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临床试验/NCT05534659
NCT05534659已完成不适用

Comparison of Benefit and Survival for Different Etiologies of Adult Patients With Hydrocephalus Between Programmable Cerebrospinal Fluid Ventricular Shunt and Non-programmable Cerebrospinal Fluid Ventricular Shunt

Chang Gung Memorial Hospital0 个研究点目标入组 325 人开始时间: 2017年1月1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
325
主要终点
Initial Shunt revision rate

研究概览

简要总结

Programmable valve (PV) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults. This study is to compare the overall revision rate, revision cause, and revision-free survival between PV and non-programmable valve (NPV) in adult patients with different hydrocephalus etiologies.

详细描述

Relatively high revision rates up to 32% of CSF shunting operations remained an unsolved problem for neurosurgeons. The cause of revisions were diverse, including overdrainage/underdrainage, shunting system obstruction, infection or technical skill related. Programmable valve (PV) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults. This study is to compare the overall revision rate, revision cause, and revision-free survival between PV and non-programmable valve (NPV) in adult patients with different hydrocephalus etiologies.

The investigators reviewed the chart of all patients with hydrocephalus receiving index ventricular CSF shunt operations conducted at a single institution in northern Taiwan from January 2017 to December 2017. Patients included in the study were followed up for at least five years. Statistical tests including independent t-test, Chi-square test and Fisher's exact test were used for comparative analysis, and Kaplan-Meier curve using log-rank test was performed to compare the revision-free survival between the PV and NPV groups

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • received shunting operations at Chang Gung Medical Foundation, Linkou Branch from 2017/01/01~2017/12/31

排除标准

  • Patients who received index ventricular CSF shunt at other hospitals,
  • Patients who received index ventricular CSF shunt before January 1st 2017,
  • Patients who were younger than 18

结局指标

主要结局

Initial Shunt revision rate

时间窗: since the time of index operation until the initial revision or 2022/07/31

the ratio of the total number of patients with at least one revision to the total number of patients included in this study

Revision-free survival

时间窗: since the time of index operation until the initial revision or 2022/07/31

the interval between index operation and the initial revision

Total Shunt revision rate

时间窗: since the time of index operation until the initial revision or 2022/07/31

the ratio of the total number of revisions to the total number of ventricular CSF shunt operations

Type of the revision operation

时间窗: since the time of index operation until the initial revision or 2022/07/31

the detailed description of the revision operation

The cause of shunt revision

时间窗: since the time of index operation until the initial revision or 2022/07/31

the cause of the shunt malfunction warranting revision operation

次要结局

  • Shunt revision-free survival among different hydrocephalus etiologies(since the time of index operation until the initial revision or 2022/07/31)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

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