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OpenTrials
Completed

NCT Number: NCT04715893

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.

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Key information

Conditions

Stoma Ileostomy Stoma Colostomy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ostomy belt

Other

Stealth ostomy belt continuous for eight weeks

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 20, 2021
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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