Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms

Cerebral Aneurysm Clinical Trial

— MININCRUSP  

Official title:

Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02345395
• Other study ID #: TRANSPALPEBRAL USP
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2015
• Last updated: January 23, 2015
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2014
• Source: University of Sao Paulo General Hospital
• Contact: Mauricio Mandel, MD
• Phone: 55 11 996299224
• Email: mauricio.mandel[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Anterior Communicating Artery
• Aneurysm, Carotid Artery
• Aneurysm, Middle Cerebral Artery
• Aneurysm, Posterior Communicating Artery
• Brain Aneurysm
• Cerebral Aneurysm
• Intracranial Aneurysm

Intervention

Procedure:
• Aneurysm Clipping
All Patients will be submitted to a surgical intervention in order to clip their unruptured brain aneurysm

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas of University of São Paulo Medical School	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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

Outcome

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