A Multi-Centre, Prospective Randomized Trial to Evaluate Routine Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Ventilation Status
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Gastroschisis
- •Birth Weight ≥ 1500 grams
- •Gestational Age ≥ 34 weeks
排除标准
- •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
结局指标
主要结局
Ventilation Status
时间窗: Data collected daily during the first 14 days after the abdominal wall closure (measured in days)
length of time on the ventilator
次要结局
- TPN(Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days))
- 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.)
- 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.)
研究者
Jacob Langer
Staff Surgeon
The Hospital for Sick Children