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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-Centre, Prospective Randomized Trial to Evaluate Routine Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis

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.

Detailed Summary:

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.


Sponsor: The Hospital for Sick Children

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: October 2, 2007
Date Started: September 2005
Date Completion:
Last Updated: October 2, 2007
Last Verified: October 2007