An interventional study of endoscopic trans-antral approach and trans-orbital surgical approach in Orbital Floor Fracture, sponsored by Nahla Mahmoud Awad. Status unknown. Per ClinicalTrials.gov, last updated 2017-07-21.
Sponsored by Nahla Mahmoud Awad · Not applicable, Interventional, and Treatment
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.
Nahla Mahmoud Awad is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
new surgical approach to repair the orbital floor fractures through the maxillary sinus
Also known as: trans-maxillary
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
Also known as: sub-ciliary incision, lower eyelid incision, skin incision
Diplopia resolution using Forced duction test positive/negative
subjective patient assessment
Time frame: 6 months
Fracture reduction Digital radiography (Cone beam CT)
Time frame: 6 months
Enophthalmus correction. Digital radiography (Cone beam CT)
mm
Time frame: 6 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Aug 2017; primary completion for Jul 2018, 11 months later.
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This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Nahla Mahmoud Awad