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Cavernous Sinus Dissection and Bleeding in Meningiomas (OCS)

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ClinicalTrials.gov Identifier: NCT02863484
Recruitment Status : Unknown
Verified August 2016 by Ahmed Hegazy, Kasr El Aini Hospital.
Recruitment status was:  Recruiting
First Posted : August 11, 2016
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmed Hegazy, Kasr El Aini Hospital

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

Condition or disease Intervention/treatment Phase
Meningiomas of the Middle Cranial Fossa Other: surgery Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Conventional surgery intra-dural
This arm will be surgically operated by direct attack of the tumour after opening the dura
Other: surgery
pealing of the outer layer of the cavernous sinus

Experimental: Pealing surgery extra-dural
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.
Other: surgery
pealing of the outer layer of the cavernous sinus




Primary Outcome Measures :
  1. Amount of blood loss as estimated by cubic centimetres during surgery [ Time Frame: three months ]

Secondary Outcome Measures :
  1. Radically of surgery as estimated by post-operative tumour volume in cubic centimetres on post-operative MRI [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meningiomas of the middle cranial fossa

Exclusion Criteria:

  • Meningiomas outside the middle cranial fossa

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863484


Contacts
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Contact: Ahmed A Hegazy, MD 01002155090 ahmed.hegazy@kasralainy.edu.eg
Contact: Noha Asem, MD 01003657120 kasralainirec@yahoo.com

Locations
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Egypt
Kasralainy medical college, Cairo University Recruiting
Cairo, Greater Cairo, Egypt, 11553
Contact: Ahmed Hegazy, MD    01002155090    ahmed.hegazy@kasralainy.edu.eg   
Contact: Noha Asem, MD    01003657120    KASEALAINIREC@YAHOO.COM   
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Principal Investigator: Ahmed Hegazy, MD Professor of neurosurgery, faculty of medicine, Cairo University
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Responsible Party: Ahmed Hegazy, Dr., Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT02863484    
Other Study ID Numbers: N-44-2016
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Meningioma
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases