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In-Clinic Polypectomy vs FESS for Nasal Polyps
N/A
Waitlist Available
Led By Shaun Kilty, MD, FRCSC
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
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 not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
No Placebo-Only Group
Summary
This trial is a practice run to see if a smaller surgical procedure for chronic sinusitis with polyps is just as effective as the current surgery, which is done in the operating room.
Who is the study for?
Adults over 18 with chronic sinusitis and nasal polyps, who've tried medical therapy without success. They must have significant nasal blockage and be generally healthy enough for surgery. People with unstable diseases, recent substance abuse, immune deficiencies, or conditions affecting the ability to assess polyps are excluded.
What is being tested?
The trial is testing a smaller in-clinic surgical procedure (Endoscopic Polypectomy) against traditional operating room sinus surgery (FESS). The goal is to see if the clinic procedure offers similar benefits but with faster recovery and lower costs.
What are the potential side effects?
Potential side effects may include discomfort from the procedures, bleeding, infection risks associated with surgeries, reactions to local anesthetics used during the procedures like lidocaine or adrenaline.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have chronic sinusitis with polyps and need surgery after trying other treatments.
Select...
I have significant nasal polyps in both nostrils.
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I often have a blocked nose, as per my recent test scores.
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My health is good enough for surgery, according to the ASA classification.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I experience significant facial pain or pressure.
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I've had surgery that affects the grading of nasal polyps.
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I have major issues with the structure of my mouth, like an unrepaired cleft palate.
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I need surgery to correct a deviated septum for further nasal procedures.
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I have a condition that weakens my immune system.
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I have been diagnosed with allergic fungal sinusitis.
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I cannot take oral corticosteroids due to health reasons.
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I have a history of Churg-Strauss syndrome, primary ciliary dyskinesia, or vasculitis.
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I am not fit for surgery under general anesthesia.
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I have been diagnosed with AERD.
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I am not pregnant or breastfeeding.
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I cannot have procedures done while awake.
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I have been diagnosed with cystic fibrosis.
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I have nasal polyps that are causing my nose to change shape.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of recruitment
Secondary study objectives
Arm cross-over
Loss to follow up
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: EPICExperimental Treatment1 Intervention
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. The participant will be discharged home from the clinic following their procedure.
Group II: FESSActive Control1 Intervention
The control intervention is functional endoscopic sinus surgery (FESS), 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
Find a Location
Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
575 Previous Clinical Trials
3,094,861 Total Patients Enrolled
Shaun Kilty, MD, FRCSCPrincipal InvestigatorThe Ottawa Hospital Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to lidocaine, adrenaline, or nasal decongestants.I experience significant facial pain or pressure.I've had surgery that affects the grading of nasal polyps.I have major issues with the structure of my mouth, like an unrepaired cleft palate.I have a history of Churg-Strauss syndrome, primary ciliary dyskinesia, or vasculitis.I cannot take oral corticosteroids due to health reasons.I am not fit for surgery under general anesthesia.I have been diagnosed with AERD.I have chronic sinusitis with polyps and need surgery after trying other treatments.I have significant nasal polyps in both nostrils.I often have a blocked nose, as per my recent test scores.My health is good enough for surgery, according to the ASA classification.I need surgery to correct a deviated septum for further nasal procedures.I have a condition that weakens my immune system.I have been diagnosed with allergic fungal sinusitis.My asthma or COPD has been stable with no flare-ups in the last 3 months.I understand the study's purpose and procedures and agree to participate.I am not pregnant or breastfeeding.I cannot have procedures done while awake.I have been diagnosed with cystic fibrosis.I have nasal polyps that are causing my nose to change shape.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: FESS
- Group 2: EPIC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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