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Ostomy Belt Use Associated Quality of Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04715893
Recruitment Status : Enrolling by invitation
First Posted : January 20, 2021
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
Vanessa Hui, University of Miami

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stoma Ileostomy Stoma Colostomy Device: Ostomy belt Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Ostomy Belt Use Associated Quality of Life
Actual Study Start Date : February 22, 2021
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in quality of life as measured by SQOLS [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04715893


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Vanessa Hui, MD University of Miami
More Information
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Responsible Party: Vanessa Hui, Assistant Professor of Clinical Surgery, University of Miami
ClinicalTrials.gov Identifier: NCT04715893    
Other Study ID Numbers: 20201333
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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