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

Orbital Floor Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03011047
• Other study ID #: CEBD-CU-2017-1-1
• Status: Not yet recruiting
• Phase: N/A
• First received: January 4, 2017
• Last updated: July 19, 2017
• Start date: August 18, 2017
• Est. completion date: September 2018

Study information

• Verified date: July 2017
• Source: Cairo University
• Contact: nahla mahmoud awad, master
• Phone: 01124439776
• Email: nahla.awad[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: September 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Orbital Floor Fracture
• Orbital Fractures

Intervention

Procedure:
• endoscopic trans-antral approach
new surgical approach to repair the orbital floor fractures through the maxillary sinus
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nahla Mahmoud Awad

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diplopia resolution using Forced duction test positive/negative	subjective patient assessment	6 months
Secondary	Fracture reduction Digital radiography (Cone beam CT)		6 months
Secondary	Enophthalmus correction. Digital radiography (Cone beam CT)	mm	6 months