Minipterional Versus Pterional Craniotomy
Prospective Randomized Study Comparing Clinical, Functional and Aesthetics Results of "Classical" Pterional and Minipterional Craniotomies.
1 other identifier
interventional
58
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2010
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 4, 2013
CompletedFirst Posted
Study publicly available on registry
June 7, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJune 7, 2013
June 1, 2013
2 years
June 4, 2013
June 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 months
Study Arms (2)
Ruptured intracranial aneurysms
ACTIVE COMPARATORPterional craniotomy Minipterional craniotomy
Unruptured intracranial aneurysms
ACTIVE COMPARATORPterional craniotomy Minipterional craniotomy
Interventions
Minipterional craniotomy approach for ruptured and unruptured aneurysms
Pterional craniotomy approach for ruptured and unruptured aneurysm
Eligibility Criteria
You may qualify if:
- Diagnosis of intracranial aneurysms
You may not qualify if:
- Giant aneurysms Intracranial hematomas
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 25526271DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leonardo C Welling, MD
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Post graduation programm
Study Record Dates
First Submitted
June 4, 2013
First Posted
June 7, 2013
Study Start
October 1, 2010
Primary Completion
October 1, 2012
Study Completion
July 1, 2013
Last Updated
June 7, 2013
Record last verified: 2013-06