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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.
(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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endoscopic trans-antral approach | Experimental | 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). |
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| trans-orbital surgical approach | Active Comparator | trans-orbital surgical approach through the lower eyelid Sub-ciliary incision ( through the lower eyelid) The skin incision is made just below the eyelashes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic trans-antral approach | Procedure | new surgical approach to repair the orbital floor fractures through the maxillary sinus |
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| Measure | Description | Time Frame |
|---|---|---|
| Diplopia resolution using Forced duction test positive/negative | subjective patient assessment | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fracture reduction Digital radiography (Cone beam CT) | 6 months | |
| Enophthalmus correction. Digital radiography (Cone beam CT) | mm | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| nahla mahmoud awad, master | Contact | 01124439776 | 0230728662 | nahla.awad@dentistry.cu.edu.eg |
| reem hossameldin, PHD | Contact | 01006250787 | reemhamdy@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed elkhadem, PHD | Cairo University | Study Chair |
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| trans-orbital surgical approach | Procedure | 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 |
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