Recruiting NCT04469439
Impact of Sinus Surgery on Individuals With Cystic Fibrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Rhinosinusitis (Diagnosis), Cystic Fibrosis. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of Sinus Surgery in the Era of Highly Effective Modulatory Therapy
Overview
This study will be a prospective, observational study of patients who undergo endoscopic sinus surgery for cystic fibrosis-related chronic rhinosinusitis (CRS). Individuals who do not undergo surgery but are treated medically for CRS will also be enrolled to serve as a control group. Outcomes analyzed will include pulmonary, quality of life, and others.
Primary outcome measures
- Change in pulmonary function [Time frame: baseline, 3, 6, 9, 12 months]
- Change in days of inpatient hospitalization [Time frame: baseline, 3, 6, 9, 12 months]
Secondary outcome measures (3)
- Change in quality of life [Time frame: baseline, 3, 6, 9, 12 months]
- Change in quality of life [Time frame: baseline, 3, 6, 9, 12 months]
- Change in olfaction [Time frame: baseline, 3, 6, 9, 12 months]
Eligibility criteria
Inclusion criteria
- Subjects between the ages of 18 years old (inclusive) and 99 years old (inclusive, subjects over the age of 89 will be recorded to be 89 years old).
- Diagnosed with cystic fibrosis as established by genetic testing combined with clinical assessment and/or sweat chloride
- Diagnosed with chronic rhinosinusitis by multidisciplinary sinusitis guidelines
- chronic rhinosinusitis symptoms persisting beyond initial medical treatment
- Counseled for endoscopic sinus surgery and ongoing medical therapy with each patient electing their preferred treatment
Exclusion criteria
- Underwent endoscopic sinus surgery in past 12 months
- Will obtain follow up care at non-participating institutions
- Unable to complete follow-up surveys
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 9 centers
- University of California, Los Angeles — Los Angeles
- Stanford University — Stanford
- University of Colorado — Aurora
- National Jewish Health — Denver
- University of North Carolina — Chapel Hill
- Oregon Health Science University — Portland
- Medical University of South Carolina — Charleston
- Vanderbilt University Medical Center — Nashville
- … and 1 more center
Publications
- Liu CM, Fischer JL, Lee MJ, Mace JC, Kimple AJ, Markarian K, Alt JA, Bodner TE, Chowdhury NI, Chung SY, Eshaghian PH, Gao YA, Getz AE, Hwang PH, Khanwalkar A, Lee JT, Li DA, Norris M, Nayak JV, Overdevest JB, Owens C, Patel ZM, Pappas LE, Poch K, Schlosser RJ, Smith KA, Smith TL, Soler ZM, Suh JD, Turner GA, Wang MB, Taylor-Cousar JL, Saavedra MT, Beswick DM. Olfaction, Eating Preference, and Qual PMID 40156369
- Liu CM, Fischer JL, Alt JA, Bodner TE, Chowdhury NI, Getz AE, Hwang PH, Kimple AJ, Mace JC, Smith TL, Soler ZM, Goss CH, Taylor-Cousar JL, Saavedra MT, Beswick DM. Impact of sinus surgery in people with cystic fibrosis and chronic rhinosinusitis in the era of highly effective modulator therapy: Protocol for a prospective observational study. PLoS One. 2024 Sep 26;19(9):e0310986. doi: 10.1371/journ PMID 39325787
- Han EJ, Liu CM, Fischer JL, Mace JC, Markarian K, Alt JA, Bodner TE, Chowdhury NI, Eshaghian PH, Gao YA, Getz AE, Hwang PH, Khanwalkar A, Kimple AJ, Lee JT, Li DA, Norris M, Nayak JV, Owens C, Patel ZM, Poch K, Schlosser RJ, Smith KA, Smith TL, Soler ZM, Suh JD, Turner GA, Wang MB, Taylor-Cousar JL, Saavedra MT, Beswick DM. Impact of sociodemographic status and sex on chronic rhinosinusitis and ol PMID 38967583
- Miller JE, Taylor-Cousar JL, Overdevest JB, Khatiwada A, Mace JC, Alt JA, Bodner TE, Chowdhury NI, DiMango EA, Eshaghian PH, Getz AE, Gudis DA, Han EJ, Hwang PH, Keating CL, Khanwalkar A, Kimple AJ, Lee JT, Li D, Markarian K, Norris M, Nayak JV, Owens C, Patel ZM, Poch K, Schlosser RJ, Smith KA, Smith TL, Soler ZM, Suh JD, Tervo JP, Turner GA, Wang MB, Saavedra MT, Beswick DM. Determining the mini PMID 38145393
Identifiers
NCT: NCT04469439 · 20-002079