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QOL Outcomes in CRS With Polyps

This study has been terminated.
(inability to promptly see local allergists as part of medical maximization which lead to delays in care for these patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT03144375
First Posted: May 8, 2017
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Corinna Levine, University of Miami
  Purpose

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.


Condition Intervention
Chronic Rhinosinusitis, Polyps Other: Medical optimization and education Procedure: Standard of Care sinus surgery

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

Further study details as provided by Corinna Levine, University of Miami:

Primary Outcome Measures:
  • SNOT-22 [ Time Frame: 4 months ]

Enrollment: 28
Study Start Date: December 2015
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Medical Optimization
Medical treatment and education x 4 months, re- eval at 4 months and possible cross-over to surgery
Other: Medical optimization and education
Medical treatment and education about the sinusitis disease process prior to surgery as compared to baseline surgical and treatment counseling
Procedure: Standard of Care sinus surgery
Active Comparator: Surgical treatment
Surgical treatment up front
Procedure: Standard of Care sinus surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144375


Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33129
Sponsors and Collaborators
University of Miami
  More Information

Responsible Party: Corinna Levine, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03144375     History of Changes
Other Study ID Numbers: 20151068
First Submitted: May 3, 2017
First Posted: May 8, 2017
Last Update Posted: May 8, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Polyps
Sinusitis
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases