QOL Outcomes in CRS With Polyps

Chronic Rhinosinusitis, Polyps Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03144375
• Other study ID #: 20151068
• Status: Terminated
• Phase: N/A
• First received: May 3, 2017
• Last updated: May 4, 2017
• Start date: December 2015
• Est. completion date: October 2016

Study information

• Verified date: May 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis, Polyps
• Polyps
• Sinusitis

Intervention

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

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SNOT-22		4 months