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Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms (MININCRUSP)

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ClinicalTrials.gov Identifier: NCT02345395
Recruitment Status : Unknown
Verified January 2014 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Cerebral Aneurysm Aneurysm, Middle Cerebral Artery Aneurysm, Anterior Communicating Artery Aneurysm, Posterior Communicating Artery Aneurysm, Carotid Artery Brain Aneurysm Procedure: Aneurysm Clipping Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms
Study Start Date : September 2013
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: 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.
Procedure: Aneurysm Clipping
All Patients will be submitted to a surgical intervention in order to clip their unruptured brain aneurysm

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

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




Primary Outcome Measures :
  1. Effective Aneurysm Clipping (no residual cerebral aneurysm) [ Time Frame: 3 months after surgery ]
    All patients will be submitted to a post operative angiography to asses the presence of residual cerebral aneurysm after clipping.


Secondary Outcome Measures :
  1. All Cause Mortality [ Time Frame: 1 year ]
  2. Neurological Outcome [ Time Frame: 1 year ]
    All patients will be classified with the Glasgow Outcome Scale, Rankin Scale

  3. Cosmetic Outcome [ Time Frame: 1 year ]
    Comparison of pre and post operative photos and asses of patients satisfaction

  4. Surgical Safety assessed by number and description of Surgical Complications (infection rate, postoperative epidural/ contusional hematomas, number of reoperations, need of blood transfusion) [ Time Frame: 1 year ]
  5. Early Hospital Discharge [ Time Frame: 15 days ]
    Safety of early Discharge in the Experimental Groups (need of early hospital readmission? and its causes)


Other Outcome Measures:
  1. Quality of Life [ Time Frame: 15 days, 3 months, 6 months and 1 year ]
    Whoqol-bref questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345395


Contacts
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Contact: Mauricio Mandel, MD 55 11 996299224 mauricio.mandel@gmail.com
Contact: Ester M Tomazini 55 11 2661-7152/8014 ester.t@hc.fm.usp.br

Locations
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Brazil
Hospital das Clínicas of University of São Paulo Medical School Recruiting
Sao Paulo, Brazil, 05403-000
Contact: Mauricio Mandel, MD    55 11 996299224    mauricio.mandel@gmail.com   
Contact: Ester M Tomazini    2661-7152/8014    ester.t@hc.fm.usp.br   
Principal Investigator: Mauricio Mandel, MD         
Principal Investigator: Eberval G Figueiredo, MD, PhD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Study Director: Eberval G Figueiredo, MD, PhD University of Sao Paulo

Publications:
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02345395     History of Changes
Other Study ID Numbers: TRANSPALPEBRAL USP
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2014

Keywords provided by University of Sao Paulo General Hospital:
Brain Aneurysm
Pterional Craniotomy
MiniPterional Craniotomy
Transpalpebral Approach
Unruptured Brain Aneurysm

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases