A Randomized Controlled Study of Microsurgical Clipping Via Keyhole Approaches Versus Traditional Open Approaches and Endovascular Coiling for Ruptured Anterior Circulation Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 主要终点
- occlusion rate of aneurysm
研究概览
简要总结
Endovascular coiling has become a strategy of choice of intracranial aneurysms due to its minimally invasiveness. However, there has few prospective randomized controlled studies on the comparison of therapeutic effect between endovascular coiling and microsurgical clipping, especially the latter via keyhole approaches, which has been widely used in recent years. Based on the data of a single center, a randomized controlled study was conducted on patients with ruptured anterior circulation aneurysms suitable for both endovascular and extravascular treatment, including endovascular coiling, microsurgical clipping via conventional craniotomy and keyhole approaches, in order to compare the efficacy of the above strategies and provide more objective basis for treatment selection for operators.
详细描述
Consecutive patients of a single center will be screened. If spontaneous subarachnoid hemorrhage (SAH) is confirmed by head computed tomography (CT), a diagnostic CT angiography (CTA) or digital subtraction angiography (DSA) will be carried out emergently. A patients harbored a single intracranial aneurysm of anterior circulation that resulted in SAH will be concerned. Based on the assessment of condition, the patient will enrolled into this study without indication of decompressive craniectomy. The enrolled patients will be divided randomly into 3 groups, who experienced endovascular coiling, microsurgical clipping via conventional craniotomy and via keyhole approaches. All of these treatment will be conducted by a same senior neurosurgeon. CTA or DSA were followed up regularly. The occlusion rate, operative period, hospitalization duration and cost, surgical complications were compared and analyzed.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single intracranial anterior circulation aneurysm diagnosed by CTA or DSA
- •CT showed that subarachnoid hemorrhage originated from the rupture of the aneurysm and was confirmed during operation
- •No indication of decompressive craniectomy (Hunt-Hess grade ≤ 4, Glasgow Coma Scale ≥ 7, no brain herniation; CT showed midline displacement < 5mm)
- •The aneurysm is suitable for both endovascular treatment and microsurgical clipping
排除标准
- •The patients and their families did not agree to join the study
- •Patients with unruptured anterior circulation aneurysms
- •Patients with posterior circulation aneurysms
- •Patients with multiple intracranial aneurysms
- •Those who cannot receive treatment due to serious concomitant diseases
研究组 & 干预措施
conventional group
patient harbored aneurysm who was treated by microsurgical clipping via conventional craniotomy.
干预措施: conventional microneurosurgery (Procedure)
endovascular group
patient harbored aneurysm who was treated by endovascular coiling via femoral approach.
干预措施: endovascular coiling (Procedure)
keyhole group
patient harbored aneurysm who was treated by microsurgical clipping via keyhole approach.
干预措施: keyhole microneurosurgery (Procedure)
结局指标
主要结局
occlusion rate of aneurysm
时间窗: an average of 1 month
occlusion rate of aneurysm
operative time
时间窗: an average of 1 month
total operative duration
hospitalization time
时间窗: up to 3 months after discharge
hospitalization duration
hospitalization cost
时间窗: up to 3 months after discharge
cost during hospitalization
postoperative complication rate
时间窗: up to 3 months after discharge
complication rate after intervention
次要结局
- recurrent rate of aneurysm(6 months after treatment)
- long-term complication rate(6 months after treatment)
研究者
ZhuQing
Chief Neurosurgeon
Second Affiliated Hospital of Soochow University