Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis
This study is enrolling participants by invitation only.
Sponsor:
Oregon Health and Science University
Collaborator:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01332136
First received: April 7, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
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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 Oregon Health and Science University:
Primary Outcome Measures:
- Disease-specific quality of life [ Time Frame: 18 months post-treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- General health-related quality-of-life [ Time Frame: 18 months post-treatment ] [ Designated as safety issue: No ]
- Olfaction [ Time Frame: 18 months post-treatment ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Sinonasal mucosal tissue specimens
| Estimated Enrollment: | 978 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | March 2016 |
| Groups/Cohorts |
|---|
|
Endoscopic sinus surgery
Patients electing endoscopic sinus surgery for chronic rhinosinusitis
|
|
Medical management
Continued medical management for symptoms of chronic rhinosinusitis
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| 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 More Information
No publications provided
| Responsible Party: | Timothy L. Smith, MD, MPH, Oregon Health & Science University - Department of Otolaryngology |
| ClinicalTrials.gov Identifier: | NCT01332136 History of Changes |
| Other Study ID Numbers: | 2R01 DC005805 |
| Study First Received: | April 7, 2011 |
| Last Updated: | April 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Sinusitis Chronic Disease Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases |
Respiratory Tract Infections Otorhinolaryngologic Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013