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Minipterional Versus Pterional Craniotomy

Primary Purpose

Intracranial Aneurysm, Muscular Atrophy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Minipterional craniotomy
Pterional craniotomy
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysm focused on measuring craniotomy,, intracerebral aneurysms,, atrophy,, temporal muscle,, outcome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of intracranial aneurysms

Exclusion Criteria:

Giant aneurysms Intracranial hematomas

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Ruptured intracranial aneurysms

    Unruptured intracranial aneurysms

    Arm Description

    Pterional craniotomy Minipterional craniotomy

    Pterional craniotomy Minipterional craniotomy

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 4, 2013
    Last Updated
    June 4, 2013
    Sponsor
    University of Sao Paulo General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01872741
    Brief Title
    Minipterional Versus Pterional Craniotomy
    Official Title
    Prospective Randomized Study Comparing Clinical, Functional and Aesthetics Results of "Classical" Pterional and Minipterional Craniotomies.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2010 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    July 2013 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intracranial Aneurysm, Muscular Atrophy
    Keywords
    craniotomy,, intracerebral aneurysms,, atrophy,, temporal muscle,, outcome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ruptured intracranial aneurysms
    Arm Type
    Active Comparator
    Arm Description
    Pterional craniotomy Minipterional craniotomy
    Arm Title
    Unruptured intracranial aneurysms
    Arm Type
    Active Comparator
    Arm Description
    Pterional craniotomy Minipterional craniotomy
    Intervention Type
    Procedure
    Intervention Name(s)
    Minipterional craniotomy
    Intervention Description
    Minipterional craniotomy approach for ruptured and unruptured aneurysms
    Intervention Type
    Procedure
    Intervention Name(s)
    Pterional craniotomy
    Intervention Description
    Pterional craniotomy approach for ruptured and unruptured aneurysm
    Primary Outcome Measure Information:
    Title
    Atrophy degree measurement (temporal muscle)
    Description
    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
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of intracranial aneurysms Exclusion Criteria: Giant aneurysms Intracranial hematomas
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leonardo C Welling, MD
    Organizational Affiliation
    University of Sao Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25526271
    Citation
    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.
    Results Reference
    derived

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    Minipterional Versus Pterional Craniotomy

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