Orbital TumorsNCT03195101
Evaluation of Transconjunctival Approach in Management of Orbital Tumors
A study testing transconjunctival orbitotomy approach in people with Orbital Tumors, run by Assiut University.
Trial summary
Many surgical approaches for excision of orbital tumors have been described. These approaches do not allow access to all orbital quadrants. Furthermore, some of these approaches are technically difficult, associated with long morbidity and post operative pain, having high rate of complications or having unacceptable… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orbital Tumors
- What is being tested?
- transconjunctival orbitotomy approach
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with orbital tumor either benign or malignant.
Who cannot join
- Patients with apical tumors not accessible with transconjunctival approach.
- Patients with too anterior tumors (superficial dermoid and lacrimal gland swelling).
- Patients with non-neoplastic orbital lesions.
- Patients with follow up period of less than 3 months
About this study
Many surgical approaches for excision of orbital tumors have been described. These approaches do not allow access to all orbital quadrants. Furthermore, some of these approaches are technically difficult, associated with long morbidity and post operative pain, having high rate of complications or having unacceptable cosmetic appearance. the investigators present the transconjunctival approach as an alternative procedure that allows access to orbital tumors in different locations as well as less morbidity and better cosmetic results
Read the detailed description
Orbital tumors are divided anatomically into intraconal and extraconal depending on their relationship with the muscle cone which is further classified into anterior and posterior orbital tumors. Excision of orbital tumors is considered a challenge for the surgeon. This is due to the complex structure of the orbit. The orbital cavity is narrow that does not allow adequate exposure. Furthermore, the orbit is full of vital structures which require careful manipulation. Many surgical approaches for excision of these tumors have been described. These approaches do not allow access to all orbital quadrants. Furthermore, some of these approaches are technically difficult, associated with long morbidity and post operative pain due to the osteotomy, having high rate of complications or having unacceptable cosmetic appearance. Few studies with limited number of patients have used transconjunctival approach in management of orbital tumors All patients with orbital tumor will be managed by the transconjunctival incisional or excisional biopsy according to the suggested nature of the tumor being benign or malignant as well as the site of the tumor using the clinicoradiological finding. In case of intraconal tumors, the mass will be approached via the transconjunctival approach but if the mass is out of reach via this approach, lateral orbitotomy approach will be used as an alternative procedure to perform the predetermined decision. This allows detection of the intraconal tumor criteria that could be excised safely via this approach
- Conditions
- Orbital Tumors
- Being tested
- transconjunctival orbitotomy approach
- Keywords
- orbital tumors, transconjunctival approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transconjunctival orbitotomy approachProcedure or surgery
approach the orbital tumor through an incision in the conjunctiva, This is followed by blunt dissection of the tenons capsule. A traction suture is applied over the corresponding rectus muscle to guide the globe toward the desired direction. The orbital fat is retracted by malleable retractor and blunt dissection through the orbital connective tissue continues until reaching the edge of the tumor. After the mass is exposed, a biopsy or complete resection of the mass is taken place
| Study group | Role | What they receive |
|---|---|---|
| patients with orbital tumors | Experimental | patients with orbital tumors will be managed by excisional or incisional biopsy via the transconjunctival orbitotomy approach Receives: Procedure: transconjunctival orbitotomy approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
successfulness of the surgical procedure
The procedure will be considered successful if the predetermined decision is achieved without sight threatening complications. The procedure will be considered a failure if the decision could not be achieved or if a sight threatening complication occurs.
Measured: every patient will be assessed 3 days postoperative
Secondary outcomes (1)
Early and late complications of the approach and their long term effects
the assessment will include intraoperative or postoperative complications. the complication will be followed up for up to three months to determine if the complication is self limited (example: self limited lid edema or subconjunctival hemorrhage) or has a long term effect (example: permanent visual loss or permanent limited ocular motility)
Measured: 3 days postoperative, 1 week, 1 month and 3 months postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital TumorsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Incisional or excisional biopsy of orbital tumors via transconjunctival approach
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Abdelnasser Awad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195101
- Sponsor's protocol ID
- 17200091
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2017
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Transconjunctival Approach in Management of Orbital Tumors
- ClinicalTrials.gov ID
- NCT03195101
- Acronym / sponsor ID
- 17200091
- Conditions
- Orbital Tumors
- Keywords
- orbital tumors, transconjunctival approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many surgical approaches for excision of orbital tumors have been described. These approaches do not allow access to all orbital quadrants. Furthermore, some of these approaches are technically difficult, associated with long morbidity and post operative pain, having high rate of complications or having unacceptable cosmetic appearance. the investigators present the transconjunctival approach as an alternative procedure that allows access to orbital tumors in different locations as well as less morbidity and better cosmetic results
Detailed description
Orbital tumors are divided anatomically into intraconal and extraconal depending on their relationship with the muscle cone which is further classified into anterior and posterior orbital tumors. Excision of orbital tumors is considered a challenge for the surgeon. This is due to the complex structure of the orbit. The orbital cavity is narrow that does not allow adequate exposure. Furthermore, the orbit is full of vital structures which require careful manipulation. Many surgical approaches for excision of these tumors have been described. These approaches do not allow access to all orbital quadrants. Furthermore, some of these approaches are technically difficult, associated with long morbidity and post operative pain due to the osteotomy, having high rate of complications or having unacceptable cosmetic appearance. Few studies with limited number of patients have used transconjunctival approach in management of orbital tumors All patients with orbital tumor will be managed by the transconjunctival incisional or excisional biopsy according to the suggested nature of the tumor being benign or malignant as well as the site of the tumor using the clinicoradiological finding. In case of intraconal tumors, the mass will be approached via the transconjunctival approach but if the mass is out of reach via this approach, lateral orbitotomy approach will be used as an alternative procedure to perform the predetermined decision. This allows detection of the intraconal tumor criteria that could be excised safely via this approach
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Incisional or excisional biopsy of orbital tumors via transconjunctival approach
| Arm | Type | Receives |
|---|---|---|
| patients with orbital tumors | Experimental | Procedure: transconjunctival orbitotomy approachpatients with orbital tumors will be managed by excisional or incisional biopsy via the transconjunctival orbitotomy approach |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with orbital tumor either benign or malignant.
Key exclusion criteria (4 listed)
- Patients with apical tumors not accessible with transconjunctival approach.
- Patients with too anterior tumors (superficial dermoid and lacrimal gland swelling).
- Patients with non-neoplastic orbital lesions.
- Patients with follow up period of less than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transconjunctival orbitotomy approachapproach the orbital tumor through an incision in the conjunctiva, This is followed by blunt dissection of the tenons capsule. A traction suture is applied over the corresponding rectus muscle to guide the globe toward the desired direction. The orbital fat is retracted by malleable retractor and blunt dissection through the orbital connective tissue continues until reaching the edge of the tumor. After the mass is exposed, a biopsy or complete resection of the mass is taken place | Procedure or surgery | patients with orbital tumors |
Primary outcome
successfulness of the surgical procedure
Time frame: every patient will be assessed 3 days postoperative
The procedure will be considered successful if the predetermined decision is achieved without sight threatening complications. The procedure will be considered a failure if the decision could not be achieved or if a sight threatening complication occurs.
1 secondary outcome
Early and late complications of the approach and their long term effects
Time frame: 3 days postoperative, 1 week, 1 month and 3 months postoperative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing transconjunctival orbitotomy approach in people with Orbital Tumors, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successfulness of the surgical procedure (time frame: every patient will be assessed 3 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.