OCS: Cavernous Sinus Dissection and Bleeding in Meningiomas

Sponsor
Kasr El Aini Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02863484
Collaborator
(none)
120
1
2
5
23.9

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2016
Anticipated Study Completion Date :
Oct 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Amount of blood loss as estimated by cubic centimetres during surgery [three months]

Secondary Outcome Measures

  1. Radically of surgery as estimated by post-operative tumour volume in cubic centimetres on post-operative MRI [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Meningiomas of the middle cranial fossa
Exclusion Criteria:
  • Meningiomas outside the middle cranial fossa

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kasralainy medical college, Cairo University Cairo Greater Cairo Egypt 11553

Sponsors and Collaborators

  • Kasr El Aini Hospital

Investigators

  • Principal Investigator: Ahmed Hegazy, MD, Professor of neurosurgery, faculty of medicine, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Hegazy, Dr., Kasr El Aini Hospital
ClinicalTrials.gov Identifier:
NCT02863484
Other Study ID Numbers:
  • N-44-2016
First Posted:
Aug 11, 2016
Last Update Posted:
Aug 11, 2016
Last Verified:
Aug 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2016