Active not recruitingNAINTERVENTIONAL

Pilot Study of The EPIC Trial

This study is a test run for a larger research project looking at new ways to treat chronic sinusitis (long-lasting sinus inflammation) and nasal polyps. Currently, surgery for these conditions is done in an operating room. Researchers are exploring a smaller, clinic-based procedure called Endoscopic Polypectomy Performed in Clinic (EPIC). This new procedure might mean a faster recovery, lower costs, and shorter waiting times for patients. This "pilot" study aims to make sure the larger study, which will compare EPIC to traditional surgery, can recruit enough patients and collect information effectively. Participants will be randomly assigned to either the clinic procedure or standard operating room surgery.

At a glance

Status

Active not recruiting

Phase

Sponsor

Ottawa Hospital Research Institute

Enrolment target

Start

01 Aug 2015

Estimated completion

01 Dec 2025

Sinusitis Nasal Polyps

What is this study about?

Imagine you have long-lasting sinus problems and growths called nasal polyps, which medical treatments haven't quite fixed. Up until now, and very commonly, the main surgical way to treat these is in an operating theatre. However, doctors are exploring a newer, less invasive option that can be done right in the clinic for some patients. This smaller procedure aims to control symptoms just as well as traditional surgery, but with the added benefits of quicker recovery, less cost, and shorter waiting times.

To be sure this clinic procedure is truly as good as the operating room surgery, a much larger study is planned to compare them. But before diving into that big study, researchers need to do a practice run, or a 'pilot study'. Think of it like a dress rehearsal before a big play. This pilot study is designed to make sure everything is ready for the main event. It will help confirm if they can find enough patients to take part and if the methods for gathering information are clear and effective.

This small pilot study will involve a limited number of patients who will be randomly assigned to either receive the new clinic-based procedure or the standard operating room surgery. The results from this practice run will help the research team fine-tune their plans for the larger, more thorough study, ensuring it runs as smoothly as possible to give us clear answers about the best treatment options.

Key takeaways

This is a 'practice run' study for a new clinic-based sinus procedure.
It compares a new clinic procedure to traditional operating room surgery.
Participation involves being randomly assigned to one of two treatments.
Follow-up appointments are similar to standard care.
The study helps prepare for larger research to find better treatments.
You can withdraw at any time without it affecting your care.

Who may be eligible?

This study is looking for adults who are 18 years or older and have been diagnosed with chronic sinusitis and nasal polyps. You would need to have already tried medical treatments, and your doctors believe surgery is the next step. Your polyps must be a certain size and seen in both nostrils during a special check-up.

You also need to have significant nasal blockage that affects your quality of life, measured by a specific health questionnaire. Your general health should be good enough for surgery, typically meaning you don't have very severe underlying health problems. If you have conditions like asthma or COPD, they need to be stable, meaning you haven't had recent flare-ups requiring emergency care or steroid use.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if your polyps are very unusual or causing your nose to change shape externally. Also, if you have very severe facial pain or have had certain types of previous nasal surgery, you might not be suitable for this particular study. The research team will review all these details carefully with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have chronic sinusitis with nasal polyps that needs surgery?
Do you have significant nasal blockage (checked by a questionnaire)?
Is your general health good enough for surgery?
Are you not pregnant or breastfeeding?
Have you not had certain types of previous nasal surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to make sure you're suitable. Once you're in the study, you'll be randomly assigned to one of two treatment groups: either the new clinic-based procedure (Endoscopic Polypectomy Performed in Clinic, or EPIC) or the standard operating room surgery (Functional Endoscopic Sinus Surgery, or FESS). You won't get to choose which one you receive, as this helps make the study fair.

The treatment itself (either the clinic procedure or the operating room surgery) will be considered 'day 0'. There won't be any changes to how these procedures are normally done just because you're part of the study. After your treatment, you'll have follow-up evaluations with the doctors. This will happen twice, which is actually the usual number of follow-up visits for someone having this type of sinus surgery. The first visit will be around 15 days after your procedure, and the final study-related check-up will be about 90 days (roughly three months) after your procedure.

Potential risks and benefits

Taking part in this study could potentially offer you access to a newer, less invasive clinic-based procedure that may lead to a shorter recovery time and less disruption to your life. The main benefit is helping doctors understand which treatment works best, which could improve care for many people in the future. As with any medical procedure, there are potential risks, including those associated with surgery and anaesthesia, though these procedures are standard. The researchers will explain all known risks to you in detail. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (5)

Royal Victoria Hospital
Verified postcode
Barrie, Canada
St Joseph's Health Care
Verified postcode
London, Canada
The Ottawa Hospital
Verified postcode
Ottawa, Canada
Algoma District Medical Group
Verified postcode
Sault Ste. Marie, Canada
Saint Michael's Hospital
Verified postcode
Toronto, Canada

Common questions

What is chronic sinusitis?

It's a long-lasting inflammation of the sinuses, causing symptoms like a blocked nose, pain, and discharge, for many weeks or months.

What are nasal polyps?

Nasal polyps are soft, painless, non-cancerous growths inside your nose or sinuses, often linked to chronic sinusitis.

What does 'randomly assigned' mean?

It means you're put into a treatment group by chance, like flipping a coin, to ensure fairness and accurate comparison between treatments.

Is this the main study?

No, this is a small 'pilot' study, like a practice run, to make sure a much larger study can be done successfully later on.

Will I have more doctor's appointments if I join?

You will have two follow-up appointments after your procedure, but these are the same as what patients normally have after this type of surgery.