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Determinants of Surgical Outcomes in Chronic Sinusitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00799097
First Posted: November 27, 2008
Last Update Posted: May 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:
Oregon Health and Science University
  Purpose

Chronic rhinosinusitis (CRS) is a common health condition in the United States resulting in more than 200,000 surgical procedures annually. The field of rhinology has had two major advances which the investigators believe make more accurate prediction of postoperative outcome possible thereby offering the potential of reducing the frequency of unsuccessful surgical procedures. The first advance is the development of validated disease-specific quality of life instruments for measuring outcome of CRS management. The major medical societies now recognize disease-specific quality of life as the gold standard for assessing outcomes in this disease and for the purposes of this study, the investigators define surgical outcome as change in disease-specific quality of life (QOL). The second advance is the better understanding of the pathological process resulting in CRS. The previous construct defined this disease as anatomic obstruction of the sinuses and their secretions. This was thought to be best measured by CT scan which has been the main method of attempting to select the best candidates for surgery.

The investigators hypothesize that utilizing this new conceptual framework, the investigators can better predict surgical outcomes. The investigators will examine several preoperative factors and their relationship to surgical outcome. The factors to be examined include measures of the pathophysiological components of inflammation and anatomic obstruction as well as preoperative extent of disease as measured by preoperative disease-specific quality of life. The investigators hypothesize that these factors provide complimentary information that may be variably expressed in individual CRS patients. Therefore, the investigators hypothesize that a novel integration of multiple preoperative factors will form a useful predictive model of surgical outcome. Finally this prospective study provides the opportunity to add to the field by identifying potentially novel risk factors and comorbidities as well as study secondary outcomes of sinus surgery including olfactory function and general health related quality of life in a systematic manner.


Condition
Chronic Rhinosinusitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinants of Surgical 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: Preoperatively, 6 months, 12 months, 18 months ]

Secondary Outcome Measures:
  • General quality of life [ Time Frame: Preoperatively, 6 months, 12 months, 18 months ]
  • Olfactory function [ Time Frame: Preoperatively, 6 months, 12 months, 18 months ]

Enrollment: 516
Study Start Date: July 2004
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Endoscopic Sinus Surgery
Subjects who have failed maximum medical management and have elected for endoscopic sinus surgery

Detailed Description:

A cohort of 500+ patients with CRS undergoing sinus surgery at three centers will be prospectively enrolled. Patient demographics, comorbidity data, objective testing, and QOL evaluation will occur preoperatively and outcomes (QOL and olfactory testing) will be measured 6, 12, and 18 months postoperatively. Determinants of change in QOL will be analyzed by univariate and multivariate methods including construction of a multivariate predictive model.

This proposal focuses on patients undergoing surgical intervention for the management of CRS. The findings can potentially be applied to the 200,000 patients annually undergoing sinus surgery and in working toward the long-term goal of developing a comprehensive system for measuring extent of disease so that disease severity and treatment response can be rigorously quantified in the 30 million patients with CRS.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The multi-institutional study population consists of adult (>17 years) patients who have had a diagnosis of chronic rhinosinusitis, have failed maximum medical management,and have elected for endoscopic sinus surgery as their next treatment option.
Criteria

Inclusion Criteria:

  • Adult (18 years and older) (see Inclusion of Children)
  • CRS by Rhinosinusitis Task Force criteria
  • Symptoms persisting following standard medical management as outlined in the Research Design and Methods.
  • Elect sinus surgery and give informed consent.
  • Patient must be able to travel to the Institution of enrollment for evaluation, treatment, and follow up.
  • Patient must be able to complete a questionnaire with the assistance of the Study Coordinator and be able to cooperate with endoscopy, olfactory and CT studies.
  • Patient (if White) selected by randomized enrollment technique

Exclusion Criteria:

  • Unable to complete questionnaires or cooperate with studies
  • Children (<18 years)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799097


Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Timothy L Smith, MD, MPH Oregon Health and Science University
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Timothy L. Smith, MD, MPH, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00799097     History of Changes
Other Study ID Numbers: R01 DC0005805
R01DC005805 ( U.S. NIH Grant/Contract )
First Submitted: November 26, 2008
First Posted: November 27, 2008
Last Update Posted: May 20, 2010
Last Verified: November 2008

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases