Outcome of Chronic Subdural Hematoma: Double Burr Hole Versus Single Burr Hole With Subdural Drain Evacuation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recurrence Of Chronic Subdural Hematoma
研究概览
简要总结
The goal of this clinical trial is to compare the outcome of double burr hole versus single burr hole in patients of chronic subdural hematoma undergoing subdural drain evacuation.
The main questions it aims to answers are
1. Which one of the surgical method i.e single burr hole or double burr hole is clinically superior with better post operative prognosis for the drainage of chronic subdural hematoma.
2 Compare the post operative complications in both the techniques in term of wound infection hospital stay duration , recurrence and mortality.
participants will be divided in two groups one group will be treated with single burr hole technique second group will be treated with double burr hole technique.
After procedure, patients will be followed-up in hospital until discharge and total hospital stay will be noted. Patients will be followed-up further in OPD . During follow-up, patients will be evaluated for wound infection, recurrence and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20-70 years both genders diagnosed with subdural hematoma
排除标准
- •• Patients in shock (BP≤100/60 mmHg) or history of seizures
- •Patients with bleeding disorder (PT>15 sec) or intake of anti-coagulants
- •Patients undergoing or already had ventriculoperitoneal shunt
- •Patients with epilepsy, or obsessive compulsive decoder
- •Patients with already operated for subdural hematoma
- •Patients with post-cerebrospinal fluid diversion subdural hematoma
研究组 & 干预措施
Double burr Hole Arm
this arm includes patient who receive double burr hole craniotomy surgical procedure for drainage of chronic subdural hematoma
干预措施: Double Burr hole Craniotomy (Procedure)
Single Burr Hole Arm
this arm includes patient who receive single burr hole craniotomy surgical procedure for drainage of chronic subdural hematoma
干预措施: Single Burr hole Craniotomy (Procedure)
结局指标
主要结局
Recurrence Of Chronic Subdural Hematoma
时间窗: From date of surgery until radiologically confirmed recurrence (defined as subdural hematoma volume >15 mL or significant mass effect on CT brain) requiring repeat intervention, assessed up to 3 months postoperatively
recurrence rate of chronic subdural hematoma evaluated if volume of sdh \>15ml or significant mass effect on CT brain within 3 months post operatively
quantity of hematoma evacuated
时间窗: Measured intraoperatively at the time of surgery and cumulatively measured postoperatively from surgery until removal of the subdural drain, assessed up to 72 hours postoperatively.
Intraoperatively evacuated hematoma quantity measured in millilitres and also includes the quantity obtained in subdural drain till 72 hours postoperatively
次要结局
未报告次要终点
研究者
Muhammad Hassan tabish
Muhammad Hassan Tabish , MBBS, Neurosurgery Resident / Principal Investigator
Services Institute of Medical Sciences, Pakistan