About this trial
Chronic rhinosinusitis, also called chronic sinusitis, is a very common life-long disease affecting over 5% of the Canadian population. Its symptoms, including daily facial pain and headache, an inability to breath through the nose and complete smell loss, regularly impair one's ability to work and to enjoy and participate in daily activities. The annual cost of chronic sinusitis to Canada is estimated at $1.3 billion while the government pays an estimated $860 million yearly for chronic sinusitis treatment. Chronic sinusitis with polyps, the most common type of chronic sinusitis, is usually treated with a combination of medications and surgery. Until now, surgical treatment has only been performed in the operating room, at a cost of about $3500 per procedure. But, recent studies have shown that a new procedure, "in-clinic polyp removal", can provide an improvement in patient symptoms to levels equal to those for sinus surgery performed in a hospital operating room. Moreover, in clinic polyp removal has additional advantages including a shorter procedure recovery time, a significantly lower cost to the health care system (about one-tenth the cost or $450), and a shorter wait time for treatment. With the proposed pragmatic trial, the investigators will determine whether the in clinic polyp removal procedure is as good as sinus surgery in the operating room at controlling patient symptoms of chronic sinusitis. The investigators will also determine the cost and health-benefits for a patient, the healthcare system and for society of in clinic polyp removal in comparison to sinus surgery done in a hospital operating room. The investigators will then know if this new treatment, in clinic polyp removal, can replace sinus surgery as the standard of care for these patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Diagnosis of chronic rhinosinusitis with polyps requiring surgical treatment after having been treated with medical therapy as designated by the Canadian clinical practice guidelines for acute and chronic sinusitis. 15
Bilateral nasal polyps present of Grade ≥ 2 on each side as determined by the Lildholdt scale score measured by nasal endoscopy at the screening visit.
Must have nasal blockage score greater than or equal to 2 on the sinonasal outcome test SNOT-22 at the screening visit.
Disqualifiers
Women who are pregnant or breast feeding as per patient's report
Patients with hyperplastic polyps or polyps large enough that they result in external nasal deformity
Facial pain/pressure score higher than 2 on the sinonasal outcome test SNOT-22 at the screening visit.
History of any surgical procedure that prevents the ability to accurately grade the nasal polyps
Trial design
Parallel
Treatments tested in this trial
Endoscopic polypectomy in clinic (EPIC)
Procedure/SurgeryThe experimental intervention is endoscopic polypectomy performed in clinic (EPIC) where nasal polyps are removed using a microdebrider under local and topical anesthesia in the outpatient clinic.
Endoscopic Sinus Surgery (ESS)
Procedure/SurgeryThe control intervention is endoscopic sinus surgery (ESS), a minimally invasive procedure that is the current standard that involves polypectomy with a microdebrider as well as sinus ostia enlargement of the affected sinuses performed in the operating room under general anesthesia.
General Anesthesia
Other interventionESS will be performed under general anesthesia in the operating room
Local and topical anesthesia
Other interventionEPIC will be performed under topical and local anesthesia in a clinic setting
Treatment groups
Trial outcomes
Primary outcomes
Sinonasal Outcome Test-22 (SNOT-22)
Secondary outcomes
Peak Nasal Inspiratory Flow (PNIF):
Iowa Satisfaction with Anesthesia Scale (ISAS)
Patient satisfaction with anesthesia for the treatment procedure
Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP)
Work Impairment related to chronic rhinosinusitis
EQ-5D-5L
Quality of Life
Other outcomes
Lund-Kennedy Endoscopic Scoring Scale
Endoscopic inflammation of the nose and paranasal sinuses after treatment
Visual Analogue Scale (VAS) for satisfaction with assigned procedure
Satisfaction with assigned procedure
Sponsors and contacts
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Ottawa Hospital Research Institute
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Medtronic
Collaborator