Cerebral Aneurysm Clinical Trial
— MININCRUSPOfficial title:
Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients with the diagnosis of incidental unruptured cerebral aneurysms (4mm to 2cm) Exclusion Criteria: - 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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clínicas of University of São Paulo Medical School | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality of Life | Whoqol-bref questionnaire | 15 days, 3 months, 6 months and 1 year | No |
Primary | 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 | No |
Secondary | All Cause Mortality | 1 year | Yes | |
Secondary | Neurological Outcome | All patients will be classified with the Glasgow Outcome Scale, Rankin Scale | 1 year | Yes |
Secondary | Cosmetic Outcome | Comparison of pre and post operative photos and asses of patients satisfaction | 1 year | No |
Secondary | 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 | Yes | |
Secondary | Early Hospital Discharge | Safety of early Discharge in the Experimental Groups (need of early hospital readmission? and its causes) | 15 days | Yes |
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