Impact of Sinus Surgery on Individuals With Cystic Fibrosis

Recruiting

• Conditions: Chronic Rhinosinusitis (Diagnosis); Cystic Fibrosis

• Registration Number: NCT04469439
• Lead Sponsor: University of California, Los Angeles

Brief Summary

This study will be a prospective, observational study of patients who undergo endoscopic sinus surgery for cystic fibrosis-related chronic rhinosinusitis (CRS). Individuals who do not undergo surgery but are treated medically for CRS will also be enrolled to serve as a control group. Outcomes analyzed will include pulmonary, quality of life, and others.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-14
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

1. Subjects between the ages of 18 years old (inclusive) and 99 years old (inclusive, subjects over the age of 89 will be recorded to be 89 years old).
2. Diagnosed with cystic fibrosis as established by genetic testing combined with clinical assessment and/or sweat chloride
3. Diagnosed with chronic rhinosinusitis by multidisciplinary sinusitis guidelines
4. chronic rhinosinusitis symptoms persisting beyond initial medical treatment
5. Counseled for endoscopic sinus surgery and ongoing medical therapy with each patient electing their preferred treatment

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Exclusion Criteria

1. Underwent endoscopic sinus surgery in past 12 months
2. Will obtain follow up care at non-participating institutions
3. Unable to complete follow-up surveys

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in pulmonary function	baseline, 3, 6, 9, 12 months	Pulmonary function will be measured using spirometry - the percent of predicted forced expiratory volume in the first second (ppFEV1)
Change in days of inpatient hospitalization	baseline, 3, 6, 9, 12 months	Days of inpatient hospitalization will be assessed

Secondary Outcome Measures

Name	Time	Method
Change in quality of life	baseline, 3, 6, 9, 12 months	Quality of life will be assessed using the Cystic Fibrosis Questionnaire-Revised instrument (range 0-100, with higher scores signifying worse quality of life)
Change in olfaction	baseline, 3, 6, 9, 12 months	Olfaction will be assessed using the Smell Identification Test (score range: 0-40, with higher scores demonstrated better olfactory ability)

Trial Locations

Locations (9)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

National Jewish Health; 🇺🇸 Denver, Colorado, United States

Oregon Health Science University; 🇺🇸 Portland, Oregon, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Stanford University; 🇺🇸 Stanford, California, United States