Comparing In-Clinic Endoscopic Polyp Removal and Sinus Surgery for Chronic Sinusitis With Nasal Polyps A National Randomized Trial Evaluating Symptoms, Quality of Life, and Costs

What this Trial Is About

Chronic rhinosinusitis with nasal polyps is a common and long-lasting condition affecting many people, causing symptoms like facial pain, headaches, nasal blockage, and loss of smell that impact daily life and work. This study aims to compare a new in-clinic polyp removal procedure to the standard sinus surgery done in an operating room, evaluating if the new approach can control symptoms as well while reducing costs and wait times. Researchers also want to assess the benefits and costs to patients, healthcare systems, and society between these two treatments. The trial compares two treatments endoscopic polypectomy performed in the clinic EPIC using local and topical anesthesia, and the current standard endoscopic sinus surgery ESS performed in an operating room under general anesthesia. EPIC uses a microdebrider to remove nasal polyps during an outpatient visit, while ESS includes polypectomy and sinus enlargement. The study is a randomized controlled trial involving multiple centers to test whether EPIC is not worse than ESS in improving quality of life and to analyze cost-effectiveness. Participants will be followed for at least three months after treatment, with assessments including a sinonasal outcome test SNOT-22 to measure symptom changes, nasal airflow tests, anesthesia satisfaction surveys, work productivity evaluations, quality of life surveys, health resource use, and monitoring for adverse events. The study monitors patients closely to compare outcomes and safety between the two procedures, helping to determine if the less invasive EPIC can become a new standard care option.

In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps