Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden

August 2, 2023 updated by: Åsa Hallqvist Everhov, Karolinska Institutet

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
      • Addis Abeba, Ethiopia
        • Tikur Anbessa Specialized Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients (≥ 18 years old) with ileostomy or colostomy for more than two months, with willingness and ability to give informed consent

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ethioperm
All patients with a permanent ostomy visiting the stoma center in Addis Abeba
Other: Quality of life assessment
EQ5D-5L and Stoma QoL
EthioTemp
All patients waiting for ostomy reversal at Tikur Anbessa Specialized Hospital
Other: Quality of life assessment
EQ5D-5L and Stoma QoL
SweSto
All patients visiting the stoma clinic at South General Hospital
Other: Quality of life assessment
EQ5D-5L and Stoma QoL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
October 2022 to Jan 2023
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.
October 2022 to Jan 2023

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Åsa Everhov, MD PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

January 30, 2023

Study Completion (Actual)

January 30, 2023

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 008/21/Surg

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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