Efficacy of Endoscopic Transantral Surgical Approach in the Repair of Orbital Blow-Out Fractures
Primary Purpose
Orbital Floor Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
endoscopic trans-antral approach
trans-orbital surgical approach
Sponsored by
About this trial
This is an interventional treatment trial for Orbital Floor Fracture focused on measuring endoscopic, trans-antral, subciliary
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
endoscopic trans-antral approach
trans-orbital surgical approach
Arm Description
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).
trans-orbital surgical approach through the lower eyelid Sub-ciliary incision ( through the lower eyelid) The skin incision is made just below the eyelashes.
Outcomes
Primary Outcome Measures
Diplopia resolution using Forced duction test positive/negative
subjective patient assessment
Secondary Outcome Measures
Fracture reduction Digital radiography (Cone beam CT)
Enophthalmus correction. Digital radiography (Cone beam CT)
mm
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03011047
Brief Title
Efficacy of Endoscopic Transantral Surgical Approach in the Repair of Orbital Blow-Out Fractures
Official Title
Efficacy of Endoscopic Transantral Versus Transorbital Surgical Approaches in the Repair of Orbital Blow-Out Fractures-Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 18, 2017 (Anticipated)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nahla Mahmoud Awad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orbital Floor Fracture
Keywords
endoscopic, trans-antral, subciliary
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
endoscopic trans-antral approach
Arm Type
Experimental
Arm Description
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).
Arm Title
trans-orbital surgical approach
Arm Type
Active Comparator
Arm Description
trans-orbital surgical approach through the lower eyelid Sub-ciliary incision ( through the lower eyelid) The skin incision is made just below the eyelashes.
Intervention Type
Procedure
Intervention Name(s)
endoscopic trans-antral approach
Other Intervention Name(s)
trans-maxillary
Intervention Description
new surgical approach to repair the orbital floor fractures through the maxillary sinus
Intervention Type
Procedure
Intervention Name(s)
trans-orbital surgical approach
Other Intervention Name(s)
sub-ciliary incision, lower eyelid incision, skin incision
Intervention Description
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
Primary Outcome Measure Information:
Title
Diplopia resolution using Forced duction test positive/negative
Description
subjective patient assessment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fracture reduction Digital radiography (Cone beam CT)
Time Frame
6 months
Title
Enophthalmus correction. Digital radiography (Cone beam CT)
Description
mm
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
nahla mahmoud awad, master
Phone
01124439776
Ext
0230728662
Email
nahla.awad@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
reem hossameldin, PHD
Phone
01006250787
Email
reemhamdy@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed elkhadem, PHD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Endoscopic Transantral Surgical Approach in the Repair of Orbital Blow-Out Fractures
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