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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 186 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Rhinosinusitis
• Sinusitis

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-07-01
• Completion: 2012-08-01
• First posted: 2010-12-07
• Last updated: 2013-04-24

Locations

3 sites across 1 country: United States