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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Mansoura University |
| Funder | Investigator initiated and funded |
- 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
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
Scientific
Ophthalmology Center
12 Gehan street
Mansoura
35516
Egypt
 ORCID ID |
0000-0002-5127-7558 |
|---|---|
| Phone | +20 (0)1005876138 |
| ayman_gh@mans.edu.eg |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional non comparative single center case series |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Transconjunctival cryo-assisted extraction of intraconal cavernous hemangioma |
| Study objectives | is 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) studied | 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 |
| Primary outcome measure(s) |
The success of the operation and complications measured using direct interview of patients after six months |
| Key secondary outcome measure(s) |
None |
| Completion date | 14/09/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 18 |
| Key inclusion criteria | Patients with intraconal cavernous hemangiomas |
| Key exclusion criteria | Intraconal, non-compressible, solid lesions that simulate cavernous hemangioma e.g. schwannoma, solitary neurofibroma, and fibrous histiocytoma |
| Date of first enrolment | 14/05/2017 |
| Date of final enrolment | 14/08/2018 |
Locations
Countries of recruitment
- Egypt
Study participating centre
Mansoura
35516
Egypt
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
