CClinicalTrials.gg
Status unknownNCT02863484OCSUpdated Aug 11, 2016

Cavernous Sinus Dissection and Bleeding in Meningiomas

A Phase 4 interventional study of surgery in Meningiomas of the Middle Cranial Fossa, sponsored by Kasr El Aini Hospital. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-08-11.

Sponsored by Kasr El Aini Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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

Read the 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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Conditions studied

  • Meningiomas of the Middle Cranial Fossa

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03

In context

Meningioma

226 studies on the registry are indexed under Meningioma; 87 are open to participants now.

This study's planned enrollment of 120 is above the median of 40 across 161 interventional studies indexed under Meningioma.

Browse Meningioma studies →

Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 273 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Meningiomas of the middle cranial fossa

Exclusion criteria

Exclusion Criteria:

  • Meningiomas outside the middle cranial fossa
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Conventional surgery intra-dural

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

    Other: surgery

  • 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

Interventions

  • Othersurgery

    pealing of the outer layer of the cavernous sinus

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What researchers measure

Primary outcomes

  1. Amount of blood loss as estimated by cubic centimetres during surgery

    Time frame: three months

Secondary outcomes

  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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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02863484
Lead sponsor
Kasr El Aini Hospital
Responsible party
Ahmed Hegazy (Dr., Kasr El Aini Hospital) — Principal investigator
First posted
Aug 11, 2016
Start date
May 2016
Primary completion
Sep 2016 (estimated)
Completion
Oct 2016 (estimated)
Last update
Aug 11, 2016

Study contacts

Ahmed A Hegazy, MD
Contact
ahmed.hegazy@kasralainy.edu.eg
01002155090
Noha Asem, MD
Contact
kasralainirec@yahoo.com
01003657120
Ahmed Hegazy, MD
principal investigator · Professor of neurosurgery, faculty of medicine, Cairo University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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