Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis

  • STATUS
    Recruiting
  • End date
    May 30, 2025
  • participants needed
    80
  • sponsor
    Oulu University Hospital
Updated on 19 February 2024
antibiotic
corticosteroids
antibiotics
antibiotic therapy
rhinorrhea
nasal congestion
congestion
sinusitis
rhinosinusitis
sinus surgery
acute sinusitis
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, Upper respiratory infection, Sinusitis, Acute
Age 18years - 100years
Treatment Endoscopic sinus surgery (ESS)
Clinical Study IdentifierNCT04241016
SponsorOulu University Hospital
Last Modified on19 February 2024

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study AnnotationsStudy Notes

Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.