跳至主要内容
临床试验/NCT06029101
NCT06029101招募中不适用

Modalities of Surgical Treatment of Chiari Malformation Disease : Clinical Study and Outcomes

Assiut University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
12
试验地点
1
主要终点
Evaluation of postoperative outcomes of Chiari Malformation Patients at Department of Neurosurgery Assiut University Hospital .

研究概览

简要总结

Evaluation of postoperative outcomes of Chiari type I Malformation Patients at Department of Neurosurgery Assiut University Hospital .

详细描述

Chiari malformation is a group of craniocervical malformations involving the brain stem, cerebellum, upper spinal cord, and surrounding bony structure, encompassing a series of hindbrain herniation symptoms. The Austrian pathologist Hans Chiari first described the malformation in 1891 and such abnormality is frequently identified in both young adult and pediatric patients.

There are four main types of chiari malformations with other subtypes. Chiari I malformation (CIM), in which the caudal poles of the cerebellar tonsils extend into the upper cervical spinal canal, is a common clinical type. Common clinical symptoms, including headache, altered sensation, weakness, dysphagia, sleep apnea.

Between 70% and 80% of patients with CIM have accompanying syringomyelia. Surgical treatment is widely accepted and is the only treatment chosen for symptomatic patients with Chiari malformations.

The aim of this study is to elucidate the most favorable procedures for CIM in terms of radiological and clinical outcomes.

Independent and dependent variables will be identified for analysis. The independent variables will include patient diagnosis, surgical techniques, patient age, patient chronic diseases and identified dependent variables including improvement of symptoms and signs, rates of intraoperative and postoperative adverse events, and perioperative mortality.

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

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

入选标准

  • Chiari I Malformation patients who suffer from clinical symptoms and radiological manifestations.
  • Patients fit for surgery

排除标准

  • Other types of Chiari malformations
  • Patients with multilevel cervical disc herniation .
  • Patients with segmental instability .
  • Patients unfit for surgery

结局指标

主要结局

Evaluation of postoperative outcomes of Chiari Malformation Patients at Department of Neurosurgery Assiut University Hospital .

时间窗: 4 weeks postoperative

using chicago chiari outcome score The Chicago Chiari Outcome Scale (CCOS) uses 4 postoperative outcome categories (pain, nonpain symptoms, functionality, and complications) graded 1 to 4 for a total possible score of 16 , when the score is higher ,it means better outcome. pain for example will be measured by Visual Analog Score for pain.

次要结局

未报告次要终点

研究者

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

Ahmed Hamdy Hussein

demonistrator

Assiut University

研究点 (1)

Loading locations...

相似试验