Impact of Sinus Surgery on Individuals With Cystic Fibrosis

University of California, Los Angeles (UCLA)

Status: Enrolling

Conditions: Cystic Fibrosis; Chronic Rhinosinusitis (Diagnosis)

Study type: Observational

Funder types: Other

Identifiers

NCT04469439

20-002079

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

170 participants in 2 patient groups

Surgical group

Description:

Individuals with cystic fibrosis and chronic rhinosinusitis who undergo endoscopic sinus surgery

Medical group

Description:

Individuals with cystic fibrosis and chronic rhinosinusitis who do not undergo endoscopic sinus surgery