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临床试验/NCT06337851
NCT06337851已完成不适用

Comparing Simultaneous and Consecutive Drainage of Bilateral Chronic Subdural Hematoma

Ataturk Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 43 人开始时间: 2003年11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
43
试验地点
2
主要终点
The Primary Outcome: Early Postoperative Success Rate (Redo Surgery)

研究概览

简要总结

Surgical evacuation CSDH via burr hole craniostomy appears to be the most widely practiced treatment technique worldwide and outcomes are generally favorable.

In previous reports, bilateral CSDH was raised as a predictor of rapid deterioration and worse outcomes attributable to brain herniation, in comparison with unilateral ones. Nevertheless, the optimal surgical considerations in bilateral CSDH still remain controversial. Thus, this study principally aims to finding out whether consecutive removal of bilateral CSDH really poses a complication risk. The secondary objectives of the study were to obtain information about the one-year prognosis of bilateral CSDH and to find factors that affect the prognosis, if any.

Inclusion criteria Symptomatic adult (≥18 years-old) patients with bilateral hemispheric CSDH

Exclusion criteria Patients with hematoma thickness smaller than 10 mm on either side, and those who previously underwent any cranial surgery

Randomization Simple randomization, without blocking, will be used to divide patients into two groups simultaneous burr hole craniostomy (Group-1) and consecutive burr hole craniostomy (Group-2).

Clinical Evaluation Neurological examination and scoring systems (Glasgow coma scale and Markwalder Grading) will be used.

Radiological Evaluation Radiological evaluations will be made with CT and MR imaging.

Operation Patients in group-1 were fixed in supine position with their heads in neutral and flexion position. Bilateral burr holes were made one after another, the dural surfaces were exposed at the same time, then the outer membranes of both sides opened and hematomas evacuated simultaneously. All the patients underwent a drainage system, performed with the insertion of a silicone tube into the subdural space and tunneled under the scalp to the exit point. In group-2, hematoma with a greater thickness was removed first (if thickness was equal on both sides, first incision was made on the right side). The head in supine position was rotated to the side with a smaller hemorrhage thickness. Previously, burr holes were made, the dural surfaces were exposed, the outer membrane opened, and the hematoma was evacuated at one side. Then, drainage system inserted into the subdural space. After the procedure of the first side was completed, as a consecutive process, the head was rotated to the other side, and the same procedure was repeated. The contralateral hematoma was evacuated.

Follow-Up Depending on the subdural fluid collected, all drains will be removed within post-operative 36-48 hours.

Only the patients with epileptic history and on epileptic medication will receive postoperative antiepileptics.

In the postoperative period, a comprehensive evaluation encompassing neurological examinations and CT imaging will be performed.

This evaluation protocol will be executed immediately following the surgical procedure, after the removal of surgical drains (usually on the second postoperative day), and at designated intervals of the 1st, 3rd, 6th, and 12th months to monitor patient progress and recovery.

详细描述

Chronic subdural hematoma (CSDH) arises at the dural border cell layer and is characterized by a pathological collection of blood, fibrin, and degradation products between the dura mater and the arachnoid mater with an insidious onset and progression. Surgical evacuation CSDH via burr hole craniostomy appears to be the most widely practiced treatment technique worldwide and outcomes are generally favorable.Although unilateral CSDH is seen in the majority of patients, bilateral involvement is not rare in neurosurgical practices.

In previous reports, bilateral CSDH was raised as a predictor of rapid deterioration and worse outcomes attributable to brain herniation, in comparison with unilateral ones. Nevertheless, the optimal surgical considerations in bilateral CSDH still remain controversial. Thus, this study principally aims to finding out whether consecutive removal of bilateral CSDH really poses a complication risk. The secondary objectives of the study were to obtain information about the one-year prognosis of bilateral CSDH and to find factors that affect the prognosis, if any.

The study is conducted as a prospective randomized controlled trial.

Inclusion criteria Symptomatic adult (≥18 years-old) patients with bilateral hemispheric CSDH

Exclusion criteria Patients with hematoma thickness smaller than 10 mm on either side, and those who previously underwent any cranial surgery will be excluded.

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

入选标准

  • - Symptomatic bilateral hemispheric CSDH

排除标准

  • Hematoma thickness smaller than 10 mm on either side
  • Previously underwent any cranial surgery

结局指标

主要结局

The Primary Outcome: Early Postoperative Success Rate (Redo Surgery)

时间窗: Postoperative first 12 months

As the Primary Outcome, we considered the success of the operation at the end of the 12-month control period (we considered patients who died or were reoperated as unsuccessful).

The Primary Outcome: Mortality

时间窗: Postoperative first 12 months

As the Primary Outcome, we considered the success of the operation at the end of the 12-month control period (we considered patients who died or were reoperated as unsuccessful).

次要结局

  • The secondary outcome: Follow-up assessment (Radiological Assessments - midline shift)(One-year)
  • The secondary outcome: Follow-up assessment (Age)(One-year)
  • The secondary outcome: Follow-up assessment (Sex)(One-year)
  • The secondary outcome: Follow-up assessment (Trauma-Relation)(One-year)
  • The secondary outcome: Follow-up assessment (Concomitant Pathologies)(One-year)
  • The secondary outcome: Follow-up assessment (The Glasgow Coma Scale)(One-year)
  • The secondary outcome: Follow-up assessment (Radiological Assessments - hematoma volum)(One-year)
  • The secondary outcome: Follow-up assessment (Neurological Examination - babinski sign)(One-year)
  • The secondary outcome: Follow-up assessment (The Markwalder Grading Scale)(One-year)
  • The secondary outcome: Follow-up assessment (Neurological Examination - Motor)(One-year)
  • The secondary outcome: Follow-up assessment (Neurological Examination - fundus oculi)(One-year)

研究者

发起方
Ataturk Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hasan Kamil Sucu

Neurosurgeon, Professor

Ataturk Training and Research Hospital

研究点 (2)

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