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NCT04715893 Clinical Trial

Ostomy Belt Use Associated Quality of Life

Stoma Ileostomy Clinical Trial

Official title:
Ostomy Belt Use Associated Quality of Life

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04715893
Other study ID # 20201333
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 22, 2021
Est. completion date February 28, 2024

Study information
Verified date February 2024
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to elucidate whether the use of an ostomy belt can improve the quality of life in patients with an ostomy.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date February 28, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Current patients at University of Miami Hospital with stoma willing to trial an ostomy belt - 18 - 70 years old - Willing and able to sign informed consent Exclusion Criteria: - Patients without stoma or unwilling to wear ostomy belt. - Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Ostomy belt
Stealth ostomy belt continuous for eight weeks

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 Change in quality of life as measured by SQOLS Quality of life will be assessed using the Stoma Quality of Life Scale questionnaire (SQOLS) with a range in score from 0 to 100 in overall satisfaction in life with a higher score indicating higher satisfaction. Baseline to 4 weeks, baseline to 8 weeks post ostomy belt use
See also
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