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Minipterional Versus Pterional Craniotomy

U

University of Sao Paulo General Hospital

Status

Unknown

Conditions

Intracranial Aneurysm
Muscular Atrophy

Treatments

Procedure: Minipterional craniotomy
Procedure: Pterional craniotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01872741
MiniPT Trial

Details and patient eligibility

About

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

Full 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

Enrollment

58 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of intracranial aneurysms

Exclusion criteria

Giant aneurysms Intracranial hematomas

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

58 participants in 2 patient groups

Ruptured intracranial aneurysms
Active Comparator group
Description:
Pterional craniotomy Minipterional craniotomy
Treatment:
Procedure: Pterional craniotomy
Procedure: Minipterional craniotomy
Unruptured intracranial aneurysms
Active Comparator group
Description:
Pterional craniotomy Minipterional craniotomy
Treatment:
Procedure: Pterional craniotomy
Procedure: Minipterional craniotomy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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