Efficacy of Endoscopic Transantral Surgical Approach in the Repair of Orbital Blow-Out Fractures
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|ClinicalTrials.gov Identifier: NCT03011047|
Recruitment Status : Not yet recruiting
First Posted : January 5, 2017
Last Update Posted : July 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Orbital Floor Fracture||Procedure: endoscopic trans-antral approach Procedure: trans-orbital surgical approach||Not Applicable|
(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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy of Endoscopic Transantral Versus Transorbital Surgical Approaches in the Repair of Orbital Blow-Out Fractures-Randomized Clinical Trial.|
|Estimated Study Start Date :||August 18, 2017|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: endoscopic trans-antral approach
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
new surgical approach to repair the orbital floor fractures through the maxillary sinus
Other Name: trans-maxillary
Active Comparator: trans-orbital surgical 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
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
- Diplopia resolution using Forced duction test positive/negative [ Time Frame: 6 months ]subjective patient assessment
- Fracture reduction Digital radiography (Cone beam CT) [ Time Frame: 6 months ]
- Enophthalmus correction. Digital radiography (Cone beam CT) [ Time Frame: 6 months ]mm
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011047
|Contact: nahla mahmoud awad, master||01124439776 ext email@example.com|
|Contact: reem hossameldin, PHDfirstname.lastname@example.org|
|Study Chair:||Ahmed elkhadem, PHD||Cairo University|