Minipterional Versus Pterional Craniotomy

Not Applicable

• Conditions: Intracranial Aneurysm; Muscular Atrophy
• Interventions: Procedure: Minipterional craniotomy; Procedure: Pterional craniotomy

• Registration Number: NCT01872741
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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

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

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2012-10
• Status Verified: 2013-06
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-04
• Last Update Submitted: 2013-06-04
• Study First Posted: 2013-06-07
• Last Update Posted: 2013-06-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Diagnosis of intracranial aneurysms

Exclusion Criteria

Giant aneurysms Intracranial hematomas

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ruptured intracranial aneurysms	Minipterional craniotomy	Pterional craniotomy Minipterional craniotomy
Ruptured intracranial aneurysms	Pterional craniotomy	Pterional craniotomy Minipterional craniotomy
Unruptured intracranial aneurysms	Minipterional craniotomy	Pterional craniotomy Minipterional craniotomy
Unruptured intracranial aneurysms	Pterional craniotomy	Pterional craniotomy Minipterional craniotomy

Primary Outcome Measures

Name	Time	Method
Atrophy degree measurement (temporal muscle)	6 months	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