Endoscopic polypectomy performed in clinic for chronic rhinosinusitis with nasal polyps: study protocol for the EPIC multicentre randomised controlled trial

Shaun Kilty, Kednapa Thavorn, Arif Janjua, John Lee, Kristian MacDonald, Eric Meen, Damian Micomonaco, Brian Rotenberg, Leigh J Sowerby, Marc Tewfik, Susan Adams, Hubert Frenette, Andrea Lasso, Dean A Fergusson, Shaun Kilty, Kednapa Thavorn, Arif Janjua, John Lee, Kristian MacDonald, Eric Meen, Damian Micomonaco, Brian Rotenberg, Leigh J Sowerby, Marc Tewfik, Susan Adams, Hubert Frenette, Andrea Lasso, Dean A Fergusson

Abstract

Introduction: Chronic 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 analysis: We 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 dissemination: This 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 number: NCT02975310.

Keywords: adult otolaryngology; endoscopic surgery; health economics.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

References

    1. Chen Y, Dales R, Lin M. The epidemiology of chronic rhinosinusitis in Canadians. Laryngoscope 2003;113:1199–205. 10.1097/00005537-200307000-00016
    1. Kilty SJ, McDonald JT, Johnson S, et al. . Socioeconomic status: a disease modifier of chronic rhinosinusitis? Rhinology 2011;49:533–7. 10.4193/Rhino10.298
    1. Gliklich RE, Metson R. The health impact of chronic sinusitis in patients seeking otolaryngologic care. Otolaryngol Head Neck Surg 1995;113:104–9. 10.1016/S0194-5998(95)70152-4
    1. Macdonald KI, McNally JD, Massoud E. The health and resource utilization of Canadians with chronic rhinosinusitis. Laryngoscope 2009;119:184–9. 10.1002/lary.20034
    1. Soler ZM, Wittenberg E, Schlosser RJ, et al. . Health state utility values in patients undergoing endoscopic sinus surgery. Laryngoscope 2011;121:2672–8. 10.1002/lary.21847
    1. Stankiewicz J, Tami T, Truitt T, et al. . Impact of chronic rhinosinusitis on work productivity through one-year follow-up after balloon dilation of the ethmoid infundibulum. Int Forum Allergy Rhinol 2011;1:38–45. 10.1002/alr.20008
    1. Stankiewicz J, Truitt T, Atkins J, et al. . Two-Year results: transantral balloon dilation of the ethmoid infundibulum. Int Forum Allergy Rhinol 2012;2:199–206. 10.1002/alr.21024
    1. Rudmik L, Smith TL, Schlosser RJ, et al. . Productivity costs in patients with refractory chronic rhinosinusitis. Laryngoscope 2014;124:2007–12. 10.1002/lary.24630
    1. Sharma R, Lakhani R, Rimmer J, et al. . Surgical interventions for chronic rhinosinusitis with nasal polyps. Cochrane Database Syst Rev 2014;11:CD006990.
    1. Au J, Rudmik L. Cost of outpatient endoscopic sinus surgery from the perspective of the Canadian government: a time-driven activity-based costing approach. Int Forum Allergy Rhinol 2013;3:748–54. 10.1002/alr.21181
    1. Hopkins C, Slack R, Lund V, et al. . Long-Term outcomes from the English national comparative audit of surgery for nasal polyposis and chronic rhinosinusitis. Laryngoscope 2009;119:2459–65. 10.1002/lary.20653
    1. Caulley L, Thavorn K, Rudmik L, et al. . Direct costs of adult chronic rhinosinusitis by using 4 methods of estimation: results of the US medical expenditure panel survey. J Allergy Clin Immunol 2015;136:1517–22. 10.1016/j.jaci.2015.08.037
    1. Tan BK, Kern RC, Schleimer RP, et al. . Chronic rhinosinusitis: the unrecognized epidemic. Am J Respir Crit Care Med 2013;188:1275–7. 10.1164/rccm.201308-1500ED
    1. Kilty SJ. In-clinic endoscopic polypectomy for chronic rhinosinusitis with polyps: a treatment strategy pilot study in ten adults. Clin Otolaryngol 2015;40:281–4. 10.1111/coa.12372
    1. Kilty SJ, Lasso A, Mfuna-Endam L, et al. . Case-Control study of endoscopic polypectomy in clinic (EPIC) versus endoscopic sinus surgery for chronic rhinosinusitis with polyps. Rhinology 2018;56:155–7. 10.4193/Rhin17.115
    1. Caulley L, Lasso A, Rudmik L, et al. . Pre-Treatment SNOT-22 score predicts response to endoscopic polypectomy in clinic (EPIC) our experience in 30 adults. Clin Otolaryngol 2017;42:732–4. 10.1111/coa.12623
    1. Kumar S, Thavorn K, van Katwyk S, et al. . Cost-Effectiveness of endoscopic polypectomy in clinic compared to endoscopic sinus surgery: a modelling study. Clin Otolaryngol 2020;45:477–85. 10.1111/coa.13533
    1. OMoHaL-T C Ontario wait times, 2010.
    1. Gan EC, Habib A-RR, Rajwani A, et al. . Five-degree, 10-degree, and 20-degree reverse Trendelenburg position during functional endoscopic sinus surgery: a double-blind randomized controlled trial. Int Forum Allergy Rhinol 2014;4:61–8. 10.1002/alr.21249
    1. Wright ED, Agrawal S. Impact of perioperative systemic steroids on surgical outcomes in patients with chronic rhinosinusitis with polyposis: evaluation with the novel perioperative sinus endoscopy (pose) scoring system. Laryngoscope 2007;117:1–28. 10.1097/MLG.0b013e31814842f8
    1. Poetker DM, Jakubowski LA, Lal D, et al. . Oral corticosteroids in the management of adult chronic rhinosinusitis with and without nasal polyps: an evidence-based review with recommendations. Int Forum Allergy Rhinol 2013;3:104–20. 10.1002/alr.21072
    1. Desrosiers M, Evans GA, Keith PK, et al. . Canadian clinical practice guidelines for acute and chronic rhinosinusitis. J Otolaryngol Head Neck Surg 2011;40 Suppl 2:S99–193.
    1. Côté DWJ, Wright E. Objectiveoutcomes in endoscopic sinus surgery : Advances in endoscopic surgery. InTech, 2011.
    1. (ASA) ASoA Asa physical status classification system, 2014. Available: [Accessed Oct 2014].
    1. Dexter F, Candiotti KA. Multicenter assessment of the Iowa satisfaction with anesthesia scale, an instrument that measures patient satisfaction with monitored anesthesia care. Anesth Analg 2011;113:364–8. 10.1213/ANE.0b013e318217f804
    1. Dexter F, Aker J, Wright WA. Development of a measure of patient satisfaction with monitored anesthesia care: the Iowa satisfaction with anesthesia scale. Anesthesiology 1997;87:865–73. 10.1097/00000542-199710000-00021
    1. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 1993;4:353–65. 10.2165/00019053-199304050-00006
    1. EuroQol Group EuroQol--a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199–208. 10.1016/0168-8510(90)90421-9
    1. Hopkins C, Gillett S, Slack R, et al. . Psychometric validity of the 22-item sinonasal outcome test. Clin Otolaryngol 2009;34:447–54. 10.1111/j.1749-4486.2009.01995.x
    1. Lachin JM. Introduction to sample size determination and power analysis for clinical trials. Control Clin Trials 1981;2:93–113. 10.1016/0197-2456(81)90001-5
    1. Hopkins C, Browne JP, Slack R, et al. . The National comparative audit of surgery for nasal polyposis and chronic rhinosinusitis. Clin Otolaryngol 2006;31:390–8. 10.1111/j.1749-4486.2006.01275.x
    1. Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ 2005;14:487–96. 10.1002/hec.944
    1. Hoch JS, Briggs AH, Willan AR, et al. . Something blue: a framework for the marriage of health econometrics and cost-effectiveness analysis. Health Econ 2002;11:415–30.

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