Determinants of Surgical Outcomes in Chronic Sinusitis

NCT00799097 | Completed

• 2 other identifiers: R01 DC0005805R01DC005805
• Study Type: observational
• Target: 516
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• Disease specific quality of life

  Preoperatively, 6 months, 12 months, 18 months

Secondary Outcomes (2)

• General quality of life

  Preoperatively, 6 months, 12 months, 18 months

• Olfactory function

  Preoperatively, 6 months, 12 months, 18 months

Study Arms (1)

Endoscopic Sinus Surgery

Subjects who have failed maximum medical management and have elected for endoscopic sinus surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Unable to complete questionnaires or cooperate with studies
• Children (\<18 years)

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (28)

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

  PMID: 16270610 BACKGROUND

• Martin TJ, Yauck JS, Smith TL. Patients undergoing sinus surgery: constructing a demographic profile. Laryngoscope. 2006 Jul;116(7):1185-91. doi: 10.1097/01.mlg.0000224506.42567.6e.

  PMID: 16826058 BACKGROUND

• 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.

  PMID: 18216743 BACKGROUND

• 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. doi: 10.1097/01.mlg.0000182825.82910.80.

  PMID: 16369166 RESULT

• 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. doi: 10.1097/01.mlg.0000224575.12945.90.

  PMID: 16826060 RESULT

• 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. doi: 10.2500/ajr.2007.21.2978.

  PMID: 17283567 RESULT

• 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. doi: 10.2500/ajr.2007.21.3005.

  PMID: 17424882 RESULT

• Robinson JL, Griest S, James KE, Smith TL. Impact of aspirin intolerance on outcomes of sinus surgery. Laryngoscope. 2007 May;117(5):825-30. doi: 10.1097/MLG.0b013e3180333121.

  PMID: 17473677 RESULT

• 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. doi: 10.1097/MLG.0b013e31814539e8.

  PMID: 17891047 RESULT

• 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. doi: 10.1097/MLG.0b013e31815d74bb.

  PMID: 18043488 RESULT

• 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.

  PMID: 18588769 RESULT

• 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.

  PMID: 18588763 RESULT

• 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.

  PMID: 18702910 RESULT

• 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.

  PMID: 18702911 RESULT

• Soler ZM, Hyer JM, Rudmik L, Ramakrishnan V, Smith TL, Schlosser RJ. Cluster analysis and prediction of treatment outcomes for chronic rhinosinusitis. J Allergy Clin Immunol. 2016 Apr;137(4):1054-1062. doi: 10.1016/j.jaci.2015.11.019. Epub 2016 Jan 22.

  PMID: 26806047 DERIVED

• Rudmik L, Mace J, Soler ZM, Smith TL. Long-term utility outcomes in patients undergoing endoscopic sinus surgery. Laryngoscope. 2014 Jan;124(1):19-23. doi: 10.1002/lary.24135. Epub 2013 May 13.

  PMID: 23670699 DERIVED

• Soler ZM, Mace JC, Litvack JR, Smith TL. Chronic rhinosinusitis, race, and ethnicity. Am J Rhinol Allergy. 2012 Mar-Apr;26(2):110-6. doi: 10.2500/ajra.2012.26.3741.

  PMID: 22487286 DERIVED

• Rudmik L, Mace J, Ferguson BJ, Smith TL. Concurrent septoplasty during endoscopic sinus surgery for chronic rhinosinusitis: does it confound outcomes assessment? Laryngoscope. 2011 Dec;121(12):2679-83. doi: 10.1002/lary.22361. Epub 2011 Oct 27.

  PMID: 22034233 DERIVED

• Soler ZM, Wittenberg E, Schlosser RJ, Mace JC, Smith TL. Health state utility values in patients undergoing endoscopic sinus surgery. Laryngoscope. 2011 Dec;121(12):2672-8. doi: 10.1002/lary.21847. Epub 2011 Oct 27.

  PMID: 22034223 DERIVED

• Bhandarkar ND, Mace JC, Smith TL. The impact of osteitis on disease severity measures and quality of life outcomes in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2011 Sep-Oct;1(5):372-8. doi: 10.1002/alr.20068.

  PMID: 22028948 DERIVED

• Rudmik L, Mace JC, Smith TL. Smoking and endoscopic sinus surgery: does smoking volume contribute to clinical outcome. Int Forum Allergy Rhinol. 2011 May-Jun;1(3):145-52. doi: 10.1002/alr.20045.

  PMID: 21731825 DERIVED

• Rudmik L, Mace J, Smith T. Low-stage computed tomography chronic rhinosinusitis: what is the role of endoscopic sinus surgery? Laryngoscope. 2011 Feb;121(2):417-21. doi: 10.1002/lary.21382.

  PMID: 21271599 DERIVED

• Soler ZM, Sauer DA, Mace JC, Smith TL. Ethmoid histopathology does not predict olfactory outcomes after endoscopic sinus surgery. Am J Rhinol Allergy. 2010 Jul-Aug;24(4):281-5. doi: 10.2500/ajra.2010.24.3477.

  PMID: 20819467 DERIVED

• Khalid AN, Mace JC, Smith TL. Outcomes of sinus surgery in ambulatory patients with immune dysfunction. Am J Rhinol Allergy. 2010 May-Jun;24(3):230-3. doi: 10.2500/ajra.2010.24.3464.

  PMID: 20537292 DERIVED

• Mace JC, Michael YL, Carlson NE, Litvack JR, Smith TL. Correlations between endoscopy score and quality of life changes after sinus surgery. Arch Otolaryngol Head Neck Surg. 2010 Apr;136(4):340-6. doi: 10.1001/archoto.2010.34.

  PMID: 20403849 DERIVED

• Soler ZM, Hwang PH, Mace J, Smith TL. Outcomes after middle turbinate resection: revisiting a controversial topic. Laryngoscope. 2010 Apr;120(4):832-7. doi: 10.1002/lary.20812.

  PMID: 20232413 DERIVED

• Soler ZM, Sauer D, Mace J, Smith TL. Impact of mucosal eosinophilia and nasal polyposis on quality-of-life outcomes after sinus surgery. Otolaryngol Head Neck Surg. 2010 Jan;142(1):64-71. doi: 10.1016/j.otohns.2009.10.005. Epub 2009 Nov 22.

  PMID: 20096225 DERIVED

• Smith TL, Litvack JR, Hwang PH, Loehrl TA, Mace JC, Fong KJ, James KE. Determinants of outcomes of sinus surgery: a multi-institutional prospective cohort study. Otolaryngol Head Neck Surg. 2010 Jan;142(1):55-63. doi: 10.1016/j.otohns.2009.10.009.

  PMID: 20096224 DERIVED

Study Officials

• Timothy L Smith, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 26, 2008
• First Posted: November 27, 2008
• Study Start: July 1, 2004
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 20, 2010

Record last verified: 2008-11

Locations

US (1)