Assessing Improvement in Cognitive Deficit in CRS in Patients Treated With Medical Vs Surgical Management

NCT ID: NCT04291118

Last Updated: 2020-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-10
• Study Completion Date: 2021-10-01

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.

Detailed Description

Purpose To compare the improvement in cognitive deficit after medical management and surgical management in the treatment of Chronic Rhinosinusitis.

Hypothesis Cognitive deficit secondary to chronic rhinosinusitis will show a greater improvement with surgical management when compared to medical management.

Cognitive deficit secondary to chronic rhinosinusitis will improve quicker postoperatively for patients offered endoscopic sinus surgery earlier than for those who are placed on long waitlists for surgery

Study Design:

This is a prospective cohort series to be conducted at the St. Paul's Sinus Centre. All patients recruited into the study would have been diagnosed with chronic rhinosinusitis and will be subjected to appropriate and standardized medical management. They will be subjected to surgical management if they are not completely relieved of their symptoms. Prior to medical or surgical management, they will be subjected to the modified mini mental state examination to assess their baseline and post treatment (medical and surgical) cognitive function.

Data storage and safeguards The data will be stored on a password protected computer at St. Paul's Hospital in the Department of Otolaryngology on an encrypted Microsoft excel spreadsheet. The computer containing study data will be password-protected for access only by the principal investigator, co-investigator and study coordinator stored in a locked office, and backed-up remotely on to a secured hospital server. All hard copy documents will be kept in binders, in the Principal Investigator's office in a locked cabinet.

Patients participating in the study will all be assigned random study ID numbers. The study code is not derived from or related to the information about the individual, i.e., name, SIN, PHN, hospital number, DOB, address, or unique characteristic. These numbers will be used on all study documentation. Participant names are being stored separately from study data in a master list with the study ID numbers.

Data Monitoring Patients will continue to be assessed at routine follow up visits. Statistics will be completed after the study is complete on its objectives. Data will be also monitored on a continuous basis.

Statistical Analysis

Descriptive statistics will be used to summarize all demographic data, comorbidities, and adverse effects reported by the patients. Paired student t-tests will be applied to investigate the difference between the mean 3M Examination scores, MLK scores, SNOT-22 scores, before commencement of each treatment arm and subsequent MLK scores, SNOT-22 scores after treatment is complete. A running total of the treatment costs for each patient will be maintained. One way Anova test will be applied to investigate the difference between the mean costs for each treatment arm. Probability values less than 0.05 will be considered statistically significant.

Conditions

Chronic Sinusitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Private system endoscopic sinus surgery

Intervention Type: PROCEDURE

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

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.

Group Type: OTHER

Public system endoscopic sinus surgery

Intervention Type: PROCEDURE

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.

Medical Management Only

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

Group Type: OTHER

Budesonide

Intervention Type: DRUG

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

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Paul's Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Amin Javer

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Athena Pascual

Role: CONTACT

apascual@providencehealth.bc.ca

604-806-9926

Facility Contacts

Athenea Pascual, PHD

Role: primary

apascual@providencehealth.bc.ca

6048069926

Other Identifiers

H19-03659

Identifier Type: -

Identifier Source: org_study_id