Clinical trial NCT03195101: Evaluation of Transconjunctival Approach in Management of Orbital Tumors
Official title: Evaluation of Transconjunctival Approach in Management of Orbital Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orbital Tumors
Keywords: orbital tumors
transconjunctival approach
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Incisional or excisional biopsy of orbital tumors via transconjunctival approach
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: successfulness of the surgical procedure
timeFrame: every patient will be assessed 3 days postoperative
Secondary outcomes:
measure: Early and late complications of the approach and their long term effects
timeFrame: 3 days postoperative, 1 week, 1 month and 3 months postoperative.
Other outcomes:
Locations:
Study officials:
References: