Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis

STATUS

Recruiting
days left to enroll

30
participants needed

80
sponsor

Oulu University Hospital

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Updated on 19 February 2024

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antibiotic

corticosteroids

antibiotics

antibiotic therapy

rhinorrhea

nasal congestion

congestion

sinusitis

rhinosinusitis

sinus surgery

acute sinusitis

hyposmia

acute rhinosinusitis

Summary

Show definitions

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.

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.

Details

Condition	Maxillary Sinusitis, Sinusitis, Upper respiratory infection, Sinusitis, Acute
Age	18years - 100years
Treatment	Endoscopic sinus surgery (ESS)
Clinical Study Identifier	NCT04241016
Sponsor	Oulu University Hospital
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	At least 3 acute sinusitis episodes during previous 6 months or 4 acute sinusitis episodes during previous 12 months
	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 4 in paranasal sinus CBCT scanning

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Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis