NCT06820736招募中不适用
A Prospective, Randomized Comparison Of Drainage Techniques After One- Or Two-Level Open Posterior Lumbar Decompression Or Decompression And Fusion
Twin Cities Spine Center1 个研究点 分布在 1 个国家目标入组 975 人开始时间: 2025年1月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 975
- 试验地点
- 1
- 主要终点
- Reoperation
研究概览
简要总结
This project is being done to understand if a drain reduces recovery problems after surgery, such as infection or the need for more surgery.
详细描述
The primary objective is to prospectively evaluate drains used in lumbar spine surgery in patients undergoing one- or two-level open posterior lumbar decompression or decompression and fusion for the relative risk of return to the operating room within 90 days.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One or two-level open spinal decompression or decompression and fusion for the treatment of lumbar stenosis and/or spondylolisthesis
排除标准
- •Infection, tumor, or trauma
- •Prior lumbar fusion surgery
- •Lumbar fusion surgery at more than 2 levels
- •Anterior lumbar surgery
- •Perioperative anticoagulation treatment
- •Intraoperative incidental durotomy
- •Intraoperative or postoperative cerebrospinal fluid leakage
- •Intraoperative EBL greater than one liter
研究组 & 干预措施
Active Drain
Experimental
The drain will be used with compression suction.
干预措施: Drain (Device)
Passive Drain
Experimental
The drain will be used with gravity alone.
干预措施: Drain (Device)
No Drain
No Intervention
No drain will be used.
结局指标
主要结局
Reoperation
时间窗: 90 days postoperatively
Relative risk of return to the operating room
次要结局
- Time to drain removal(90 days postoperatively)
- Length of Stay(90 days postoperatively)
- Complications(90 days postoperatively)
- Drain volume(90 days postoperatively)
- Transfusion(90 days postoperatively)
研究者
研究点 (1)
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