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

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03813732

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orbital Fractures	Procedure: orbital fracture	N/A

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.

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,

Interventions:
Pre-operative phase:

Patients will be subjected to:

Case history including personal data, medical, surgical and family history.
Clinical examination.
Preoperative anesthesia assessment for fitness for general anesthesia.
Treatment planning.
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.

Postoperative care:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pre-operative phase: Patients will be subjected to: Case history including personal data, medical, surgical and family history. Clinical examination. Preoperative anesthesia assessment for fitness for general anesthesia. Treatment planning. Operative phase: All cases will undergo surgery under general anesthesia. Postoperative care: Proper postoperative instructions will be given the patient, in addition to the postoperative medications including antibiotics, corticosteroids and analgesics. Postoperative evaluation and follow-up: 12) Outcomes: outcome Method of measurement Measuring unit Primary outcome Assessment of the esthetics. Visual analog scale Numerical Secondary outcome pain Visual analog scale Numerical (1-10)Pre-operative phase:Patients will be subjected to:Case history including personal data, medical, surgical and family history. Clinical examination. Preoperative anesthesia assessment for fitness for general anesthesia. Treatment planning.Operative phase:All cases will undergo surgery under general anesthesia.Postoperative care:Proper postoperative instructions will be given the patient, in addition to the postoperative medications including antibiotics, corticosteroids and analgesics.Postoperative evaluation and follow-up:Outcomes: outcome Method of measurement Measuring unit Primary outcome Assessment of the esthetics. Visual analog scale Numerical Secondary outcome pain Visual analog scale Numerical (1-10)

Masking:

None (Open Label)

Masking Description:

Outcomes: outcome Method of measurement Measuring unit Primary outcome Assessment of the esthetics. Visual analog scale Numerical Secondary outcome pain Visual analog scale Numerical (1-10)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 15, 2019

Anticipated Primary Completion Date :

Jan 15, 2020

Anticipated Study Completion Date :

Jan 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: orbital fracture using the trans-conjunctival approach with lateral canthotomy	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

Arm

Intervention/Treatment

Other: orbital fracture

using the trans-conjunctival approach with lateral canthotomy

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

Outcome Measures

Primary Outcome Measures

Assessment of the esthetics [3 months]
Visual analog scale numerical1-10

Secondary Outcome Measures

Infection [3month]
Accent/present

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria:
Age group: from 15 to 60 years old.
Patients with blow-out fractures.
Exclusion criteria:
Patients suffering from dermatological diseases,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alasr elany	Giza	Manial	Egypt	12112

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nashwa Osama, assistant researcher in national research centre, Cairo University

ClinicalTrials.gov Identifier:

NCT03813732

Other Study ID Numbers:

CEBD-CU-2019-01-03

First Posted:

Jan 23, 2019

Last Update Posted:

Jan 23, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nashwa Osama, assistant researcher in national research centre, Cairo University

trans-conjunctival approach

Additional relevant MeSH terms:

Orbital Fractures

Fractures, Bone

Study Results

No Results Posted as of Jan 23, 2019