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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03813732
Recruitment Status : Unknown
Verified January 2019 by Nashwa Osama, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Nashwa Osama, Cairo University

Study Description
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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 Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

  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.

  3. Postoperative care:

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

  4. 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)
Primary Purpose: Treatment
Official Title: the Effect of Using the Tyransconjunctival Approach Alone Versus Using Transconjunctival Approach Together With Lateral Canthotomy in Orbital Fractures
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : January 15, 2020
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. Assessment of the esthetics [ Time Frame: 3 months ]
    Visual analog scale numerical1-10


Secondary Outcome Measures :
  1. Infection [ Time Frame: 3month ]
    Accent/present


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03813732


Contacts
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Contact: Khaled M Amr, Prof 01006029231 ext 231 Khaledamr82@hotmail..com
Contact: Nashwa M Osama 01006835113 ext 321 Nashwaosama@hotmail.com

Locations
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Egypt
Alasr elany
Giza, Manial, Egypt, 12112
Contact: Khaled M Amr, Prof    01006029231 ext 321    Khaledamr82@hotmail.com   
Contact: Nashwa M Osama    0100 6835113 ext M    Nashwaosama@hotmail.com   
Sponsors and Collaborators
Cairo University
More Information
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Publications of Results:

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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: January 23, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nashwa Osama, Cairo University:
trans-conjunctival approach
Additional relevant MeSH terms:
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Orbital Fractures
Fractures, Bone
Wounds and Injuries
Maxillofacial Injuries
Facial Injuries
 Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures