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Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis

Oregon Health & Science University (OHSU) logo

Oregon Health & Science University (OHSU)

Status

Completed

Conditions

Chronic Rhinosinusitis

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT01332136
2R01DC005805

Details and patient eligibility

About

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.

Enrollment

966 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

966 participants in 2 patient groups

Endoscopic sinus surgery
Description:
Patients electing endoscopic sinus surgery for chronic rhinosinusitis
Medical management
Description:
Continued medical management for symptoms of chronic rhinosinusitis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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