Clinical trial NCT01564355: Postoperative Systemic Corticosteroids When Utilizing a Steroid-Eluting Spacer Following Endoscopic Sinus Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Sinusitis
Endoscopic Sinus Surgery
Post-operative Care
Steroids
Drug-eluting Spacer
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2012-03-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Health Related Quality of Life Score (based on SNOT-22, VAS, and RSDI questionnaires)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Sinus mucosal disease endoscopic grading score (based on Lund-Kennedy and POSE Scoring systems)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Richmond Road Diagnostic and Treatment Centre
state: Alberta
Study officials:
References:
citation: 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.