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Completed

NCT Number: NCT05970458

Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden

Cross-sectional comparative study of general and stoma-specific quality of life in patients with stoma in Addis Abeba, Ethiopia, and Stockholm, Sweden.

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Key information

Conditions

Stoma Colostomy Stoma Ileostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tikur Anbessa Specialized Hospital

Addis Ababa, Ethiopia

About this study

Objective: To evaluate the quality of life for patients with ostomy in Ethiopia and Sweden using a general and a specific assessment tool.

Design: Comparative descriptive cross-sectional study. Setting: Tikur Anbessa Specialized Hospital (TASH), Addis Abeba and South General Hospital, Stockholm.

Participants/Exposure: Patients with a permanent ostomy visiting the stoma center in Addis Abeba, patients waiting for ostomy reversal at TASH, and patients visiting the stoma clinic at South General Hospital.

Main outcomes and measure: Quality of life and stoma specific quality of life: EQ5D-5L and Stoma QoL.

Who can participate

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

Inclusion criteria

  • adult patients (≥ 18 years old)
  • having an ostomy for more than two months
  • willingness and ability to give informed consent

Exclusion criteria

  • non-intestinal stoma

Treatment and study plan

Quality of Life Assessment

Other

EQ5D-5L and Stoma QoL

Primary outcomes

  1. General quality of life

    Time frame: October 2022 to Jan 2023

    Overall health through visual analogue scale (VAS) from zero (the worst imaginable health) to 100 (the best imaginable health) from the European Quality of Life 5 Dimensions 5 Level Version (EQ5D-5L).

  2. Stoma-specific quality of life

    Time frame: October 2022 to Jan 2023

    The Stoma Quality of life questionnaire consists of 20 questions about stoma-specific aspects of quality of life where each variable is valued equally. Answers are graded in a four-point scale; 1: always, 2: sometimes, 3: rarely, and 4: not at all, with a maximum score of 80. The higher score the better QoL. To get a comparable overall result, the total score (range 20-80) can be converted to a zero to 100 score.

Secondary outcomes

  1. Stoma complications

    Time frame: October 2022 to Jan 2023

    Nipple necrosis, prolapse, parastomal hernia, leakage, itching, bleeding, pain

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Stoma Related Complications and Quality of Life Assessment: a Cross-sectional Study With Patients From Ethiopia and Sweden

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2023
Registry last updated
Aug 4, 2023

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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