Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis

This study is enrolling participants by invitation only.
Sponsor:
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
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332136

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
  More Information

No publications provided by Oregon Health and Science University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 April 17, 2014