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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Medtronic | INDUSTRY |
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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.
Chronic rhinosinusitis (CRS) is common, with a Canadian prevalence of 5%, and associated with significant morbidity having a health state utility value equivalent to end-stage renal disease. Understandably, CRS impairs workplace productivity but that productivity substantially increases following surgical treatment.
However, the wait time to receive surgical treatment (ESS) maybe up to 8 months or longer, with a cost to the Government of $3500/ESS procedure. The annual direct cost of CRS is estimated at $860 million with an overall financial impact of 1.3 billion dollars per year for Canada. Endoscopic polypectomy in clinic (EPIC), a potential disruptive innovation, is a drastically deescalated form of ESS performed in clinic instead of the operating room. EPIC appears to provide quality of life (QofL) improvement equivalent to that reported for ESS. EPIC has a shorter wait time and lower cost to a government, i.e. nearly one-tenth of ESS or about $450. A pilot economic evaluation study demonstrated that EPIC was cost-effective compared to ESS. This has created a controversy about which treatment should be employed for these patients. Further, a recent Cochrane review identified the need for high-quality randomised controlled trials to determine if ESS has additional benefit over polypectomy as there is currently insufficient evidence to draw conclusions about the superiority of polypectomy or ESS for the management of CRS with polyps.
The proposed national multicenter randomised controlled trial will determine whether EPIC is non-inferior to the current treatment standard, ESS, in QofL improvement for patients with CRS with polyps. It will also assess the cost-effectiveness of performing EPIC in place of ESS. The investigators hypothesize that EPIC will be non-inferior to ESS for QofL improvement while reducing health care cost. This would imply that EPIC is a dominant strategy and that the ESS strategy represents over-treatment in this patient population. The study findings would position EPIC into the current CRS treatment paradigm thereby transforming care and reducing costs both nationally and internationally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic polypectomy in clinic (EPIC) | Experimental | Patients assigned to this arm of the study will undergo the In Clinic Polypectomy Performed in Clinic |
|
| Endoscopic Sinus Surgery (ESS) | Active Comparator | Patients assigned to this arm will undergo endoscopic sinus surgery (ESS), |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic polypectomy in clinic (EPIC) | Procedure | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sinonasal Outcome Test-22 (SNOT-22) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Nasal Inspiratory Flow (PNIF): | 3 months | |
| Iowa Satisfaction with Anesthesia Scale (ISAS) | Patient satisfaction with anesthesia for the treatment procedure | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lund-Kennedy Endoscopic Scoring Scale | Endoscopic inflammation of the nose and paranasal sinuses after treatment | 3 months |
| Visual Analogue Scale (VAS) for satisfaction with assigned procedure | Satisfaction with assigned procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Lasso, MSc | Contact | 6137985555 | 10222 | alasso@toh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Shaun Kilty, MD | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Recruiting | Vancouver | British Columbia | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33268434 | Derived | Kilty S, Thavorn K, Janjua A, Lee J, MacDonald K, Meen E, Micomonaco D, Rotenberg B, Sowerby LJ, Tewfik M, Adams S, Frenette H, Lasso A, Fergusson DA. Endoscopic polypectomy performed in clinic for chronic rhinosinusitis with nasal polyps: study protocol for the EPIC multicentre randomised controlled trial. BMJ Open. 2020 Dec 2;10(12):e042413. doi: 10.1136/bmjopen-2020-042413. |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| ID | Term |
|---|---|
| D000554 | Ambulatory Care Facilities |
| D000768 | Anesthesia, General |
| D000758 | Anesthesia |
| ID | Term |
|---|---|
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |
| D000760 | Anesthesia and Analgesia |
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| Endoscopic Sinus Surgery (ESS) | Procedure | The 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 | ESS will be performed under general anesthesia in the operating room |
|
| Local and topical anesthesia | Other | EPIC will be performed under topical and local anesthesia in a clinic setting |
|
| Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) | Work Impairment related to chronic rhinosinusitis | 3 months |
| EQ-5D-5L | Quality of Life | 3 months |
| Participant Health Resource Consumption Survey | Individual Health Resource Consumption | 3 months |
| Adverse Events | 3 months |
| 3 months |
| St. Joseph's Hospital London | Recruiting | London | Ontario | N6A 4V2 | Canada |
|
| Ottawa Hospital Research Institute | Recruiting | Ottawa | Ontario | K1Y 1J8 | Canada |
|
| McGill University Health Center | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
|
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |