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

NCT01564355 | Completed

• 1 other identifier: 24336
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Sinus mucosal disease endoscopic grading score (based on Lund-Kennedy and POSE Scoring systems)

  Up to 3 years

Study Arms (2)

Systemic Steroid Group

EXPERIMENTAL

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); Drug: Post-op Oral Steroids

Placebo

PLACEBO COMPARATOR

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)

Interventions

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

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.

Placebo; Systemic Steroid Group

Post-op Oral Steroids DRUG

Post-operative oral prednisone 20 mg QD x 5 days , then 10 mg x 5 days, as per usual protocol.

Systemic Steroid Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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":
• Received 3 months of topical corticosteroid spray
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Richmond Road Diagnostic and Treatment Centre

Calgary, Alberta, T2T 5C7, Canada

Location

Related Publications (1)

• 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.

  PMID: 24482348 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 27, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

CA (1)