In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Nov 23, 2016

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option for people suffering from chronic sinusitis with nasal polyps, a condition that can cause daily facial pain, headaches, and difficulty breathing. Traditionally, surgery to remove these polyps has been performed in a hospital, but this trial is exploring a new procedure that can be done in the clinic. Researchers want to find out if this "in-clinic polyp removal" is just as effective as the surgery typically done in an operating room, but at a much lower cost and with less recovery time.

To participate in the trial, individuals must be 18 years or older and diagnosed with chronic sinusitis with nasal polyps that require surgical treatment. They should have moderate to severe nasal blockage and meet specific health criteria. Participants can expect to undergo the new polyp removal procedure, and they will be closely monitored to assess how well it works compared to traditional surgery. This study aims to determine if this new approach could become the standard treatment for patients with this condition, potentially making care more accessible and affordable.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years or older
• • 2. 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
• • 3. 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.
• • 4. Must have nasal blockage score greater than or equal to 2 on the sinonasal outcome test SNOT-22 at the screening visit.
• • 5. Must have an American Society of Anesthesiologists physical status PS3 classification or less.
• • 6. 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.
• • 7. 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:
• • 1. Women who are pregnant or breast feeding as per patient's report
• • 2. Patients with hyperplastic polyps or polyps large enough that they result in external nasal deformity
• • 3. Facial pain/pressure score higher than 2 on the sinonasal outcome test SNOT-22 at the screening visit.
• • 4. History of any surgical procedure that prevents the ability to accurately grade the nasal polyps
• • 5. Participants who will not be able to complete the follow-up appointments/evaluations
• • 6. Have significant oral structural abnormalities, e.g. unrepaired cleft palate
• • 7. Septal deviation requiring correction in order to perform either EPIC or ESS procedures
• • 8. Diagnosis of an immunodeficiency or immunocompromised state
• • 9. Diagnosis of cystic fibrosis
• • 10. Diagnosis of allergic fungal sinusitis
• • 11. Contraindication to the use of oral corticosteroids (e.g. uncontrolled diabetes, congestive heart failure, uncontrolled hypertension, known renal insufficiency, known peptic ulcer disease, known glaucoma, pregnancy)
• • 12. History of either Churg-Strauss syndrome, primary ciliary dyskinesia, or vasculitis (e.g. granulomatosis with polyangiitis(GPA))
• • 13. Allergy, hypersensitivity, or contraindication to the use of local or topical lidocaine anesthetics, nasal topical 1:1000 adrenaline, nasal decongestants, nasal steroid spray
• • 14. Any serious or unstable concurrent disease, psychiatric disorder, or any significant condition that, in the opinion of the investigator, could confound the results of the study or could interfere with the participant's participation or compliance with the study
• • 15. A recent (within 1 year of the screening visit) clinically significant history of drug or alcohol abuse, or dependence that, in the opinion of the investigator could interfere with the participant's participation or compliance with the study
• • 16. Inability to read and understand English
• • 17. Any medical condition that in the opinion of the investigator would interfere with the treatment
• • 18. Any participant who is unfit to undergo surgery under general anesthesia
• • 19. Current participation in another clinical trial at the time of the screening visit.
• • 20. Participant is unable to undergo an awake procedure
• • 21. Diagnosis or Aspirin Exacerbated Respiratory Disease (AERD)