QOL Outcomes in CRS With Polyps

Not Applicable

Terminated

• Conditions: Chronic Rhinosinusitis, Polyps
• Interventions: Other: Medical optimization and education; Procedure: Standard of Care sinus surgery

• Registration Number: NCT03144375
• Lead Sponsor: University of Miami

Brief Summary

Chronic rhinosinusits (CRS) is common disease with reports of prevalence ranging from 4-16% in the western population. The main outcome measure for chronic disease treatment, such as CRS, is quality of life. Several large multi-institutional studies have shown that improvement in disease specific Quality of life was greater in patients who had surgery for their CRS with polyps. The timing of surgery in these patients has not been well studied but it is generally agreed upon that surgical candidates much had failed medical management. The definition of medical management varies greatly but usually includes some form of nasal or oral steroids and a prolonged ( \>10 days) course of antibiotics.

Another known way to improve QOL is through education and individualized optimization. This has been utilized successfully in other fields with good success and improved QOL. Similar studies looking at combining non-surgical optimization and education have not been performed in CRS. This study aims to address this potential area for improvement in patient quality of life outcomes. Investigators plan to assess the potential role for pre-operative non-surgical medical and educational optimization in CRS standard of care treatment.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-12
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-05
• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-04
• Last Update Submitted: 2017-05-04
• Study First Posted: 2017-05-08
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Adults with Rhinosinusitis with polyps who have had appropriate treatment qualifying them for surgery and are good surgical candidates

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Exclusion Criteria

• Cystic fibrosis, Cilia disorders, other specialized forms of sinus disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Medical Optimization	Standard of Care sinus surgery	Medical treatment and education x 4 months, re- eval at 4 months and possible cross-over to surgery
Surgical treatment	Standard of Care sinus surgery	Surgical treatment up front
Medical Optimization	Medical optimization and education	Medical treatment and education x 4 months, re- eval at 4 months and possible cross-over to surgery

Primary Outcome Measures

Name	Time	Method
SNOT-22	4 months

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States