Cavernous Sinus Dissection and Bleeding in Meningiomas

Meningiomas of the Middle Cranial Fossa Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02863484
• Other study ID #: N-44-2016
• Status: Recruiting
• Phase: Phase 4
• First received: August 1, 2016
• Last updated: August 6, 2016
• Start date: May 2016
• Est. completion date: October 2016

Study information

• Verified date: August 2016
• Source: Kasr El Aini Hospital
• Contact: Ahmed A Hegazy, MD
• Phone: 01002155090
• Email: ahmed.hegazy[@]kasralainy.edu.eg
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Meningiomas of the middle cranial fossa

Exclusion Criteria:

• Meningiomas outside the middle cranial fossa

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meningioma
• Meningiomas of the Middle Cranial Fossa

Intervention

Other:
• surgery
pealing of the outer layer of the cavernous sinus

Locations

Country	Name	City	State
Egypt	Kasralainy medical college, Cairo University	Cairo	Greater Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of blood loss as estimated by cubic centimetres during surgery		three months	No
Secondary	Radically of surgery as estimated by post-operative tumour volume in cubic centimetres on post-operative MRI		3 months	No