Intracranial AneurysmNCT01872741
Minipterional Versus Pterional Craniotomy
A study testing Minipterional craniotomy and Pterional craniotomy in people with Intracranial Aneurysm and Muscular Atrophy, run by University of Sao Paulo General Hospital.
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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intracranial Aneurysm, Muscular Atrophy
- What is being tested?
- Minipterional craniotomy and Pterional craniotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of intracranial aneurysms
Who cannot join
- Giant aneurysms Intracranial hematomas
About this study
Official title: 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
Read the 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
- Conditions
- Intracranial Aneurysm, Muscular Atrophy
- Being tested
- Minipterional craniotomy, Pterional craniotomy
- Keywords
- craniotomy,, intracerebral aneurysms,, atrophy,, temporal muscle,, outcome
- Medical subject headings
- Intracranial Aneurysm, Muscular Atrophy, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minipterional craniotomyProcedure or surgery
Minipterional craniotomy approach for ruptured and unruptured aneurysms
Pterional craniotomyProcedure or surgery
Pterional craniotomy approach for ruptured and unruptured aneurysm
| Study group | Role | What they receive |
|---|---|---|
| Ruptured intracranial aneurysms | Active comparator | Pterional craniotomy Minipterional craniotomy Receives: Procedure: Minipterional craniotomy; Procedure: Pterional craniotomy |
| Unruptured intracranial aneurysms | Active comparator | Pterional craniotomy Minipterional craniotomy Receives: Procedure: Minipterional craniotomy; Procedure: Pterional craniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo C. Welling, University of Sao Paulo General Hospital
- Investigators
- Leonardo C Welling, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872741
- Sponsor's protocol ID
- MiniPT Trial
- Status last verified
- Jun 2013
- First submitted
- 4 Jun 2013
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25526271
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing Clinical, Functional and Aesthetics Results of "Classical" Pterional and Minipterional Craniotomies.
- ClinicalTrials.gov ID
- NCT01872741
- Acronym / sponsor ID
- MiniPT Trial
- Conditions
- Intracranial Aneurysm, Muscular Atrophy
- Keywords
- craniotomy,, intracerebral aneurysms,, atrophy,, temporal muscle,, outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jul 2013 (estimated)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ruptured intracranial aneurysms | Active comparator | Procedure: Minipterional craniotomy, Procedure: Pterional craniotomyPterional craniotomy Minipterional craniotomy |
| Unruptured intracranial aneurysms | Active comparator | Procedure: Minipterional craniotomy, Procedure: Pterional craniotomyPterional craniotomy Minipterional craniotomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of intracranial aneurysms
Key exclusion criteria (1 listed)
- Giant aneurysms Intracranial hematomas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minipterional craniotomyMinipterional craniotomy approach for ruptured and unruptured aneurysms | Procedure or surgery | Ruptured intracranial aneurysms, Unruptured intracranial aneurysms |
| Pterional craniotomyPterional craniotomy approach for ruptured and unruptured aneurysm | Procedure or surgery | Ruptured intracranial aneurysms, Unruptured intracranial aneurysms |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2013.
- Derived from this study: PubMed 25526271Welling 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonardo C Welling, MD principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Minipterional craniotomy and Pterional craniotomy in people with Intracranial Aneurysm and Muscular Atrophy, run by University of Sao Paulo General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrophy degree measurement (temporal muscle) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01872741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2013.