Cavernous Sinus Dissection and Bleeding in Meningiomas | NCT02863484

Studies
Cavernous Sinus Dissection and Bleeding in Meningiomas

NCT02863484

Sponsor

Kasr El Aini Hospital

Status

Unknown status

Last Update Posted

Aug 11, 2016Estimated

Enrollment

120Estimated

Phase

Phase 4

Conditions

Meningiomas of the Middle Cranial Fossa

Interventions

surgery

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Sep 2016Estimated

Completion Date

Oct 2016Estimated

First Submitted Date

Aug 1, 2016

First Submission Date that Met QC Criteria

Aug 6, 2016

First Posted Date

Aug 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2016

Last Update Posted Date

Aug 11, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
surgery	Other	pealing of the outer layer of the cavernous sinus	Conventional surgery intra-dural Pealing surgery extra-dural

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of blood loss as estimated by cubic centimetres during surgery		three months

Secondary Outcomes

Measure	Description	Time Frame
Radically of surgery as estimated by post-operative tumour volume in cubic centimetres on post-operative MRI		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meningiomas of the middle cranial fossa

Exclusion Criteria:

Meningiomas outside the middle cranial fossa

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed A Hegazy, MD	Contact	01002155090		ahmed.hegazy@kasralainy.edu.eg
Noha Asem, MD	Contact	01003657120		kasralainirec@yahoo.com

Overall Officials

Name	Affiliation	Role
Ahmed Hegazy, MD	Professor of neurosurgery, faculty of medicine, Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasralainy medical college, Cairo University	Recruiting	Cairo	Greater Cairo	11553	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

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Browse Branches

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