Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis

Oulu University Hospital80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Maxillary Sinusitis Sinusitis, Acute Sinusitis

Interventions

Endoscopic sinus surgery (ESS)PROCEDURE

Uncinectomy, middle meatal antrostomy by enlarging the natural maxillary ostium and partial ethmoidectomy or septoplasty according to clinical evaluation of the operator.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Oulu University Hospital

Oulu, Finland

RECRUITING

Tampere University Hospital

Tampere, Finland

RECRUITING

Outcomes

Primary Outcomes

Sinonasal Outcome Test-22 score

Difference between the mean disease-specific Sinonasal Outcome Test 22 (SNOT-22) change scores (from baseline to 5-6 months) of ESS and control group. SNOT-22 summary scores vary between 0 and 110 with higher values indicating poorer quality of life.

Time frame: 5-6 months

Secondary Outcomes

36-Item Short Form Survey (SF-36, RAND) score

Difference between the mean generic RAND-36 domains change scores (from baseline to 5-6 months) of ESS and control group. RAND-36 instrument produces eight individual values between 0 and 100 (one for each domain), with higher scores indicating better quality of life.

Time frame: 5-6 months

Difference in proportions of patients benefiting

Difference in proportions of patients benefiting clinically significantly from the treatment in ESS and control group (Minimum important change in SNOT-22 score)

Time frame: 5-6 months

Difference in numbers of sinusitis episodes

Difference in the numbers of sinusitis episodes between the ESS and control groups.

Time frame: 5-6 months

Difference in numbers of medical visits

Difference in the numbers of medical visits between the ESS and control groups.

Time frame: 5-6 months

Difference in numbers of antimicrobial treatments

Difference in the numbers of antimicrobial treatments between the ESS and control groups.

Time frame: 5-6 months

Difference in numbers of days lost from work or studies

Central Contacts

Heidi M Kaski, MD

CONTACT

+385442730022 heidi.kaski@student.oulu.fi

Data from ClinicalTrials.gov

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