Postoperative Outcomes Following Primary Lumbar Fusion in Patients With and Without a Drain: A Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Incidence of postoperative complications
研究概览
简要总结
Postoperative drain placement is often used following spine surgery. These drains are placed with the intention to decrease the incidence of postoperative hematoma and its associated complications including wound complications, infections and neurologic compression.
The use of drains, however, are not without its disadvantages including the risk of retrograde infection, increased postoperative blood loss, increased length of stay and increased hospital costs. The purpose of this study is to evaluate the postoperative outcomes and complications in patients undergoing primary lumbar fusion with and without a postoperative drain
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18
- •Undergoing primary lumbar fusion or decompression and fusion for 1-2 levels
- •Surgery indicated for lumbar degenerative disease
排除标准
- •Undergoing revision surgery
- •Surgery indicated for infection
- •Intraoperative dural tear
- •Surgery requiring intraoperative transfusion
结局指标
主要结局
Incidence of postoperative complications
时间窗: 1 year
Incidence of postoperative complications will be measured but recording the number of emergency department visits
次要结局
未报告次要终点