Clinical trial NCT04241016: Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis
Official title: A Randomised Controlled Study of Endoscopic Sinus Surgery for Recurrent Acute Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillary Sinusitis
Sinusitis, Acute
Sinusitis
Keywords: adult
endoscopic sinus surgery
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
First posted: 2020-01-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Sinonasal Outcome Test-22 score
timeFrame: 5-6 months
Secondary outcomes:
measure: 36-Item Short Form Survey (SF-36, RAND) score
timeFrame: 5-6 months
measure: Difference in proportions of patients benefiting
timeFrame: 5-6 months
measure: Difference in numbers of sinusitis episodes
timeFrame: 5-6 months
measure: Difference in numbers of medical visits
timeFrame: 5-6 months
measure: Difference in numbers of antimicrobial treatments
timeFrame: 5-6 months
measure: Difference in numbers of days lost from work or studies
timeFrame: 5-6 months
measure: Difference in numbers of days with nasal obstruction
timeFrame: 5-6 months
measure: Difference in numbers of days with nasal discharge
timeFrame: 5-6 months
measure: Difference in numbers of days with facial pain or pressure
timeFrame: 5-6 months
measure: Difference in numbers of days with nasal pain
timeFrame: 5-6 months
measure: Difference in numbers of days with nasal hemorrhage
timeFrame: 5-6 months
measure: Difference of numbers of days with fever
timeFrame: 5-6 months
measure: Adverse effects - postoperative synechia formation
timeFrame: 5-6 months
measure: Adverse effects - postoperative infection
timeFrame: 5-6 months
measure: Adverse effects - postoperative orbital complication
timeFrame: 5-6 months
measure: Adverse effects - postoperative intracranial complication
timeFrame: 5-6 months
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Oulu University Hospital
name: Olli-Pekka Alho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaski HM, Alakarppa A, Lantto U, Laajala A, Tokola P, Penna T, Ohtonen P, Alho OP. Endoscopic sinus surgery (ESS) to change quality of life for adults with recurrent rhinosinusitis: study protocol for a randomized controlled trial. Trials. 2021 Sep 8;22(1):606. doi: 10.1186/s13063-021-05576-z.