Ostomy Belt Use Associated Quality of Life

NCT ID: NCT04715893

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-22

Study Completion Date

2024-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Stoma Ileostomy Stoma Colostomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Ostomy belt group

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

Group Type EXPERIMENTAL

Ostomy belt

Intervention Type OTHER

Stealth ostomy belt continuous for eight weeks

Interventions

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Ostomy belt

Stealth ostomy belt continuous for eight weeks

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Vanessa Hui

Assistant Professor of Clinical Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vanessa Hui, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20201333

Identifier Type: -

Identifier Source: org_study_id

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