Minipterional Versus Pterional Craniotomy

June 4, 2013 updated by: Leonardo C. Welling, University of Sao Paulo General Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Diagnosis of intracranial aneurysms

Exclusion Criteria:

Giant aneurysms Intracranial hematomas

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Leonardo C Welling, MD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ANTICIPATED)

July 1, 2013

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (ESTIMATE)

June 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 7, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MiniPT Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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