NCT04715893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

January 17, 2025

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

January 14, 2021

Last Update Submit

January 15, 2025

Conditions

Stoma IleostomyStoma Colostomy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Ostomy belt group

EXPERIMENTAL

Participants in this group will receive ostomy belts for eight weeks.

Other: Ostomy belt

Interventions

Ostomy beltOTHER

Stealth ostomy belt continuous for eight weeks

Ostomy belt group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current patients at University of Miami Hospital with stoma willing to trial an ostomy belt
  • years old
  • Willing and able to sign informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Study Officials

  • Vanessa Hui, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Surgery

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 20, 2021

Study Start

February 22, 2021

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

January 17, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)