Clinical trial NCT01255566: Medical Therapy Versus Sinus Surgery for Chronic Rhinosinusitis: A Prospective, Multi-institutional Study
Official title: A Comparison of Medical Therapy to Medical Therapy Plus Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Rhinosinusitis
Sinusitis
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: Northwestern University
name: University of Pennsylvania
First posted: 2010-12-07
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult subjects (\> 18 years) were prospectively enrolled from four tertiary rhinology practices including Oregon Health \& Science University (OHSU); Northwestern University (NWU); Medical University of South Carolina (MUSC); and the University of Pennsylvania (UPenn). All patients were diagnosed with chronic rhinosinusitis (CRS) as defined by the 2007 Adult Sinusitis Guidelines.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rhinosinusitis Disability Index and Chronic Sinusitis Survey
timeFrame: Change from baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
citation: 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.
citation: 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.