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Results of Endoscopic Sinus Surgery in Management of Ophthalmological Complications of Chronic Rhino Sinusitis

T

Tanta University

Status

Completed

Conditions

Chronic Sinusitis

Treatments

Procedure: Endoscopic sinus evacuation

Study type

Interventional

Funder types

Other

Identifiers

NCT04617223
34062/8/20

Details and patient eligibility

About

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

Full 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

Enrollment

64 patients

Sex

All

Ages

1 month to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

64 participants in 1 patient group

Treatment
Other group
Treatment:
Procedure: Endoscopic sinus evacuation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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