Postoperative Systemic Corticosteroids When Utilizing a Steroid-Eluting Spacer Following Endoscopic Sinus Surgery
Study Details
Study Description
Brief Summary
Chronic rhinosinusitis (CRS) is an inflammatory condition of the nose and sinuses. It affects about 5 to 10% of Canadians. Patients suffer from congestion in the nose and sinuses, nasal discharge, pressure in the face, and a reduced sense of smell. This affects people's enjoyment of life. Medical management uses sprays or pills to treat these symptoms but for some patients sinus surgery is needed. This type of surgery is called endoscopic sinus surgery (ESS).
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Systemic Steroid Group Will receive post-operative oral steroids for 10 days as per usual protocol. |
Device: 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.
Drug: 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 Comparator: Placebo Will receive placebo pills for 10 days post-operatively |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- Health Related Quality of Life Score (based on SNOT-22, VAS, and RSDI questionnaires) [Up to 2 years]
Do systemic steroids following sinus surgery improve surgical results in patients where a steroid-eluting nasal spacer is placed at the completion of surgery. This will be based on validated chronic sinusitis-symptom specific HRQOL questionnaires (SNOT-22, VAS, RSDI)and mucosal disease grading scores via endoscopic examination (POSE, Lund-Kennedy).
Secondary Outcome Measures
- Sinus mucosal disease endoscopic grading score (based on Lund-Kennedy and POSE Scoring systems) [Up to 3 years]
Do systemic steroids following sinus surgery improve surgical results in patients where a steroid-eluting nasal spacer is placed at the completion of surgery. This will be based on validated mucosal disease grading scores via endoscopic examination (POSE, Lund-Kennedy).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult ( > 18 years of age)
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CRS defined by 2007 Adult Sinusitis Guidelines19
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Electing endoscopic sinus surgery for the indication medically refractory CRS, as defined by having persistent symptoms despite the following "maximal medical therapy":
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Received 3 months of topical corticosteroid spray
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Received a 2 week course of a broad-spectrum antibiotic combined with a 2 week course of systemic corticosteroid
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Provide written informed consent
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Subject must be able to complete all study evaluations and HRQoL questionnaires written in English
Exclusion Criteria:
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Children (< 18 years of age)
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Unable to complete questionnaires or clinical testing or cooperate with study evaluations in English.
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Unwilling to provide written, informed consent
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Patients who have not undergone previous "maximum" prescribed medical therapy
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Patients with suspected systemic inflammatory disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Richmond Road Diagnostic and Treatment Centre | Calgary | Alberta | Canada | T2T 5C7 |
Sponsors and Collaborators
- University of Calgary
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 24336