Efficacy of Endoscopic Transantral Surgical Approach in the Repair of Orbital Blow-Out Fractures

Study Overview
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Brief Summary
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Aim of this study is to assess the efficacy of endoscopic trans-maxillary surgical approach versus traditional trans-orbital surgical approach (control group) in orbital blow out fractures in terms of postoperative clinical and digital radio-graphical assessments.

Detailed Description
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(N.M) Operator, data entry & corresponding author; Assistant lecturer , surgery department . (I.E) Main supervisor, data monitoring & auditing; Professor, surgery department. (R.H) Co-supervisor, data entry & auditing; Lecturer, surgery department . (AM) Assistant lecturer, surgery department .Faculty of Oral & Dental Medicine Cairo University outcome assessors and data collection. (YA) Assistant Lecturer of Surgery department , faculty of oral and dental medicine - Cairo University , for baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents. intervention: Preoperative preparation: Preoperative cone beam CT. A clearance from the ophthalmology department after examination of papillary reflexes, motility restriction and measurement of the visual acuity. Laboratory Investigations: blood picture, liver functions, kidneys functions,coagulation profile Informed consent signed by the patient. (NM and RH) will perform all procedures under general anesthesia . Intervention :Endoscopic trans-maxillary (through the maxillary sinus) surgical approach. control group: Traditional trans-orbital surgical approaches. follow up clinically and radio-graphically for 6 months.

Official Title
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Efficacy of Endoscopic Transantral Versus Transorbital Surgical Approaches in the Repair of Orbital Blow-Out Fractures-Randomized Clinical Trial.

Conditions
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Orbital Floor Fracture

Intervention / Treatment
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* Procedure: endoscopic trans-antral approach
* Procedure: trans-orbital surgical approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with unilateral/bilateral orbital blow out fractures. Positive forced-duction test. ( to ensure the muscular entrapment). Exclusion Criteria: Medical condition affecting bone healing. Medically compromised conditions, not proper candidate for general anesthesia. Tumor case encroaching on the orbital floor. Pathological orbital blow out fractures. Allergy/ metal hypersensitivity.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endoscopic trans-antral approach<br>The maxillary sinus and prolapsed orbital contents will be visualized employing a 30-degree endoscope for the repair of orbital blow out fracture (sinus scope 4 mm, 30 degrees short one 17 cm). | Procedure: endoscopic trans-antral approach<br>* new surgical approach to repair the orbital floor fractures through the maxillary sinus<br>* Other names: trans-maxillary;|
| Active Comparator: trans-orbital surgical approach<br>trans-orbital surgical approach through the lower eyelid Sub-ciliary incision ( through the lower eyelid) The skin incision is made just below the eyelashes. | Procedure: trans-orbital surgical approach<br>* through the lower eyelid below the eyelashes ,then down to bone the herniated orbital content will be reduced through this incision traditional surgical approach to repair orbital floor fractures<br>* Other names: skin incision;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diplopia resolution using Forced duction test positive/negative | subjective patient assessment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture reduction Digital radiography (Cone beam CT) |  | 6 months | 
| Enophthalmus correction. Digital radiography (Cone beam CT) | mm | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic, trans-antral, subciliary