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

NCT03011047 | Unknown DMC

• 1 other identifier: CEBD-CU-2017-1-1
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Orbital Floor Fracture

Keywords

endoscopic, trans-antral, subciliary

Outcome Measures

Primary Outcomes (1)

• Diplopia resolution using Forced duction test positive/negative

  subjective patient assessment

  6 months

Secondary Outcomes (2)

• Fracture reduction Digital radiography (Cone beam CT)

  6 months

• Enophthalmus correction. Digital radiography (Cone beam CT)

  6 months

Study Arms (2)

endoscopic trans-antral approach

EXPERIMENTAL

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

trans-orbital surgical approach

ACTIVE COMPARATOR

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

Interventions

endoscopic trans-antral approach PROCEDURE

new surgical approach to repair the orbital floor fractures through the maxillary sinus

Also known as: trans-maxillary

endoscopic trans-antral approach

trans-orbital surgical approach PROCEDURE

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

Also known as: sub-ciliary incision, lower eyelid incision, skin incision

trans-orbital surgical approach

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nahla Mahmoud Awad: lead

Study Officials

• Ahmed elkhadem, PHD

  Cairo University

  STUDY CHAIR

Central Study Contacts

nahla mahmoud awad, master

CONTACT

01124439776; nahla.awad@dentistry.cu.edu.eg

reem hossameldin, PHD

CONTACT

01006250787; reemhamdy@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer , Oral and Maxillofacial surgery Department, Faculty of Oral & Dental Medicine Cairo University

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 5, 2017
• Study Start: August 18, 2017
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: July 21, 2017

Record last verified: 2017-07