NCT02863484

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

4 months

First QC Date

August 1, 2016

Last Update Submit

August 6, 2016

Conditions

Meningiomas of the Middle Cranial Fossa

Outcome Measures

Primary Outcomes (1)

  • Amount of blood loss as estimated by cubic centimetres during surgery

    three months

Secondary Outcomes (1)

  • Radically of surgery as estimated by post-operative tumour volume in cubic centimetres on post-operative MRI

    3 months

Study Arms (2)

Conventional surgery intra-dural

ACTIVE COMPARATOR

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

Other: surgery

Pealing surgery extra-dural

EXPERIMENTAL

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

surgeryOTHER

pealing of the outer layer of the cavernous sinus

Conventional surgery intra-duralPealing surgery extra-dural

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meningiomas of the middle cranial fossa

You may not qualify if:

  • Meningiomas outside the middle cranial fossa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasralainy medical college, Cairo University

Cairo, Greater Cairo, 11553, Egypt

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Ahmed Hegazy, MD

    Professor of neurosurgery, faculty of medicine, Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed A Hegazy, MD

CONTACT

01002155090ahmed.hegazy@kasralainy.edu.eg

Noha Asem, MD

CONTACT

01003657120kasralainirec@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 11, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

August 11, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)