Endoscopic polypectomy performed in clinic for chronic rhinosinusitis with nasal polyps: study protocol for the EPIC multicentre randomised controlled trial
| Autor: | Marc A. Tewfik, Dean Fergusson, Susan Adams, Kristian I. Macdonald, Hubert Frenette, Andrea Lasso, Damian Christopher Micomonaco, Arif Janjua, Kednapa Thavorn, John M. Lee, Shaun Kilty, Brian W. Rotenberg, Leigh J. Sowerby, Eric Meen |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment adult otolaryngology law.invention 03 medical and health sciences endoscopic surgery 0302 clinical medicine Nasal Polyps Quality of life Randomized controlled trial law Medicine Humans Multicenter Studies as Topic health economics Nasal polyps 030212 general & internal medicine Sinusitis 030223 otorhinolaryngology Randomized Controlled Trials as Topic Rhinitis Protocol (science) Ontario Research ethics Ear Nose and Throat/Otolaryngology Health economics business.industry Endoscopy General Medicine medicine.disease Polypectomy 3. Good health Treatment Outcome Emergency medicine Chronic Disease Quality of Life business Biomedical sciences |
| Zdroj: | BMJ Open, Vol 10, Iss 12 (2020) BMJ Open |
| ISSN: | 2044-6055 |
| Popis: | IntroductionChronic rhinosinusitis (CRS) is common, with a Canadian prevalence of 5%, and associated with significant morbidity. Understandably, CRS impairs workplace productivity but that productivity substantially increases following surgical treatment. CRS with nasal polyps (CRSwNP), the most common type of CRS, is usually treated with a combination of medications and endoscopic sinus surgery (ESS). Historically, surgical treatment has only been performed in the operating room at a cost of about $C3500. However, recent studies have shown that a de-escalated procedure, endoscopic polypectomy performed in clinic (EPIC), can provide an improvement in patient symptoms to levels equal to those for ESS. Moreover, EPIC has additional proposed advantages including shorter recovery time, significantly lower cost to the healthcare system and shorter wait time for the patient. There is currently insufficient evidence to draw conclusions about the superiority of polypectomy or ESS for the management of CRSwNP.Methods and analysisWe designed a multicentre, open-label, randomised controlled trial to evaluate whether EPIC was non-inferior to the current clinical standard, ESS for the treatment of CRSwNP. The primary outcome is the Sinonasal Outcome Test-22 score measured at baseline and at 3 months after surgery. Other outcomes include peak nasal inspiratory flow, quality of life measured by the EuroQoL 5 Dimensions 5 Levels questionnaire and work impairment using the Work Productivity and Activity Impairment Questionnaire.We aim to recruit 140 patients from sites across Canada. Participants will be randomly assigned to EPIC or ESS and followed up for 3 months in clinic after the procedure. Additionally, participants will enter a 5-year long-term follow-up period.Ethics and disseminationThis study was approved by the Ottawa Health Sciences Network Research Ethics Board for all sites in Ontario, Canada (study number CTO0801). Sites located outside of Ontario obtained approval from their local/institutional research ethics board.Trial registration numberNCT02975310. |
| Databáze: | OpenAIRE |
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