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

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ClinicalTrials.gov Identifier: NCT04291118
Recruitment Status : Recruiting
First Posted : March 2, 2020
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Amin Javer, St. Paul's Hospital, Canada

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : February 10, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
Drug Information available for: Budesonide

Arm Intervention/treatment
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.

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.

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.




Primary Outcome Measures :
  1. Change in Modified mini mental state examination [ Time Frame: 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 :
  1. Change in Cognitive failures Questionnaire [ Time Frame: 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.

  2. Change in Sino-nasal Outcome Test-22 (SNOT-22) scores: [ Time Frame: 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.

  3. Change in Nasal endoscopy [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04291118


Contacts
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Contact: Athena Pascual 604-806-9926 apascual@providencehealth.bc.ca

Locations
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Canada, British Columbia
E.N.T. Clinic, St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Athenea Pascual, PHD    6048069926    apascual@providencehealth.bc.ca   
Principal Investigator: Amin R Javer, MD,FRCSC,FARS         
Sponsors and Collaborators
St. Paul's Hospital, Canada

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Responsible Party: Amin Javer, Clinical Professor, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT04291118    
Other Study ID Numbers: H19-03659
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amin Javer, St. Paul's Hospital, Canada:
Endoscopic Sinus Surgery
Medical Management
Cognitive Dysfunction
Modified Mini Mental State Examination
Additional relevant MeSH terms:
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Sinusitis
Cognition Disorders
Cognitive Dysfunction
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Neurocognitive Disorders
Mental Disorders
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists