Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms
MININCRUSP
1 other identifier
interventional
120
1 country
1
Brief Summary
The study is designed to evaluate the efficacy and safety of minimally invasive neurosurgical techniques for patients with incidental cerebral aneurysms of the anterior circulation in the Hospital das Clínicas of the University of São Paulo Medical School.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 19, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 26, 2015
January 1, 2014
1.8 years
January 19, 2015
January 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effective Aneurysm Clipping (no residual cerebral aneurysm)
All patients will be submitted to a post operative angiography to asses the presence of residual cerebral aneurysm after clipping.
3 months after surgery
Secondary Outcomes (5)
All Cause Mortality
1 year
Neurological Outcome
1 year
Cosmetic Outcome
1 year
Surgical Safety assessed by number and description of Surgical Complications (infection rate, postoperative epidural/ contusional hematomas, number of reoperations, need of blood transfusion)
1 year
Early Hospital Discharge
15 days
Other Outcomes (1)
Quality of Life
15 days, 3 months, 6 months and 1 year
Study Arms (3)
Transpalpebral Approach
EXPERIMENTALAneurysm 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.
NanoPterional Approach
EXPERIMENTALAneurysm 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.
Classical Pterional Craniotomy
SHAM COMPARATORAneurysm 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.
Interventions
All Patients will be submitted to a surgical intervention in order to clip their unruptured brain aneurysm
Eligibility Criteria
You may qualify if:
- Patients with the diagnosis of incidental unruptured cerebral aneurysms (4mm to 2cm)
You may not qualify if:
- Patients who do not have adequate family care during the immediate post-operative period (the patient's family must commit to stay with the patient in the first five days after hospital discharge)
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital das Clínicas of University of São Paulo Medical School
São Paulo, São Paulo, 05403-000, Brazil
Related Publications (5)
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.
PMID: 17171150BACKGROUNDAndaluz 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.
PMID: 18671651BACKGROUNDAbdel 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.
PMID: 21499147BACKGROUNDFigueiredo 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.
PMID: 17041490BACKGROUNDFigueiredo 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.
PMID: 18091240BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eberval G Figueiredo, MD, PhD
University of Sao Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2015
First Posted
January 26, 2015
Study Start
September 1, 2013
Primary Completion
July 1, 2015
Study Completion
December 1, 2015
Last Updated
January 26, 2015
Record last verified: 2014-01