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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
Sponsor:
Information provided by (Responsible Party):
Nahla Mahmoud Awad, Cairo University

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.

Condition or disease Intervention/treatment Phase
Orbital Floor Fracture Procedure: endoscopic trans-antral approach Procedure: trans-orbital surgical approach Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Fractures

Arm Intervention/treatment
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
Other Names:
  • sub-ciliary incision
  • lower eyelid incision
  • skin incision




Primary Outcome Measures :
  1. Diplopia resolution using Forced duction test positive/negative [ Time Frame: 6 months ]
    subjective patient assessment


Secondary Outcome Measures :
  1. Fracture reduction Digital radiography (Cone beam CT) [ Time Frame: 6 months ]
  2. Enophthalmus correction. Digital radiography (Cone beam CT) [ Time Frame: 6 months ]
    mm



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with unilateral/bilateral orbital blow out fractures.
  2. Positive forced-duction test. ( to ensure the muscular entrapment).

Exclusion Criteria:

  1. Medical condition affecting bone healing.
  2. Medically compromised conditions, not proper candidate for general anesthesia.
  3. Tumor case encroaching on the orbital floor.
  4. Pathological orbital blow out fractures.
  5. Allergy/ metal hypersensitivity.

Information from the National Library of Medicine

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


Contacts
Contact: nahla mahmoud awad, master 01124439776 ext 0230728662 nahla.awad@dentistry.cu.edu.eg
Contact: reem hossameldin, PHD 01006250787 reemhamdy@hotmail.com

Sponsors and Collaborators
Nahla Mahmoud Awad
Investigators
Study Chair: Ahmed elkhadem, PHD Cairo University

Responsible Party: Nahla Mahmoud Awad, Assistant lecturer , Oral and Maxillofacial surgery Department, Faculty of Oral & Dental Medicine Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT03011047     History of Changes
Other Study ID Numbers: CEBD-CU-2017-1-1
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nahla Mahmoud Awad, Cairo University:
endoscopic, trans-antral, subciliary

Additional relevant MeSH terms:
Fractures, Bone
Orbital Fractures
Wounds and Injuries
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures