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Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01332136
First Posted: April 8, 2011
Last Update Posted: March 29, 2016
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.
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Dr. Timothy L. Smith, Oregon Health and Science University
  Purpose
This research study will be completed by enrolling a prospective, observational cohort study to evaluate medical versus surgical treatment outcomes for chronic sinus disease. This investigation will compare quality of life outcomes between each treatment type, as well as measure cellular and molecular markers of inflammation in the sinus mucosa, to create models that predict improvement in quality of life following treatment.

Condition
Chronic Rhinosinusitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis

Resource links provided by NLM:


Further study details as provided by Dr. Timothy L. Smith, Oregon Health and Science University:

Primary Outcome Measures:
  • Disease-specific quality of life [ Time Frame: 18 months post-treatment ]

Secondary Outcome Measures:
  • General health-related quality-of-life [ Time Frame: 18 months post-treatment ]
  • Olfaction [ Time Frame: 18 months post-treatment ]

Biospecimen Retention:   Samples Without DNA
Sinonasal mucosal tissue specimens

Enrollment: 966
Study Start Date: April 2011
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Endoscopic sinus surgery
Patients electing endoscopic sinus surgery for chronic rhinosinusitis
Medical management
Continued medical management for symptoms of chronic rhinosinusitis

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients who have failed intial medical management for chronic sinusitis and have presented to a tertiary care clinic for continued treatment.
Criteria

Inclusion Criteria:

  • Adult (>= 18 years)
  • Chronic rhinosinusitis as defined by the 2007 multi-disciplinary adult sinusitis guidelines
  • Able to complete all surveys/questionnaires in English
  • Persistent symptoms following initial medical management
  • Received at least 1 course of broad spectrum antibiotics or culture directed antibiotics for at least a total of 14 days
  • Received at least a 3 week trial of topical steroid sprays OR at least a 5 day trial of systemic corticosteroid therapy.
  • Counseled for subsequent treatment options including either medical management or endoscopic sinus surgery

Exclusion Criteria:

  • Children (<18 years)
  • Unable to complete all surveys/questionnaires at baseline
  Contacts and Locations
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): NCT01332136


Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Institute on Deafness and Other Communication Disorders (NIDCD)
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Steele TO, Buniel MC, Mace JC, El Rassi E, Smith TL. Lymphoma of the nasal cavity and paranasal sinuses: A case series. Am J Rhinol Allergy. 2016 Sep;30(5):335-9. doi: 10.2500/ajra.2016.30.4347.
Cox DR, Ashby S, DeConde AS, Mace JC, Orlandi RR, Smith TL, Alt JA. Dyad of pain and depression in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2016 Mar;6(3):308-14. doi: 10.1002/alr.21664. Epub 2015 Nov 19.
Soler ZM, Hyer JM, Rudmik L, Ramakrishnan V, Smith TL, Schlosser RJ. Cluster analysis and prediction of treatment outcomes for chronic rhinosinusitis. J Allergy Clin Immunol. 2016 Apr;137(4):1054-1062. doi: 10.1016/j.jaci.2015.11.019. Epub 2016 Jan 22.
El Rassi E, Mace JC, Steele TO, Alt JA, Smith TL. Improvements in sleep-related symptoms after endoscopic sinus surgery in patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2016 Apr;6(4):414-22. doi: 10.1002/alr.21682. Epub 2015 Dec 17.
El Rassi E, Mace JC, Steele TO, Alt JA, Soler ZM, Fu R, Smith TL. Sensitivity analysis and diagnostic accuracy of the Brief Smell Identification Test in patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2016 Mar;6(3):287-92. doi: 10.1002/alr.21670. Epub 2015 Dec 1.
Alt JA, DeConde AS, Mace JC, Steele TO, Orlandi RR, Smith TL. Quality of Life in Patients With Chronic Rhinosinusitis and Sleep Dysfunction Undergoing Endoscopic Sinus Surgery: A Pilot Investigation of Comorbid Obstructive Sleep Apnea. JAMA Otolaryngol Head Neck Surg. 2015 Oct;141(10):873-81.
Tarasidis GS, DeConde AS, Mace JC, Ashby S, Smith TL, Orlandi RR, Alt JA. Cognitive dysfunction associated with pain and quality of life in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2015 Nov;5(11):1004-9. doi: 10.1002/alr.21578. Epub 2015 Jun 22.
Luk LJ, Steele TO, Mace JC, Soler ZM, Rudmik L, Smith TL. Health utility outcomes in patients undergoing medical management for chronic rhinosinusitis: a prospective multiinstitutional study. Int Forum Allergy Rhinol. 2015 Nov;5(11):1018-27. doi: 10.1002/alr.21588. Epub 2015 Jul 3.
DeConde AS, Mace JC, Ashby S, Smith TL, Orlandi RR, Alt JA. Characterization of facial pain associated with chronic rhinosinusitis using validated pain evaluation instruments. Int Forum Allergy Rhinol. 2015 Aug;5(8):682-90. doi: 10.1002/alr.21539. Epub 2015 Jun 13.
Soler ZM, Pallanch JF, Sansoni ER, Jones CS, Lawrence LA, Schlosser RJ, Mace JC, Smith TL. Volumetric computed tomography analysis of the olfactory cleft in patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2015 Sep;5(9):846-54. doi: 10.1002/alr.21552. Epub 2015 May 26.
Steele TO, Mace JC, Smith TL. Does comorbid anxiety predict quality of life outcomes in patients with chronic rhinosinusitis following endoscopic sinus surgery? Int Forum Allergy Rhinol. 2015 Sep;5(9):829-38. doi: 10.1002/alr.21543. Epub 2015 Apr 23.
Sansoni ER, Sautter NB, Mace JC, Smith TL, Yawn JR, Lawrence LA, Schlosser RJ, Soler ZM, Mulligan JK. Vitamin D3 as a novel regulator of basic fibroblast growth factor in chronic rhinosinusitis with nasal polyposis. Int Forum Allergy Rhinol. 2015 Mar;5(3):191-6. doi: 10.1002/alr.21474. Epub 2015 Jan 5.
DeConde AS, Mace JC, Alt JA, Rudmik L, Soler ZM, Smith TL. Longitudinal improvement and stability of the SNOT-22 survey in the evaluation of surgical management for chronic rhinosinusitis. Int Forum Allergy Rhinol. 2015 Mar;5(3):233-9. doi: 10.1002/alr.21458. Epub 2014 Dec 15.
DeConde AS, Mace JC, Bodner T, Hwang PH, Rudmik L, Soler ZM, Smith TL. SNOT-22 quality of life domains differentially predict treatment modality selection in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014 Dec;4(12):972-9. doi: 10.1002/alr.21408. Epub 2014 Oct 16.
DeConde AS, Mace JC, Alt JA, Soler ZM, Orlandi RR, Smith TL. Investigation of change in cardinal symptoms of chronic rhinosinusitis after surgical or ongoing medical management. Int Forum Allergy Rhinol. 2015 Jan;5(1):36-45. doi: 10.1002/alr.21410. Epub 2014 Sep 18.
DeConde AS, Barton MD, Mace JC, Smith TL. Can sinus anatomy predict quality of life outcomes and operative times of endoscopic frontal sinus surgery? Am J Otolaryngol. 2015 Jan-Feb;36(1):13-9. doi: 10.1016/j.amjoto.2014.08.011. Epub 2014 Aug 27.
Smith KA, Smith TL, Mace JC, Rudmik L. Endoscopic sinus surgery compared to continued medical therapy for patients with refractory chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014 Oct;4(10):823-7. doi: 10.1002/alr.21366. Epub 2014 Sep 11.
Detwiller KY, Smith TL, Alt JA, Trune DR, Mace JC, Sautter NB. Differential expression of innate immunity genes in chronic rhinosinusitis. Am J Rhinol Allergy. 2014 Sep-Oct;28(5):374-7. doi: 10.2500/ajra.2014.28.4082.
DeConde AS, Bodner TE, Mace JC, Smith TL. Response shift in quality of life after endoscopic sinus surgery for chronic rhinosinusitis. JAMA Otolaryngol Head Neck Surg. 2014 Aug;140(8):712-9. doi: 10.1001/jamaoto.2014.1045.
DeConde AS, Mace JC, Smith TL. The impact of comorbid gastroesophageal reflux disease on endoscopic sinus surgery quality-of-life outcomes. Int Forum Allergy Rhinol. 2014 Aug;4(8):663-9. doi: 10.1002/alr.21333. Epub 2014 Apr 10.
DeConde AS, Mace JC, Smith TL. The impact of comorbid migraine on quality-of-life outcomes after endoscopic sinus surgery. Laryngoscope. 2014 Aug;124(8):1750-5. doi: 10.1002/lary.24592. Epub 2014 Feb 20.
Alt JA, Mace JC, Buniel MC, Soler ZM, Smith TL. Predictors of olfactory dysfunction in rhinosinusitis using the brief smell identification test. Laryngoscope. 2014 Jul;124(7):E259-66. doi: 10.1002/lary.24587. Epub 2014 Feb 10.
Smith KA, Rudmik L. Impact of continued medical therapy in patients with refractory chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014 Jan;4(1):34-8. doi: 10.1002/alr.21238. Epub 2013 Oct 25.
Alt JA, Sautter NB, Mace JC, Detwiller KY, Smith TL. Antisomnogenic cytokines, quality of life, and chronic rhinosinusitis: a pilot study. Laryngoscope. 2014 Apr;124(4):E107-14. doi: 10.1002/lary.24412. Epub 2013 Oct 22.
Alt JA, Smith TL. Chronic rhinosinusitis and sleep: a contemporary review. Int Forum Allergy Rhinol. 2013 Nov;3(11):941-9. doi: 10.1002/alr.21217. Epub 2013 Aug 26. Review.
Alt JA, Smith TL, Mace JC, Soler ZM. Sleep quality and disease severity in patients with chronic rhinosinusitis. Laryngoscope. 2013 Oct;123(10):2364-70. doi: 10.1002/lary.24040. Epub 2013 Aug 5.
Soler ZM, Rudmik L, Hwang PH, Mace JC, Schlosser RJ, Smith TL. Patient-centered decision making in the treatment of chronic rhinosinusitis. Laryngoscope. 2013 Oct;123(10):2341-6. doi: 10.1002/lary.24027. Epub 2013 Jul 15.
Henriquez OA, Schlosser RJ, Mace JC, Smith TL, Soler ZM. Impact of synechiae after endoscopic sinus surgery on long-term outcomes in chronic rhinosinusitis. Laryngoscope. 2013 Nov;123(11):2615-9. doi: 10.1002/lary.24150. Epub 2013 May 13.
Detwiller KY, Smith TL, Mace JC, Trune DR, Sautter NB. Steroid-independent upregulation of matrix metalloproteinase 9 in chronic rhinosinusitis patients with radiographic evidence of osteitis. Int Forum Allergy Rhinol. 2013 May;3(5):364-8. doi: 10.1002/alr.21135. Epub 2013 Feb 8.

Responsible Party: Dr. Timothy L. Smith, Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01332136     History of Changes
Other Study ID Numbers: 2R01DC005805 ( U.S. NIH Grant/Contract )
First Submitted: April 7, 2011
First Posted: April 8, 2011
Last Update Posted: March 29, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases


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