Back to resultsNeurocognitive 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
About this trial
This is an interventional treatment trial for Neurocognitive Outcome Assesment in Patients With Perioptic Meningiomas
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.
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
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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