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Endoscopic Sinus Surgery for Refractory Chronic Sinusitis

NCT02506426 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2015-07-23

No results posted yet for this study

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.

Conditions

  • Sinusitis

Interventions

PROCEDURE

Endoscopic sinus surgery + Septoplasty

Opening of the paranasal sinuses along with correcting the nasal septum

PROCEDURE

Septoplasty alone

Straightening of the nasal septum without opening the paranasal sinuses

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Candice Werner · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-07-31
Completion
2018-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02506426 on ClinicalTrials.gov