Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden
1 other identifier
observational
66
1 country
1
Brief Summary
Cross-sectional comparative study of general and stoma-specific quality of life in patients with stoma in Addis Abeba, Ethiopia, and Stockholm, Sweden.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2023
CompletedFirst Submitted
Initial submission to the registry
July 24, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedAugust 4, 2023
August 1, 2023
4 months
July 24, 2023
August 2, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Stoma complications
October 2022 to Jan 2023
Study Arms (3)
Ethioperm
All patients with a permanent ostomy visiting the stoma center in Addis Abeba
EthioTemp
All patients waiting for ostomy reversal at Tikur Anbessa Specialized Hospital
SweSto
All patients visiting the stoma clinic at South General Hospital
Interventions
Eligibility Criteria
Adult patients (≥ 18 years old) with ileostomy or colostomy for more than two months, with willingness and ability to give informed consent
You may qualify if:
- adult patients (≥ 18 years old)
- having an ostomy for more than two months
- willingness and ability to give informed consent
You may not qualify if:
- non-intestinal stoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tikur Anbessa Specialized Hospital
Addis Ababa, Ethiopia
Related Publications (1)
Eklov K, Shiferaw A, Rosen A, Bekele S, Ayalew B; ACROSS Collaborative Group; Bringman S, Nygren J, Lofgren J, Everhov AH. Stoma-related complications and quality-of-life assessment: A cross-sectional study with patients from Ethiopia and Sweden. World J Surg. 2024 Jul;48(7):1739-1748. doi: 10.1002/wjs.12209. Epub 2024 May 14.
PMID: 38743388DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Åsa Everhov, MD PhD
Karolinska Institutet
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Ass professor
Study Record Dates
First Submitted
July 24, 2023
First Posted
August 1, 2023
Study Start
October 1, 2022
Primary Completion
January 30, 2023
Study Completion
January 30, 2023
Last Updated
August 4, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share