Orbital Floor FractureNCT03011047
Efficacy of Endoscopic Transantral Surgical Approach in the Repair of Orbital Blow-Out Fractures
A study testing endoscopic trans-antral approach and trans-orbital surgical approach in people with Orbital Floor Fracture, run by Nahla Mahmoud Awad.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Orbital Floor Fracture
- What is being tested?
- endoscopic trans-antral approach and trans-orbital surgical approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 18 Aug 2017to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with unilateral/bilateral orbital blow out fractures.
- Positive forced-duction test. ( to ensure the muscular entrapment).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Endoscopic Transantral Versus Transorbital Surgical Approaches in the Repair of Orbital Blow-Out Fractures-Randomized Clinical Trial.
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.
Read the 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.
- Conditions
- Orbital Floor Fracture
- Being tested
- endoscopic trans-antral approach, trans-orbital surgical approach
- Keywords
- endoscopic, trans-antral, subciliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic trans-antral approachProcedure or surgery
Also called trans-maxillary
new surgical approach to repair the orbital floor fractures through the maxillary sinus
trans-orbital surgical approachProcedure or surgery
Also called sub-ciliary incision, lower eyelid incision, skin incision
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
| Study group | Role | What they receive |
|---|---|---|
| endoscopic trans-antral approach | Experimental | 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). Receives: Procedure: endoscopic trans-antral approach |
| trans-orbital surgical approach | Active comparator | trans-orbital surgical approach through the lower eyelid Sub-ciliary incision ( through the lower eyelid) The skin incision is made just below the eyelashes. Receives: Procedure: trans-orbital surgical approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diplopia resolution using Forced duction test positive/negative
subjective patient assessment
Measured: 6 months
Secondary outcomes (2)
Fracture reduction Digital radiography (Cone beam CT)
Measured: 6 months
Enophthalmus correction. Digital radiography (Cone beam CT)
mm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start18 Aug 2017 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital Floor FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nahla Mahmoud Awad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nahla Mahmoud Awad, Cairo University
- Investigators
- Ahmed elkhadem, PHD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011047
- Sponsor's protocol ID
- CEBD-CU-2017-1-1
- Status last verified
- Jul 2017
- First submitted
- 4 Jan 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Endoscopic Transantral Versus Transorbital Surgical Approaches in the Repair of Orbital Blow-Out Fractures-Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03011047
- Acronym / sponsor ID
- CEBD-CU-2017-1-1
- Conditions
- Orbital Floor Fracture
- Keywords
- endoscopic, trans-antral, subciliary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Nahla Mahmoud AwadUniversity, hospital or other
- Study start
- 18 Aug 2017 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endoscopic trans-antral approach | Experimental | Procedure: endoscopic trans-antral approachThe 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 | Active comparator | Procedure: trans-orbital surgical approachtrans-orbital surgical approach through the lower eyelid Sub-ciliary incision ( through the lower eyelid) The skin incision is made just below the eyelashes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with unilateral/bilateral orbital blow out fractures.
- Positive forced-duction test. ( to ensure the muscular entrapment).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic trans-antral approachAlso: trans-maxillarynew surgical approach to repair the orbital floor fractures through the maxillary sinus | Procedure or surgery | endoscopic trans-antral approach |
| trans-orbital surgical approachAlso: sub-ciliary incision, lower eyelid incision, skin incisionthrough 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 | Procedure or surgery | trans-orbital surgical approach |
Primary outcome
Diplopia resolution using Forced duction test positive/negative
Time frame: 6 months
subjective patient assessment
2 secondary outcomes
Fracture reduction Digital radiography (Cone beam CT)
Time frame: 6 months
Enophthalmus correction. Digital radiography (Cone beam CT)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Orbital Floor Fracture
Not yet recruiting
A Trial to Evaluate Two Ectropion Preventive Measures Using the Subciliary Approach in Orbital Fracture Surgery.
Orbital Fractures, Orbital Floor Fractures
Active, not recruiting
Endoscopically Assisted Management of Maxillofacial Fractures: A Prospective Study on Efficacy and Outcomes
Maxillofacial Injuries, Maxillofacial Trauma
Enrolling by invitationObservational study
Multi-Institutional IMPACT Validation
Facial Injuries, Mandible Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed elkhadem, PHD study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic trans-antral approach and trans-orbital surgical approach in people with Orbital Floor Fracture, run by Nahla Mahmoud Awad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nahla mahmoud awad, master (01124439776 ext. 0230728662, nahla.awad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diplopia resolution using Forced duction test positive/negative (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.