Using the Transconjuctival Approach Alone Versus Using it Together With Lateral Canthotomy in Orbital Fractures
Primary Purpose
Orbital Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
orbital fracture
Sponsored by
About this trial
This is an interventional treatment trial for Orbital Fractures focused on measuring trans-conjunctival approach
Eligibility Criteria
- Inclusion criteria:
- Age group: from 15 to 60 years old.
- Patients with blow-out fractures.
Exclusion criteria:
- Patients suffering from dermatological diseases,
Sites / Locations
- Alasr elany
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
orbital fracture
Arm Description
using the trans-conjunctival approach with lateral canthotomy
Outcomes
Primary Outcome Measures
Assessment of the esthetics
Visual analog scale numerical1-10
Secondary Outcome Measures
Infection
Accent/present
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03813732
Brief Title
Using the Transconjuctival Approach Alone Versus Using it Together With Lateral Canthotomy in Orbital Fractures
Official Title
the Effect of Using the Tyransconjunctival Approach Alone Versus Using Transconjunctival Approach Together With Lateral Canthotomy in Orbital Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Anticipated)
Primary Completion Date
January 15, 2020 (Anticipated)
Study Completion Date
January 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orbital Fractures
Keywords
trans-conjunctival approach
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
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)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
orbital fracture
Arm Type
Other
Arm Description
using the trans-conjunctival approach with lateral canthotomy
Intervention Type
Procedure
Intervention Name(s)
orbital fracture
Intervention Description
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
Primary Outcome Measure Information:
Title
Assessment of the esthetics
Description
Visual analog scale numerical1-10
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Infection
Description
Accent/present
Time Frame
3month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Age group: from 15 to 60 years old.
Patients with blow-out fractures.
Exclusion criteria:
Patients suffering from dermatological diseases,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled M Amr, Prof
Phone
01006029231
Ext
231
Email
Khaledamr82@hotmail..com
First Name & Middle Initial & Last Name or Official Title & Degree
Nashwa M Osama
Phone
01006835113
Ext
321
Email
Nashwaosama@hotmail.com
Facility Information:
Facility Name
Alasr elany
City
Giza
State/Province
Manial
ZIP/Postal Code
12112
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khaled M Amr, Prof
Phone
01006029231
Ext
321
Email
Khaledamr82@hotmail.com
First Name & Middle Initial & Last Name & Degree
Nashwa M Osama
Phone
0100 6835113
Ext
M
Email
Nashwaosama@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30613085
Citation
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.
Results Reference
result
Learn more about this trial
Using the Transconjuctival Approach Alone Versus Using it Together With Lateral Canthotomy in Orbital Fractures
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