Comparison of Clipping Via Keyhole Versus Traditional Approaches and Coiling for Ruptured Aneurysms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Study of Microsurgical Clipping Via Keyhole Approaches Versus Traditional Open Approaches and Endovascular Coiling for Ruptured Anterior Circulation Aneurysms

Conditions
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Randomized Controlled Trial, Intracranial Aneurysm, Microsurgery, Endovascular Procedures

Intervention / Treatment
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* Procedure: keyhole microneurosurgery
* Procedure: conventional microneurosurgery
* Procedure: endovascular coiling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: keyhole group<br>patient harbored aneurysm who was treated by microsurgical clipping via keyhole approach. | Procedure: keyhole microneurosurgery<br>* microsurgical clipping via keyhole approach<br>|
| Experimental: conventional group<br>patient harbored aneurysm who was treated by microsurgical clipping via conventional craniotomy. | Procedure: conventional microneurosurgery<br>* microsurgical clipping via conventional craniotomy<br>|
| Experimental: endovascular group<br>patient harbored aneurysm who was treated by endovascular coiling via femoral approach. | Procedure: endovascular coiling<br>* endovascular coiling via femoral approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occlusion rate of aneurysm | occlusion rate of aneurysm | an average of 1 month | 
| operative time | total operative duration | an average of 1 month | 
| hospitalization time | hospitalization duration | up to 3 months after discharge | 
| hospitalization cost | cost during hospitalization | up to 3 months after discharge | 
| postoperative complication rate | complication rate after intervention | up to 3 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrent rate of aneurysm | recurrent rate after treatment of aneurysm | 6 months after treatment | 
| long-term complication rate | complication rate during follow-up | 6 months after treatment |