Endoscopic sinus surgery for recurrent acute rhinosinusitis
A Randomised Controlled Study of Endoscopic Sinus Surgery for Recurrent Acute Rhinosinusitis
This study is testing if endoscopic sinus surgery can help people with recurring sinus infections feel better and improve their quality of life compared to just medical treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oulu University Hospital Academic / other |
| Locations | 2 sites (Oulu and 1 other locations) |
| Trial ID | NCT04241016 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of endoscopic sinus surgery in improving the quality of life for patients suffering from recurrent acute rhinosinusitis. Participants will be randomly assigned to either an intervention group receiving the surgery along with medical treatment or a control group receiving only medical treatment. The primary outcome will be measured using the SNOT-22 quality of life questionnaire, with follow-ups occurring 5 to 6 months after the intervention. Additional data will be collected on sinusitis episodes, medical appointments, medication use, and any adverse events related to the surgery.
Who should consider this trial
Good fit: Ideal candidates are adults who have experienced multiple episodes of acute sinusitis and have not responded to conservative medical treatments.
Not a fit: Patients with chronic rhinosinusitis or those with conditions that prevent same-day surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the quality of life for patients with recurrent acute rhinosinusitis.
How similar studies have performed: Previous studies have shown that surgical interventions for sinusitis can lead to improved patient outcomes, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Oulu and 1 other locations
- Oulu University Hospital — Oulu, Finland (Recruiting)
- Tampere University Hospital — Tampere, Finland (Recruiting)
Study contacts
- Principal investigator: Olli-Pekka Alho, MD, PhD — Oulu University Hospital
- Study coordinator: Heidi M Kaski, MD
- Email: heidi.kaski@student.oulu.fi
- Phone: +385442730022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.