Trial record 5 of 17 for:    Open Studies | "Postoperative Care"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of Calgary
Sponsor:
Information provided by (Responsible Party):
Dr. Luke Rudmik, University of Calgary
ClinicalTrials.gov Identifier:
NCT01564355
First received: March 22, 2012
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Chronic Sinusitis
Endoscopic Sinus Surgery
Post-operative Care
Steroids
Drug-eluting Spacer
Device: Steroid-eluting middle meatal spacer (Nasopore (TM) spacer impregnated with 1 cc of 40mg/mL triamcinolone liquid)
Drug: Post-op Oral Steroids

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Health Related Quality of Life Score (based on SNOT-22, VAS, and RSDI questionnaires) [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Sinus mucosal disease endoscopic grading score (based on Lund-Kennedy and POSE Scoring systems) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 80
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Systemic Steroid Group
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)
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.
Placebo Comparator: Placebo
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564355

Contacts
Contact: Luke R Rudmik, MD 403-944-3628 lukerudmik@gmail.com

Locations
Canada, Alberta
Richmond Road Diagnostic and Treatment Centre Recruiting
Calgary, Alberta, Canada, T2T 5C7
Contact: Luke R Rudmik, MD, FRCSC       lukerudmik@gmail.com   
Sponsors and Collaborators
University of Calgary
  More Information

No publications provided

Responsible Party: Dr. Luke Rudmik, Clinical Assistant Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT01564355     History of Changes
Other Study ID Numbers: 24336
Study First Received: March 22, 2012
Last Updated: August 6, 2012
Health Authority: Ethics Review Committee: Conjoint Health Research Ethics Board

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014