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Clinical Trials/NCT03144375
NCT03144375
Terminated
Not Applicable

Comparison of Outcomes After Peri-operative Optimization and Standard Surgical Treatment or Standard of Care Surgical Treatment in Patients Who Have Chronic Rhinosinusitis With Polyposis.

University of Miami1 site in 1 country28 target enrollmentDecember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Rhinosinusitis, Polyps
Sponsor
University of Miami
Enrollment
28
Locations
1
Primary Endpoint
SNOT-22
Status
Terminated
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
October 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Corinna Levine

Assistant Professor

University of Miami

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

Outcomes

Primary Outcomes

SNOT-22

Time Frame: 4 months

Study Sites (1)

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