In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps

NCT02975310 | Recruiting DMC

• 1 other identifier: CTO-0801
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Sinonasal Outcome Test-22 (SNOT-22)

  3 months

Secondary Outcomes (6)

• Peak Nasal Inspiratory Flow (PNIF):

  3 months

• Iowa Satisfaction with Anesthesia Scale (ISAS)

  3 months

• Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP)

  3 months

• EQ-5D-5L

  3 months

• Participant Health Resource Consumption Survey

  3 months

Other Outcomes (2)

• Lund-Kennedy Endoscopic Scoring Scale

  3 months

• Visual Analogue Scale (VAS) for satisfaction with assigned procedure

  3 months

Study Arms (2)

Endoscopic polypectomy in clinic (EPIC)

EXPERIMENTAL

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

Procedure: Endoscopic polypectomy in clinic (EPIC); Other: Local and topical anesthesia

Endoscopic Sinus Surgery (ESS)

ACTIVE COMPARATOR

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

Procedure: Endoscopic Sinus Surgery (ESS); Other: General Anesthesia

Interventions

Endoscopic Sinus Surgery (ESS) PROCEDURE

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.

Endoscopic Sinus Surgery (ESS)

Endoscopic polypectomy in clinic (EPIC) PROCEDURE

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 polypectomy in clinic (EPIC)

General Anesthesia OTHER

ESS will be performed under general anesthesia in the operating room

Endoscopic Sinus Surgery (ESS)

Local and topical anesthesia OTHER

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

Endoscopic polypectomy in clinic (EPIC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• 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
• 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.
• Must have nasal blockage score greater than or equal to 2 on the sinonasal outcome test SNOT-22 at the screening visit.
• Must have an American Society of Anesthesiologists physical status PS3 classification or less.
• 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.
• 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.

You may not qualify if:

• Women who are pregnant or breast feeding as per patient's report
• Patients with hyperplastic polyps or polyps large enough that they result in external nasal deformity
• Facial pain/pressure score higher than 2 on the sinonasal outcome test SNOT-22 at the screening visit.
• History of any surgical procedure that prevents the ability to accurately grade the nasal polyps
• Participants who will not be able to complete the follow-up appointments/evaluations
• Have significant oral structural abnormalities, e.g. unrepaired cleft palate
• Septal deviation requiring correction in order to perform either EPIC or ESS procedures
• Diagnosis of an immunodeficiency or immunocompromised state
• Diagnosis of cystic fibrosis
• Diagnosis of allergic fungal sinusitis
• 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)
• History of either Churg-Strauss syndrome, primary ciliary dyskinesia, or vasculitis (e.g. granulomatosis with polyangiitis(GPA))
• Allergy, hypersensitivity, or contraindication to the use of local or topical lidocaine anesthetics, nasal topical 1:1000 adrenaline, nasal decongestants, nasal steroid spray
• 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
• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Medtronic: collaborator

Study Sites (4)

Vancouver General Hospital

Vancouver, British Columbia, Canada

RECRUITING

St. Joseph's Hospital London

London, Ontario, N6A 4V2, Canada

RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 1J8, Canada

RECRUITING

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Publications (1)

• Kilty S, Thavorn K, Janjua A, Lee J, MacDonald K, Meen E, Micomonaco D, Rotenberg B, Sowerby LJ, Tewfik M, Adams S, Frenette H, Lasso A, Fergusson DA. 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.

  PMID: 33268434 DERIVED

MeSH Terms

Conditions

Sinusitis; Nasal Polyps

Interventions

Ambulatory Care Facilities; Anesthesia, General; Anesthesia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services; Anesthesia and Analgesia

Study Officials

• Shaun Kilty, MD

  The Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Lasso, MSc

CONTACT

6137985555; alasso@toh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 29, 2016
• Study Start: April 11, 2017
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)