Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis

This study has been completed.
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Dr. Timothy L. Smith, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01332136
First received: April 7, 2011
Last updated: March 28, 2016
Last verified: March 2016

April 7, 2011
March 28, 2016
April 2011
March 2016   (final data collection date for primary outcome measure)
Disease-specific quality of life [ Time Frame: 18 months post-treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01332136 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Sinonasal mucosal tissue specimens
Non-Probability Sample
Adult patients who have failed intial medical management for chronic sinusitis and have presented to a tertiary care clinic for continued treatment.
Chronic Rhinosinusitis
Not Provided
  • Endoscopic sinus surgery
    Patients electing endoscopic sinus surgery for chronic rhinosinusitis
  • Medical management
    Continued medical management for symptoms of chronic rhinosinusitis

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
966
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01332136
2R01DC005805
No
Not Provided
Not Provided
Dr. Timothy L. Smith, Oregon Health and Science University
Oregon Health and Science University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Not Provided
Oregon Health and Science University
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP