RecruitingNot ApplicableNCT02975310

In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps

Endoscopic Polypectomy Performed In Clinic for Chronic Rhinosinusitis With Polyps: The EPIC Randomised Controlled Trial


Sponsor

Ottawa Hospital Research Institute

Enrollment

140 participants

Start Date

Apr 11, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Endoscopic Sinus Surgery (ESS), a procedure called Endoscopic polypectomy in clinic (EPIC), and others for people with nasal polyps and sinusitis. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndoscopic 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.

PROCEDUREEndoscopic 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.

OTHERGeneral Anesthesia

ESS will be performed under general anesthesia in the operating room

OTHERLocal and topical anesthesia

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


Locations(4)

Vancouver General Hospital

Vancouver, British Columbia, Canada

St. Joseph's Hospital London

London, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

McGill University Health Center

Montreal, Quebec, Canada

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NCT02975310


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