Stoma ColostomyNCT05970458
Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden
An observational study of Stoma Colostomy and Stoma Ileostomy, run by Karolinska Institutet at 1 site in Ethiopia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Colostomy, Stoma Ileostomy
- What is being tested?
- Quality of life assessment
- How many people
- 66 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Oct 2022to 30 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients (≥ 18 years old) with ileostomy or colostomy for more than two months, with willingness and ability to give informed consent
Who may be able to join
- adult patients (≥ 18 years old)
- having an ostomy for more than two months
- willingness and ability to give informed consent
Who cannot join
- non-intestinal stoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stoma Related Complications and Quality of Life Assessment: a Cross-sectional Study With Patients From 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.
Read the detailed 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.
- Conditions
- Stoma Colostomy, Stoma Ileostomy
- Being tested
- Quality of life assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life assessmentOther
EQ5D-5L and Stoma QoL
| Study group | Role | What they receive |
|---|---|---|
| Ethioperm | All patients with a permanent ostomy visiting the stoma center in Addis Abeba Receives: Other: Quality of life assessment | |
| EthioTemp | All patients waiting for ostomy reversal at Tikur Anbessa Specialized Hospital Receives: Other: Quality of life assessment | |
| SweSto | All patients visiting the stoma clinic at South General Hospital Receives: Other: Quality of life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: October 2022 to Jan 2023
Secondary outcomes (1)
Stoma complications
Nipple necrosis, prolapse, parastomal hernia, leakage, itching, bleeding, pain
Measured: October 2022 to Jan 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Oct 2022
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stoma ColostomyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Åsa Hallqvist Everhov, Karolinska Institutet
- Investigators
- Åsa Everhov, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970458
- Sponsor's protocol ID
- 008/21/Surg
- Status last verified
- Aug 2023
- First submitted
- 24 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38743388
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stoma Related Complications and Quality of Life Assessment: a Cross-sectional Study With Patients From Ethiopia and Sweden
- ClinicalTrials.gov ID
- NCT05970458
- Acronym / sponsor ID
- 008/21/Surg
- Conditions
- Stoma Colostomy, Stoma Ileostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ethioperm | – | Other: Quality of life assessmentAll patients with a permanent ostomy visiting the stoma center in Addis Abeba |
| EthioTemp | – | Other: Quality of life assessmentAll patients waiting for ostomy reversal at Tikur Anbessa Specialized Hospital |
| SweSto | – | Other: Quality of life assessmentAll patients visiting the stoma clinic at South General Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥ 18 years old) with ileostomy or colostomy for more than two months, with willingness and ability to give informed consent
Key inclusion criteria (3 listed)
- adult patients (≥ 18 years old)
- having an ostomy for more than two months
- willingness and ability to give informed consent
Key exclusion criteria (1 listed)
- non-intestinal stoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life assessmentEQ5D-5L and Stoma QoL | Other | EthioTemp, Ethioperm, SweSto |
Primary outcome
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).
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.
1 secondary outcome
Stoma complications
Time frame: October 2022 to Jan 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Derived from this study: PubMed 38743388Eklov 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.
- Individual participant dataSharing planned: No
Related trials for Stoma Colostomy
RecruitingObservational study
Parastomal Hernia at 1 and 3 Years: Radiological Incidence, Progression, and Impact on Quality of Life
Parastomal Hernia, Colorectal Cancer (Diagnosis)
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Active, not recruiting
The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
Ostomy - Ileostomy or Colostomy
RecruitingObservational study
Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma
Colostomy - Stoma, Ileostomy - Stoma
Active, not recruiting
Impact of Resilience Training on Quality of Life in New Ostomy Patients and Their Partners
Ileostomy - Stoma, Colostomy - Stoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Åsa Everhov, MD PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stoma Colostomy and Stoma Ileostomy, run by Karolinska Institutet at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General quality of life (time frame: October 2022 to Jan 2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05970458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.