Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis

  • STATUS
    Recruiting
  • End date
    May 30, 2025
  • participants needed
    80
  • sponsor
    Oulu University Hospital
Updated on 25 February 2022
antibiotic therapy
antibiotics
congestion
rhinosinusitis
nasal congestion
rhinorrhea
acute sinusitis
sinusitis
sinus surgery
hyposmia
acute rhinosinusitis

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.

Description

This is a randomized controlled trial. Patients suffering from recurrent acute sinusitis episodes will be randomly allocated to two groups: intervention group, where they will receive endoscopic sinus surgery in addition to medical treatment and control group, where they will receive mere medical treatment. Both groups will be followed-up for 5 to 6 months. At baseline and after 5 to 6 months, patients will answer the life quality questionnaires SNOT-22 and RAND 36-item Health Survey. The numbers of sinusitis episodes, medical appointments for respiratory symptoms, use of medications, numbers of days lost from work or studies and numbers of days with various respiratory and adverse symptoms will be recorded with patient diaries. The potential serious adverse events (e.g. cerebrospinal fluid leak, orbital complications) related to surgery will be collected from the medical records.

Details
Condition Maxillary Sinusitis, Sinusitis, Acute, Sinusitis
Treatment Endoscopic Sinus Surgery (ESS)
Clinical Study IdentifierNCT04241016
SponsorOulu University Hospital
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

At least 3 acute sinusitis episodes during previous 6 months or 4 acute sinusitis episodes during previous 12 months
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 4 in paranasal sinus CBCT scanning
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