Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms
NCT ID: NCT02345395
Last Updated: 2015-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2013-09-30
2015-12-31
Brief Summary
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Detailed Description
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Patients with the diagnosis of incidental brain aneurysms of the anterior circulation will be recruited from the spontaneous demand of the Hospital das Clínicas of University of São Paulo Medical School. The investigators expect to recruit 60 patients for the experimental group and 60 for the control group.
In the study group patients will be submitted to a minimally invasive approach (transpalpebral mini fronto-orbital craniotomy or modified minipterional craniotomy). All patients in this group will be submitted to surgery starting at 8 o'clock in the morning. After 6 hours of the end of surgery, all patients will have a control CT scan and if the result is adequate, they are going to be discharged from the ICU with no IV drugs. The hospital discharge will be in the next day. The control group are patients that will be submitted to a classical pterional craniotomy with hospital discharge occurring in 4-5 days.
All patients will be submitted to the standard care offered by the Hospital das Clinicas. All surgical and ambulatory data will be collected by the main investigators (Dr. Mauricio Mandel and Dr. Eberval Figueiredo). The adverse events will be promptly reported to the chair of the department and to the CAPPESQ (the ethics committee of the hospital).
Ambulatory data will be collected during the regular post operative medical appointments and a web based questionnaire. The post operative follow-up is unified in only one ambulatory center and day (thursdays mornings).
Statistical analysis will compare primary and secondary objectives of the two groups, as specified in the study protocol.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transpalpebral Approach
Aneurysm Clipping - Patients will be submitted to a Transpalpebral Approach to Unruptured Anterior Circulation Aneurysm and they will be discharged from the hospital on the next day.
Aneurysm Clipping
All Patients will be submitted to a surgical intervention in order to clip their unruptured brain aneurysm
NanoPterional Approach
Aneurysm Clipping - Patients will be submitted to a Modified MiniPterional Approach (Nanopterional) to Unruptured Anterior Circulation Aneurysm and they will be discharged from the hospital on the next day.
Aneurysm Clipping
All Patients will be submitted to a surgical intervention in order to clip their unruptured brain aneurysm
Classical Pterional Craniotomy
Aneurysm Clipping - Patients will be submitted to a Classical Pterional Approach to Unruptured Anterior Circulation Aneurysm and they will be discharged from the hospital 4-5 days after the procedure.
Aneurysm Clipping
All Patients will be submitted to a surgical intervention in order to clip their unruptured brain aneurysm
Interventions
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Aneurysm Clipping
All Patients will be submitted to a surgical intervention in order to clip their unruptured brain aneurysm
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who are unable to communicate by telephone
* People with cardiovascular disease, liver or kidney failure.
* Pregnant women or breastfeeding
* Patients with coagulation abnormalities
* Patients with High Surgical Risk evaluated by different risk scores (ASA, AHA, Goldman, Detsky)
18 Years
80 Years
ALL
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Sao Paulo General Hospital
OTHER
Responsible Party
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Principal Investigators
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Eberval G Figueiredo, MD, PhD
Role: STUDY_DIRECTOR
University of Sao Paulo
Locations
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Hospital das Clínicas of University of São Paulo Medical School
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Ohjimi H, Taniguchi Y, Tanahashi S, Era K, Fukushima T. Accessing the Orbital Roof via an Eyelid Incision: The Transpalpebral Approach. Skull Base Surg. 2000;10(4):211-6. doi: 10.1055/s-2000-9337.
Andaluz N, Romano A, Reddy LV, Zuccarello M. Eyelid approach to the anterior cranial base. J Neurosurg. 2008 Aug;109(2):341-6. doi: 10.3171/JNS/2008/109/8/0341.
Abdel Aziz KM, Bhatia S, Tantawy MH, Sekula R, Keller JT, Froelich S, Happ E. Minimally invasive transpalpebral "eyelid" approach to the anterior cranial base. Neurosurgery. 2011 Dec;69(2 Suppl Operative):ons195-206; discussion 206-7. doi: 10.1227/NEU.0b013e31821c3ea3.
Figueiredo EG, Deshmukh V, Nakaji P, Deshmukh P, Crusius MU, Crawford N, Spetzler RF, Preul MC. An anatomical evaluation of the mini-supraorbital approach and comparison with standard craniotomies. Neurosurgery. 2006 Oct;59(4 Suppl 2):ONS212-20; discussion ONS220. doi: 10.1227/01.NEU.0000223365.55701.F2.
Figueiredo EG, Deshmukh P, Nakaji P, Crusius MU, Crawford N, Spetzler RF, Preul MC. The minipterional craniotomy: technical description and anatomic assessment. Neurosurgery. 2007 Nov;61(5 Suppl 2):256-64; discussion 264-5. doi: 10.1227/01.neu.0000303978.11752.45.
Other Identifiers
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TRANSPALPEBRAL USP
Identifier Type: -
Identifier Source: org_study_id
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