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