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In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps

This study is currently recruiting participants.
Verified September 2017 by Ottawa Hospital Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02975310
First Posted: November 29, 2016
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Canadian Institutes of Health Research (CIHR)
Medtronic
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
  Purpose
Chronic rhinosinusitis, also called chronic sinusitis, is a very common life-long disease affecting over 5% of the Canadian population. Its symptoms, including daily facial pain and headache, an inability to breath through the nose and complete smell loss, regularly impair one's ability to work and to enjoy and participate in daily activities. The annual cost of chronic sinusitis to Canada is estimated at $1.3 billion while the government pays an estimated $860 million yearly for chronic sinusitis treatment. Chronic sinusitis with polyps, the most common type of chronic sinusitis, is usually treated with a combination of medications and surgery. Until now, surgical treatment has only been performed in the operating room, at a cost of about $3500 per procedure. But, recent studies have shown that a new procedure, "in-clinic polyp removal", can provide an improvement in patient symptoms to levels equal to those for sinus surgery performed in a hospital operating room. Moreover, in clinic polyp removal has additional advantages including a shorter procedure recovery time, a significantly lower cost to the health care system (about one-tenth the cost or $450), and a shorter wait time for treatment. With the proposed pragmatic trial, the investigators will determine whether the in clinic polyp removal procedure is as good as sinus surgery in the operating room at controlling patient symptoms of chronic sinusitis. The investigators will also determine the cost and health-benefits for a patient, the healthcare system and for society of in clinic polyp removal in comparison to sinus surgery done in a hospital operating room. The investigators will then know if this new treatment, in clinic polyp removal, can replace sinus surgery as the standard of care for these patients.

Condition Intervention
Sinusitis Nasal Polyps Procedure: Endoscopic polypectomy in clinic (EPIC) Procedure: Endoscopic Sinus Surgery (ESS) Other: General Anesthesia Other: Local and topical anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Polypectomy Performed In Clinic for Chronic Rhinosinusitis With Polyps: The EPIC Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Sinonasal Outcome Test-22 (SNOT-22) [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Peak Nasal Inspiratory Flow (PNIF): [ Time Frame: 3 months ]
  • Iowa Satisfaction with Anesthesia Scale (ISAS) [ Time Frame: 3 months ]
    Patient satisfaction with anesthesia for the treatment procedure

  • Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) [ Time Frame: 3 months ]
    Work Impairment related to chronic rhinosinusitis

  • EQ-5D-5L [ Time Frame: 3 months ]
    Quality of Life

  • Participant Health Resource Consumption Survey [ Time Frame: 3 months ]
    Individual Health Resource Consumption

  • Adverse Events [ Time Frame: 3 months ]

Other Outcome Measures:
  • Lund-Kennedy Endoscopic Scoring Scale [ Time Frame: 3 months ]
    Endoscopic inflammation of the nose and paranasal sinuses after treatment

  • Visual Analogue Scale (VAS) for satisfaction with assigned procedure [ Time Frame: 3 months ]
    Satisfaction with assigned procedure


Estimated Enrollment: 140
Actual Study Start Date: April 11, 2017
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endoscopic polypectomy in clinic (EPIC)
Patients assigned to this arm of the study will undergo the In Clinic Polypectomy Performed in Clinic
Procedure: Endoscopic polypectomy in clinic (EPIC)
The experimental intervention is endoscopic polypectomy performed in clinic (EPIC) where nasal polyps are removed using a microdebrider under local and topical anesthesia in the outpatient clinic.
Other: Local and topical anesthesia
EPIC will be performed under topical and local anesthesia in a clinic setting
Active Comparator: Endoscopic Sinus Surgery (ESS)
Patients assigned to this arm will undergo endoscopic sinus surgery (ESS),
Procedure: Endoscopic Sinus Surgery (ESS)
The control intervention is endoscopic sinus surgery (ESS), a minimally invasive procedure that is the current standard that involves polypectomy with a microdebrider as well as sinus ostia enlargement of the affected sinuses performed in the operating room under general anesthesia.
Other: General Anesthesia
ESS will be performed under general anesthesia in the operating room

Detailed Description:

Chronic rhinosinusitis (CRS) is common, with a Canadian prevalence of 5%, and associated with significant morbidity having a health state utility value equivalent to end-stage renal disease. Understandably, CRS impairs workplace productivity but that productivity substantially increases following surgical treatment.

However, the wait time to receive surgical treatment (ESS) maybe up to 8 months or longer, with a cost to the Government of $3500/ESS procedure. The annual direct cost of CRS is estimated at $860 million with an overall financial impact of 1.3 billion dollars per year for Canada. Endoscopic polypectomy in clinic (EPIC), a potential disruptive innovation, is a drastically deescalated form of ESS performed in clinic instead of the operating room. EPIC appears to provide quality of life (QofL) improvement equivalent to that reported for ESS. EPIC has a shorter wait time and lower cost to a government, i.e. nearly one-tenth of ESS or about $450. A pilot economic evaluation study demonstrated that EPIC was cost-effective compared to ESS. This has created a controversy about which treatment should be employed for these patients. Further, a recent Cochrane review identified the need for high-quality randomised controlled trials to determine if ESS has additional benefit over polypectomy as there is currently insufficient evidence to draw conclusions about the superiority of polypectomy or ESS for the management of CRS with polyps.

The proposed national multicenter randomised controlled trial will determine whether EPIC is non-inferior to the current treatment standard, ESS, in QofL improvement for patients with CRS with polyps. It will also assess the cost-effectiveness of performing EPIC in place of ESS. The investigators hypothesize that EPIC will be non-inferior to ESS for QofL improvement while reducing health care cost. This would imply that EPIC is a dominant strategy and that the ESS strategy represents over-treatment in this patient population. The study findings would position EPIC into the current CRS treatment paradigm thereby transforming care and reducing costs both nationally and internationally.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975310


Contacts
Contact: Andrea Lasso, MSc,CCRP 6137985555 ext 10222 alasso@toh.ca

Locations
Canada, Ontario
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1Y 1J8
Contact: Andrea Lasso, MSc    613-798-5555 ext 10222    alasso@toh.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Medtronic
Investigators
Principal Investigator: Shaun Kilty, MD The Ottawa Hospital Research Institute
  More Information

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02975310     History of Changes
Other Study ID Numbers: CTO-0801
First Submitted: November 17, 2016
First Posted: November 29, 2016
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Polyps
Sinusitis
Nasal Polyps
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs