Plain English Summary
Background and study aims
Hemangioma is a benign tumor that is found to grow within the orbit. Most commonly located behind the eye globe, it can push the eye forward causing eye-bulging doctors call proptosis.
The tumor can be removed through surgery entering via the lower eyelid (transconjunctival orbitotomy) using cryotherapy. Cryotherapy uses imaging guidance, a needle-like applicator called a cryoprobe, and liquid nitrogen or argon gas to create intense cold to freeze and destroy diseased tissue, including cancer cells.
The aim of this study is to evaluate the safety and efficacy of cryo-assisted transconjunctival orbitotomy for the extraction of intraconal cavernous hemangiomas.
Who can participate?
Patients with intraconal cavernous hemangiomas
What does the study involve?
The transconjunctival approach will be used for cryo-assisted lesion extraction. Cases will be followed for six months after the surgery.
What are the possible benefits and risks of participating?
Benefits: excision of the orbital tumors, avoid compression of the optic nerve and avoid exposure keratitis
Risks: trauma to the optic nerve, trauma to the globe, rupture of the mass and inability to remove the tumor
Where is the study run from?
Mansoura ophthalmic center (Egypt)
When is the study starting and how long is it expected to run for?
April 2017 to September 2018
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Abd El Ghafar, aiman_eg_123@yahoo.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ayman Abd El Ghafar
ORCID ID
http://orcid.org/0000-0002-5127-7558
Contact details
Ophthalmology Center
12 Gehan street
Mansoura
35516
Egypt
+20 (0)1005876138
ayman_gh@mans.edu.eg
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Transconjunctival cryo-assisted extraction of intraconal cavernous hemangioma
Acronym
Study hypothesis
is the transconjunctival cryo-assisted approach for excision of intraconal cavernous hemangioma is safe and effective?
Ethics approval
Approved 10/05/2017, Mansoura institutional review board (IRB) (Mansoura University Faculty of Medicine, Mansoura, Egypt; +20 (0)1092127930; IRB.MFM@hotmail.com), ref: R/17.05.26
Study design
Interventional non comparative single center case series
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Orbital intraconal cavernous hemangioma
Intervention
Excision of intraconal cavernous hemangiomas were performed through the transconjunctival approach assisted by the cryo-probe.
Patients enrolled were informed about the nature of surgery and benefits and possible complications of the procedure. they were admitted from May 2017 to August 2018 and followed for 6 months after surgery.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
The success of the operation and complications measured using direct interview of patients after six months
Secondary outcome measures
None
Overall trial start date
02/04/2017
Overall trial end date
14/09/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with intraconal cavernous hemangiomas
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
18
Participant exclusion criteria
Intraconal, non-compressible, solid lesions that simulate cavernous hemangioma e.g. schwannoma, solitary neurofibroma, and fibrous histiocytoma
Recruitment start date
14/05/2017
Recruitment end date
14/08/2018
Locations
Countries of recruitment
Egypt
Trial participating centre
Mansoura ophthalmic center
Gomhoria steet
Mansoura
35516
Egypt
Sponsor information
Organisation
Mansoura University
Sponsor details
Mansoura Ophthalmic Center
Mansoura Faculty of Medicine
Elgomhoria street
Mansoura
35516
Egypt
+20 (0)1000641607
aiman_eg_123@yahoo.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
BMC ophthalmology journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Intention to publish date
15/05/2020
Participant level data
Available on request
Basic results (scientific)
Publication list