Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden

NCT ID: NCT05970458

Last Updated: 2023-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-01-30

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.

Conditions

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Stoma Colostomy Stoma Ileostomy

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Ethioperm

All patients with a permanent ostomy visiting the stoma center in Addis Abeba

Quality of life assessment

Intervention Type OTHER

EQ5D-5L and Stoma QoL

EthioTemp

All patients waiting for ostomy reversal at Tikur Anbessa Specialized Hospital

Quality of life assessment

Intervention Type OTHER

EQ5D-5L and Stoma QoL

SweSto

All patients visiting the stoma clinic at South General Hospital

Quality of life assessment

Intervention Type OTHER

EQ5D-5L and Stoma QoL

Interventions

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Quality of life assessment

EQ5D-5L and Stoma QoL

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Åsa Hallqvist Everhov

Principal Investigator, Ass professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Åsa Everhov, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Tikur Anbessa Specialized Hospital

Addis Ababa, , Ethiopia

Site Status

Countries

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Ethiopia

References

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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.

Reference Type DERIVED
PMID: 38743388 (View on PubMed)

Other Identifiers

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008/21/Surg

Identifier Type: -

Identifier Source: org_study_id

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