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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
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis, Polyps

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts 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

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

First Posted
May 3, 2017
Last Updated
May 4, 2017
Sponsor
University of Miami
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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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