CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 516 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT00799097
NCT00799097N/ACompleted

Determinants of Surgical Outcomes in Chronic Sinusitis

Oregon Health and Science University·observational·Posted Nov 27, 2008·Updated May 20, 2010

In Brief

An observational study for Chronic Rhinosinusitis. Completed, enrolled 516 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 27, 2008
Enrollment StartJul 1, 2004
Primary CompletionJun 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 17.6 years ago