Endoscopic polypectomy performed in clinic for chronic rhinosinusitis with nasal polyps: study protocol for the EPIC multicentre randomised controlled trial.
Shaun Kilty, Kednapa Thavorn, Arif Janjua...
https://pubmed.ncbi.nlm.nih.gov/33268434Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID02975310
Endoscopic Polypectomy Performed In Clinic for Chronic Rhinosinusitis With Polyps: The EPIC Randomised Controlled Trial
Led by Ottawa Hospital Research Institute · Updated on 2025-12-30
140
Participants Needed
4
Research Sites
52 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 with nasal polyps is a common and long-lasting condition affecting many people, causing symptoms like facial pain, headaches, nasal blockage, and loss of smell that impact daily life and work. This study aims to compare a new in-clinic polyp removal procedure to the standard sinus surgery done in an operating room, evaluating if the new approach can control symptoms as well while reducing costs and wait times. Researchers also want to assess the benefits and costs to patients, healthcare systems, and society between these two treatments. The trial compares two treatments: endoscopic polypectomy performed in the clinic (EPIC) using local and topical anesthesia, and the current standard endoscopic sinus surgery (ESS) performed in an operating room under general anesthesia. EPIC uses a microdebrider to remove nasal polyps during an outpatient visit, while ESS includes polypectomy and sinus enlargement. The study is a randomized controlled trial involving multiple centers to test whether EPIC is not worse than ESS in improving quality of life and to analyze cost-effectiveness. Participants will be followed for at least three months after treatment, with assessments including a sinonasal outcome test (SNOT-22) to measure symptom changes, nasal airflow tests, anesthesia satisfaction surveys, work productivity evaluations, quality of life surveys, health resource use, and monitoring for adverse events. The study monitors patients closely to compare outcomes and safety between the two procedures, helping to determine if the less invasive EPIC can become a new standard care option.
CONDITIONS
Brief Title
In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with chronic rhinosinusitis with polyps requiring surgical treatment after medical therapy
- Bilateral nasal polyps of Grade 2 or higher on each side measured by nasal endoscopy
- Nasal blockage score of 2 or greater on the sinonasal outcome test SNOT-22 at screening
- American Society of Anesthesiologists physical status classification of PS3 or less
- Stable asthma or chronic obstructive pulmonary disease without exacerbations in the past 3 months
- Ability to provide informed consent and understand the study procedures
You will not qualify if you...
- Women who are pregnant or breastfeeding
- Patients with hyperplastic polyps or polyps causing external nasal deformity
- Facial pain or pressure score higher than 2 on the sinonasal outcome test SNOT-22 at screening
- History of surgery preventing accurate grading of nasal polyps
- Inability to complete follow-up appointments and evaluations
- Significant oral structural abnormalities (e.g., unrepaired cleft palate)
- Septal deviation requiring correction to perform procedures
- Immunodeficiency or immunocompromised state
- Diagnosis of cystic fibrosis
- Diagnosis of allergic fungal sinusitis
- Contraindications to oral corticosteroids (e.g., uncontrolled diabetes, heart failure, hypertension, renal insufficiency, peptic ulcer disease, glaucoma, pregnancy)
- History of Churg-Strauss syndrome, primary ciliary dyskinesia, or vasculitis
- Allergy or contraindication to local or topical anesthetics, nasal adrenaline, decongestants, or nasal steroid spray
- Serious or unstable diseases or psychiatric disorders interfering with participation
- Recent history (within 1 year) of drug or alcohol abuse affecting compliance
- Inability to read and understand English
- Medical conditions interfering with treatment
- Unfit for surgery under general anesthesia
- Current participation in another clinical trial
- Unable to undergo awake procedure
- Diagnosis of Aspirin Exacerbated Respiratory Disease (AERD)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single procedure with immediate recovery
Participants undergo either endoscopic polypectomy performed in clinic (EPIC) under local and topical anesthesia or endoscopic sinus surgery (ESS) in the operating room under general anesthesia to treat chronic rhinosinusitis with nasal polyps.
1 procedure visit (in-person)
Follow-up
Duration - 3 months
Participants are monitored after treatment to assess outcomes including quality of life, nasal airflow, satisfaction with anesthesia, work productivity, health resource use, and adverse events.
Multiple visits over 3 months
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
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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