<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/NCT03011047</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2017-1-1</org_study_id>
    <nct_id>NCT03011047</nct_id>
  </id_info>
  <brief_title>Efficacy of Endoscopic Transantral Surgical Approach in the Repair of Orbital Blow-Out Fractures</brief_title>
  <official_title>Efficacy of Endoscopic Transantral Versus Transorbital Surgical Approaches in the Repair of Orbital Blow-Out Fractures-Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nahla Mahmoud Awad</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>
      Aim of this study is to assess the efficacy of endoscopic trans-maxillary surgical approach&#xD;
      versus traditional trans-orbital surgical approach (control group) in orbital blow out&#xD;
      fractures in terms of postoperative clinical and digital radio-graphical assessments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      (N.M) Operator, data entry &amp; corresponding author; Assistant lecturer , surgery department .&#xD;
&#xD;
      (I.E) Main supervisor, data monitoring &amp; auditing; Professor, surgery department.&#xD;
&#xD;
      (R.H) Co-supervisor, data entry &amp; auditing; Lecturer, surgery department . (AM) Assistant&#xD;
      lecturer, surgery department .Faculty of Oral &amp; Dental Medicine Cairo University outcome&#xD;
      assessors and data collection.&#xD;
&#xD;
      (YA) Assistant Lecturer of Surgery department , faculty of oral and dental medicine - Cairo&#xD;
      University , for baseline data collection, recruitment, sequence generation, allocation&#xD;
      concealment, patient retention and taking participants consents.&#xD;
&#xD;
      intervention:&#xD;
&#xD;
      Preoperative preparation:&#xD;
&#xD;
      Preoperative cone beam CT. A clearance from the ophthalmology department after examination of&#xD;
      papillary reflexes, motility restriction and measurement of the visual acuity.&#xD;
&#xD;
      Laboratory Investigations: blood picture, liver functions, kidneys functions,coagulation&#xD;
      profile Informed consent signed by the patient. (NM and RH) will perform all procedures under&#xD;
      general anesthesia . Intervention :Endoscopic trans-maxillary (through the maxillary sinus)&#xD;
      surgical approach.&#xD;
&#xD;
      control group: Traditional trans-orbital surgical approaches. follow up clinically and&#xD;
      radio-graphically for 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 18, 2017</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diplopia resolution using Forced duction test positive/negative</measure>
    <time_frame>6 months</time_frame>
    <description>subjective patient assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fracture reduction Digital radiography (Cone beam CT)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enophthalmus correction. Digital radiography (Cone beam CT)</measure>
    <time_frame>6 months</time_frame>
    <description>mm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">38</enrollment>
  <condition>Orbital Floor Fracture</condition>
  <arm_group>
    <arm_group_label>endoscopic trans-antral approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The maxillary sinus and prolapsed orbital contents will be visualized employing a 30-degree endoscope for the repair of orbital blow out fracture (sinus scope 4 mm, 30 degrees short one 17 cm).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>trans-orbital surgical approach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>trans-orbital surgical approach through the lower eyelid Sub-ciliary incision ( through the lower eyelid) The skin incision is made just below the eyelashes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>endoscopic trans-antral approach</intervention_name>
    <description>new surgical approach to repair the orbital floor fractures through the maxillary sinus</description>
    <arm_group_label>endoscopic trans-antral approach</arm_group_label>
    <other_name>trans-maxillary</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>trans-orbital surgical approach</intervention_name>
    <description>through the lower eyelid below the eyelashes ,then down to bone the herniated orbital content will be reduced through this incision traditional surgical approach to repair orbital floor fractures</description>
    <arm_group_label>trans-orbital surgical approach</arm_group_label>
    <other_name>sub-ciliary incision</other_name>
    <other_name>lower eyelid incision</other_name>
    <other_name>skin incision</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with unilateral/bilateral orbital blow out fractures.&#xD;
&#xD;
          2. Positive forced-duction test. ( to ensure the muscular entrapment).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Medical condition affecting bone healing.&#xD;
&#xD;
          2. Medically compromised conditions, not proper candidate for general anesthesia.&#xD;
&#xD;
          3. Tumor case encroaching on the orbital floor.&#xD;
&#xD;
          4. Pathological orbital blow out fractures.&#xD;
&#xD;
          5. Allergy/ metal hypersensitivity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed elkhadem, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>nahla mahmoud awad, master</last_name>
    <phone>01124439776</phone>
    <phone_ext>0230728662</phone_ext>
    <email>nahla.awad@dentistry.cu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>reem hossameldin, PHD</last_name>
    <phone>01006250787</phone>
    <email>reemhamdy@hotmail.com</email>
  </overall_contact_backup>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>July 19, 2017</last_update_submitted>
  <last_update_submitted_qc>July 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Nahla Mahmoud Awad</investigator_full_name>
    <investigator_title>Assistant lecturer , Oral and Maxillofacial surgery Department, Faculty of Oral &amp; Dental Medicine Cairo University</investigator_title>
  </responsible_party>
  <keyword>endoscopic, trans-antral, subciliary</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/NCT03011047
org study id: CEBD-CU-2017-1-1
nct id: NCT03011047
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Aim of this study is to assess the efficacy of endoscopic trans-maxillary surgical approach
      versus traditional trans-orbital surgical approach (control group) in orbital blow out
      fractures in terms of postoperative clinical and digital radio-graphical assessments.
(N.M) Operator, data entry & corresponding author; Assistant lecturer , surgery department .

