NCT00539292

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 1 Day – 30 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroschisis

Interventions

Type	Name	Description
PROCEDURE	Primary placement of a spring-loaded silo
PROCEDURE	Primary Closure	primary closure of abdomen

Timeline

• Start date: 2001-06-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2007-10-04
• Last updated: 2024-06-24
• Results posted: 2024-06-24

Locations

1 site across 1 country: Canada