Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-10 @ 9:43 AM
Study NCT ID:
NCT00539292
Status:
TERMINATED
Last Update Posted:
2024-06-24
First Post:
2007-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis
Sponsor:
The Hospital for Sick Children
Organization:
Study Overview
Official Title:
A Multi-Centre, Prospective Randomized Trial to Evaluate Routine Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
With the existing rate of patient accrual, it would take an extensive amount of time to reach the initial target of 88 patients. During this period, other changes in perioperative management of surgical neonates may invalidate the study comparisons.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: