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Clinical Trials/NCT03144375
NCT03144375TerminatedNot 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 enrollmentStarted: December 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
28
Locations
1
Primary Endpoint
SNOT-22

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Care Provider)

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Medical Optimization

Active Comparator

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

Intervention: Medical optimization and education (Other)

Medical Optimization

Active Comparator

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

Intervention: Standard of Care sinus surgery (Procedure)

Surgical treatment

Active Comparator

Surgical treatment up front

Intervention: Standard of Care sinus surgery (Procedure)

Outcomes

Primary Outcomes

SNOT-22

Time Frame: 4 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Corinna Levine

Assistant Professor

University of Miami

Study Sites (1)

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