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

Overview

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.

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

Study Type

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

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.

Interventions

  • Procedure: Primary placement of a spring-loaded silo
  • Procedure: Primary Closure
    • primary closure of abdomen

Arms, Groups and Cohorts

  • Experimental: 1
    • Silastic Spring-Loaded Silo
  • Active Comparator: 2
    • Primary Closure of Abdomen

Clinical Trial Outcome Measures

Primary Measures

  • length of time on the ventilator
    • Time Frame: days

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 30 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Hospital for Sick Children
  • Overall Official(s)
    • Jacob Langer, MD, Principal Investigator, The Hospital for Sick Children, Toronto Canada

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