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

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: Terminated
• Conditions: Gastroschisis
• Intervention / Treatment: Procedure: Primary placement of a spring-loaded silo; Procedure: Primary Closure

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (Child)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Measure Description	Time Frame
Ventilation Status	length of time on the ventilator	Data collected daily during the first 14 days after the abdominal wall closure (measured in days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraabdominal Pressure (IAP) as Reflected by Intragastric Pressure		intraabdominal pressure at the time of definitive closure
TPN	use of total parenteral nutrition (TPN)	Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days)
Length of Hospital Stay	days in hospital	Data collected daily during the first 14 days after the abdominal wall closure (measured in days), then monthly for 3 months until discharge.
Complications During Hospitalization (e.g., Sepsis)	Clinical sepsis confirmed with a positive blood culture	post-surgery to hospital discharge; Data collected daily during the first 14 days after the abdominal wall closure (measured in days), then monthly for 3 months until discharge.

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Pastor AC, Phillips JD, Fenton SJ, Meyers RL, Lamm AW, Raval MV, Lehman E, Karp TB, Wales PW, Langer JC. Routine use of a SILASTIC spring-loaded silo for infants with gastroschisis: a multicenter randomized controlled trial. J Pediatr Surg. 2008 Oct;43(10):1807-12. doi: 10.1016/j.jpedsurg.2008.04.003.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2001
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: October 2, 2007
• First Submitted That Met QC Criteria: October 2, 2007
• First Posted (Estimated): October 4, 2007

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: pediatrics; gastroschisis; silastic spring-loaded silo
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Musculoskeletal Abnormalities; Hernia; Gastroschisis
• Other Study ID Numbers: 0020010078