Surgery to remove orbital bloody tumors through the conjunctiva by aid of a device that facilitates the procedure

ISRCTN ISRCTN45970569
DOI https://doi.org/10.1186/ISRCTN45970569
Submission date
16/04/2020
Registration date
24/04/2020
Last edited
03/06/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Ayman Abd El Ghafar
Scientific

Ophthalmology Center
12 Gehan street
Mansoura
35516
Egypt

ORCiD logoORCID ID 0000-0002-5127-7558
Phone +20 (0)1005876138
Email ayman_gh@mans.edu.eg

Study information

Study designInterventional non comparative single center case series
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titleTransconjunctival cryo-assisted extraction of intraconal cavernous hemangioma
Study objectivesis the transconjunctival cryo-assisted approach for excision of intraconal cavernous hemangioma is safe and effective?
Ethics approval(s)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
Health condition(s) or problem(s) studiedOrbital intraconal cavernous hemangioma
InterventionExcision 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 typeProcedure/Surgery
Primary outcome measureThe success of the operation and complications measured using direct interview of patients after six months
Secondary outcome measuresNone
Overall study start date02/04/2017
Completion date14/09/2018

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants18
Key inclusion criteriaPatients with intraconal cavernous hemangiomas
Key exclusion criteriaIntraconal, non-compressible, solid lesions that simulate cavernous hemangioma e.g. schwannoma, solitary neurofibroma, and fibrous histiocytoma
Date of first enrolment14/05/2017
Date of final enrolment14/08/2018

Locations

Countries of recruitment

  • Egypt

Study participating centre

Mansoura ophthalmic center
Gomhoria steet
Mansoura
35516
Egypt

Sponsor information

Mansoura University
Hospital/treatment centre

Mansoura Ophthalmic Center
Mansoura Faculty of Medicine
Elgomhoria street
Mansoura
35516
Egypt

Phone +20 (0)1000641607
Email aiman_eg_123@yahoo.com
Website http://ophc.mans.edu.eg/
ROR logo "ROR" https://ror.org/01k8vtd75

Funders

Funder type

Not defined

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date15/05/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planBMC ophthalmology journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Editorial Notes

03/06/2020: The following changes have been made:
1. The recruitment start date has been changed from 02/05/2017 to 14/05/2017.
2. The overall trial start date has been changed from 02/03/2017 to 02/04/2017.
3. The overall trial end date has been changed from 05/05/2019 to 14/09/2018.
4. The plain English summary has been updated to reflect the changes above.
23/04/2020: Trial’s existence confirmed by Mansoura institutional review board.