Minipterional Versus Pterional Craniotomy

NCT ID: NCT01872741

Last Updated: 2013-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-07-31

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

Conditions

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Intracranial Aneurysm Muscular Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ruptured intracranial aneurysms

Pterional craniotomy Minipterional craniotomy

Group Type ACTIVE_COMPARATOR

Minipterional craniotomy

Intervention Type PROCEDURE

Minipterional craniotomy approach for ruptured and unruptured aneurysms

Pterional craniotomy

Intervention Type PROCEDURE

Pterional craniotomy approach for ruptured and unruptured aneurysm

Unruptured intracranial aneurysms

Pterional craniotomy Minipterional craniotomy

Group Type ACTIVE_COMPARATOR

Minipterional craniotomy

Intervention Type PROCEDURE

Minipterional craniotomy approach for ruptured and unruptured aneurysms

Pterional craniotomy

Intervention Type PROCEDURE

Pterional craniotomy approach for ruptured and unruptured aneurysm

Interventions

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Minipterional craniotomy

Minipterional craniotomy approach for ruptured and unruptured aneurysms

Intervention Type PROCEDURE

Pterional craniotomy

Pterional craniotomy approach for ruptured and unruptured aneurysm

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Diagnosis of intracranial aneurysms

Exclusion Criteria

Giant aneurysms Intracranial hematomas
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Leonardo C. Welling

MD, Post graduation programm

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leonardo C Welling, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

References

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Welling LC, Figueiredo EG, Wen HT, Gomes MQ, Bor-Seng-Shu E, Casarolli C, Guirado VM, Teixeira MJ. Prospective randomized study comparing clinical, functional, and aesthetic results of minipterional and classic pterional craniotomies. J Neurosurg. 2015 May;122(5):1012-9. doi: 10.3171/2014.11.JNS146. Epub 2014 Dec 19.

Reference Type DERIVED
PMID: 25526271 (View on PubMed)

Other Identifiers

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MiniPT Trial

Identifier Type: -

Identifier Source: org_study_id

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