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

Chronic Sinusitis Clinical Trial

Official title:

The Role of Postoperative Systemic Corticosteroids When Utilizing a Steroid-Eluting Middle Meatal Spacer Following Endoscopic Sinus Surgery: A Randomized, Double-Blind, Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564355
• Other study ID #: 24336
• Status: Completed
• Phase: N/A
• First received: March 22, 2012
• Last updated: December 1, 2014
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethics Review Committee: Conjoint Health Research Ethics Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Sinusitis
• Drug-eluting Spacer
• Endoscopic Sinus Surgery
• Post-operative Care
• Steroids

Intervention

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.

Locations

Country	Name	City	State
Canada	Richmond Road Diagnostic and Treatment Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Related Quality of Life Score (based on SNOT-22, VAS, and RSDI questionnaires)	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).	Up to 2 years	Yes
Secondary	Sinus mucosal disease endoscopic grading score (based on Lund-Kennedy and POSE Scoring systems)	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).	Up to 3 years	No