Cavernous Sinus Dissection and Bleeding in Meningiomas

NCT ID: NCT02863484

Last Updated: 2016-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2016-10-31

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.

Conditions

Meningiomas of the Middle Cranial Fossa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional surgery intra-dural

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

Group Type: ACTIVE_COMPARATOR

surgery

Intervention Type: OTHER

pealing of the outer layer of the cavernous sinus

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.

Group Type: EXPERIMENTAL

surgery

Intervention Type: OTHER

pealing of the outer layer of the cavernous sinus

Interventions

surgery

pealing of the outer layer of the cavernous sinus

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Meningiomas of the middle cranial fossa

Exclusion Criteria

• Meningiomas outside the middle cranial fossa

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Hegazy

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Hegazy, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of neurosurgery, faculty of medicine, Cairo University

Locations

Kasralainy medical college, Cairo University

Cairo, Greater Cairo, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed A Hegazy, MD

Role: CONTACT

ahmed.hegazy@kasralainy.edu.eg

01002155090

Noha Asem, MD

Role: CONTACT

kasralainirec@yahoo.com

01003657120

Facility Contacts

Ahmed Hegazy, MD

Role: primary

ahmed.hegazy@kasralainy.edu.eg

01002155090

Noha Asem, MD

Role: backup

KASEALAINIREC@YAHOO.COM

01003657120

Other Identifiers

N-44-2016

Identifier Type: -

Identifier Source: org_study_id