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

University of Calgary

Status: Completed

Conditions: Drug-eluting Spacer; Post-operative Care; Chronic Sinusitis; Endoscopic Sinus Surgery; Steroids

Treatments: Drug: Post-op Oral Steroids; Device: Steroid-eluting middle meatal spacer (Nasopore (TM) spacer impregnated with 1 cc of 40mg/mL triamcinolone liquid)

Study type: Interventional

Funder types: Other

Identifiers

NCT01564355

24336

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Systemic Steroid Group

Experimental group

Description:

Will receive post-operative oral steroids for 10 days as per usual protocol.

Treatment:

Drug: Post-op Oral Steroids

Device: Steroid-eluting middle meatal spacer (Nasopore (TM) spacer impregnated with 1 cc of 40mg/mL triamcinolone liquid)

Placebo

Placebo Comparator group

Description:

Will receive placebo pills for 10 days post-operatively

Treatment:

Device: Steroid-eluting middle meatal spacer (Nasopore (TM) spacer impregnated with 1 cc of 40mg/mL triamcinolone liquid)