Ostomy Belt Use Associated Quality of Life

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.

Study Overview

• Status: Completed
• Conditions: Stoma Ileostomy; Stoma Colostomy
• Intervention / Treatment: Device: Ostomy belt

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ostomy belt group; Participants in this group will receive ostomy belts for eight weeks.	Device: Ostomy belt; Stealth ostomy belt continuous for eight weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Vanessa Hui, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 20201333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No