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

This study has been completed.
Sponsor:
Collaborators:
Medical University of South Carolina
Northwestern University
University of Pennsylvania
Information provided by (Responsible Party):
Dr. Timothy L. Smith, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01255566
First received: December 6, 2010
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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
Chronic Rhinosinusitis
Sinusitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparison of Medical Therapy to Medical Therapy Plus Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Rhinosinusitis Disability Index and Chronic Sinusitis Survey [ Time Frame: Change from baseline to 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 186
Study Start Date: August 2009
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255566

Locations
United States, Illinois
Northwestern University
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
Sponsors and Collaborators
Oregon Health and Science University
Medical University of South Carolina
Northwestern University
University of Pennsylvania
  More Information

No publications provided by Oregon Health and Science University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Timothy L. Smith, Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01255566     History of Changes
Other Study ID Numbers: unfunded
Study First Received: December 6, 2010
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 30, 2014