Efficacy of Endoscopic Transantral Versus Transorbital Surgical Approaches in the Repair of Orbital Blow-Out Fractures-Randomized Clinical Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Orbital Floor Fracture
- Sponsor
- Nahla Mahmoud Awad
- Enrollment
- 38
- Primary Endpoint
- Diplopia resolution using Forced duction test positive/negative
- Last Updated
- 8 years ago
Overview
Brief Summary
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
(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.
Investigators
Nahla Mahmoud Awad
Assistant lecturer , Oral and Maxillofacial surgery Department, Faculty of Oral & Dental Medicine Cairo University
Cairo University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Diplopia resolution using Forced duction test positive/negative
Time Frame: 6 months
subjective patient assessment
Secondary Outcomes
- Fracture reduction Digital radiography (Cone beam CT)(6 months)
- Enophthalmus correction. Digital radiography (Cone beam CT)(6 months)