Endoscopic Sinus Surgery for Refractory Chronic Sinusitis

NCT02506426 | Unknown

• 1 other identifier: REB15-0809
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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

Keywords

Chronic Sinusitis; Chronic Rhinosinusitis; Endoscopic sinus surgery; Septoplasty

Outcome Measures

Primary Outcomes (1)

• Disease specific-quality of life using the 22-item sinonasal outcome test (SNOT-22)

  The SNOT-22 is validated quality of life (QoL) questionnaire and it is 22-item outcome measure applicable to both sinonasal conditions and surgical treatments (score range: 0-110). Derived from the SNOT-20, two additional questions were added to measure nasal blockage and sense of taste/smell. Lower total scores on the SNOT-22 imply better QoL.

  Change in baseline compared to 12 months post surgery

Secondary Outcomes (5)

• Strength of Patient Blinding using a group selection scale

  3 months after surgery

• Generic quality of life using the EQ-5D questionnaire

  Change in baseline compared to 12 months post surgery

• Daily productivity using the Work Productivity and Activity Impairment (WPAI) questionnaire

  Change in baseline compared to 12 months post surgery

• Adherence/compliance to medical therapy using the Morisky 8-item Adherence Questionnaire

  Change in baseline compared to 12 months post surgery

• Patient Satisfaction with care using the Patient Satisfaction Questionnaire Short-form (PSQ-18)

  Change in baseline compared to 12 months post surgery

Study Arms (2)

Endoscopic Sinus Surgery + Septoplasty

ACTIVE COMPARATOR

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.

Procedure: Endoscopic sinus surgery + Septoplasty

Septoplasty alone

EXPERIMENTAL

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.

Procedure: Septoplasty alone

Interventions

Endoscopic sinus surgery + Septoplasty PROCEDURE

Opening of the paranasal sinuses along with correcting the nasal septum

Endoscopic Sinus Surgery + Septoplasty

Septoplasty alone PROCEDURE

Straightening of the nasal septum without opening the paranasal sinuses

Septoplasty alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Diagnosis of CRS WITHOUT nasal polyps (as per Canadian Rhinosinusitis Guidelines22)
• Septal deviation greater then 10-degrees on the CT sinuses scan10.
• 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.
• Lund-MacKay CT Sinus score ≥ 5 points23.
• Patient elects to proceed with a surgical intervention for their medically refractory CRS.
• Must be capable, in the opinion of the investigator, of providing informed consent to participate in the study.
• 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

You may not qualify if:

• Women who are pregnant or breast feeding or plan to become pregnant during the study period.
• History of prior sinus or septal surgery.
• Participants who will not be able to complete the follow-up appointments/evaluations.
• Have significant oral structural abnormalities, eg. Un-repaired cleft palate.
• History of a systemic inflammatory disease (eg. Sarcoidosis), primary ciliary dyskinesia, or systemic vasculitis (eg. granulomatosis with polyangiitis (GPA)).
• 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.
• Inability to read and understand English.
• Any participant who unfit to undergo surgery under general anesthesia .
• Current participation in another clinical trial at the time of the screening visit.
• Any patient that the investigator has reason to believe that they will not follow the study procedures, treatment and/or follow-up schedule.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (2)

University of Calgary

Calgary, Alberta, Canada

RECRUITING

University of Ottawa

Ottawa, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Candice Werner

  University of Calgary

  STUDY DIRECTOR

Central Study Contacts

Luke R Rudmik, MD,MSc,FRCSC

CONTACT

403-955-8425; Lukerudmik@gmail.com

Candice Werner

CONTACT

Candice.Warner@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 23, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2018
• Last Updated: July 23, 2015

Record last verified: 2015-07

Locations

CA (2)