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Clinical Trials/NCT01332136
NCT01332136
Completed
Not Applicable

Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis

Oregon Health and Science University1 site in 1 country966 target enrollmentApril 2011
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ConditionsChronic Rhinosinusitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Rhinosinusitis
Sponsor
Oregon Health and Science University
Enrollment
966
Locations
1
Primary Endpoint
Disease-specific quality of life
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
March 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Timothy L. Smith

Professor

Oregon Health and Science University

Eligibility 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

Outcomes

Primary Outcomes

Disease-specific quality of life

Time Frame: 18 months post-treatment

Secondary Outcomes

  • Olfaction(18 months post-treatment)
  • General health-related quality-of-life(18 months post-treatment)

Study Sites (1)

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