An interventional study of keyhole microneurosurgery and conventional microneurosurgery in Randomized Controlled Trial, Intracranial Aneurysm and Microsurgery, sponsored by ZhuQing. Completed. Per ClinicalTrials.gov, last updated 2021-09-20.
Sponsored by ZhuQing · Not applicable, Interventional, and Treatment
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.
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.
427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.
This study's enrollment of 150 is above the median of 110 across 207 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →This is the only study on the registry with ZhuQing as lead sponsor.
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Exclusion Criteria:
patient harbored aneurysm who was treated by microsurgical clipping via keyhole approach.
Procedure: keyhole microneurosurgery
patient harbored aneurysm who was treated by microsurgical clipping via conventional craniotomy.
Procedure: conventional microneurosurgery
patient harbored aneurysm who was treated by endovascular coiling via femoral approach.
Procedure: endovascular coiling
microsurgical clipping via keyhole approach
microsurgical clipping via conventional craniotomy
endovascular coiling via femoral approach
occlusion rate of aneurysm
occlusion rate of aneurysm
Time frame: an average of 1 month
operative time
total operative duration
Time frame: an average of 1 month
hospitalization time
hospitalization duration
Time frame: up to 3 months after discharge
hospitalization cost
cost during hospitalization
Time frame: up to 3 months after discharge
postoperative complication rate
complication rate after intervention
Time frame: up to 3 months after discharge
recurrent rate of aneurysm
recurrent rate after treatment of aneurysm
Time frame: 6 months after treatment
long-term complication rate
complication rate during follow-up
Time frame: 6 months after treatment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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