Determinants of Surgical Outcomes in Chronic Sinusitis

Chronic Rhinosinusitis Clinical Trial

Official title:

Determinants of Surgical Outcomes in Chronic Sinusitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799097
• Other study ID #: R01 DC0005805
• Secondary ID: R01DC005805
• Status: Completed
• Phase: N/A
• First received: November 26, 2008
• Last updated: May 19, 2010
• Start date: July 2004
• Est. completion date: December 2009

Study information

• Verified date: November 2008
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Rhinosinusitis

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (14)

Chester AC, Sindwani R, Smith TL, Bhattacharyya N. Fatigue improvement following endoscopic sinus surgery: a systematic review and meta-analysis. Laryngoscope. 2008 Apr;118(4):730-9. doi: 10.1097/MLG.0b013e318161e57b. Review. — View Citation

Litvack JR, Griest S, James KE, Smith TL. Endoscopic and quality-of-life outcomes after revision endoscopic sinus surgery. Laryngoscope. 2007 Dec;117(12):2233-8. — View Citation

Mace J, Michael YL, Carlson NE, Litvack JR, Smith TL. Effects of depression on quality of life improvement after endoscopic sinus surgery. Laryngoscope. 2008 Mar;118(3):528-34. — View Citation

Martin TJ, Yauck JS, Smith TL. Patients undergoing sinus surgery: constructing a demographic profile. Laryngoscope. 2006 Jul;116(7):1185-91. — View Citation

Mendolia-Loffredo S, Laud PW, Sparapani R, Loehrl TA, Smith TL. Sex differences in outcomes of sinus surgery. Laryngoscope. 2006 Jul;116(7):1199-203. — View Citation

Poetker DM, Litvack JR, Mace JC, Smith TL. Recurrent acute rhinosinusitis: presentation and outcomes of sinus surgery. Am J Rhinol. 2008 May-Jun;22(3):329-33. doi: 10.2500/ajr.2008.22.3177. — View Citation

Poetker DM, Mendolia-Loffredo S, Smith TL. Outcomes of endoscopic sinus surgery for chronic rhinosinusitis associated with sinonasal polyposis. Am J Rhinol. 2007 Jan-Feb;21(1):84-8. — View Citation

Reh DD, Mace J, Robinson JL, Smith TL. Impact of age on presentation of chronic rhinosinusitis and outcomes of endoscopic sinus surgery. Am J Rhinol. 2007 Mar-Apr;21(2):207-13. — View Citation

Robinson JL, Griest S, James KE, Smith TL. Impact of aspirin intolerance on outcomes of sinus surgery. Laryngoscope. 2007 May;117(5):825-30. — View Citation

Sautter NB, Mace J, Chester AC, Smith TL. The effects of endoscopic sinus surgery on level of fatigue in patients with chronic rhinosinusitis. Am J Rhinol. 2008 Jul-Aug;22(4):420-6. doi: 10.2500/ajr.2008.22.3196. — View Citation

Smith TL, Mendolia-Loffredo S, Loehrl TA, Sparapani R, Laud PW, Nattinger AB. Predictive factors and outcomes in endoscopic sinus surgery for chronic rhinosinusitis. Laryngoscope. 2005 Dec;115(12):2199-205. — View Citation

Soler ZM, Mace J, Smith TL. Fibromyalgia and chronic rhinosinusitis: outcomes after endoscopic sinus surgery. Am J Rhinol. 2008 Jul-Aug;22(4):427-32. doi: 10.2500/ajr.2008.22.3198. — View Citation

Soler ZM, Mace J, Smith TL. Symptom-based presentation of chronic rhinosinusitis and symptom-specific outcomes after endoscopic sinus surgery. Am J Rhinol. 2008 May-Jun;22(3):297-301. doi: 10.2500/ajr.2008.22.3172. — View Citation

Stewart MG, Smith TL. Objective versus subjective outcomes assessment in rhinology. Am J Rhinol. 2005 Sep-Oct;19(5):529-35. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease specific quality of life		Preoperatively, 6 months, 12 months, 18 months	No
Secondary	General quality of life		Preoperatively, 6 months, 12 months, 18 months	No
Secondary	Olfactory function		Preoperatively, 6 months, 12 months, 18 months	No