Trans-tarsal Stair-step Lateral Extension of the Transconjunctival Approach

Alexandria University

Status: Completed

Conditions: Lower Eyelid Entropion; Zygomatic Fractures

Treatments: Procedure: transconjunctival approach; Procedure: trans-tarsal stair-step lateral extension of the transconjunctival approach

Study type: Interventional

Funder types: Other

Identifiers

NCT07044258

Mod-Trans-2/25

Details and patient eligibility

About

Open reduction and internal fixation of orbito-zygomaticomaxillary complex (OMC) fractures has challenging impact on the selection of suitable surgical approach to orbital and zygomatic skeleton. Precise repair of the OMC fractures needs a quite understanding of the regional anatomy, precise diagnosis, an accessible exposure and an accurate rigid fixation of fracture to restore the normal form. The esthetic results are one of the most important requirements for this incision in the facial fracture reduction. conventional approaches to the infraorbital rim/orbital floor include (subciliary mid lower eyelid, or subtarsal) and infraorbital incisions. A thorough understanding of each incisional technique requires an appreciation of the relevant anatomy putting in considerations the risk of associated complications. Transconjuctival incision has a lot of advantages, among which is the production of non-visible scar with low incidence of post -operative ectropion and limited access. Trans-tarsal stair-step lateral extension of the transconjunctival approach provides excellent surgical exposure of OMC fractures avoiding the use of a second incision in the area of zygomatic frontal suture. This technique provides good exposure and excellent esthetics.

the aim of this study is to compare Trans-tarsal Stair-Step Lateral Extension of the Transconjunctival approach with transconjunctival approach in the management of orbital and zygomaticomaxillary complex fractures.

Full description

This study will be made on twenty patients who will undergo fracture repair of the zygomaticomaxillary complex. Post- operative patient evaluation will be performed with specific attention paid towards accessibility, the exposure duration (time from incision till exposure of the field), esthetic appearance, post- operative pain, postoperative edema, orbital movement, wound healing, scarring, infra orbital nerve sensation and the post- operative ocular complications such as ectropion, entropion, enophthalmos, scleral show and corneal abrasion. Post- operative clinical examinations along with radiographic examination will be done to evaluate the position of zygoma and determine the adequacy of fracture reduction.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with OMC fractures that require open reduction with internal fixation.
2. Patients with orbital wall defects.
3. Patients with blow out fractures.
4. Adult patient between 18 and 60 years with no gender predilections.

Exclusion criteria

1. Existing lacerations in the inferior and lateral periorbital regions.
2. Comminuted fracture with bone loss.
3. Existence of infection at the fracture line.
4. Presence of acute or chronic conjunctival diseases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

trans-tarsal stair-step lateral extension of the transconjunctival approach

Active Comparator group

Description:

patients presented with oribto-zygomaticomaxillary complex fractures that requires open reduction and internal fixation via trans-tarsal stair-step lateral extension of the transconjunctival approach

Treatment:

Procedure: trans-tarsal stair-step lateral extension of the transconjunctival approach

transconjunctival approach

Experimental group

Description:

patients presented with oribto-zygomaticomaxillary complex fractures that requires open reduction and internal fixation via transconjunctival approach

Treatment:

Procedure: transconjunctival approach