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
About this trial
This is an interventional treatment trial for Intracranial Aneurysm focused on measuring craniotomy,, intracerebral aneurysms,, atrophy,, temporal muscle,, outcome
Eligibility Criteria
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
NCT ID
NCT01872741
First Posted
June 4, 2013
Last Updated
June 4, 2013
Sponsor
University of Sao Paulo General Hospital
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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