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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05970458
Other study ID # 008/21/Surg
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date January 30, 2023

Study information

Verified date August 2023
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Quality of life assessment
EQ5D-5L and Stoma QoL

Locations

Country Name City State
Ethiopia Tikur Anbessa Specialized Hospital Addis Abeba

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Ethiopia, 

Outcome

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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