Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT02975310

In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps

Led by Ottawa Hospital Research Institute · Updated on 2025-12-30

140

Participants Needed

4

Research Sites

503 weeks

Total Duration

On this page

Sponsors

O

Ottawa Hospital Research Institute

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Chronic rhinosinusitis, also called chronic sinusitis, is a very common life-long disease affecting over 5% of the Canadian population. Its symptoms, including daily facial pain and headache, an inability to breath through the nose and complete smell loss, regularly impair one's ability to work and to enjoy and participate in daily activities. The annual cost of chronic sinusitis to Canada is estimated at $1.3 billion while the government pays an estimated $860 million yearly for chronic sinusitis treatment. Chronic sinusitis with polyps, the most common type of chronic sinusitis, is usually treated with a combination of medications and surgery. Until now, surgical treatment has only been performed in the operating room, at a cost of about $3500 per procedure. But, recent studies have shown that a new procedure, "in-clinic polyp removal", can provide an improvement in patient symptoms to levels equal to those for sinus surgery performed in a hospital operating room. Moreover, in clinic polyp removal has additional advantages including a shorter procedure recovery time, a significantly lower cost to the health care system (about one-tenth the cost or $450), and a shorter wait time for treatment. With the proposed pragmatic trial, the investigators will determine whether the in clinic polyp removal procedure is as good as sinus surgery in the operating room at controlling patient symptoms of chronic sinusitis. The investigators will also determine the cost and health-benefits for a patient, the healthcare system and for society of in clinic polyp removal in comparison to sinus surgery done in a hospital operating room. The investigators will then know if this new treatment, in clinic polyp removal, can replace sinus surgery as the standard of care for these patients.

CONDITIONS

Official Title

In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with chronic rhinosinusitis with polyps requiring surgery after medical therapy
  • Bilateral nasal polyps of Grade 65 2 on each side as measured by nasal endoscopy
  • Nasal blockage score of 2 or higher on the SNOT-22 test
  • American Society of Anesthesiologists physical status classification of PS3 or less
  • Stable asthma or COPD with no exacerbations in the past 3 months
  • Able and willing to provide informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Patients with hyperplastic polyps or polyps causing external nasal deformity
  • Facial pain/pressure score higher than 2 on the SNOT-22 test
  • History of surgery preventing accurate nasal polyp grading
  • Unable to complete follow-up appointments or evaluations
  • Significant oral structural abnormalities such as unrepaired cleft palate
  • Septal deviation requiring correction before EPIC or ESS procedures
  • Diagnosed immunodeficiency or immunocompromised state
  • Cystic fibrosis diagnosis
  • Allergic fungal sinusitis diagnosis
  • Contraindications to oral corticosteroids
  • History of Churg-Strauss syndrome, primary ciliary dyskinesia, or vasculitis
  • Allergy or contraindication to local or topical anesthetics or nasal medications
  • Serious or unstable diseases or psychiatric disorders interfering with participation
  • Recent history of drug or alcohol abuse interfering with participation
  • Inability to read and understand English
  • Any medical condition interfering with treatment
  • Unfit for surgery under general anesthesia
  • Current participation in another clinical trial
  • Unable to undergo an awake procedure
  • Diagnosis of Aspirin Exacerbated Respiratory Disease (AERD)

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Vancouver General Hospital

Vancouver, British Columbia, Canada

Actively Recruiting

2

St. Joseph's Hospital London

London, Ontario, Canada, N6A 4V2

Actively Recruiting

3

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada, K1Y 1J8

Actively Recruiting

4

McGill University Health Center

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

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Research Team

A

Andrea Lasso, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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