Dataset Information

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

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.

SUBMITTER: Kilty S

PROVIDER: S-EPMC7713191 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Kilty Shaun S Thavorn Kednapa K Janjua Arif A Lee John J MacDonald Kristian K Meen Eric E Micomonaco Damian D Rotenberg Brian B Sowerby Leigh J LJ Tewfik Marc M Adams Susan S Frenette Hubert H Lasso Andrea A Fergusson Dean A DA

BMJ open 20201202 12

<h4>Introduction</h4>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 c ...[more]

PMID: 33268434

Similar Datasets

Project description:BackgroundChronic rhinosinusitis (CRS) is a common source of ill health; 11% of UK adults reported CRS symptoms in a worldwide population study. Guidelines are conflicting regarding whether antibiotics should be included in primary medical management, reflecting the lack of evidence in systematic reviews. Insufficient evidence to inform the role of surgery contributes to a fivefold variation in UK intervention rates. The objective of this trial is to establish the comparative effectiveness of endoscopic sinus surgery (ESS) or a prolonged course of antibiotics (clarithromycin) in adult patients with CRS in terms of symptomatic improvement and costs to the National Health Service compared with standard medical care (intranasal medication) at 6 months.Methods/designA three-arm parallel-group trial will be conducted with patients who remain symptomatic after receiving appropriate medical therapy (either in primary or secondary care). They will be randomised to receive: (1) intranasal medication plus ESS, (2) intranasal medication plus clarithromycin (250 mg) or (3) intranasal medication plus a placebo. Intranasal medication (current standard medical care) is defined as a spray or drops of intranasal corticosteroids and saline irrigations. The primary outcome measure is the SNOT-22 questionnaire, which assesses disease-specific health-related quality of life. The study sample size is 600. Principal analyses will be according to the randomised groups irrespective of compliance. The trial will be conducted in at least 16 secondary or tertiary care centres with an internal pilot at six sites for 6 months.DiscussionThe potential cardiovascular side effects of macrolide antibiotics have been recently highlighted. The effectiveness of antibiotics will be established through this trial, which may help to reduce unnecessary usage and potential morbidity. If ESS is shown to be clinically effective and cost-effective, the trial may encourage earlier intervention. In contrast, if it is shown to be ineffective, then there should be a significant reduction in surgery rates. The trial results will feed into the other components of the MACRO research programme to establish best practice for the management of adults with CRS and design the ideal patient pathway across primary and secondary care.Trial registrationISRCTN36962030 . Registered on 17 October 2018.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure