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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 below

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I have chronic sinusitis with polyps and need surgery after trying other treatments.

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

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

0 / 19Eligibility criteria met