Recruiting

Endoscopic Polypectomy

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT02975310

Conditions

Sinusitis

Nasal Polyps

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endoscopic polypectomy in clinic (EPIC)

Endoscopic Sinus Surgery (ESS)

General Anesthesia

Local and topical anesthesia

Study Details

Brief summary:

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

Sinusitis

Nasal Polyps

Study ID

NCT02975310

Start date

Apr 11, 2017

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18 years or older
2. Diagnosis of chronic rhinosinusitis with polyps requiring surgical treatment after having been treated with medical therapy as designated by the Canadian clinical practice guidelines for acute and chronic sinusitis. 15
3. Bilateral nasal polyps present of Grade ≥ 2 on each side as determined by the Lildholdt scale score measured by nasal endoscopy at the screening visit.
4. Must have nasal blockage score greater than or equal to 2 on the sinonasal outcome test SNOT-22 at the screening visit.
5. Must have an American Society of Anesthesiologists physical status PS3 classification or less.
6. Participants with comorbid asthma or chronic obstructive pulmonary disease (COPD) must have stable disease with no exacerbations (no emergency room visits, hospitalisations, or oral or parental steroid use for these lower respiratory conditions) within 3 months before the screening visit.
7. Must be capable, in the opinion of the investigator, of providing informed consent to participate in the study. Participants must sign an informed consent document indicating that they understand the purpose of and procedures of the study and are willing to participate in the study.

Exclusion Criteria:

1. Women who are pregnant or breast feeding as per patient's report
2. Patients with hyperplastic polyps or polyps large enough that they result in external nasal deformity
3. Facial pain/pressure score higher than 2 on the sinonasal outcome test SNOT-22 at the screening visit.
4. History of any surgical procedure that prevents the ability to accurately grade the nasal polyps
5. Participants who will not be able to complete the follow-up appointments/evaluations
6. Have significant oral structural abnormalities, e.g. unrepaired cleft palate
7. Septal deviation requiring correction in order to perform either EPIC or ESS procedures
8. Diagnosis of an immunodeficiency or immunocompromised state
9. Diagnosis of cystic fibrosis
10. Diagnosis of allergic fungal sinusitis
11. Contraindication to the use of oral corticosteroids (e.g. uncontrolled diabetes, congestive heart failure, uncontrolled hypertension, known renal insufficiency, known peptic ulcer disease, known glaucoma, pregnancy)
12. History of either Churg-Strauss syndrome, primary ciliary dyskinesia, or vasculitis (e.g. granulomatosis with polyangiitis(GPA))
13. Allergy, hypersensitivity, or contraindication to the use of local or topical lidocaine anesthetics, nasal topical 1:1000 adrenaline, nasal decongestants, nasal steroid spray
14. Any serious or unstable concurrent disease, psychiatric disorder, or any significant condition that, in the opinion of the investigator, could confound the results of the study or could interfere with the participant's participation or compliance with the study
15. A recent (within 1 year of the screening visit) clinically significant history of drug or alcohol abuse, or dependence that, in the opinion of the investigator could interfere with the participant's participation or compliance with the study
16. Inability to read and understand English
17. Any medical condition that in the opinion of the investigator would interfere with the treatment
18. Any participant who is unfit to undergo surgery under general anesthesia
19. Current participation in another clinical trial at the time of the screening visit.
20. Participant is unable to undergo an awake procedure
21. Diagnosis or Aspirin Exacerbated Respiratory Disease (AERD)

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Endoscopic polypectomy in clinic (EPIC)

Patients assigned to this arm of the study will undergo the In Clinic Polypectomy Performed in Clinic

active comparator: Endoscopic Sinus Surgery (ESS)

Patients assigned to this arm will undergo endoscopic sinus surgery (ESS),

Interventions

Endoscopic polypectomy in clinic (EPIC)

The experimental intervention is endoscopic polypectomy performed in clinic (EPIC) where nasal polyps are removed using a microdebrider under local and topical anesthesia in the outpatient clinic.

Endoscopic Sinus Surgery (ESS)

The control intervention is endoscopic sinus surgery (ESS), a minimally invasive procedure that is the current standard that involves polypectomy with a microdebrider as well as sinus ostia enlargement of the affected sinuses performed in the operating room under general anesthesia.

General Anesthesia

ESS will be performed under general anesthesia in the operating room

Local and topical anesthesia

EPIC will be performed under topical and local anesthesia in a clinic setting

Primary outcome measure

  • Sinonasal Outcome Test-22 (SNOT-22) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Andrea Lasso, MSc

6137985555alasso@toh.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada

Contacts

St. Joseph's Hospital London

Recruiting

London, Ontario, Canada, N6A 4V2

Contacts

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 1J8

Contacts

McGill University Health Center

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2025-12-30.