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Minipterional Versus Pterional Craniotomy

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ClinicalTrials.gov Identifier: NCT01872741
Recruitment Status : Unknown
Verified June 2013 by Leonardo C. Welling, University of Sao Paulo General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 7, 2013
Last Update Posted : June 7, 2013
Sponsor:
Information provided by (Responsible Party):
Leonardo C. Welling, University of Sao Paulo General Hospital

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

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Muscular Atrophy Procedure: Minipterional craniotomy Procedure: Pterional craniotomy Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study Comparing Clinical, Functional and Aesthetics Results of "Classical" Pterional and Minipterional Craniotomies.
Study Start Date : October 2010
Actual Primary Completion Date : October 2012
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ruptured intracranial aneurysms
Pterional craniotomy Minipterional craniotomy
Procedure: Minipterional craniotomy
Minipterional craniotomy approach for ruptured and unruptured aneurysms

Procedure: Pterional craniotomy
Pterional craniotomy approach for ruptured and unruptured aneurysm

Active Comparator: Unruptured intracranial aneurysms
Pterional craniotomy Minipterional craniotomy
Procedure: Minipterional craniotomy
Minipterional craniotomy approach for ruptured and unruptured aneurysms

Procedure: Pterional craniotomy
Pterional craniotomy approach for ruptured and unruptured aneurysm




Primary Outcome Measures :
  1. Atrophy degree measurement (temporal muscle) [ Time Frame: 6 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Diagnosis of intracranial aneurysms

Exclusion Criteria:

Giant aneurysms Intracranial hematomas


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872741


Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Leonardo C Welling, MD University of Sao Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Leonardo C. Welling, MD, Post graduation programm, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01872741     History of Changes
Other Study ID Numbers: MiniPT Trial
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: June 2013

Keywords provided by Leonardo C. Welling, University of Sao Paulo General Hospital:
craniotomy,
intracerebral aneurysms,
atrophy,
temporal muscle,
outcome

Additional relevant MeSH terms:
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Aneurysm
Atrophy
Muscular Atrophy
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases