Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT05970458
Collaborator
(none)
66
1
4
16.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Quality of life assessment

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 Design

Study Type:
Observational
Actual Enrollment :
66 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
Stoma Related Complications and Quality of Life Assessment: a Cross-sectional Study With Patients From Ethiopia and Sweden
Actual Study Start Date :
Oct 1, 2022
Actual Primary Completion Date :
Jan 30, 2023
Actual Study Completion Date :
Jan 30, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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

  1. Stoma complications [October 2022 to Jan 2023]

    Nipple necrosis, prolapse, parastomal hernia, leakage, itching, bleeding, pain

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tikur Anbessa Specialized Hospital Addis Abeba Ethiopia

Sponsors and Collaborators

  • Karolinska Institutet

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Åsa Hallqvist Everhov, Principal Investigator, Ass professor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT05970458
Other Study ID Numbers:
  • 008/21/Surg
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 4, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 4, 2023