NCT00539292

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2007

Completed
16.7 years until next milestone

Results Posted

Study results publicly available

June 24, 2024

Completed
Last Updated

June 24, 2024

Status Verified

January 1, 2024

Enrollment Period

5.5 years

First QC Date

October 2, 2007

Results QC Date

April 24, 2020

Last Update Submit

January 12, 2024

Conditions

Gastroschisis

Keywords

pediatricsgastroschisissilastic spring-loaded silo

Outcome Measures

Primary Outcomes (1)

  • Ventilation Status

    length of time on the ventilator

    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

    intraabdominal pressure at the time of definitive closure

  • TPN

    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

    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)

    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.

Study Arms (2)

1

EXPERIMENTAL

Silastic Spring-Loaded Silo

Procedure: Primary placement of a spring-loaded silo

2

ACTIVE COMPARATOR

Primary Closure of Abdomen

Procedure: Primary Closure

Interventions

Primary placement of a spring-loaded siloPROCEDURE
1
Primary ClosurePROCEDURE

primary closure of abdomen

2

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 18926212RESULT

MeSH Terms

Conditions

Gastroschisis

Condition Hierarchy (Ancestors)

Musculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Limitations and Caveats

Difficulty with patient enrollment because of parent refusal or absence for consent and individual surgeon preference not to randomize patients; this limited the number of patients enrolled and prevented adequate statistical power to be achieved.

Results Point of Contact

Title
Dr Jacob C Langer
Organization
The Hospital for Sick Children
jacob.langer@sickkids.ca
416-813-7340

Study Officials

  • Jacob Langer, MD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Surgeon

Study Record Dates

First Submitted

October 2, 2007

First Posted

October 4, 2007

Study Start

June 1, 2001

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

June 24, 2024

Results First Posted

June 24, 2024

Record last verified: 2024-01

Locations

CA(1)