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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.