QOL Outcomes in CRS With Polyps
Primary Purpose
Chronic Rhinosinusitis, Polyps
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medical optimization and education
Standard of Care sinus surgery
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis, Polyps
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
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Medical Optimization
Surgical treatment
Arm Description
Medical treatment and education x 4 months, re- eval at 4 months and possible cross-over to surgery
Surgical treatment up front
Outcomes
Primary Outcome Measures
SNOT-22
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03144375
Brief Title
QOL Outcomes in CRS With Polyps
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
inability to promptly see local allergists as part of medical maximization which lead to delays in care for these patients
Study Start Date
December 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis, Polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medical Optimization
Arm Type
Active Comparator
Arm Description
Medical treatment and education x 4 months, re- eval at 4 months and possible cross-over to surgery
Arm Title
Surgical treatment
Arm Type
Active Comparator
Arm Description
Surgical treatment up front
Intervention Type
Other
Intervention Name(s)
Medical optimization and education
Intervention Description
Medical treatment and education about the sinusitis disease process prior to surgery as compared to baseline surgical and treatment counseling
Intervention Type
Procedure
Intervention Name(s)
Standard of Care sinus surgery
Primary Outcome Measure Information:
Title
SNOT-22
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33129
Country
United States
12. IPD Sharing Statement
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QOL Outcomes in CRS With Polyps
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