Endoscopic sinus surgery in adult patients with chronic rhinosinusitis with nasal polyps (PolypESS): study protocol for a randomised controlled trial

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.

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Chronic rhinosinusitis in adult patients with cystic fibrosis: clinical manifestation and therapeutic approaches

Russian Pulmonology ◽

10.18093/0869-0189-2019-29-3-311-320 ◽

2019 ◽

Vol 29 (3) ◽

pp. 311-320

Author(s):

G. L. Shumkova ◽

E. L. Amelina ◽

V. M. Svistushkin ◽

E. V. Sin’kov ◽

S. A. Krasovskiy ◽

...

Keyword(s):

Cystic Fibrosis ◽

Surgical Treatment ◽

Treatment Group ◽

Chronic Rhinosinusitis ◽

Paranasal Sinuses ◽

Endoscopic Sinus Surgery ◽

Nasal Polyps ◽

Adult Patients ◽

Sinus Surgery ◽

Markers Of Inflammation

The aim of this study was to evaluate prevalence of chronic rhinosinusitis (CRS) and nasal polyps in adult patients with cystic fibrosis (CF) in Russian Federation. Additionally, we investigated the clinical course of CRS and developed the optimal therapeutic strategy.Methods. Three hundred and forty eight CF patients were involved in the study. Physical examination, computed tomography (CT) of paranasal sinuses and audiometry, if needed, were used. CRS and bilateral nasal polyps were diagnosed in 28 patients. Nasal endoscopy, SNOT-20 questionnaire, rhinomanometry, micro - biological examination of sputum and mucus from paranasal sinuses (obtained during puncture or surgery), spirometry, and measurement of serum markers of inflammation were used. Endoscopic sinus surgery was used in 14 patients (the group 1) and others were treated non-surgically (the group 2). Both group were treated during 6 months using intranasal mometasone, mucolytics and antibiotics via PARI SINUSTM nebulizer.Results. An improvement in symptoms, CT signs, rhinomanometry parameters and endoscopic signs was seen in both groups after treatment and was more prominent in the surgical treatment group compared to the non-surgical treatment group. Bacterial load reduction in nasal sinuses, decrease in the rate of pulmonary disease exacerbations, and an improvement in oxygen blood saturation were found in the surgical treatment group only. Treatment of CRS did not affect lung function, sputum microbiology and serum inflammatory markers.Conclusion. Endoscopic sinus surgery followed by intranasal mucolytics and antibacterials is an effective and well-tolerated treatment in adult CF patients with CRS.

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