In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps
|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.|
|ClinicalTrials.gov Identifier: NCT02975310|
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : January 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sinusitis Nasal Polyps||Procedure: Endoscopic polypectomy in clinic (EPIC) Procedure: Endoscopic Sinus Surgery (ESS) Other: General Anesthesia Other: Local and topical anesthesia||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Polypectomy Performed In Clinic for Chronic Rhinosinusitis With Polyps: The EPIC Randomised Controlled Trial|
|Actual Study Start Date :||April 11, 2017|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2025|
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
- Sinonasal Outcome Test-22 (SNOT-22) [ Time Frame: 3 months ]
- 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 ]
- 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
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
|Contact: Andrea Lasso, MSc,CCRP||6137985555 ext firstname.lastname@example.org|
|Ottawa Hospital Research Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y 1J8|
|Contact: Andrea Lasso, MSc 613-798-5555 ext 10222 email@example.com|
|Principal Investigator:||Shaun Kilty, MD||The Ottawa Hospital Research Institute|