Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis
Primary Purpose
Gastroschisis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Primary placement of a spring-loaded silo
Primary Closure
Sponsored by
About this trial
This is an interventional treatment trial for Gastroschisis focused on measuring pediatrics, gastroschisis, silastic 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
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Silastic Spring-Loaded Silo
Primary Closure of Abdomen
Outcomes
Primary Outcome Measures
length of time on the ventilator
Secondary Outcome Measures
return to bowel function as measured by serum lactate and intragastric pressure
urine output
tpn
time to full enteral feeding
length of hospital stay
complications during hospitalization (e.g., NEC, sepsis)
height and weight
urine output
Full Information
NCT ID
NCT00539292
First Posted
October 2, 2007
Last Updated
October 2, 2007
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT00539292
Brief Title
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
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroschisis
Keywords
pediatrics, gastroschisis, silastic spring-loaded silo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Silastic Spring-Loaded Silo
Arm Title
2
Arm Type
Active Comparator
Arm Description
Primary Closure of Abdomen
Intervention Type
Procedure
Intervention Name(s)
Primary placement of a spring-loaded silo
Intervention Type
Procedure
Intervention Name(s)
Primary Closure
Intervention Description
primary closure of abdomen
Primary Outcome Measure Information:
Title
length of time on the ventilator
Time Frame
days
Secondary Outcome Measure Information:
Title
return to bowel function as measured by serum lactate and intragastric pressure
Time Frame
preop and 2 hours postop on day of definitive closure, then daily; intragastric pressure at time of closure;
Title
urine output
Time Frame
5 days post closure
Title
tpn
Time Frame
days
Title
time to full enteral feeding
Time Frame
days
Title
length of hospital stay
Time Frame
days
Title
complications during hospitalization (e.g., NEC, sepsis)
Time Frame
post-surgery to hospital discharge
Title
height and weight
Time Frame
post-discharge
Title
urine output
Time Frame
for 5 days after definitive closure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Langer, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
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Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis
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