Minipterional Versus Pterional Craniotomy

Intracranial Aneurysm Clinical Trial

Official title:

Prospective Randomized Study Comparing Clinical, Functional and Aesthetics Results of "Classical" Pterional and Minipterional Craniotomies.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01872741
• Other study ID #: MiniPT Trial
• Status: Active, not recruiting
• Phase: N/A
• First received: June 4, 2013
• Last updated: June 4, 2013
• Start date: October 2010
• Est. completion date: July 2013

Study information

• Verified date: June 2013
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: July 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

Diagnosis of intracranial aneurysms

Exclusion Criteria:

Giant aneurysms Intracranial hematomas

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intracranial Aneurysm
• Muscular Atrophy

Intervention

Procedure:
• Minipterional craniotomy
Minipterional craniotomy approach for ruptured and unruptured aneurysms
• Pterional craniotomy
Pterional craniotomy approach for ruptured and unruptured aneurysm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No