QOL Outcomes in CRS With Polyps

NCT ID: NCT03144375

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-10-31

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.

Conditions

Chronic Rhinosinusitis, Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Medical Optimization

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

Group Type: ACTIVE_COMPARATOR

Medical optimization and education

Intervention Type: OTHER

Medical treatment and education about the sinusitis disease process prior to surgery as compared to baseline surgical and treatment counseling

Standard of Care sinus surgery

Intervention Type: PROCEDURE

Surgical treatment

Surgical treatment up front

Group Type: ACTIVE_COMPARATOR

Standard of Care sinus surgery

Intervention Type: PROCEDURE

Interventions

Medical optimization and education

Medical treatment and education about the sinusitis disease process prior to surgery as compared to baseline surgical and treatment counseling

Intervention Type: OTHER

Standard of Care sinus surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Corinna Levine

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20151068

Identifier Type: -

Identifier Source: org_study_id