NCT03011047

Efficacy of Endoscopic Transantral Surgical Approach in the Repair of Orbital Blow-Out Fractures

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Nahla Mahmoud Awad · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Orbital Floor Fracture

Interventions

Type	Name	Description
PROCEDURE	endoscopic trans-antral approach	new surgical approach to repair the orbital floor fractures through the maxillary sinus
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

Timeline

• Start date: 2017-08-18
• Primary completion: 2018-07-01
• Completion: 2018-09-01
• First posted: 2017-01-05
• Last updated: 2017-07-21