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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00539292
Recruitment Status : Completed
First Posted : October 4, 2007
Last Update Posted : October 4, 2007
Information provided by:
The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Gastroschisis Procedure: Primary placement of a spring-loaded silo Procedure: Primary Closure Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Centre, Prospective Randomized Trial to Evaluate Routine Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis
Study Start Date : September 2005
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. length of time on the ventilator [ Time Frame: days ]

Secondary Outcome Measures :
  1. 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; ]
  2. urine output [ Time Frame: 5 days post closure ]
  3. tpn [ Time Frame: days ]
  4. time to full enteral feeding [ Time Frame: days ]
  5. length of hospital stay [ Time Frame: days ]
  6. complications during hospitalization (e.g., NEC, sepsis) [ Time Frame: post-surgery to hospital discharge ]
  7. height and weight [ Time Frame: post-discharge ]
  8. urine output [ Time Frame: for 5 days after definitive closure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00539292

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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
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Principal Investigator: Jacob Langer, MD The Hospital for Sick Children, Toronto Canada

Layout table for additonal information Identifier: NCT00539292    
Other Study ID Numbers: 0020010078
First Posted: October 4, 2007    Key Record Dates
Last Update Posted: October 4, 2007
Last Verified: October 2007
Keywords provided by The Hospital for Sick Children:
silastic spring-loaded silo
Additional relevant MeSH terms:
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Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Pathological Conditions, Anatomical