Medical Therapy Versus Sinus Surgery for Chronic Rhinosinusitis: A Prospective, Multi-institutional Study
|ClinicalTrials.gov Identifier: NCT01255566|
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : April 24, 2013
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.
|Condition or disease|
|Chronic Rhinosinusitis Sinusitis|
|Study Type :||Observational|
|Actual Enrollment :||186 participants|
|Official Title:||A Comparison of Medical Therapy to Medical Therapy Plus Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||August 2012|
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.
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.
- Rhinosinusitis Disability Index and Chronic Sinusitis Survey [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255566
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|