Postoperative Systemic Corticosteroids When Utilizing a Steroid-Eluting Spacer Following Endoscopic Sinus Surgery

Not Applicable

Completed

• Conditions: Steroids; Drug-eluting Spacer; Chronic Sinusitis; Endoscopic Sinus Surgery; Post-operative Care
• Interventions: Device: Steroid-eluting middle meatal spacer (Nasopore (TM) spacer impregnated with 1 cc of 40mg/mL triamcinolone liquid); Drug: Post-op Oral Steroids

• Registration Number: NCT01564355
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-27
• Study Start: 2012-04
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Adult ( > 18 years of age)

• 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

• Children (< 18 years of age)
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systemic Steroid Group	Steroid-eluting middle meatal spacer (Nasopore (TM) spacer impregnated with 1 cc of 40mg/mL triamcinolone liquid)	Will receive post-operative oral steroids for 10 days as per usual protocol.
Systemic Steroid Group	Post-op Oral Steroids	Will receive post-operative oral steroids for 10 days as per usual protocol.
Placebo	Steroid-eluting middle meatal spacer (Nasopore (TM) spacer impregnated with 1 cc of 40mg/mL triamcinolone liquid)	Will receive placebo pills for 10 days post-operatively

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Richmond Road Diagnostic and Treatment Centre; 🇨🇦 Calgary, Alberta, Canada