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临床试验/NCT06341946
NCT06341946尚未招募不适用

Role of Endoscopic Third Ventriculostomy in Management of Malfunctioning Ventriculoperitoneal Shunt

Sohag University0 个研究点目标入组 30 人开始时间: 2024年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Glasgow Coma Scale (GCS)

研究概览

简要总结

The aim of this study is to analyze our experience in management of malfunctioning ventriculoperitoneal shunt by using endoscopic third ventriculostomy (ETV).

详细描述

Cerebrospinal fluid shunting remains the most common line of treatment for hydrocephalus. Endoscopic third ventriculostomy (ETV) is an alternative to cerebrospinal fluid (CSF) shunting that is potentially favorable due to the lack of implanted hardware. Most previous studies of ETV have focused on its role as an initial treatment for hydrocephalus and on comparing ETV with CSF shunting. However ,some patients who have previously been treated with a CSF shunt then developed malfunction are candidate for ETV.

The ETV Success Score (ETVSS) is the most widely used scale to estimate the likelihood of ETV success for a given patient .

Although the age of the patient is the most important component of the ETVSS, history of previous treatment with a shunt is also included in the model. According to the ETVSS, previous shunting reduces the likelihood of ETV success by approximately 10%.

There have been numerous previous studies of ETV in patients with a history of a CSF shunt (post shunt ETV), reporting success rates from 50% to 80% . Two review articles also covered this topic, one of which reported ETV success by meta-analysis in 68% of 519 pooled patients .

Most patients with shunt malfunction and or infection are treated with revision procedures, but ETV can be used as an alternative treatment in such cases .The role of endoscopic management of hydrocephalus in shunt malfunction was not investigated extensively so far.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • • All patients with malfunctioning VP shunt will be included in this study.

排除标准

  • Patients with contraindications for endoscopic procedure such as intracranial infection or bleeding disorders
  • Previous unsuccessful attempts of endoscopic third ventriculostomy.
  • Active infection or inflammation in the central nervous system.
  • Recent history of intracranial hemorrhage.
  • Medically unfit for surgery.

结局指标

主要结局

Glasgow Coma Scale (GCS)

时间窗: base line

clinical symptoms improvement this Score has values between 3 and 15, 3 being the worst and 15 being the highest

visual analogue scale( VAS )

时间窗: base line

clinical symptoms improvement this Score has values between 0 and 10, 0 being the best and 10 being the worst

visual acuity

时间窗: base line

clinical symptoms improvement

次要结局

  • radiological CT brain and or MRI brain(base line)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Mahmoud Abdellah

assistant lecturer

Sohag University

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