跳至主要内容
临床试验/NCT06290791
NCT06290791已完成不适用

Does a Drain Tube Influence the Postoperative Epidural Haematoma for Lumbar Biportal Endoscopic Surgery? A Randomized, Controlled Trial

The Fourth Affiliated Hospital of Zhejiang University School of Medicine1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2020年12月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
89
试验地点
1
主要终点
the cross-sectional area of POSEH

研究概览

简要总结

The purpose of this study was to evaluate if wound drains could influence postoperative spinal epidural hematoma (POSEH) in biportal endoscopic spinal surgery (BESS) procedures for decompression of lumbar spinal stenosis.

详细描述

How to reduce the rate of POSEH after lumbar spinal surgery is an obvious concern for spine surgeon. Wound drains were recognized as effective methods and typically used to prevent the development of symptomatic epidural hematomas after spinal surgery. However, whether range prophylactic postoperative drainage after spinal decompression for the prevention of POSEH is still controversial. Although there have been many studies focusing on the potential associations between wound drains and POSEH after lumbar spinal surgery, a prospective study focusing on the role of drains in minimally invasive surgery of BESS for lumbar spinal decompression has been rare. In present study, our team sought to investigate the influence of wound drains for POSEH and provide clinical evidence for the selection of drainage in BESS procedures for the decompression of lumbar spinal stenosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with two level lumbar stenosis and neurogenic claudication with or without lumbar radiculopathy were eligible for inclusion.

排除标准

  • Patients were excluded if radiography revealed lumbar instability (motion of >3mm at the level of listhesis), if they had had previous lumbar spinal surgery, or they had American Society of Anesthesiologists (ASA) class Ⅳ or severe systemic disease.

结局指标

主要结局

the cross-sectional area of POSEH

时间窗: 24 hours after drain withdrawal

the cross-sectional area of the 72th-hour POSEH after surgery

次要结局

  • the volume of drain output(48 hours after surgery)

研究者

发起方
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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