Pilot Study of The EPIC Trial (NCT02533206) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pilot Study of The EPIC Trial
Canada20 participantsStarted 2015-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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. 21
✓. Bilateral nasal polyps present of Grade ≥ 2 on each side as determined by the Lildholdt scale score measured by nasal endoscopy (Appendix 2) at the screening visit.
✓. Must have nasal blockage score greater than or equal to 4 on the sinonasal outcome test SNOT-22 (Appendix 3) at the screening visit.
✓. Must have an American Society of Anesthesiologists physical status (ASA PS) 3 classification or less. ASA PS 3: Patients with severe systemic disease: Some functional limitation; has a controlled disease of more than one body system or one major system; no immediate danger of death. ASA PS 2: Patients with mild systemic disease. No functional limitations; has a well-controlled disease of one body system. ASA PS 1: Normal healthy patient. No organic, physiologic, or psychiatric disturbance; excludes the very young and very old.
✓. Participants with comorbid asthma or chronic obstructive pulmonary disease (COPD) must have stable disease with no exacerbations (no emergency room visits, hospitalisations, or oral or parental steroid use for these lower respiratory conditions) within 3 months before the screening visit.
. Must be capable, in the opinion of the investigator, of providing informed consent to participate in the study. Participants must sign an informed consent document indicating that they understand the purpose of and procedures of the study and are willing to participate in the study.
Exclusion criteria
✕. Women who are pregnant or breast feeding
✕. 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
✕. Participants who will not be able to complete the follow-up appointments/evaluations
✕. Have significant oral structural abnormalities, e.g. unrepaired cleft palate
✕. Septal deviation requiring correction in order to perform either EPIC or FESS procedures
✕. Diagnosis of an immunodeficiency or immunocompromised state