Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis

Oulu University Hospital

Status: Enrolling

Conditions: Maxillary Sinusitis; Sinusitis, Acute; Sinusitis

Treatments: Procedure: Endoscopic sinus surgery (ESS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04241016

01234

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Endoscopic sinus surgery (ESS)

Active Comparator group

Description:

Endoscopic sinus surgery. Postoperative treatment consists of daily nasal douching, daily nasal steroid sprays, pain medication when necessary and at least one postoperative control visit including endoscopy two weeks after the operation. Additionally medical treatment including nasal corticosteroids, nasal douching and other allergy medication as necessary.

Treatment:

Procedure: Endoscopic sinus surgery (ESS)

Control

No Intervention group

Description:

Conservative treatment including nasal corticosteroids, nasal douching and other allergy medication as necessary.