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Efficacy of Endoscopic Transantral Surgical Approach in the Repair of Orbital Blow-Out Fractures

Primary Purpose

Orbital Floor Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
endoscopic trans-antral approach
trans-orbital surgical approach
Sponsored by
Nahla Mahmoud Awad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orbital Floor Fracture focused on measuring endoscopic, trans-antral, subciliary

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients with unilateral/bilateral orbital blow out fractures.
  2. Positive forced-duction test. ( to ensure the muscular entrapment).

Exclusion Criteria:

  1. Medical condition affecting bone healing.
  2. Medically compromised conditions, not proper candidate for general anesthesia.
  3. Tumor case encroaching on the orbital floor.
  4. Pathological orbital blow out fractures.
  5. Allergy/ metal hypersensitivity.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    endoscopic trans-antral approach

    trans-orbital surgical approach

    Arm 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).

    trans-orbital surgical approach through the lower eyelid Sub-ciliary incision ( through the lower eyelid) The skin incision is made just below the eyelashes.

    Outcomes

    Primary Outcome Measures

    Diplopia resolution using Forced duction test positive/negative
    subjective patient assessment

    Secondary Outcome Measures

    Fracture reduction Digital radiography (Cone beam CT)
    Enophthalmus correction. Digital radiography (Cone beam CT)
    mm

    Full Information

    First Posted
    January 4, 2017
    Last Updated
    July 19, 2017
    Sponsor
    Nahla Mahmoud Awad
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03011047
    Brief Title
    Efficacy of Endoscopic Transantral Surgical Approach in the Repair of Orbital Blow-Out Fractures
    Official Title
    Efficacy of Endoscopic Transantral Versus Transorbital Surgical Approaches in the Repair of Orbital Blow-Out Fractures-Randomized Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 18, 2017 (Anticipated)
    Primary Completion Date
    July 2018 (Anticipated)
    Study Completion Date
    September 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Nahla Mahmoud Awad

    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
    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.
    Detailed Description
    (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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Orbital Floor Fracture
    Keywords
    endoscopic, trans-antral, subciliary

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    38 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    endoscopic trans-antral approach
    Arm Type
    Experimental
    Arm 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 Title
    trans-orbital surgical approach
    Arm Type
    Active Comparator
    Arm 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(s)
    endoscopic trans-antral approach
    Other Intervention Name(s)
    trans-maxillary
    Intervention Description
    new surgical approach to repair the orbital floor fractures through the maxillary sinus
    Intervention Type
    Procedure
    Intervention Name(s)
    trans-orbital surgical approach
    Other Intervention Name(s)
    sub-ciliary incision, lower eyelid incision, skin incision
    Intervention 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
    Primary Outcome Measure Information:
    Title
    Diplopia resolution using Forced duction test positive/negative
    Description
    subjective patient assessment
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Fracture reduction Digital radiography (Cone beam CT)
    Time Frame
    6 months
    Title
    Enophthalmus correction. Digital radiography (Cone beam CT)
    Description
    mm
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with unilateral/bilateral orbital blow out fractures. Positive forced-duction test. ( to ensure the muscular entrapment). Exclusion Criteria: Medical condition affecting bone healing. Medically compromised conditions, not proper candidate for general anesthesia. Tumor case encroaching on the orbital floor. Pathological orbital blow out fractures. Allergy/ metal hypersensitivity.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    nahla mahmoud awad, master
    Phone
    01124439776
    Ext
    0230728662
    Email
    nahla.awad@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    reem hossameldin, PHD
    Phone
    01006250787
    Email
    reemhamdy@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed elkhadem, PHD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Efficacy of Endoscopic Transantral Surgical Approach in the Repair of Orbital Blow-Out Fractures

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