Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden

Stoma Ileostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05970458
• Other study ID #: 008/21/Surg
• Status: Completed
• Start date: October 1, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: August 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stoma Colostomy
• Stoma Ileostomy

Intervention

Other:
• Quality of life assessment
EQ5D-5L and Stoma QoL

Locations

Country	Name	City	State
Ethiopia	Tikur Anbessa Specialized Hospital	Addis Abeba

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Ethiopia, 

Outcome

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