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Septoplasty alone for Sinusitis

N/A
Waitlist Available
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in baseline compared to 12 months post surgery
Awards & highlights
No Placebo-Only Group

Summary

Chronic sinusitis is a disease involving severe swelling of your facial sinuses and nasal cavity. Chronic sinusitis is a common disorder and roughly 5% of adult men and women have chronic sinusitis in Canada. Surgery has shown to have benefits for people suffering from chronic sinusitis. There are two surgeries which have been shown to help people: 1) Endoscopic sinus surgery with septoplasty and 2) Septoplasty alone. Both surgeries have research which show they help improve quality of life and reduce symptoms. However, it is unknown which surgery is better. 'Endoscopic sinus surgery with Septoplasty' uses special telescopes through the nostrils to make the nasal septum straight and open the facial sinuses without any incisions. The sinuses are opened using special microscopic instruments and the procedure takes approximately 90-120 minutes. 'Septoplasty alone' is a shorter (take approximately 25-30 minutes) and less invasive (do not open the facial sinuses) that might provide the same benefits compared to the larger and longer endoscopic sinus surgery. Currently, performing 'Endoscopic Sinus Surgery and Septoplasty' together is the standard of care, however, there is limited evidence to support just performing 'Septoplasty alone' provides similar results but it is shorter and has lower risks. This represents a significant gap in the investigators' knowledge, which adversely impacts a doctor's ability to counsel patients who have chronic sinusitis and elect to undergo surgery. The purpose of this study is to understand which surgery (endoscopic sinus surgery plus septoplasty OR septoplasty alone) is the most appropriate for people with chronic sinusitis. You are being asked to participate in this study because you have chronic sinusitis and are also going to have surgery to improve your quality of life.

Eligible Conditions
  • Sinusitis
  • Sinus Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in baseline compared to 12 months post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in baseline compared to 12 months post surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease specific-quality of life using the 22-item sinonasal outcome test (SNOT-22)
Secondary study objectives
Adherence/compliance to medical therapy using the Morisky 8-item Adherence Questionnaire
Daily productivity using the Work Productivity and Activity Impairment (WPAI) questionnaire
Generic quality of life using the EQ-5D questionnaire
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Septoplasty aloneExperimental Treatment1 Intervention
A surgery that is performed to straighten a bent nasal septum. It is shorter (take approximately 25 - 30 minutes) and less invasive (do not open the facial sinuses) that might provide the same benefits compared to the larger and longer endoscopic sinus surgery.
Group II: Endoscopic Sinus Surgery + SeptoplastyActive Control1 Intervention
A surgery that uses special telescopes through the nostrils to make the nasal septum straight and open the facial sinuses without any incisions. The sinuses are opened using special microscopic instruments and the procedure takes approximately 90 - 120 minutes.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
809 Previous Clinical Trials
886,339 Total Patients Enrolled
3 Trials studying Sinusitis
194 Patients Enrolled for Sinusitis
Candice WernerStudy DirectorUniversity of Calgary
~4 spots leftby Nov 2025