Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis

October 2, 2007 updated by: The Hospital for Sick Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
length of time on the ventilator
Time Frame: days
days

Secondary Outcome Measures

Outcome Measure
Time Frame
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;
preop and 2 hours postop on day of definitive closure, then daily; intragastric pressure at time of closure;
urine output
Time Frame: 5 days post closure
5 days post closure
tpn
Time Frame: days
days
time to full enteral feeding
Time Frame: days
days
length of hospital stay
Time Frame: days
days
complications during hospitalization (e.g., NEC, sepsis)
Time Frame: post-surgery to hospital discharge
post-surgery to hospital discharge
height and weight
Time Frame: post-discharge
post-discharge
urine output
Time Frame: for 5 days after definitive closure
for 5 days after definitive closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Jacob Langer, MD, The Hospital for Sick Children, Toronto Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

October 2, 2007

First Submitted That Met QC Criteria

October 2, 2007

First Posted (Estimate)

October 4, 2007

Study Record Updates

Last Update Posted (Estimate)

October 4, 2007

Last Update Submitted That Met QC Criteria

October 2, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0020010078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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