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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01564355
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Luke Rudmik, University of Calgary

Tracking Information
First Submitted Date  ICMJE March 22, 2012
First Posted Date  ICMJE March 27, 2012
Last Update Posted Date December 3, 2014
Study Start Date  ICMJE April 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2012)
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 [ 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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
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).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postoperative Systemic Corticosteroids When Utilizing a Steroid-Eluting Spacer Following Endoscopic Sinus Surgery
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Sinusitis
  • Endoscopic Sinus Surgery
  • Post-operative Care
  • Steroids
  • Drug-eluting Spacer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Systemic Steroid Group
    Will receive post-operative oral steroids for 10 days as per usual protocol.
    Interventions:
    • Device: Steroid-eluting middle meatal spacer (Nasopore (TM) spacer impregnated with 1 cc of 40mg/mL triamcinolone liquid)
    • Drug: Post-op Oral Steroids
  • Placebo Comparator: Placebo
    Will receive placebo pills for 10 days post-operatively
    Intervention: Device: Steroid-eluting middle meatal spacer (Nasopore (TM) spacer impregnated with 1 cc of 40mg/mL triamcinolone liquid)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2012)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01564355
Other Study ID Numbers  ICMJE 24336
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Luke Rudmik, University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Calgary
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP