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

Gastroschisis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539292
• Other study ID #: 0020010078
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2007
• Last updated: October 2, 2007
• Start date: September 2005
• Est. completion date: August 2007

Study information

• Verified date: October 2007
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroschisis

Intervention

Procedure:
• Primary placement of a spring-loaded silo

• Primary Closure
primary closure of abdomen

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of time on the ventilator		days
Secondary	return to bowel function as measured by serum lactate and intragastric pressure		preop and 2 hours postop on day of definitive closure, then daily; intragastric pressure at time of closure;
Secondary	urine output		5 days post closure
Secondary	tpn		days
Secondary	time to full enteral feeding		days
Secondary	length of hospital stay		days
Secondary	complications during hospitalization (e.g., NEC, sepsis)		post-surgery to hospital discharge
Secondary	height and weight		post-discharge
Secondary	urine output		for 5 days after definitive closure