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

Trans-tarsal Stair-step Lateral Extension of the Transconjunctival Approach Versus Transconjunctival Approach in the Management of Orbito-zygomaticomaxillary Complex Fractures (Randomized Controlled Clinical Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07044258
Enrollment
20
Registered
2025-06-29
Start date
2024-10-01
Completion date
2025-06-15
Last updated
2025-06-29

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

Conditions

Lower Eyelid Entropion, Zygomatic Fractures

Keywords

Orbito-zygomaticomaxillary Fracture, Transconjunctival Incision, Lower eyelid

Brief summary

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.

Detailed 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.

Interventions

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

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

PROCEDUREtransconjunctival approach

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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Sequentially numbered, opaque, sealed envelopes (SNOSE) allocation concealment method will be utilized. Each participant included in the study will be given a serial number that will be used in the allocation. These numbers will be written in identical sheets of paper with the group to which each participant is allocated and placed inside opaque envelopes carrying the respective names of participants. A trial independent personnel will be assigned the role of keeping the envelopes and unfolding them only at the time of the operation, so that the participant is allocated to a group which is concealed from the operator

Intervention model 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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
exposure durationDuring the surgeryThe time taken between performing the incision till exposure of the field will be recorded using a stopwatch.

Secondary

MeasureTime frameDescription
postoperative edema1.5 monthThe postoperative edema will be categorized subjectively into mild (just noticeable), mild to moderate (more obvious edema without occlusion of palpebral fissure), moderate to severe (edema partially occluding palpebral fissure), and severe (edema totally occluding palpebral fissure).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026