Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms

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Brief Title

Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms

Official Title

Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms

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.
    


Study Type

Interventional


Primary Outcome

Effective Aneurysm Clipping (no residual cerebral aneurysm)

Secondary Outcome

 All Cause Mortality

Condition

Cerebral Aneurysm

Intervention

Aneurysm Clipping

Study Arms / Comparison Groups

 Transpalpebral Approach
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

120

Start Date

September 2013

Completion Date

December 2015

Primary Completion Date

July 2015

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)
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Eberval G Figueiredo, MD, PhD, 55 11 996299224, maurici[email protected]

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT02345395

Organization ID

TRANSPALPEBRAL USP


Responsible Party

Sponsor

Study Sponsor

University of Sao Paulo General Hospital

Collaborators

 Fundação de Amparo à Pesquisa do Estado de São Paulo

Study Sponsor

Eberval G Figueiredo, MD, PhD, Study Director, University of Sao Paulo


Verification Date

January 2014