Cavernous Sinus Dissection and Bleeding in Meningiomas (OCS)

Kasr El Aini Hospital

Status and phase: Unknown; Phase 4

Conditions: Meningiomas of the Middle Cranial Fossa

Treatments: Other: surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02863484

N-44-2016

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meningiomas of the middle cranial fossa

Exclusion criteria

• Meningiomas outside the middle cranial fossa

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Conventional surgery intra-dural

Active Comparator group

Description:

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

Treatment:

Other: surgery

Pealing surgery extra-dural

Experimental group

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.

Treatment:

Other: surgery