Minipterional Versus Pterional Craniotomy

Study Overview
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Brief Summary
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This randomized prospective study was designed to compare the clinical, functional and aesthetic results of two surgical techniques for microsurgical clipping of anterior circulation aneurysms

Detailed Description
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This randomized prospective study was designed to compare the clinical, functional and aesthetic results of two surgical techniques for microsurgical clipping of anterior circulation aneurysms. Overall, 60 eligible patients admitted with ruptured and unruptured anterior circulation aneurysms will enrolled in the study. The aesthetic results will be analyzed with 2 methods. In the first, the patients will be showed to a rule, with a scale from 0 to 100, in which 0 mean the best result and 100 the worst result. Photos will be taken and showed to two independent observers, the results will be classified as excellent, good, regular or poor. The degree of atrophy will be measured with three methods. In the first one, the authors wiil observes the percentage of thick reduction in the temporal muscle, subcutaneous tissue and skin. In the second method the percentage thick reduction of the isolated temporal muscle will be measured and the third the volumetric analysis of the temporal muscle, subcutaneous tissue and skin will be calculated from the superior edge of zygomatic arch to superior temporal line. The functional results wiil be compared using the Modified Rankin Score. Others variables such frontal facial palsy, post-operative hemorrhage, cerebrospinal fistulas, hydrocephalus and mortality will be also analyzed

Official Title
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Prospective Randomized Study Comparing Clinical, Functional and Aesthetics Results of Classical Pterional and Minipterional Craniotomies.

Conditions
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Intracranial Aneurysm, Muscular Atrophy

Intervention / Treatment
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* Procedure: Minipterional craniotomy
* Procedure: Pterional craniotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of intracranial aneurysms Exclusion Criteria: Giant aneurysms Intracranial hematomas

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ruptured intracranial aneurysms<br>Pterional craniotomy Minipterional craniotomy | Procedure: Minipterional craniotomy<br>* Minipterional craniotomy approach for ruptured and unruptured aneurysms<br>Procedure: Pterional craniotomy<br>* Pterional craniotomy approach for ruptured and unruptured aneurysm<br>|
| Active Comparator: Unruptured intracranial aneurysms<br>Pterional craniotomy Minipterional craniotomy | Procedure: Minipterional craniotomy<br>* Minipterional craniotomy approach for ruptured and unruptured aneurysms<br>Procedure: Pterional craniotomy<br>* Pterional craniotomy approach for ruptured and unruptured aneurysm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrophy degree measurement (temporal muscle) | The degree of atrophy was measured with three methods. In the first one, the authors observed the percentage of thick reduction in the temporal muscle, subcutaneous tissue and skin. In the second method the percentage thick reduction of the isolated temporal muscle was observed. Both measures were made in the beginning of the sphenoid wing. The volumetric analysis of the temporal muscle, subcutaneous tissue and skin was calculated from the superior edge of zygomatic arch to superior temporal line using the OsiriX software | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrophy,, craniotomy,, intracerebral aneurysms,, temporal muscle,, outcome