Endoscopic Third Ventriculostomy versus Ventriculoperitoneal Shunt followed by definitive surgery in Infratentorial tumours with hydrocephalus– A prospective randomized control study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- To compare the success rate of the two CSF diversion procedures prior to definitive surgery in patients of Infratentorial tumours with hydrocephalus on the basis of development of pseudomeningocele, CSF leak and need for revision of the CSF diversion procedure postoperatively.
研究概览
简要总结
The study has been proposed with the aim to study and decide the standard of care for patients suffering with Infratentorial tumours with hydrocephalus requiring CSF diversion procedure preoperatively in the form of Endoscopic Third Ventriculostomy or Ventriculoperitoneal Shunt and do a comparative analysis as to which procedure is more beneficial in the study population. The proposed study was not done previously in the institute as well as in any institute as far as my understanding and research. This study can help us to understand the implications, pros, and cons of both of the CSF diversion procedures and help in deciding which procedure to be followed as per the results of the research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Month(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All Patients with single Infratentorial brain tumour with radiological and clinical features of hydrocephalus on presentation.
- •Patients who give written informed consent for the study.
排除标准
- •Multicentric tumours 2) Patients less than 6 months of age.
- •Patients with posterior fossa tumours without clinical and radiological features of hydrocephalus 4) Recurrent lesions 5) Pregnancy.
结局指标
主要结局
To compare the success rate of the two CSF diversion procedures prior to definitive surgery in patients of Infratentorial tumours with hydrocephalus on the basis of development of pseudomeningocele, CSF leak and need for revision of the CSF diversion procedure postoperatively.
时间窗: Baseline on admission and follow-up at 3 months if uneventful or as and when needed in case of emeregency
次要结局
- • To determine the complications in each group of patients.(• To check for the functional outcome in each group)
研究者
Kshitij Raj Mahajan
AIIMS Jodhpur