Clinical trial NCT04617223: Results of Endoscopic Sinus Surgery in Management of Ophthalmological Complications of Chronic Rhino Sinusitis
Official title: Results of Endoscopic Sinus Surgery in Management of Ophthalmological Complications of Chronic Rhino Sinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Sinusitis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 64
Sex: ALL
Minimum age (years): 1
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigate the clinical features of orbital complications of sinusitis in the Egyptian population, and observed that certain ophthalmological manifestations and outcomes were significantly associated with disease stage

Detailed description: Retrospectively review of the medical records of all patients with orbital complications of paranasal sinusitis hospitalized at the ORL-HNS department at the University of Tanta between 2010 and 2020. Sex, age, symptoms, history, ophthalmological findings, laboratory and imaging findings, treatments, and outcomes were analyzed by staging.

The data that will be retrieved from the medical records including:

1. History taking including personal present and previous medical history.
2. General examination
3. Oto-rhinolaryngological clinical examination
4. Routine preoperative laboratory investigations (e.g. complete total and differential blood count, blood sugar, coagulation profile, and renal and liver function)
5. Diagnostic nasal Endoscopy with zero and/or a 30-degree telescope.
6. CT paranasal sinuses with contrast, fine cuts in coronal axial, and sagittal planes.
7. The type of intervention whether medical or surgical. 8- Culture results, treatments, hospital stay durations, and outcomes.

Ophthalmology data collection:

1. Visual acuity (onset of decrease) (unilateral or bilateral) ant its improvement after sinus surgery
2. Presence or absence of double vision (Diplopia)
3. Ocular motility and if its associated with pain
4. Proptosis (present or absent) and calculate the degree and direction
5. Ptosis (present or absent)
6. Pupil reactivity
7. Fundus examination to exclude optic nerve neuropathy
8. Association between ocular pain and headache and its improvement after surgery
9. CT data collection (CT orbit, MRI of sinus and head)
10. Fundus photography after surgery to see improvement of optic nerve neuropathy if present

Eligibility criteria: Inclusion Criteria:

* Patient presented with preseptal/orbital inflammation secondary to acute (\<1 month), subacute (1±3 months), or chronic sinusitis (\>3 months) of bacterial, fungal or unidentified pathogens

Exclusion Criteria:

* Patients with chronic rhinosinusitis without orbital complication, Systemic diseases that affect the paranasal sinuses and the orbit e.g autoimmune diseases, lymphoma, leukaemia, Sinus or orbital malignancy, Data is missed from the charts

Primary outcomes:
measure: observe improvement of ophthalmological manifestation after surgical intervention
timeFrame: 1 month
measure: Improvement of the degree of proptosis after surgery
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: El-Garbeia
Study officials:
References:
citation: Hastan D, Fokkens WJ, Bachert C, Newson RB, Bislimovska J, Bockelbrink A, Bousquet PJ, Brozek G, Bruno A, Dahlen SE, Forsberg B, Gunnbjornsdottir M, Kasper L, Kramer U, Kowalski ML, Lange B, Lundback B, Salagean E, Todo-Bom A, Tomassen P, Toskala E, van Drunen CM, Bousquet J, Zuberbier T, Jarvis D, Burney P. Chronic rhinosinusitis in Europe--an underestimated disease. A GA(2)LEN study. Allergy. 2011 Sep;66(9):1216-23. doi: 10.1111/j.1398-9995.2011.02646.x. Epub 2011 May 24.
citation: Shi JB, Fu QL, Zhang H, Cheng L, Wang YJ, Zhu DD, Lv W, Liu SX, Li PZ, Ou CQ, Xu G. Epidemiology of chronic rhinosinusitis: results from a cross-sectional survey in seven Chinese cities. Allergy. 2015 May;70(5):533-9. doi: 10.1111/all.12577. Epub 2015 Mar 4.
citation: Chang YS, Chen PL, Hung JH, Chen HY, Lai CC, Ou CY, Chang CM, Wang CK, Cheng HC, Tseng SH. Orbital complications of paranasal sinusitis in Taiwan, 1988 through 2015: Acute ophthalmological manifestations, diagnosis, and management. PLoS One. 2017 Oct 3;12(10):e0184477. doi: 10.1371/journal.pone.0184477. eCollection 2017.