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ACTIVE NOT RECRUITING
NCT02533206
NA

Pilot Study of The EPIC Trial

Sponsor: Ottawa Hospital Research Institute

View on ClinicalTrials.gov

Summary

Chronic sinusitis is one of the most common chronic diseases in North America, with over 5% of the Canadian population affected by the disease. Until now, treatment with surgery has been performed only in the operating room. Recently a smaller surgical procedure that is done in the clinic for some patients with chronic sinusitis with polyps has been found to result in symptom control that appears to be similar to that which occurs with sinus surgery. Performing the smaller clinical procedure has advantages including a shorter recovery time for the patient, a much lower cost to the health care system for the procedure, and a shorter patient wait time for the procedure to be done in comparison to sinus surgery performed in the operating room. To know with greater certainty that the procedure performed in the clinic is as good as the operating room sinus surgery, a large multiple investigator randomised clinical trial has been designed. However, before carrying out that trial, a practice run or internal pilot study of that trial is required to ensure that the trial can recruit patients at the rate that is anticipated and that the procedures to obtain the measurements being used for the larger study are adequate.

Official title: Endoscopic Polypectomy Performed In Clinic (EPIC) for Chronic Rhinosinusitis With Polyps: Pilot Study of The EPIC Randomised Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2015-08

Completion Date

2025-12

Last Updated

2025-12-30

Healthy Volunteers

No

Interventions

PROCEDURE

Endoscopic Polypectomy Performed in Clinic

Endoscopic polypectomy performed in clinic under local and topical anesthesia

PROCEDURE

Functional Endoscopic Sinus Surgery (FESS)

Functional Endoscopic Sinus Surgery

Locations (5)

Royal Victoria Hospital

Barrie, Ontario, Canada

St Joseph's Health Care

London, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Algoma District Medical Group

Sault Ste. Marie, Ontario, Canada

Saint Michael's Hospital

Toronto, Ontario, Canada