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NCT Number: NCT01564355

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richmond Road Diagnostic and Treatment Centre

Calgary, Alberta, T2T 5C7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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":
  • 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

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Health Related Quality of Life Score (based on SNOT-22, VAS, and RSDI questionnaires)

    Time frame: 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 outcomes

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 27, 2012
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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