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

Nahla Mahmoud Awad

Status: Unknown

Conditions: Orbital Floor Fracture

Treatments: Procedure: endoscopic trans-antral approach; Procedure: trans-orbital surgical approach

Study type: Interventional

Funder types: Other

Identifiers

NCT03011047

CEBD-CU-2017-1-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

endoscopic trans-antral approach

Experimental group

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).

Treatment:

Procedure: endoscopic trans-antral approach

trans-orbital surgical approach

Active Comparator group

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.

Treatment:

Procedure: trans-orbital surgical approach