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

Sponsor

St. Paul's Hospital, Canada (Other)

Overall Status

Unknown status

CT.gov ID

NCT04291118

Collaborator

(none)

150

Enrollment

Location

Arms

19.7

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Sinusitis	Procedure: Private system endoscopic sinus surgery Procedure: Public system endoscopic sinus surgery Drug: Budesonide	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

New patients diagnosed with CRS (with or without polyps) who will receive medical or/and surgical management will be recruited for the study. They will be separated into one of 3 study arms based on the clinical care they require.New patients diagnosed with CRS (with or without polyps) who will receive medical or/and surgical management will be recruited for the study. They will be separated into one of 3 study arms based on the clinical care they require.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

A Comparative Study Assessing Improvement in Cognitive Deficit Secondary to CRS in Patients Treated With Medical Vs Surgical Management: A Prospective Trial

Actual Study Start Date :

Feb 10, 2020

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: 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.
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.	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.
Other: Medical Management Only These patients will only receive medical management for their symptoms as they will not require sinus surgery.	Drug: 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.

Arm

Intervention/Treatment

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.

Procedure: 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.

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.

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.

Other: Medical Management Only

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

Drug: 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.

Outcome Measures

Primary Outcome Measures

Change in Modified mini mental state examination [Before starting medical or surgical management and then 6 months after]
This short test consists of questions to assess memory which will take 5-10 minutes to complete.

Secondary Outcome Measures

Change in Cognitive failures Questionnaire [Before starting medical or surgical management and then 6 months after]
This includes 25 questions for patients to self-report everyday errors of perception, memory and motor functioning. It is scored out of 100 with higher score indicating worse more cognitive failures.
Change in Sino-nasal Outcome Test-22 (SNOT-22) scores: [Before starting medical or surgical management and then 6 months after]
This is a standard of care form that includes 22 questions about symptoms and social/emotional consequences of participants nasal disorder. Participants will be asked to rate their problems based on the past two weeks. The questionnaire is out of 110 points with higher score indicating worse symptoms.
Change in Nasal endoscopy [Before starting medical or surgical management and then 6 months after]
This is standard-of-care at St. Paul's Sinus Centre. Participants sinuses will be examined using an instrument called an endoscope which is a metal rod with a camera attached at the end. During the sinus examination, pictures and scores of the sinuses will be recorded. Endoscopic score are given from 0-2 based on endoscopic evidence of polyps, edema and discharge. A higher score indicates worse symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)