- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01255566
Medical Therapy Versus Sinus Surgery for Chronic Rhinosinusitis: A Prospective, Multi-institutional Study
A Comparison of Medical Therapy to Medical Therapy Plus Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis
This investigation is a prospective, multi-institutional cohort study comparing the differences in health-related quality-of-life (HRQoL) improvements between subjects electing continued medical management for chronic rhinosinusitis and those electing medical management plus surgical intervention.
Our hypothesis is 3 fold: 1. That patients electing continued medical management will have less disease severity as measured by CT and baseline HRQoL scores, 2. Patients undergoing medical management plus ESS for chronic rhinosinusitis will experience a larger improvement in health related quality of life (HRQoL)compared to patients electing medical management alone, and 3. Patients undergoing medical management plus ESS for chronic rhinosinusitis will use fewer antibiotics, systemic steroids, and miss fewer days of work/school compared to patients electing medical management alone.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults (>= 18 years old)
- Diagnosed with chronic rhinosinusitis
- Failed medical management to date
- Self-selected either sinus surgery or continued medical therapy as next treatment option
- Able to complete surveys in English
Exclusion Criteria:
- Unable to complete surveys in English
- Children (< 18 years old)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Medical therapy cohort
For patients electing continued medical therapy, medication was prescribed based on the disease process and the judgment of the treating rhinologist.
Treatment was not specifically dictated or prescribed by the study protocol.
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Surgical cohort
For patients electing ESS, surgery was performed by the enrolling rhinologist.
In addition, medical management was administered in the perioperative and postoperative periods as dictated by the disease process and the judgment of the treating rhinologist.
Treatment was not specifically dictated or prescribed by the study protocol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rhinosinusitis Disability Index and Chronic Sinusitis Survey
Time Frame: Change from baseline to 12 months
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The RSDI is a validated, disease-specific quality-of-life survey designed for patients with sinonasal disease.
The RSDI has three separate subscales incorporating 30 questions with a total score range of 0-120.
The CSS is a validated, 6 question survey with two separate subscales which measure the impact of sinonasal symptoms and medication use in the preceding 8-week period.
Total score range of 0-100 for total and subscale measures.
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Change from baseline to 12 months
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Collaborators and Investigators
Publications and helpful links
General Publications
- Smith TL, Kern R, Palmer JN, Schlosser R, Chandra RK, Chiu AG, Conley D, Mace JC, Fu RF, Stankiewicz J. Medical therapy vs surgery for chronic rhinosinusitis: a prospective, multi-institutional study with 1-year follow-up. Int Forum Allergy Rhinol. 2013 Jan;3(1):4-9. doi: 10.1002/alr.21065. Epub 2012 Jun 26.
- Smith TL, Kern RC, Palmer JN, Schlosser RJ, Chandra RK, Chiu AG, Conley D, Mace JC, Fu RF, Stankiewicz JA. Medical therapy vs surgery for chronic rhinosinusitis: a prospective, multi-institutional study. Int Forum Allergy Rhinol. 2011 Jul-Aug;1(4):235-41. doi: 10.1002/alr.20063. Epub 2011 Jun 6.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- unfunded (UBC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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