.g., NEC, sepsis) [post-surgery to hospital discharge]
- height and weight [post-discharge]
- urine output [for 5 days after definitive closure]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Hospital for Sick Children | Toronto | Ontario | Canada | M5G 1X8 |
Sponsors and Collaborators
- The Hospital for Sick Children
Investigators
- Principal Investigator: Jacob Langer, MD, The Hospital for Sick Children, Toronto Canada
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0020010078