Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden

Completed

• Conditions: Stoma Colostomy; Stoma Ileostomy
• Interventions: Other: Quality of life assessment

• Registration Number: NCT05970458
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2023-01-30
• Study Completion: 2023-01-30
• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-07-24
• Status Verified: 2023-08
• Study First Posted: 2023-08-01
• Last Update Submitted: 2023-08-02
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ethioperm	Quality of life assessment	All patients with a permanent ostomy visiting the stoma center in Addis Abeba
EthioTemp	Quality of life assessment	All patients waiting for ostomy reversal at Tikur Anbessa Specialized Hospital
SweSto	Quality of life assessment	All patients visiting the stoma clinic at South General Hospital

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Stoma complications	October 2022 to Jan 2023	Nipple necrosis, prolapse, parastomal hernia, leakage, itching, bleeding, pain

Trial Locations

Locations (1)

Tikur Anbessa Specialized Hospital; 🇪🇹 Addis Abeba, Ethiopia