<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03813732</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2019-01-03</org_study_id>
    <nct_id>NCT03813732</nct_id>
  </id_info>
  <brief_title>Using the Transconjuctival Approach Alone Versus Using it Together With Lateral Canthotomy in Orbital Fractures</brief_title>
  <official_title>the Effect of Using the Tyransconjunctival Approach Alone Versus Using Transconjunctival Approach Together With Lateral Canthotomy in Orbital Fractures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      All cases will undergo surgery under general anesthesia. Evaluation of patients with&#xD;
      suspected orbital fracture should involve radiologic examination, motility test, diplopia&#xD;
      field test and exophthalmometry. Plain X-ray films, although rarely used, with the Caldwell&#xD;
      and Waters view may be done as a screening evaluation for possible fractures and foreign&#xD;
      bodies. An orbital computed tomography, the gold standard in trauma, CT with contiguous thin&#xD;
      axial and coronal sections should be ordered to confirm the diagnosis and plan for treatment&#xD;
&#xD;
      Postoperative care:&#xD;
&#xD;
      Proper postoperative instructions will be given the patient, in addition to the postoperative&#xD;
      medications including antibiotics, corticosteroids and analgesics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be carried out on patients attending the outpatient clinic in Oral and&#xD;
      Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University.&#xD;
&#xD;
      10. Eligibility criteria:&#xD;
&#xD;
        -  Inclusion criteria:&#xD;
&#xD;
        -  Age group: from 15 to 60 years old.&#xD;
&#xD;
        -  Patients with pure blow-out fractures.&#xD;
&#xD;
        -  Exclusion criteria:&#xD;
&#xD;
             -  Patients suffering from dermatological diseases,&#xD;
&#xD;
                11. Interventions:&#xD;
&#xD;
                  1. Pre-operative phase:&#xD;
&#xD;
                     Patients will be subjected to:&#xD;
&#xD;
                       1. Case history including personal data, medical, surgical and family&#xD;
                          history.&#xD;
&#xD;
                       2. Clinical examination.&#xD;
&#xD;
                       3. Preoperative anesthesia assessment for fitness for general anesthesia.&#xD;
&#xD;
                       4. Treatment planning.&#xD;
&#xD;
                  2. Operative phase:&#xD;
&#xD;
                     All cases will undergo surgery under general anesthesia. The inferior wall can&#xD;
                     be easily accessed through transcutaneous or transconjunctival approach (with&#xD;
                     or without lateral canthotomy). The latter avoids a visible scar and is less&#xD;
                     likely to result in eyelid retraction. The medial wall can be accessed through&#xD;
                     transcaruncular approach. Careful exploration under the periosteum allows easy&#xD;
                     visualization of the fracture boundaries as well as correction of the&#xD;
                     herniated tissue.&#xD;
&#xD;
                     Then various implants can be used to support the orbital soft tissue and&#xD;
                     prevent recurrent herniation. Porous polyethylene sheets (Medpor) are one of&#xD;
                     most commonly used implant materials. Other autogenous (cranial, rib or iliac&#xD;
                     bone graft) or alloplastic (gelatin film, silicone sheet, Teflon, Supramid,&#xD;
                     titanium mesh or bioresorbable copolymer plates) materials are also available.&#xD;
&#xD;
                     Periocular fractures are often managed first by the ophthalmologist. With good&#xD;
                     clinical examination and radiographic imaging, an informed decision can be&#xD;
                     made whether surgical intervention is required.&#xD;
&#xD;
                  3. Postoperative care:&#xD;
&#xD;
      Proper postoperative instructions will be given the patient, in addition to the postoperative&#xD;
      medications including antibiotics, corticosteroids and analgesics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 15, 2019</start_date>
  <completion_date type="Anticipated">January 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Pre-operative phase:&#xD;
Patients will be subjected to:&#xD;
Case history including personal data, medical, surgical and family history.&#xD;
Clinical examination.&#xD;
Preoperative anesthesia assessment for fitness for general anesthesia.&#xD;
Treatment planning.&#xD;
Operative phase:&#xD;
All cases will undergo surgery under general anesthesia.&#xD;
Postoperative care:&#xD;
Proper postoperative instructions will be given the patient, in addition to the postoperative medications including antibiotics, corticosteroids and analgesics.&#xD;
Postoperative evaluation and follow-up:&#xD;
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)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Outcomes:&#xD;
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_description>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of the esthetics</measure>
    <time_frame>3 months</time_frame>
    <description>Visual analog scale numerical1-10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infection</measure>
    <time_frame>3month</time_frame>
    <description>Accent/present</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Orbital Fractures</condition>
  <arm_group>
    <arm_group_label>orbital fracture</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>using the trans-conjunctival approach with lateral canthotomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>orbital fracture</intervention_name>
    <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</description>
    <arm_group_label>orbital fracture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  Inclusion criteria:&#xD;
&#xD;
          -  Age group: from 15 to 60 years old.&#xD;
&#xD;
          -  Patients with blow-out fractures.&#xD;
&#xD;
          -  Exclusion criteria:&#xD;
&#xD;
               -  Patients suffering from dermatological diseases,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Khaled M Amr, Prof</last_name>
    <phone>01006029231</phone>
    <phone_ext>231</phone_ext>
    <email>Khaledamr82@hotmail..com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nashwa M Osama</last_name>
    <phone>01006835113</phone>
    <phone_ext>321</phone_ext>
    <email>Nashwaosama@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Alasr elany</name>
      <address>
        <city>Giza</city>
        <state>Manial</state>
        <zip>12112</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Khaled M Amr, Prof</last_name>
      <phone>01006029231</phone>
      <phone_ext>321</phone_ext>
      <email>Khaledamr82@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Nashwa M Osama</last_name>
      <phone>0100 6835113</phone>
      <phone_ext>M</phone_ext>
      <email>Nashwaosama@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>30613085</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Nashwa Osama</investigator_full_name>
    <investigator_title>assistant researcher in national research centre</investigator_title>
  </responsible_party>
  <keyword>trans-conjunctival approach</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Orbital Fractures</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03813732
org study id: CEBD-CU-2019-01-03
nct id: NCT03813732
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
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)
primary purpose: Treatment
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)
measure: Assessment of the esthetics
time frame: 3 months
description: Visual analog scale numerical1-10
measure: Infection
time frame: 3month
description: Accent/present
arm group label: orbital fracture
arm group type: Other
description: using the trans-conjunctival approach with lateral canthotomy
intervention type: Procedure
intervention name: orbital fracture
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
arm group label: orbital fracture
criteria: 
gender: All
minimum age: 15 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Khaled M Amr, Prof
phone: 01006029231
phone ext: 231
email: Khaledamr82@hotmail..com
last name: Nashwa M Osama
phone: 01006835113
phone ext: 321
email: Nashwaosama@hotmail.com
facility: 
contact: 
contact backup: 
country: Egypt
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.
PMID: 30613085
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Nashwa Osama
investigator title: assistant researcher in national research centre
mesh term: Orbital Fractures
mesh term: Fractures, Bone
sharing ipd: Undecided