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Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial.

Primary Purpose

Neurocognitive Outcome Assesment in Patients With Perioptic Meningiomas

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
surgical excision of the tumor
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurocognitive Outcome Assesment in Patients With Perioptic Meningiomas

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • preoptic meningioma, not recurrent, size is operative.

Exclusion Criteria:

  • other meningiomas than preoptic , recurrent cases, size is not operative, other medical conditions affect the mental condition of the patient.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    group with pealing of the outer layer of cavernous sinus

    group without pealing of the outer layer of cavernous sinus

    Arm Description

    Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Pealing Of The Outer Layer Of The Cavernous Sinus

    Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision Without Pealing Of The Outer Layer Of The Cavernous Sinus

    Outcomes

    Primary Outcome Measures

    Neurocognitive Outcome Assessment using MOCA scale
    aggregated by our researchers in data base system in our department.

    Secondary Outcome Measures

    Neurocognitive Outcome using neuropsychological assessment questionnaire
    aggregated by our researchers in data base system in our department.

    Full Information

    First Posted
    May 10, 2017
    Last Updated
    June 15, 2017
    Sponsor
    Kasr El Aini Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03190122
    Brief Title
    Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial.
    Official Title
    Neurocognitive Outcome Assessment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2017 (Anticipated)
    Primary Completion Date
    April 2018 (Anticipated)
    Study Completion Date
    April 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kasr El Aini Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neurocognitive Outcome Assesment in Patients With Perioptic Meningiomas

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group with pealing of the outer layer of cavernous sinus
    Arm Type
    Active Comparator
    Arm Description
    Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Pealing Of The Outer Layer Of The Cavernous Sinus
    Arm Title
    group without pealing of the outer layer of cavernous sinus
    Arm Type
    Experimental
    Arm Description
    Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision Without Pealing Of The Outer Layer Of The Cavernous Sinus
    Intervention Type
    Procedure
    Intervention Name(s)
    surgical excision of the tumor
    Intervention Description
    Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial. [NCT ID not yet assigned]
    Primary Outcome Measure Information:
    Title
    Neurocognitive Outcome Assessment using MOCA scale
    Description
    aggregated by our researchers in data base system in our department.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Neurocognitive Outcome using neuropsychological assessment questionnaire
    Description
    aggregated by our researchers in data base system in our department.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: preoptic meningioma, not recurrent, size is operative. Exclusion Criteria: other meningiomas than preoptic , recurrent cases, size is not operative, other medical conditions affect the mental condition of the patient.

    12. IPD Sharing Statement

    Learn more about this trial

    Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial.

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