Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis (NCT04241016) | Clinical Trial Compass
UnknownNot Applicable
Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis
Finland80 participantsStarted 2020-05-01
Plain-language summary
The aim of this study is to find out if endoscopic sinus surgery improves the quality of life in patients suffering from recurrent acute rhinosinusitis. Our main outcome is the difference between the average change in disease-specific SNOT-22 quality of life questionnaire scores (from baseline to 5-6 months follow-up) between the intervention and the control groups.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 3 acute sinusitis episodes during previous 6 months or 4 acute sinusitis episodes during previous 12 months or at least 2 episodes per year for 3 consecutive years
* Episodes must last less than 4 weeks and be diagnosed and treated as acute rhinosinusitis by a physician
* Episode symptoms include nasal discharge, nasal congestion, hyposmia and facial pressure or pain and the episodes have to be severe enough for the patient to seek medical help and for daily life to be significantly disturbed
* Patients must have failed a three-month conservative therapy (medication for possible allergies, nasal corticosteroids and douching and courses of antibiotics as necessary)
Exclusion Criteria:
* Age under 18 years,
* Immunodeficiency or immunosuppression
* Pregnancy,
* Previous illness making same-day surgery unfeasible
* Ongoing antibiotic treatment for other reasons,
* Primary complaint of nasal septal deviation and
* Chronic rhinosinusitis with or without nasal polyposis
* Symptoms for over 12 weeks and/or Lund-Mackay score over 8 in paranasal sinus CBCT scanning