Determinants of Olfactory Dysfunction in Chronic Rhinosinusitis
NCT ID: NCT02720653
Last Updated: 2022-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
418 participants
OBSERVATIONAL
2016-07-01
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Appropriate Medical Therapy
Patients will self-select continued, non-standardized, appropriate medical management of symptoms associated with chronic sinusitis.
No interventions assigned to this group
Endoscopic Sinus Surgery
Patients will self-select endoscopic sinus surgery for symptoms associated with chronic sinusitis.
Endoscopic sinus surgery
Interventions
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Endoscopic sinus surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A diagnosis of medical recalcitrant CRS as defined by 2015 Adult Sinusitis Guidelines outlined by the American Academy of Otolaryngology
* Provide written informed consent and authorization.
* Study participants must be able to complete consent, all study evaluations, olfactory testing, and study-related health questionnaires written in the English language.
* Patients must self-select subsequent treatment option (endoscopic sinus surgery or continued medical therapy) to be dictated by the disease process and judgment and preferences of each individual, following counseling for each treatment option.
* Present to the enrolling site with indication for a CT scan or a CT scan completed, off-site, from another provider
* Complete appropriate standardized medical treatment by the Interim Assessment, 6-week follow-up period including, but not limited to, at least one course of either topical corticosteroids (\>21-days) or a 5-day course of oral corticosteroid therapy, and at least one course (\>14-days) of culture-directed or broad spectrum antibiotic therapy.
* Individuals of any vulnerable population including: children, pregnant women, neonates, decisionally impaired adults, or prisoners.
Exclusion Criteria
* Any patient unable and/or unwilling to complete questionnaires or clinical testing or cooperate with all study protocols.
* Non-English speaking / English translation services required
* Unwilling or unable to provide informed, written consent.
* Contra-indications for any type of continued medical therapy required for treatment of symptoms related to CRS
18 Years
100 Years
ALL
No
Sponsors
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Medical University of South Carolina
OTHER
Oregon Health and Science University
OTHER
Responsible Party
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Dr. Timothy L. Smith
Professor, Chief of Rhinology
References
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Patel PA, Kallenberger EM, Nguyen SA, Mace JC, Duffy AN, Soler ZM, Smith TL, Schlosser RJ. Factors Affecting Nasal Discharge in Chronic Rhinosinusitis Patients. Laryngoscope. 2025 May 26. doi: 10.1002/lary.32288. Online ahead of print.
Pandrangi VC, Mace JC, Kim JH, Geltzeiler M, Detwiller KY, Soler ZM, Schlosser RJ, Alt JA, Ramakrishnan VR, Mattos JL, Smith TL. Work productivity and activity impairment in patients with chronic rhinosinusitis undergoing endoscopic sinus surgery-A prospective, multi-institutional study. Int Forum Allergy Rhinol. 2023 Mar;13(3):216-229. doi: 10.1002/alr.23070. Epub 2022 Aug 23.
Gill AS, Beswick DM, Mace JC, Menjivar D, Ashby S, Rimmer RA, Ramakrishnan VR, Soler ZM, Alt JA. Evaluating Distance Bias in Chronic Rhinosinusitis Outcomes. JAMA Otolaryngol Head Neck Surg. 2022 Jun 1;148(6):507-514. doi: 10.1001/jamaoto.2022.0268.
Allensworth JJ, Schlosser RJ, Smith TL, Mace JC, Soler ZM. Use of the Diet History Questionnaire III to determine the impact of dysosmia on dietary quality. Int Forum Allergy Rhinol. 2022 Jun;12(6):849-858. doi: 10.1002/alr.22926. Epub 2021 Dec 18.
Soler ZM, Schlosser RJ, Bodner TE, Alt JA, Ramakrishnan VR, Mattos JL, Mulligan JK, Mace JC, Smith TL. Endotyping chronic rhinosinusitis based on olfactory cleft mucus biomarkers. J Allergy Clin Immunol. 2021 May;147(5):1732-1741.e1. doi: 10.1016/j.jaci.2021.01.021. Epub 2021 Feb 4.
Beswick DM, Smith TL, Mace JC, Alt JA, Farrell NF, Ramakrishnan VR, Schlosser RJ, Soler ZM. Ethmoid-to-maxillary opacification ratio: a predictor of postoperative olfaction and outcomes in nasal polyposis? Int Forum Allergy Rhinol. 2021 Jan;11(1):48-57. doi: 10.1002/alr.22625. Epub 2020 Jun 18.
