Recruiting

Medical vs. Surgical

Sponsor:

St. Paul's Hospital, Canada

Code:

NCT04291118

Conditions

Chronic Sinusitis

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Accepted

Interventions

Private system endoscopic sinus surgery

Public system endoscopic sinus surgery

Budesonide

Study Details

Brief summary:

Chronic rhinosinusitis presents with a plethora of symptoms including non-rhinologic symptoms such as depression, sleep disturbances \& the more recently recognized cognitive dysfunction. It has recently been identified that sinus specific treatments such as endoscopic sinus surgery can improve cognitive outcomes in patients with cognitive deficit secondary to chronic inflammation in the upper and lower airway. However, it remains to be seen whether or not offering surgery to these patients at an earlier date has an impact on the degree of improvement on cognitive function in comparison to patients who have to wait long periods for their treatment.

Conditions

Chronic Sinusitis

Study ID

NCT04291118

Start date

Feb 10, 2020

Status verified date

Feb, 2020

Completion date

Oct 1, 2021

Anticipated

Primary completion date

Sep 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Diagnosed with CRS (with/without polyps) and are willing to undergo medical management with antibiotics or steroids, and/or surgical management with functional endoscopic sinus surgery if required

Exclusion Criteria:

  • Patients currently having sinonasal tumors - as the middle turbinate may have to be resected in certain cases
  • Has undergone functional endoscopic sinus surgery
  • Patients with autoimmune diseases affecting the upper airway (e.g. systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, etc.)
  • Are immuno-compromised, and have impairment in mucociliary function (e.g. cystic fibrosis, Kartagener syndrome)

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Medical Management and Sinus Surgery in private system

These patients will first receive medical management for their symptoms and then will undergo sinus surgery much earlier than the other group as they will include patients being operated in the private system.

other: Medical Management and Sinus Surgery in public system

These patients will first receive medical management for their symptoms, and then will undergo sinus surgery after a waiting period of at least 1 year since they are on the public wait-list.

other: Medical Management Only

These patients will only receive medical management for their symptoms as they will not require sinus surgery.

Interventions

Private system endoscopic sinus surgery

Patients that will undergo endoscopic sinus surgery though the private system. Beforehand they could of used medical management including, budesonide for their symptoms.

Public system endoscopic sinus surgery

Patients that undergo endoscopic sinus surgery though the public system after waiting for at least 1 year. Beforehand they could of used medical management, including budesonide for their symptoms.

Budesonide

Patients will receive medical management for their symptoms that will consist of topical nasal steroid, budesonide and any other required medication for their disease.

Primary outcome measure

  • Change in Modified mini mental state examination [ Time Frame: Before starting medical or surgical management and then 6 months after ]

Central Contacts and Locations

Central contacts

Athena Pascual

604-806-9926apascual@providencehealth.bc.ca

Locations

E.N.T. Clinic, St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Athenea Pascual, PHD

6048069926apascual@providencehealth.bc.ca

Principal Investigator:

Amin R Javer, MD,FRCSC,FARS

More Information

Sponsor

St. Paul's Hospital, Canada

Last update posted

Mar 2, 2020

Last verified

Feb, 2020

Keywords

  • Endoscopic Sinus Surgery
  • Medical Management
  • Cognitive Dysfunction
  • Modified Mini Mental State Examination

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Paul's Hospital, Canada on 2020-03-02.