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Early Versus Late Surgical Wait Times

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02636790
Recruitment Status : Unknown
Verified May 2018 by Arif Janjua, University of British Columbia.
Recruitment status was:  Not yet recruiting
First Posted : December 22, 2015
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Arif Janjua, University of British Columbia

Brief Summary:
The sinus surgical wait list in British Columbia continues to grow. The current wait list is beyond what is acceptable by the province's standard; however, this is not likely to improve given the budget constraints of the health care system. The outcome of having patients to wait longer than medically reasonable for surgery, not only affects the patients' quality of life but presents financial difficulties, both directly to the patient, the healthcare system and the economy as a whole. Therefore, the investigators need to determine which patients need to be prioritized for surgery. The investigators will follow two groups of patients - one group from Stanford University who get surgery always before 8 weeks and compare them to patients on the VGH wait list which is often more than one year.

Condition or disease Intervention/treatment Phase
Rhinosinusitis Procedure: Surgery wait time Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Is Prioritization of the Sinus Surgical Waitlist Required?
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Active Comparator: Surgery wait time (< 8 weeks)
Outcomes of patients with sinus surgery of less than 8 weeks.
Procedure: Surgery wait time
VCH CRS patients need a waitlist system that promotes wellness and ensures care that focuses on quality - this can be achieved with a prioritized waitlist based on quality of life improvement and decreased healthcare expenditure.

Active Comparator: Surgery wait time (> 1 year)
Outcomes of patients with sinus surgery of more than 1 year.
Procedure: Surgery wait time
VCH CRS patients need a waitlist system that promotes wellness and ensures care that focuses on quality - this can be achieved with a prioritized waitlist based on quality of life improvement and decreased healthcare expenditure.




Primary Outcome Measures :
  1. Questionnaire relating to demographics. [ Time Frame: 30 min to complete questionnaire (once) ]
    Patient demographic information to be completed once after surgery to determine if there is a distinct group of chronic Rhinosinusitis patients who would benefit from early surgical intervention.

  2. Change relating to personal costs over 1 year following surgery. [ Time Frame: 30 min to complete questionnaire, every two months for 1 year (post-surgery). ]
    Personal costs related to surgical wait times.

  3. Change to the quality of life over 1 year following surgery based on the WPAI-SHP questionnaire. [ Time Frame: 10 min to complete questionnaire, every two months for 1 year (post-surgery). ]
    The questionnaire WPAI-SHP relates to quality of life after surgery. The Work Productivity and Activity - Specific Health Problem (WPAI:SHP) is a validated instrument to evaluate impairment of daily activities and work productivity associated with a specific health problem (Chronic Rhinosinusitis).

  4. Change to the quality of life over 1 year following surgery based on the SNOT-22 questionnaire. [ Time Frame: 10 min to complete questionnaire, every two months for 1 year (post-surgery). ]
    The questionnaire SNOT-22 relates to quality of life after surgery. SNOT-22 is a disease-specific health-related quality of life instrument in CRS patients.

  5. Change to the quality of life over 1 year following surgery based on the EQ5-D questionnaire. [ Time Frame: 10 min to complete questionnaire, every two months for 1 year (post-surgery). ]
    The questionnaire EQ5-D relates to quality of life after surgery. The EQ-5D has 5 questions addressing: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with CRS based on 2 major symptoms (congestion, facial pain, nasal obstruction, nasal discharge, decreased sense of smell) and evidence of sino-nasal inflammation on CT scan and nasal endoscopy. Symptoms must also be present for >12 weeks.

Exclusion Criteria:

  • History of or requiring surgery for a sino-nasal tumour

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): NCT02636790


Contacts
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Contact: Andrew Thamboo, MD 650-308-6376 andrew.thamboo@gmail.com
Contact: Javier Ospina, MD 604-715-8276 jospinadiaz@gmail.com

Locations
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Canada, British Columbia
UBC - Department of Surgery Division of Otolaryngology - Head and Neck Surgery
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Arif Janjua, MD    604-875-8296    dr.janjua.office@gmail.com   
Contact: Javier Ospina, MD    604-715-8276    jospinadiaz@gmail.com   
UBC
Vancouver, British Columbia, Canada, V6H 0A5
Contact: Vancouver G Hospital, MD    6048758296    janjua.arif@gmail.com   
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Arif Janjua, MD UBC
Publications:
Mickleburgh, R. (2013, January 18). Ministers says BC wait lists too long. The Globe and Mail, Health Care, http://m.theglobeandmail.com/news/british-columbia/minister-says-bc-wait-lists-too-long/article7508904/?service=mobile (accessed on January 30, 2013).
The economic cost of wait times in Canada. Retrieved from www.cma.ca/multimedia/CMA/Content.../EconomicReport.pdf (accessed on February 2, 2013).
Western Canada Waiting List Investigators .(2013). Retrieved on February 2, 2013 from http://www.wcwl.ca/.
Bhattacharyya, N., Orlandi, R., & Martinson, M. (2010). Cost Burden of Chronic Rhinosinusitis A Claims-Based Study. Otolaryngology--Head and Neck Surgery, 143(2 suppl), P127-P127.
EuroQoL Group. EQ-5D. [Online] [Cited: January 30, 2013.] http://www.euroqol.org/.
Diggle, P.J., Heagerty, P., Liang K-Y. and Zeger, S.L. (2002). Analysis of Longitudinal Data (second edition). Oxford: Oxford University Press.

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Responsible Party: Arif Janjua, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02636790    
Other Study ID Numbers: H15-02020
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No