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

doi:10.1136/bmjopen-2020-042413

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.

Authors

Shaun Kilty^{1

2}, Kednapa Thavorn^{3

4

5}, Arif Janjua⁶, John Lee⁷, Kristian MacDonald⁸, Eric Meen⁹, Damian Micomonaco¹⁰, Brian Rotenberg¹¹, Leigh J Sowerby¹¹, Marc Tewfik¹², Susan Adams¹³, Hubert Frenette¹³, Andrea Lasso³, Dean A Fergusson^{3

5

14}

Affiliations

¹ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada skilty@toh.ca.
² Department of Otolaryngology- Head & Neck Surgery, University of Ottawa, Ottawa, Ontario, Canada.
³ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
⁴ ICES uOttawa, Institute for Clinical Evaluative Sciences, Ottawa, Ontario, Canada.
⁵ School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
⁶ Department of Surgery, Division of Otolaryngology-Head and Neck Surgery, The University of British Columbia, Vancouver, British Columbia, Canada.
⁷ Department of Otolaryngology-Head and Neck Surgery, Saint Michael's Hospital, Toronto, Ontario, Canada.
⁸ Department of Surgery, Dalhousie University, Halifax, Nova Scotia, Canada.
⁹ Department of Otolaryngology, University of Manitoba, Winnipeg, Manitoba, Canada.
¹⁰ Department of Clinical Sciences, Northern Ontario School of Medicine, Thunder Bay, Ontario, Canada.
¹¹ Department of Otolaryngology - Head and Neck Surgery, Western University, London, Ontario, Canada.
¹² Department of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, Quebec, Canada.
¹³ Patient Representative, Ottawa, Ontario, Canada.
¹⁴ Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.

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.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Chronic Disease
Endoscopy
Humans
Multicenter Studies as Topic
Nasal Polyps* / complications
Nasal Polyps* / surgery
Ontario
Quality of Life
Randomized Controlled Trials as Topic
Rhinitis* / surgery
Sinusitis* / surgery
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT02975310

Grants and funding

PJT148734/CAPMC/ CIHR/Canada