Stoma Colostomy, Stoma Ileostomy
Conditions
Brief 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.
Interventions
OTHEROstomy belt
Stealth ostomy belt continuous for eight weeks
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life as measured by SQOLS | Baseline to 4 weeks, baseline to 8 weeks post ostomy belt use | 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. |
Countries
United States
Outcome results
None listed