Orbital Complications of RhinosinusitisNCT06606873
Complicated Rhinosinusitis
An observational study of Orbital Complications of Rhinosinusitis, run by Assiut University at 1 site in Egypt.
Trial summary
Rhinosinusitis is among the most common conditions encountered in the primary care clinic. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orbital Complications of Rhinosinusitis
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 1 Jun 2027
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: OBSERVATIONAL Split-half case-comparison study.
Who may be able to join
- Patients with orbital complications of rhinosinusitis
Who cannot join
- 1- Previous maxillofacial trauma history. 2- Previous nasal or paranasal surgery. 3- Invasive fungal rhinosinusitis. 4- Cases with odontogenic rhinosinusitis. 5- Immotile cilia syndrome, cystic fibrosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Anatomical Risk Factors for Orbital Complications in Patients With Acute Rhinosinusitis
Rhinosinusitis is among the most common conditions encountered in the primary care clinic.
Read the detailed description
serious sequelae of ARS, including orbital and intracranial complications as Like Periorbital oedema and Displaced globe and Double vision and Ophthalmoplegia Reduced visual acuity
- Conditions
- Orbital Complications of Rhinosinusitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Orbital complications of rhinosinusitis
The presence of agger nasi cells (AGC), concha bullosa, Haller, Onodi or frontal recess cells, septal deviation, lower turbinate hypertrophy and hypoplasia or agenesis of the PNS
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Orbital Complications of RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Abd El_Atty Sayed Harb, Assiut University
- Investigators
- Mohamed Abdelaziz, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606873
- Sponsor's protocol ID
- Orbital complications of AR
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lucas JW, Schiller JS, Benson V. Summary health statistics for U.S. adults: National Health Interview Survey, 2001. Vital Health Stat 10. 2004 Jan;(218):1-134.
PubMed 15791758Mekhitarian Neto L, Pignatari S, Mitsuda S, Fava AS, Stamm A. Acute sinusitis in children: a retrospective study of orbital complications. Braz J Otorhinolaryngol. 2007 Jan-Feb;73(1):75-9. doi: 10.1016/s1808-8694(15)31126-5.
PubMed 17505603Sedaghat AR, Wilke CO, Cunningham MJ, Ishman SL. Socioeconomic disparities in the presentation of acute bacterial sinusitis complications in children. Laryngoscope. 2014 Jul;124(7):1700-6. doi: 10.1002/lary.24492. Epub 2013 Dec 11.
PubMed 24338779
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Risk Factors for Orbital Complications in Patients With Acute Rhinosinusitis
- ClinicalTrials.gov ID
- NCT06606873
- Acronym / sponsor ID
- Orbital complications of AR
- Conditions
- Orbital Complications of Rhinosinusitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 23 Sep 2024 (actual)
- 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.
Rhinosinusitis is among the most common conditions encountered in the primary care clinic.
Detailed description
serious sequelae of ARS, including orbital and intracranial complications as Like Periorbital oedema and Displaced globe and Double vision and Ophthalmoplegia Reduced visual acuity
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 36 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- OBSERVATIONAL Split-half case-comparison study.
Key inclusion criteria (1 listed)
- Patients with orbital complications of rhinosinusitis
Key exclusion criteria (1 listed)
- 1- Previous maxillofacial trauma history. 2- Previous nasal or paranasal surgery. 3- Invasive fungal rhinosinusitis. 4- Cases with odontogenic rhinosinusitis. 5- Immotile cilia syndrome, cystic fibrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Orbital complications of rhinosinusitis
Time frame: One year
The presence of agger nasi cells (AGC), concha bullosa, Haller, Onodi or frontal recess cells, septal deviation, lower turbinate hypertrophy and hypoplasia or agenesis of the PNS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Background: PubMed 15791758Lucas JW, Schiller JS, Benson V. Summary health statistics for U.S. adults: National Health Interview Survey, 2001. Vital Health Stat 10. 2004 Jan;(218):1-134.
- Results publication: PubMed 17505603Mekhitarian Neto L, Pignatari S, Mitsuda S, Fava AS, Stamm A. Acute sinusitis in children: a retrospective study of orbital complications. Braz J Otorhinolaryngol. 2007 Jan-Feb;73(1):75-9. doi: 10.1016/s1808-8694(15)31126-5.
- Results publication: PubMed 24338779Sedaghat AR, Wilke CO, Cunningham MJ, Ishman SL. Socioeconomic disparities in the presentation of acute bacterial sinusitis complications in children. Laryngoscope. 2014 Jul;124(7):1700-6. doi: 10.1002/lary.24492. Epub 2013 Dec 11.
- Individual participant dataSharing planned: Undecided
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.
Mohamed Abdelaziz, MD study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orbital Complications of Rhinosinusitis, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma AbdElAtty Harb (+20 1096397822, drfatmaharb225@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orbital complications of rhinosinusitis (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06606873, which also lists 3 linked publications.
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 23 Sep 2024.