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

Phase 2

Terminated

• Conditions: Gastroschisis
• Interventions: Procedure: Primary Closure; Procedure: Primary placement of a spring-loaded silo

• Registration Number: NCT00539292
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2001-06
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2007-10-02
• Study First Submitted QC: 2007-10-02
• Study First Posted: 2007-10-04
• Results First Submitted: 2020-04-24
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Results First Posted: 2024-06-24
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Primary Closure	Primary Closure of Abdomen
1	Primary placement of a spring-loaded silo	Silastic Spring-Loaded Silo

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada