Overview

This trial is active, not recruiting.

Conditions intracranial aneurysm, muscular atrophy
Treatments minipterional craniotomy, pterional craniotomy
Sponsor University of Sao Paulo General Hospital
Start date October 2010
End date October 2012
Trial size 58 participants
Trial identifier NCT01872741, MiniPT 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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Pterional craniotomy Minipterional craniotomy
minipterional craniotomy
Minipterional craniotomy approach for ruptured and unruptured aneurysms
pterional craniotomy
Pterional craniotomy approach for ruptured and unruptured aneurysm
(Active Comparator)
Pterional craniotomy Minipterional craniotomy
minipterional craniotomy
Minipterional craniotomy approach for ruptured and unruptured aneurysms
pterional craniotomy
Pterional craniotomy approach for ruptured and unruptured aneurysm

Primary Outcomes

Measure
Atrophy degree measurement (temporal muscle)
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: Diagnosis of intracranial aneurysms Exclusion Criteria: Giant aneurysms Intracranial hematomas

Additional Information

Official title Prospective Randomized Study Comparing Clinical, Functional and Aesthetics Results of "Classical" Pterional and Minipterional Craniotomies.
Principal investigator Leonardo C Welling, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by University of Sao Paulo General Hospital.