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

This study has been completed.
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00539292
First received: October 2, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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 Intervention Phase
Gastroschisis
 Procedure: Primary placement of a spring-loaded silo
Procedure: Primary Closure
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

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

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

Enrollment: 88
Study Start Date: September 2005
Study Completion Date: August 2007
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539292

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

No publications provided

ClinicalTrials.gov Identifier: NCT00539292     History of Changes
Other Study ID Numbers: 0020010078
Study First Received: October 2, 2007
Last Updated: October 2, 2007
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
pediatrics
gastroschisis
silastic spring-loaded silo

Additional relevant MeSH terms:
Gastroschisis
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
 Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013