      (I.E) Main supervisor, data monitoring & auditing; Professor, surgery department.

      (R.H) Co-supervisor, data entry & auditing; Lecturer, surgery department . (AM) Assistant
      lecturer, surgery department .Faculty of Oral & Dental Medicine Cairo University outcome
      assessors and data collection.

      (YA) Assistant Lecturer of Surgery department , faculty of oral and dental medicine - Cairo
      University , for baseline data collection, recruitment, sequence generation, allocation
      concealment, patient retention and taking participants consents.

      intervention:

      Preoperative preparation:

      Preoperative cone beam CT. A clearance from the ophthalmology department after examination of
      papillary reflexes, motility restriction and measurement of the visual acuity.

      Laboratory Investigations: blood picture, liver functions, kidneys functions,coagulation
      profile Informed consent signed by the patient. (NM and RH) will perform all procedures under
      general anesthesia . Intervention :Endoscopic trans-maxillary (through the maxillary sinus)
      surgical approach.

      control group: Traditional trans-orbital surgical approaches. follow up clinically and
      radio-graphically for 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Diplopia resolution using Forced duction test positive/negative
time frame: 6 months
description: subjective patient assessment
measure: Fracture reduction Digital radiography (Cone beam CT)
time frame: 6 months
measure: Enophthalmus correction. Digital radiography (Cone beam CT)
time frame: 6 months
description: mm
arm group label: endoscopic trans-antral approach
arm group type: Experimental
description: The maxillary sinus and prolapsed orbital contents will be visualized employing a 30-degree endoscope for the repair of orbital blow out fracture (sinus scope 4 mm, 30 degrees short one 17 cm).
arm group label: trans-orbital surgical approach
arm group type: Active Comparator
description: trans-orbital surgical approach through the lower eyelid Sub-ciliary incision ( through the lower eyelid) The skin incision is made just below the eyelashes.
intervention type: Procedure
intervention name: endoscopic trans-antral approach
description: new surgical approach to repair the orbital floor fractures through the maxillary sinus
arm group label: endoscopic trans-antral approach
other name: trans-maxillary
intervention type: Procedure
intervention name: trans-orbital surgical approach
description: through the lower eyelid below the eyelashes ,then down to bone the herniated orbital content will be reduced through this incision traditional surgical approach to repair orbital floor fractures
arm group label: trans-orbital surgical approach
other name: sub-ciliary incision
other name: lower eyelid incision
other name: skin incision
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmed elkhadem, PHD
role: Study Chair
affiliation: Cairo University
last name: nahla mahmoud awad, master
phone: 01124439776
phone ext: 0230728662
email: nahla.awad@dentistry.cu.edu.eg
last name: reem hossameldin, PHD
phone: 01006250787
email: reemhamdy@hotmail.com
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Nahla Mahmoud Awad
investigator title: Assistant lecturer , Oral and Maxillofacial surgery Department, Faculty of Oral & Dental Medicine Cairo University
mesh term: Orbital Fractures
mesh term: Fractures, Bone
sharing ipd: Undecided