Medical Therapy Versus Sinus Surgery for Chronic Rhinosinusitis: A Prospective, Multi-institutional Study

Completed

• Conditions: Chronic Rhinosinusitis; Sinusitis

• Registration Number: NCT01255566
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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.

Detailed Description

Chronic rhinosinusitis (CRS) is a common health condition in the United States resulting in more than 500,000 surgical procedures annually. Since CRS is a disease process that is known to adversely affect quality of life, it is important to understand the short-term and long-term implications of different treatment options as documented by our patients' perception of their quality of life.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-06
• Study First Posted: 2010-12-07
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-23
• Last Update Posted: 2013-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rhinosinusitis Disability Index and Chronic Sinusitis Survey	Change from baseline to 12 months	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.

Trial Locations

Locations (3)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States