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Cavernous Sinus Dissection and Bleeding in Meningiomas (OCS)

Primary Purpose

Meningiomas of the Middle Cranial Fossa

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
surgery
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meningiomas of the Middle Cranial Fossa

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meningiomas of the middle cranial fossa

Exclusion Criteria:

  • Meningiomas outside the middle cranial fossa

Sites / Locations

  • Kasralainy medical college, Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional surgery intra-dural

Pealing surgery extra-dural

Arm Description

This arm will be surgically operated by direct attack of the tumour after opening the dura

This arm the pealing of the outer layer of the lateral wall of the cavernous sinus will be done before the dura is opened. After the pealing is completed, the middle meningeal artery will be divided at the foramen spinosum. Then, the dura will be opened and the tumour attacked.

Outcomes

Primary Outcome Measures

Amount of blood loss as estimated by cubic centimetres during surgery

Secondary Outcome Measures

Radically of surgery as estimated by post-operative tumour volume in cubic centimetres on post-operative MRI

Full Information

First Posted
August 1, 2016
Last Updated
August 6, 2016
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02863484
Brief Title
Cavernous Sinus Dissection and Bleeding in Meningiomas
Acronym
OCS
Official Title
Dissection of the Outer Layer of the Lateral Wall of the Cavernous Sinus Decreases Bleeding as Compared to Direct Tumor Attack in Middle Fossa Meningiomas: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The blood loss will be compared in middle fossa meningiomas which will receive pealing of the outer layer of the lateral wall of the cavernous sinus and those which will not revive pealing before the dura is opened
Detailed Description
Cases with middle fossa meningiomas will be randomised to one of two surgical techniques. The first technique will involve pealing of the outer layer of the lateral wall of the cavernous sinus before the dura is opened and the tumour attacked, and the second group of cases will be operated by a standard technique, where the tumour will be directly attacked with out pealing of the outer layer of the lateral wall of the cavernous sinus. Blood loss will be monitored in each case by calculating the amount of blood in the suction container and subtracting it from the amount of fluids used for irrigation during surgery. The number of cotton patties and dressings will be also counted with each case as well as the number of gauzes used. The pre-operative complete blood picture will be documented particularly the haemoglobin , hematocrits and others. The same lab data will be also monitored after surgery. The amount of blood transfusion required will also be calculated in each case.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningiomas of the Middle Cranial Fossa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional surgery intra-dural
Arm Type
Active Comparator
Arm Description
This arm will be surgically operated by direct attack of the tumour after opening the dura
Arm Title
Pealing surgery extra-dural
Arm Type
Experimental
Arm Description
This arm the pealing of the outer layer of the lateral wall of the cavernous sinus will be done before the dura is opened. After the pealing is completed, the middle meningeal artery will be divided at the foramen spinosum. Then, the dura will be opened and the tumour attacked.
Intervention Type
Other
Intervention Name(s)
surgery
Intervention Description
pealing of the outer layer of the cavernous sinus
Primary Outcome Measure Information:
Title
Amount of blood loss as estimated by cubic centimetres during surgery
Time Frame
three months
Secondary Outcome Measure Information:
Title
Radically of surgery as estimated by post-operative tumour volume in cubic centimetres on post-operative MRI
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meningiomas of the middle cranial fossa Exclusion Criteria: Meningiomas outside the middle cranial fossa
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A Hegazy, MD
Phone
01002155090
Email
ahmed.hegazy@kasralainy.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Noha Asem, MD
Phone
01003657120
Email
kasralainirec@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Hegazy, MD
Organizational Affiliation
Professor of neurosurgery, faculty of medicine, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasralainy medical college, Cairo University
City
Cairo
State/Province
Greater Cairo
ZIP/Postal Code
11553
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Hegazy, MD
Phone
01002155090
Email
ahmed.hegazy@kasralainy.edu.eg
First Name & Middle Initial & Last Name & Degree
Noha Asem, MD
Phone
01003657120
Email
KASEALAINIREC@YAHOO.COM

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cavernous Sinus Dissection and Bleeding in Meningiomas

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