Stoma Ileostomy Clinical Trial
Official title:
Stoma Related Complications and Quality of Life Assessment: a Cross-sectional Study With Patients From Ethiopia and Sweden
Verified date | August 2023 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Cross-sectional comparative study of general and stoma-specific quality of life in patients with stoma in Addis Abeba, Ethiopia, and Stockholm, Sweden.
Status | Completed |
Enrollment | 66 |
Est. completion date | January 30, 2023 |
Est. primary completion date | January 30, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Ethiopia | Tikur Anbessa Specialized Hospital | Addis Abeba |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Ethiopia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | General quality of life | 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). | October 2022 to Jan 2023 | |
Primary | Stoma-specific quality of life | 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. | October 2022 to Jan 2023 | |
Secondary | Stoma complications | Nipple necrosis, prolapse, parastomal hernia, leakage, itching, bleeding, pain | October 2022 to Jan 2023 |
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