Clinical trial NCT02345395: Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms
Official title: Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Aneurysm
Aneurysm, Middle Cerebral Artery
Aneurysm, Anterior Communicating Artery
Aneurysm, Posterior Communicating Artery
Aneurysm, Carotid Artery
Brain Aneurysm
Keywords: Brain Aneurysm
Pterional Craniotomy
MiniPterional Craniotomy
Transpalpebral Approach
Unruptured Brain Aneurysm
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2015-01-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Minimally Invasive Neurosurgery is a inexorable tendency and it is already a reality in many centers of the world. It is a broad and relative concept and there is few consistent medical data to validate its benefits. In this manner, this is the first clinical trial in Brazil questioning the safety of the of minimally invasive surgery to treat incidental cerebral aneurysms of the anterior circulation. For countries like Brazil, the indirect demonstration of reduction in hospital costs through lower hospital stays is a breakthrough to provide better health for the entire population.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Effective Aneurysm Clipping (no residual cerebral aneurysm)
timeFrame: 3 months after surgery
Secondary outcomes:
measure: All Cause Mortality
timeFrame: 1 year
measure: Neurological Outcome
timeFrame: 1 year
measure: Cosmetic Outcome
timeFrame: 1 year
measure: Surgical Safety assessed by number and description of Surgical Complications (infection rate, postoperative epidural/ contusional hematomas, number of reoperations, need of blood transfusion)
timeFrame: 1 year
measure: Early Hospital Discharge
timeFrame: 15 days
Other outcomes:
measure: Quality of Life
timeFrame: 15 days, 3 months, 6 months and 1 year
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas of University of São Paulo Medical School
Study officials:
affiliation: University of Sao Paulo
name: Eberval G Figueiredo, MD, PhD
role: STUDY_DIRECTOR
References:
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. doi: 10.1055/s-2000-9337.
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.
citation: 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.
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. doi: 10.1227/01.NEU.0000223365.55701.F2.
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.