Thomas AJ, Mace JC, Ramakrishnan VR, Alt JA, Mattos JL, Schlosser RJ, Soler ZM, Smith TL. Quality-of-life and olfaction changes observed with short-term medical management of chronic rhinosinusitis. Int Forum Allergy Rhinol. 2020 May;10(5):656-664. doi: 10.1002/alr.22532. Epub 2020 Feb 3.
Beswick DM, Ayoub NF, Mace JC, Mowery A, Hwang PH, Smith TL. Acute Exacerbations in Recurrent Acute Rhinosinusitis: Differences in Quality of Life and Endoscopy. Laryngoscope. 2020 Dec;130(12):E736-E741. doi: 10.1002/lary.28460. Epub 2019 Dec 14.
Loftus C, Schlosser RJ, Smith TL, Alt JA, Ramakrishnan VR, Mattos JL, Mappus E, Storck K, Yoo F, Soler ZM. Olfactory cleft and sinus opacification differentially impact olfaction in chronic rhinosinusitis. Laryngoscope. 2020 Oct;130(10):2311-2318. doi: 10.1002/lary.28332. Epub 2019 Oct 11.
Beswick DM, Mace JC, Soler ZM, Rudmik L, Alt JA, Smith KA, Detwiller KY, Ramakrishnan VR, Smith TL. Socioeconomic status impacts postoperative productivity loss and health utility changes in refractory chronic rhinosinusitis. Int Forum Allergy Rhinol. 2019 Sep;9(9):1000-1009. doi: 10.1002/alr.22374. Epub 2019 Jun 27.
Smith TL, Schlosser RJ, Mace JC, Alt JA, Beswick DM, DeConde AS, Detwiller KY, Mattos JL, Soler ZM. Long-term outcomes of endoscopic sinus surgery in the management of adult chronic rhinosinusitis. Int Forum Allergy Rhinol. 2019 Aug;9(8):831-841. doi: 10.1002/alr.22369. Epub 2019 Jun 17.
Alt JA, Orlandi RR, Mace JC, Soler ZM, Smith TL. Does Delaying Endoscopic Sinus Surgery Adversely Impact Quality-of-Life Outcomes? Laryngoscope. 2019 Feb;129(2):303-311. doi: 10.1002/lary.27473. Epub 2018 Sep 12.
Beswick DM, Mace JC, Rudmik L, Soler ZM, DeConde AS, Smith TL. Productivity changes following medical and surgical treatment of chronic rhinosinusitis by symptom domain. Int Forum Allergy Rhinol. 2018 Dec;8(12):1395-1405. doi: 10.1002/alr.22191. Epub 2018 Jul 28.
Beswick DM, Mace JC, Soler ZM, Ayoub NF, Rudmik L, DeConde AS, Smith TL. Appropriateness criteria predict outcomes for sinus surgery and may aid in future patient selection. Laryngoscope. 2018 Nov;128(11):2448-2454. doi: 10.1002/lary.27227. Epub 2018 May 14.
Mattos JL, Schlosser RJ, Mace JC, Smith TL, Soler ZM. Establishing the minimal clinically important difference for the Questionnaire of Olfactory Disorders. Int Forum Allergy Rhinol. 2018 Sep;8(9):1041-1046. doi: 10.1002/alr.22135. Epub 2018 May 2.
Othieno F, Schlosser RJ, Rowan NR, Storck KA, Mattos JL, Smith TL, Soler ZM. Taste impairment in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2018 Jul;8(7):783-789. doi: 10.1002/alr.22113. Epub 2018 Mar 23.
Smith TL. THE 2017 13TH ANNUAL DAVID W. KENNEDY, MD, LECTURE The evolution of outcomes in sinus surgery for chronic rhinosinusitis: past, present, and future. Int Forum Allergy Rhinol. 2017 Dec;7(12):1121-1126. doi: 10.1002/alr.22026. Epub 2017 Oct 13.
Beswick DM, Mace JC, Chowdhury NI, Alt JA, Hwang PH, DeConde AS, Smith TL. Comparison of surgical outcomes between patients with unilateral and bilateral chronic rhinosinusitis. Int Forum Allergy Rhinol. 2017 Dec;7(12):1162-1169. doi: 10.1002/alr.22020. Epub 2017 Sep 22.
DeConde AS, Mace JC, Ramakrishnan VR, Alt JA, Smith TL. Analysis of factors associated with electing endoscopic sinus surgery. Laryngoscope. 2018 Feb;128(2):304-310. doi: 10.1002/lary.26788. Epub 2017 Aug 4.
Other Identifiers
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DC005805-11
Identifier Type: -
Identifier Source: org_study_id
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