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

Phase 2TerminatedNCT00539292

The Hospital for Sick Children88 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastroschisis

Interventions

Primary placement of a spring-loaded siloPROCEDURE

Primary ClosurePROCEDURE

primary closure of abdomen

Eligibility

Sex: ALLMin age: 1 DayMax age: 30 Days

Medical Language ↔ Plain English

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

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Ventilation Status

length of time on the ventilator

Time frame: Data collected daily during the first 14 days after the abdominal wall closure (measured in days)

Secondary Outcomes

Intraabdominal Pressure (IAP) as Reflected by Intragastric Pressure

Time frame: intraabdominal pressure at the time of definitive closure

TPN

use of total parenteral nutrition (TPN)

Time frame: 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

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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