Using the Transconjuctival Approach Alone Versus Using it Together With Lateral Canthotomy in Orbital Fractures

Orbital Fractures Clinical Trial

Official title:

the Effect of Using the Tyransconjunctival Approach Alone Versus Using Transconjunctival Approach Together With Lateral Canthotomy in Orbital Fractures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03813732
• Other study ID #: CEBD-CU-2019-01-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: January 15, 2021

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: Khaled M Amr, Prof
• Phone: 01006029231
• Email: Khaledamr82[@]hotmail..com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

All cases will undergo surgery under general anesthesia. Evaluation of patients with suspected orbital fracture should involve radiologic examination, motility test, diplopia field test and exophthalmometry. Plain X-ray films, although rarely used, with the Caldwell and Waters view may be done as a screening evaluation for possible fractures and foreign bodies. An orbital computed tomography, the gold standard in trauma, CT with contiguous thin axial and coronal sections should be ordered to confirm the diagnosis and plan for treatment

Postoperative care:

Proper postoperative instructions will be given the patient, in addition to the postoperative medications including antibiotics, corticosteroids and analgesics.

Description:

This study will be carried out on patients attending the outpatient clinic in Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University.

10. Eligibility criteria:

• Inclusion criteria:

• Age group: from 15 to 60 years old.

• Patients with pure blow-out fractures.

• Exclusion criteria:

• Patients suffering from dermatological diseases,

11. Interventions:

1. Pre-operative phase:

Patients will be subjected to:

1. Case history including personal data, medical, surgical and family history.

2. Clinical examination.

3. Preoperative anesthesia assessment for fitness for general anesthesia.

4. Treatment planning.

2. Operative phase:

All cases will undergo surgery under general anesthesia. The inferior wall can be easily accessed through transcutaneous or transconjunctival approach (with or without lateral canthotomy). The latter avoids a visible scar and is less likely to result in eyelid retraction. The medial wall can be accessed through transcaruncular approach. Careful exploration under the periosteum allows easy visualization of the fracture boundaries as well as correction of the herniated tissue.

Then various implants can be used to support the orbital soft tissue and prevent recurrent herniation. Porous polyethylene sheets (Medpor) are one of most commonly used implant materials. Other autogenous (cranial, rib or iliac bone graft) or alloplastic (gelatin film, silicone sheet, Teflon, Supramid, titanium mesh or bioresorbable copolymer plates) materials are also available.

Periocular fractures are often managed first by the ophthalmologist. With good clinical examination and radiographic imaging, an informed decision can be made whether surgical intervention is required.

3. Postoperative care:

Proper postoperative instructions will be given the patient, in addition to the postoperative medications including antibiotics, corticosteroids and analgesics.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 15, 2021
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

• Inclusion criteria:

• Age group: from 15 to 60 years old.

• Patients with blow-out fractures.

• Exclusion criteria:

• Patients suffering from dermatological diseases,

Related Conditions & MeSH terms

• Fractures, Bone
• Orbital Fractures

Intervention

Procedure:
• orbital fracture
using the trans-conjunctival approach alone in restoring the esthetics compared with using it along in addition to lateral canthotomy which is important in providing wider surgical area

Locations

Country	Name	City	State
Egypt	Alasr elany	Giza	Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Lee HB, Lee SH. New anthropometric data for preoperative planning in orbital wall fracture treatment: the use of eyelid drooping. Arch Craniofac Surg. 2018 Dec;19(4):248-253. doi: 10.7181/acfs.2018.02096. Epub 2018 Dec 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the esthetics	Visual analog scale numerical1-10	3 months
Secondary	Infection	Accent/present	3month