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OpenTrials
Completed

NCT Number: NCT01332136

Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis

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.

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Key information

Conditions

Chronic Rhinosinusitis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Disease-specific quality of life

    Time frame: 18 months post-treatment

Secondary outcomes

  1. General health-related quality-of-life

    Time frame: 18 months post-treatment

  2. Olfaction

    Time frame: 18 months post-treatment

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Apr 8, 2011
Registry last updated
Mar 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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