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.
Sponsor
Kasr El Aini Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03190122
Collaborator
(none)
90
2
10
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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.
Anticipated Study Start Date
:
Jun 1, 2017
Anticipated Primary Completion Date
:
Apr 1, 2018
Anticipated Study Completion Date
:
Apr 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: group with pealing of the outer layer of cavernous sinus Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Pealing Of The Outer Layer Of The Cavernous Sinus |
Procedure: surgical excision of the tumor
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]
|
| Experimental: group without pealing of the outer layer of cavernous sinus Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision Without Pealing Of The Outer Layer Of The Cavernous Sinus |
Procedure: surgical excision of the tumor
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]
|
Outcome Measures
Primary Outcome Measures
- Neurocognitive Outcome Assessment using MOCA scale [1 year]
aggregated by our researchers in data base system in our department.
Secondary Outcome Measures
- Neurocognitive Outcome using neuropsychological assessment questionnaire [1 year]
aggregated by our researchers in data base system in our department.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kasr El Aini Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ahmed Hegazy,
professor of neurosurgery,
Kasr El Aini Hospital
ClinicalTrials.gov Identifier:
NCT03190122
Other Study ID Numbers:
- N-71-2016
First Posted:
Jun 16, 2017
Last Update Posted:
Jun 16, 2017
Last Verified:
Jun 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: