QOL Outcomes in CRS With Polyps

University of Miami

Status: Terminated

Conditions: Chronic Rhinosinusitis, Polyps

Treatments: Other: Medical optimization and education; Procedure: Standard of Care sinus surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03144375

20151068

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Medical Optimization

Active Comparator group

Description:

Medical treatment and education x 4 months, re- eval at 4 months and possible cross-over to surgery

Treatment:

Other: Medical optimization and education

Procedure: Standard of Care sinus surgery

Surgical treatment

Active Comparator group

Description:

Surgical treatment up front

Treatment:

Procedure: Standard of Care sinus surgery