Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis

March 28, 2016 updated by: Dr. Timothy L. Smith, Oregon Health and Science University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

966

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Endoscopic sinus surgery
Patients electing endoscopic sinus surgery for chronic rhinosinusitis
Medical management
Continued medical management for symptoms of chronic rhinosinusitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-specific quality of life
Time Frame: 18 months post-treatment
18 months post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
General health-related quality-of-life
Time Frame: 18 months post-treatment
18 months post-treatment
Olfaction
Time Frame: 18 months post-treatment
18 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 7, 2011

First Submitted That Met QC Criteria

April 7, 2011

First Posted (Estimate)

April 8, 2011

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2R01DC005805 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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