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Pattern and Management of Intracranial Cavernoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04181086
Recruitment Status : Unknown
Verified November 2019 by Moataz Elshenawi, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : November 29, 2019
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Moataz Elshenawi, Assiut University

Brief Summary:
Intracranial cavernous vascular malformations are variously known as cavernous angiomas, cavernous hemangiomas, or, more simply, cavernomas. Cavernomas are congenital low flow vascular lesions. It composed of irregular sinusoidal vascular channels, lacking smooth muscle, and elastic fibers. They lack feeding arteries or draining veins and contain no neural tissue. The first description of an intracranial cavernoma was given by Virchow, in 1863. For over a century, it was considered to be an extremely rare malformation, usually found at autopsy, and exceptionally diagnosed during life. The prevalence of cerebral cavernous malformations (CCM) is estimated to be 0.4-0.9%.

Condition or disease Intervention/treatment
Management of Intracranial Cavernous Hemangioma Procedure: surgical excision of intracranial cavernoma

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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Pattern and Management of Intracranial Cavernoma
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks


Intervention Details:
  • Procedure: surgical excision of intracranial cavernoma
    microvascular excision of intracranial cavernoma


Primary Outcome Measures :
  1. clinical outcome [ Time Frame: one month post operative ]

    Measured by Modified Rankin Scale Measures the degree of disability or dependence in the daily activities of people who have suffered any cause of neurological disability.

    The scale runs from 0-6, running from perfect health without symptoms to death.

    0 - No symptoms.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
all patients with confirmed diagnosis of intracranial cavernoma with MRI and will undergo surgery
Criteria

Inclusion Criteria:

  • All patients presented with intracranial cavernomas (single or multiple, superficial or deep, supratentorial or infratentorial)
  • Denovo or recurrent patients.

Exclusion Criteria:

  • None
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Responsible Party: Moataz Elshenawi, assistant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT04181086    
Other Study ID Numbers: intracranial cavernoma
First Posted: November 29, 2019    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemangioma
Hemangioma, Cavernous
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases