Determinants of Surgical Outcomes in Chronic Sinusitis
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|ClinicalTrials.gov Identifier: NCT00799097|
Recruitment Status : Completed
First Posted : November 27, 2008
Last Update Posted : May 20, 2010
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 or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||516 participants|
|Official Title:||Determinants of Surgical Outcomes in Chronic Sinusitis|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||December 2009|
Endoscopic Sinus Surgery
Subjects who have failed maximum medical management and have elected for endoscopic sinus surgery
- Disease specific quality of life [ Time Frame: Preoperatively, 6 months, 12 months, 18 months ]
- General quality of life [ Time Frame: Preoperatively, 6 months, 12 months, 18 months ]
- Olfactory function [ Time Frame: Preoperatively, 6 months, 12 months, 18 months ]
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
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Timothy L Smith, MD, MPH||Oregon Health and Science University|