GastroschisisPhase 2NCT00539292
Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis
A Phase 2 study testing Primary placement of a spring-loaded silo and Primary Closure in people with Gastroschisis, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Gastroschisis
- What is being tested?
- Primary placement of a spring-loaded silo and Primary Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2001to Dec 2006
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Gastroschisis
- Birth Weight ≥ 1500 grams
- Gestational Age ≥ 34 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Centre, Prospective Randomized Trial to Evaluate Routine Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis
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.
Read the 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.
- Conditions
- Gastroschisis
- Being tested
- Primary placement of a spring-loaded silo, Primary Closure
- Keywords
- pediatrics, gastroschisis, silastic spring-loaded silo
- Medical subject headings
- Gastroschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary placement of a spring-loaded siloProcedure or surgery
Primary ClosureProcedure or surgery
primary closure of abdomen
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Silastic Spring-Loaded Silo Receives: Procedure: Primary placement of a spring-loaded silo |
| 2 | Active comparator | Primary Closure of Abdomen Receives: Procedure: Primary Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation Status
length of time on the ventilator
Measured: Data collected daily during the first 14 days after the abdominal wall closure (measured in days)
Secondary outcomes (4)
Intraabdominal Pressure (IAP) as Reflected by Intragastric Pressure
Measured: intraabdominal pressure at the time of definitive closure
TPN
use of total parenteral nutrition (TPN)
Measured: Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days)
Length of Hospital Stay
days in hospital
Measured: Data collected daily during the first 14 days after the abdominal wall closure (measured in days), then monthly for 3 months until discharge.
Complications During Hospitalization (e.g., Sepsis)
Clinical sepsis confirmed with a positive blood culture
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2007 (estimated)
- Study startJun 2001
- Primary completionDec 2006
- Study completionDec 2006
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroschisisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Langer, The Hospital for Sick Children
- Investigators
- Jacob Langer, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539292
- Sponsor's protocol ID
- 0020010078
- Status last verified
- Jan 2024
- First submitted
- 2 Oct 2007
- Last updated
- 24 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 18926212
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Prospective Randomized Trial to Evaluate Routine Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis
- ClinicalTrials.gov ID
- NCT00539292
- Acronym / sponsor ID
- 0020010078
- Conditions
- Gastroschisis
- Keywords
- pediatrics, gastroschisis, silastic spring-loaded silo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 88 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jun 2001 (actual)
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 4 Oct 2007 (estimated)
- Results
- Posted 24 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Primary placement of a spring-loaded siloSilastic Spring-Loaded Silo |
| 2 | Active comparator | Procedure: Primary ClosurePrimary Closure of Abdomen |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of Gastroschisis
- Birth Weight ≥ 1500 grams
- Gestational Age ≥ 34 weeks
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary placement of a spring-loaded silo | Procedure or surgery | 1 |
| Primary Closureprimary closure of abdomen | Procedure or surgery | 2 |
Primary outcome
Ventilation Status
Time frame: Data collected daily during the first 14 days after the abdominal wall closure (measured in days)
length of time on the ventilator
4 secondary outcomes
Intraabdominal Pressure (IAP) as Reflected by Intragastric Pressure
Time frame: intraabdominal pressure at the time of definitive closure
TPN
Time frame: Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days)
Length of Hospital Stay
Time frame: Data collected daily during the first 14 days after the abdominal wall closure (measured in days), then monthly for 3 months until discharge.
Complications During Hospitalization (e.g., Sepsis)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18926212Pastor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Langer, MD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Primary placement of a spring-loaded silo and Primary Closure in people with Gastroschisis, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation Status (time frame: Data collected daily during the first 14 days after the abdominal wall closure (measured in days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00539292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.