Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05970458

Enrollment

Registered

2023-08-01

Start date

2022-10-01

Completion date

2023-01-30

Last updated

2023-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stoma Colostomy, Stoma Ileostomy

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.

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.

Interventions

OTHERQuality of life assessment

EQ5D-5L and Stoma QoL

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
General quality of life	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	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.

Secondary

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

Countries

Ethiopia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026