Sutureless vs Sutured Gastroschisis Closure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Time on ventilator
研究概览
简要总结
This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. The parameters of this trial were determined using our retrospective study as pilot data. Primary outcome measures will be time on ventilator and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death.
详细描述
This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. The parameters of this trial were determined using our retrospective study as pilot data. Primary outcome measures will be time on ventilator and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death.
In comparing these techniques of gastroschisis closure, we can further evaluate which is the safer and more efficacious method, thereby improving patient care while decreasing hospital cost.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria are the diagnosis of gastroschisis, birth weight of 1500 grams or greater, and gestational age of 34 weeks or more.
排除标准
- •Exclusion criteria are infants with other major abnormalities or medical conditions, grade IV intraventricular hemorrhage, inability to obtain informed consent, and the presence of a closed-type gastroschisis defect.
研究组 & 干预措施
Sutured closure
干预措施: Gastroschisis closure with suture (Procedure)
Sutureless closure
干预措施: Gastroschisis closure without suture (Procedure)
结局指标
主要结局
Time on ventilator
时间窗: Up to 1 week
Time to initiating enteral feeds
时间窗: Up to 4 weeks
次要结局
- Cosmesis(6 months after hospital discharge)
- Length of hospital stay(Up to 6 weeks)
- Complications including bowel resection, sepsis, and death.(Up to 45 days)
研究者
Matias Bruzoni
Principal Investigator
Stanford University