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Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis

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: NCT01332136
Recruitment Status : Completed
First Posted : April 8, 2011
Last Update Posted : March 29, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Chronic Rhinosinusitis

Study Design

Study Type : Observational
Actual Enrollment : 966 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis
Study Start Date : April 2011
Primary Completion Date : March 2016
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Endoscopic sinus surgery
Patients electing endoscopic sinus surgery for chronic rhinosinusitis
Medical management
Continued medical management for symptoms of chronic rhinosinusitis


Outcome Measures

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

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

Biospecimen Retention:   Samples Without DNA
Sinonasal mucosal tissue specimens

Eligibility Criteria

Information from the National Library of Medicine

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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):

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 Posted: April 8, 2011    Key Record Dates
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