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Chronic RhinosinusitisNCT00799097

Determinants of Surgical Outcomes in Chronic Sinusitis

An observational study of Chronic Rhinosinusitis, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Rhinosinusitis
How many people
516 participants
Where
1 siteUnited States
Study dates
Jul 2004to Dec 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon Health & Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

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.

Read the 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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00799097
Study groupRoleWhat they receive
Endoscopic Sinus SurgerySubjects who have failed maximum medical management and have elected for endoscopic sinus surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease specific quality of life

    Measured: Preoperatively, 6 months, 12 months, 18 months

Secondary outcomes (2)

  1. General quality of life

    Measured: Preoperatively, 6 months, 12 months, 18 months

  2. Olfactory function

    Measured: Preoperatively, 6 months, 12 months, 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2008 (estimated)
  2. Study startJul 2004
  3. Primary completionJun 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
516 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00799097
Sponsor's protocol ID
R01 DC0005805
Other IDs
R01DC005805
Status last verified
Nov 2008
First submitted
26 Nov 2008
Last updated
20 May 2010
Results posted
No
Data monitoring committee
No

Publications

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

    PubMed 16270610

  • 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.

    PubMed 16826058

  • 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.

    PubMed 18216743

  • 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.

    PubMed 16369166

  • 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.

    PubMed 16826060

  • 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.

    PubMed 17283567

  • 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.

    PubMed 17424882

  • 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.

    PubMed 17473677

  • 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.

    PubMed 17891047

  • 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.

    PubMed 18043488

  • 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.

    PubMed 18588769

  • 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.

    PubMed 18588763

  • 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.

    PubMed 18702910

  • 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.

    PubMed 18702911

  • 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.

    PubMed 26806047

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Rhinosinusitis, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease specific quality of life (time frame: Preoperatively, 6 months, 12 months, 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00799097, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2010.

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