Evaluation of Transconjunctival Approach in Management of Orbital Tumors

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

Study Overview

• Status: Unknown
• Conditions: Orbital Tumors
• Intervention / Treatment: Procedure: transconjunctival orbitotomy approach

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: patients with orbital tumors; patients with orbital tumors will be managed by excisional or incisional biopsy via the transconjunctival orbitotomy approach

Procedure: transconjunctival 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	every patient will be assessed 3 days postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 days postoperative, 1 week, 1 month and 3 months postoperative.

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): June 22, 2017
• Last Update Submitted That Met QC Criteria: June 21, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: orbital tumors; transconjunctival approach
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Eye Diseases; Musculoskeletal Diseases; Bone Diseases; Orbital Diseases; Eye Neoplasms; Skull Neoplasms; Bone Neoplasms; Orbital Neoplasms
• Other Study ID Numbers: 17200091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No