Postoperative Systemic Corticosteroids When Utilizing a Steroid-Eluting Spacer Following Endoscopic Sinus Surgery
NCT ID: NCT01564355
Last Updated: 2014-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2012-04-30
2013-12-31
Brief Summary
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There is no single correct approach to take care of patients after sinus surgery. Most experts would use a nasal spray and a short-course of oral steroid pills to reduce sinus swelling and minimize complications related to scarring.
"Steroid-eluting nasal spacers" are devices placed inside the sinus during surgery and slowly release topical steroids into the sinuses better than steroid sprays. These "spacers" have been shown to improve results following sinus surgery. When using these special "spacers", there may no longer be a need for oral steroid pills following surgery. This would help to avoid potential side effects associated with these medications.
The purpose of this study is to find out whether taking oral (systemic) steroid pills following sinus surgery is necessary to improve surgical results, now that steroid-eluting nasal spacers are commonly used during surgery.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Systemic Steroid Group
Will receive post-operative oral steroids for 10 days as per usual protocol.
Steroid-eluting middle meatal spacer (Nasopore (TM) spacer impregnated with 1 cc of 40mg/mL triamcinolone liquid)
All study arms will receive bilateral Nasopore spacers impregnated with 1 cc of Triamcinolone to remain in the nasal cavity for 1 week post-operatively as per usual protocol.
Post-op Oral Steroids
Post-operative oral prednisone 20 mg QD x 5 days , then 10 mg x 5 days, as per usual protocol.
Placebo
Will receive placebo pills for 10 days post-operatively
Steroid-eluting middle meatal spacer (Nasopore (TM) spacer impregnated with 1 cc of 40mg/mL triamcinolone liquid)
All study arms will receive bilateral Nasopore spacers impregnated with 1 cc of Triamcinolone to remain in the nasal cavity for 1 week post-operatively as per usual protocol.
Interventions
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Steroid-eluting middle meatal spacer (Nasopore (TM) spacer impregnated with 1 cc of 40mg/mL triamcinolone liquid)
All study arms will receive bilateral Nasopore spacers impregnated with 1 cc of Triamcinolone to remain in the nasal cavity for 1 week post-operatively as per usual protocol.
Post-op Oral Steroids
Post-operative oral prednisone 20 mg QD x 5 days , then 10 mg x 5 days, as per usual protocol.
Eligibility Criteria
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Inclusion Criteria
* CRS defined by 2007 Adult Sinusitis Guidelines19
* Electing endoscopic sinus surgery for the indication medically refractory CRS, as defined by having persistent symptoms despite the following "maximal medical therapy":
1. Received 3 months of topical corticosteroid spray
2. Received a 2 week course of a broad-spectrum antibiotic combined with a 2 week course of systemic corticosteroid
* Provide written informed consent
* Subject must be able to complete all study evaluations and HRQoL questionnaires written in English
Exclusion Criteria
* Unable to complete questionnaires or clinical testing or cooperate with study evaluations in English.
* Unwilling to provide written, informed consent
* Patients who have not undergone previous "maximum" prescribed medical therapy
* Patients with suspected systemic inflammatory disease
18 Years
ALL
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Dr. Luke Rudmik
Clinical Assistant Professor
Locations
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Richmond Road Diagnostic and Treatment Centre
Calgary, Alberta, Canada
Countries
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References
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Dautremont JF, Mechor B, Rudmik L. The role of immediate postoperative systemic corticosteroids when utilizing a steroid-eluting spacer following sinus surgery. Otolaryngol Head Neck Surg. 2014 Apr;150(4):689-95. doi: 10.1177/0194599814521373. Epub 2014 Jan 30.
Other Identifiers
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24336
Identifier Type: -
Identifier Source: org_study_id