Response Shift in Sinus Surgery Outcomes

NCT01391910 | Completed

• 1 other identifier: 40578-E/A
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of the study are: 1)to assess pre and post-operative Quality of Life (QOL) as measured by the Sino-Nasal Outcomes Test(SNOT)-20 questionnaire and 2)determine the significance of response shift on treatment effect. This is a prospective cohort study. The investigators will recruit patients who are within a 6 month post-functional endoscopic sinus surgery (FESS) timeframe and completed a pre-operative SNOT-20. The investigators will ask subjects to complete two more SNOT-20 forms and a Transition Quality of Life (QOL) scale. The SNOT-20 forms will be labelled "pre" and "post" operative. The "pre" should be completed based on subject's memory of their condition prior to surgery and "post" based on how they feel now.

Conditions

Chronic Rhinosinusitis

Keywords

rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• Sino-Nasal Outcome 20 (SNOT-20)

  The SNOT-20 "pre" and "post" surgery will be compared to the pre-surgery SNOT-20

  6 months post surgery

Study Arms (1)

post endoscopic sinus surgery for chronic rhinosinusitis

Patients who have undergone functional endoscopic sinus surgery for treatment of chronic rhinosinusitis and completed a pre-surgery SNOT-20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be surgery patients from Dr. Davis' clinic at the University of Washington. They will have undergone FESS for treatment of CRS.

You may qualify if:

• age greater than 18 years
• ICD 9 code for CRS and CPT code for FESS
• completed a pre-operative SNOT-20 questionnaire
• within 6 months of surgical treatment
• pts. of PI

You may not qualify if:

• unable to give informed consent or complete questionnaires written in English due to cognitive impairment, language barriers or severe medical conditions
• CRS secondary to malignancy
• incomplete or incorrectly completed pre-operative SNOT-20

Sponsors & Collaborators

• Greg Davis: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Rhinosinusitis

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Greg E Davis, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 12, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

US (1)