Impact of Sinus Surgery on Individuals With Cystic Fibrosis

ConditionsChronic Rhinosinusitis (Diagnosis)Cystic Fibrosis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-99

SponsorUniversity of California, Los Angeles

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Diagnosed with cystic fibrosis as established by genetic testing combined with clinical assessment and/or sweat chloride

Diagnosed with chronic rhinosinusitis by multidisciplinary sinusitis guidelines

chronic rhinosinusitis symptoms persisting beyond initial medical treatment

Disqualifiers

Underwent endoscopic sinus surgery in past 12 months

Will obtain follow up care at non-participating institutions

Unable to complete follow-up surveys

Trial population

Subjects will be recruited from cystic fibrosis and otolaryngology outpatient clinics.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

170 Participants

are grouped into 2 trial groups

Group A: Surgical group

Group B: Medical group

Trial outcomes

Primary outcomes

Change in pulmonary function

Pulmonary function will be measured using spirometry - the percent of predicted forced expiratory volume in the first second (ppFEV1)

Time frame

baseline, 3, 6, 9, 12 months

Change in days of inpatient hospitalization

Days of inpatient hospitalization will be assessed

Time frame

baseline, 3, 6, 9, 12 months

Secondary outcomes

Change in quality of life

Quality of life will be assessed using the 22-question SinoNasal Outcome test (range 0-110, with higher scores signifying worse quality of life)

Time frame

baseline, 3, 6, 9, 12 months

Change in quality of life

Quality of life will be assessed using the Cystic Fibrosis Questionnaire-Revised instrument (range 0-100, with higher scores signifying worse quality of life)

Time frame

baseline, 3, 6, 9, 12 months

Change in olfaction

Olfaction will be assessed using the Smell Identification Test (score range: 0-40, with higher scores demonstrated better olfactory ability)

Time frame

baseline, 3, 6, 9, 12 months

Other outcomes

Patient satisfaction regarding treatment for chronic rhinosinusitis

Satisfaction will be assessed using 5-point Likert scales, ranging from 1 to 5 with 1 signifying "not important" and 5 signifying "very important"

Time frame

at baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

Cystic Fibrosis Foundation

Collaborator

Source ClinicalTrials.gov

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