In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endoscopic polypectomy in clinic (EPIC)

    Procedure/Surgery

    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 Sinus Surgery (ESS)

    Procedure/Surgery

    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.

  • General Anesthesia

    Other intervention

    ESS will be performed under general anesthesia in the operating room

  • Local and topical anesthesia

    Other intervention

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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Endoscopic polypectomy in clinic (EPIC)Experimental treatment 2 interventions
Group B: Endoscopic Sinus Surgery (ESS)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Sinonasal Outcome Test-22 (SNOT-22)

Time frame
3 months

Secondary outcomes

1

Peak Nasal Inspiratory Flow (PNIF):

Time frame
3 months
2

Iowa Satisfaction with Anesthesia Scale (ISAS)

Patient satisfaction with anesthesia for the treatment procedure

Time frame
3 months
3

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

Work Impairment related to chronic rhinosinusitis

Time frame
3 months
4

EQ-5D-5L

Quality of Life

Time frame
3 months

Other outcomes

1

Lund-Kennedy Endoscopic Scoring Scale

Endoscopic inflammation of the nose and paranasal sinuses after treatment

Time frame
3 months
2

Visual Analogue Scale (VAS) for satisfaction with assigned procedure

Satisfaction with assigned procedure

Time frame
3 months

Sponsors and contacts

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Ottawa Hospital Research Institute

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Medtronic

Collaborator