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Evaluation of Transconjunctival Approach in Management of Orbital Tumors

Evaluation of Transconjunctival Approach in Management of Orbital Tumors

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03195101
Enrollment
30
Registered
2017-06-22
Start date
2017-07-01
Completion date
2021-01-01
Last updated
2017-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orbital Tumors

Keywords

orbital tumors, transconjunctival approach

Brief 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 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

Interventions

PROCEDUREtransconjunctival orbitotomy approach

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Incisional or excisional biopsy of orbital tumors via transconjunctival approach

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients with orbital tumor either benign or malignant.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
successfulness of the surgical procedureevery patient will be assessed 3 days postoperativeThe 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.

Secondary

MeasureTime frameDescription
Early and late complications of the approach and their long term effects3 days postoperative, 1 week, 1 month and 3 months postoperative.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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026