Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis

Last updated: May 30, 2023
Sponsor: Oulu University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sinusitis

Sinus Infections

Treatment

Endoscopic sinus surgery (ESS)

Clinical Study ID

NCT04241016
01234
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 3 acute sinusitis episodes during previous 6 months or 4 acute sinusitisepisodes during previous 12 months or at least 2 episodes per year for 3 consecutiveyears
  • Episodes must last less than 4 weeks and be diagnosed and treated as acuterhinosinusitis by a physician
  • Episode symptoms include nasal discharge, nasal congestion, hyposmia and facialpressure or pain and the episodes have to be severe enough for the patient to seekmedical help and for daily life to be significantly disturbed
  • Patients must have failed a three-month conservative therapy (medication for possibleallergies, nasal corticosteroids and douching and courses of antibiotics as necessary)

Exclusion

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 CBCTscanning

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Endoscopic sinus surgery (ESS)
Phase:
Study Start date:
May 01, 2020
Estimated Completion Date:
May 30, 2025

Study 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.

Connect with a study center

  • Oulu University Hospital

    Oulu,
    Finland

    Active - Recruiting

  • Tampere University Hospital

    Tampere,
    Finland

    Active - Recruiting

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