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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

(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.


Sponsor: Nahla Mahmoud Awad

Current Primary Outcome: Diplopia resolution using Forced duction test positive/negative [ Time Frame: 6 months ]

subjective patient assessment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Fracture reduction Digital radiography (Cone beam CT) [ Time Frame: 6 months ]
  • Enophthalmus correction. Digital radiography (Cone beam CT) [ Time Frame: 6 months ]
    mm


Original Secondary Outcome: Same as current

Information By: Cairo University

Dates:
Date Received: January 4, 2017
Date Started: February 2017
Date Completion: September 2017
Last Updated: January 4, 2017
Last Verified: January 2017