Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden

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

Detailed Description
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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.

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

Conditions
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Stoma Colostomy, Stoma Ileostomy

Intervention / Treatment
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* Other: Quality of life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ethioperm<br>All patients with a permanent ostomy visiting the stoma center in Addis Abeba | Other: Quality of life assessment<br>* EQ5D-5L and Stoma QoL<br>|
| EthioTemp<br>All patients waiting for ostomy reversal at Tikur Anbessa Specialized Hospital | Other: Quality of life assessment<br>* EQ5D-5L and Stoma QoL<br>|
| SweSto<br>All patients visiting the stoma clinic at South General Hospital | Other: Quality of life assessment<br>* EQ5D-5L and Stoma QoL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stoma complications | Nipple necrosis, prolapse, parastomal hernia, leakage, itching, bleeding, pain | October 2022 to Jan 2023 |