Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis

This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

National Institute on Deafness and Other Communication Disorders (NIDCD)

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

Tracking Information
First Received Date ^ICMJE	April 7, 2011
Last Updated Date	April 7, 2011
Start Date ^ICMJE	April 2011
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: April 7, 2011)	Disease-specific quality of life [ Time Frame: 18 months post-treatment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: April 7, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis
Official Title ^ICMJE	Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: Sinonasal mucosal tissue specimens
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.
Condition ^ICMJE	Chronic Rhinosinusitis
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Endoscopic sinus surgery Patients electing endoscopic sinus surgery for chronic rhinosinusitis Medical management Continued medical management for symptoms of chronic rhinosinusitis
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	978
Estimated Completion Date	March 2016
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 90 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01332136
Other Study ID Numbers ^ICMJE	2R01 DC005805
Has Data Monitoring Committee	No
Responsible Party	Timothy L. Smith, MD, MPH, Oregon Health & Science University - Department of Otolaryngology
Study Sponsor ^ICMJE	Oregon Health and Science University
Collaborators ^ICMJE	National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators ^ICMJE	Not Provided
Information Provided By	Oregon Health and Science University
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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