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Minipterional Versus Pterional Craniotomy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01872741
Enrollment
58
Registered
2013-06-07
Start date
2010-10-31
Completion date
2013-07-31
Last updated
2013-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Aneurysm, Muscular Atrophy

Keywords

craniotomy,, intracerebral aneurysms,, atrophy,, temporal muscle,, outcome

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

Interventions

PROCEDUREMinipterional craniotomy

Minipterional craniotomy approach for ruptured and unruptured aneurysms

Pterional craniotomy approach for ruptured and unruptured aneurysm

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Diagnosis of intracranial aneurysms

Exclusion criteria

Giant aneurysms Intracranial hematomas

Design outcomes

Primary

MeasureTime frameDescription
Atrophy degree measurement (temporal muscle)6 monthsThe 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026