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

NCT ID: NCT03813732

Last Updated: 2019-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2021-01-15

Brief 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.

Detailed 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.

Conditions

Orbital Fractures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

orbital fracture

using the trans-conjunctival approach with lateral canthotomy

Group Type: OTHER

orbital fracture

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age group: from 15 to 60 years old.
• Patients with blow-out fractures.

Exclusion Criteria

• Patients suffering from dermatological diseases,

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nashwa Osama

assistant researcher in national research centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alasr elany

Giza, Manial, Egypt

Countries

Egypt

Central Contacts

Khaled M Amr, Prof

Role: CONTACT

Khaledamr82@hotmail..com

01006029231 ext. 231

Nashwa M Osama

Role: CONTACT

Nashwaosama@hotmail.com

01006835113 ext. 321

Facility Contacts

Khaled M Amr, Prof

Role: primary

Khaledamr82@hotmail.com

01006029231 ext. 321

Nashwa M Osama

Role: backup

Nashwaosama@hotmail.com

0100 6835113 ext. M

References

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.

Reference Type: RESULT

PMID: 30613085 (View on PubMed)

Other Identifiers

CEBD-CU-2019-01-03

Identifier Type: -

Identifier Source: org_study_id