Recruiting

Endoscopic Surgery

Sponsor:

University of Calgary

Code:

NCT02506426

Conditions

Sinusitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Endoscopic sinus surgery + Septoplasty

Septoplasty alone

Study Details

Brief 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

Study ID

NCT02506426

Start date

Jul, 2015

Status verified date

Jul, 2015

Completion date

Jul, 2018

Anticipated

Primary completion date

Jul, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18 years or older
2. Diagnosis of CRS WITHOUT nasal polyps (as per Canadian Rhinosinusitis Guidelines22)
3. Septal deviation greater then 10-degrees on the CT sinuses scan10.
4. Failed medical therapy as defined by having persistent symptoms and reduced disease-specific QoL despite receiving a minimum of the following treatment: 3 months topical sinonasal corticosteroid therapy along with a minimum of a 7-day course of systemic corticosteroid + 2-week course of broad-spectrum antibiotic13.
5. Lund-MacKay CT Sinus score ≥ 5 points23.
6. Patient elects to proceed with a surgical intervention for their medically refractory CRS.
7. Must be capable, in the opinion of the investigator, of providing informed consent to participate in the study.
8. Participants must sign an informed consent document indicating that they understand the purpose of and procedures of the study and are willing to participate in the study

Exclusion Criteria:

1. Women who are pregnant or breast feeding or plan to become pregnant during the study period.
2. History of prior sinus or septal surgery.
3. Participants who will not be able to complete the follow-up appointments/evaluations.
4. Have significant oral structural abnormalities, eg. Un-repaired cleft palate.
5. History of a systemic inflammatory disease (eg. Sarcoidosis), primary ciliary dyskinesia, or systemic vasculitis (eg. granulomatosis with polyangiitis (GPA)).
6. Any serious or unstable concurrent disease, psychiatric disorder, or any significant condition that, in the opinion of the investigator could confound the results of the study or could interfere with the participant's participation or compliance with the study.
7. Inability to read and understand English.
8. Any participant who unfit to undergo surgery under general anesthesia .
9. Current participation in another clinical trial at the time of the screening visit.
10. Any patient that the investigator has reason to believe that they will not follow the study procedures, treatment and/or follow-up schedule.

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Endoscopic Sinus Surgery + Septoplasty

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.

experimental: Septoplasty alone

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.

Interventions

Endoscopic sinus surgery + Septoplasty

Opening of the paranasal sinuses along with correcting the nasal septum

Septoplasty alone

Straightening of the nasal septum without opening the paranasal sinuses

Primary outcome measure

  • Disease specific-quality of life using the 22-item sinonasal outcome test (SNOT-22) [ Time Frame: Change in baseline compared to 12 months post surgery ]

Central Contacts and Locations

Central contacts

Luke R Rudmik, MD,MSc,FRCSC

403-955-8425Lukerudmik@gmail.com

Candice Werner

Candice.Warner@albertahealthservices.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada

Contacts

Luke Rudmik, MD,MSc,FRCSC

lukerudmik@gmail.com

Kristine Smith, MD

kasmi@ucalgary.ca

University of Ottawa

Recruiting

Ottawa, Ontario, Canada

Contacts

Shaun Kilty, MD,FRCSC

kiltysj@gmail.com

More Information

Sponsor

University of Calgary

Last update posted

Jul 23, 2015

Last verified

Jul, 2015

Keywords

  • Chronic Sinusitis
  • Chronic Rhinosinusitis
  • Endoscopic sinus surgery
  • Septoplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2015-07-23.