Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT05970458
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2023-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-02', 'studyFirstSubmitDate': '2023-07-24', 'studyFirstSubmitQcDate': '2023-07-24', 'lastUpdatePostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'General quality of life', 'timeFrame': 'October 2022 to Jan 2023', 'description': '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).'}, {'measure': 'Stoma-specific quality of life', 'timeFrame': 'October 2022 to Jan 2023', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Stoma complications', 'timeFrame': 'October 2022 to Jan 2023', 'description': 'Nipple necrosis, prolapse, parastomal hernia, leakage, itching, bleeding, pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stoma Colostomy', 'Stoma Ileostomy']}, 'referencesModule': {'references': [{'pmid': '38743388', 'type': 'DERIVED', 'citation': 'Eklov K, Shiferaw A, Rosen A, Bekele S, Ayalew B; ACROSS Collaborative Group; Bringman S, Nygren J, Lofgren J, Everhov AH. Stoma-related complications and quality-of-life assessment: A cross-sectional study with patients from Ethiopia and Sweden. World J Surg. 2024 Jul;48(7):1739-1748. doi: 10.1002/wjs.12209. Epub 2024 May 14.'}]}, 'descriptionModule': {'briefSummary': 'Cross-sectional comparative study of general and stoma-specific quality of life in patients with stoma in Addis Abeba, Ethiopia, and Stockholm, Sweden.', 'detailedDescription': 'Objective: To evaluate the quality of life for patients with ostomy in Ethiopia and Sweden using a general and a specific assessment tool.\n\nDesign: Comparative descriptive cross-sectional study. Setting: Tikur Anbessa Specialized Hospital (TASH), Addis Abeba and South General Hospital, Stockholm.\n\nParticipants/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.\n\nMain outcomes and measure: Quality of life and stoma specific quality of life: EQ5D-5L and Stoma QoL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (≥ 18 years old) with ileostomy or colostomy for more than two months, with willingness and ability to give informed consent', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients (≥ 18 years old)\n* having an ostomy for more than two months\n* willingness and ability to give informed consent\n\nExclusion Criteria:\n\n* non-intestinal stoma'}, 'identificationModule': {'nctId': 'NCT05970458', 'briefTitle': 'Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Stoma Related Complications and Quality of Life Assessment: a Cross-sectional Study With Patients From Ethiopia and Sweden', 'orgStudyIdInfo': {'id': '008/21/Surg'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ethioperm', 'description': 'All patients with a permanent ostomy visiting the stoma center in Addis Abeba', 'interventionNames': ['Other: Quality of life assessment']}, {'label': 'EthioTemp', 'description': 'All patients waiting for ostomy reversal at Tikur Anbessa Specialized Hospital', 'interventionNames': ['Other: Quality of life assessment']}, {'label': 'SweSto', 'description': 'All patients visiting the stoma clinic at South General Hospital', 'interventionNames': ['Other: Quality of life assessment']}], 'interventions': [{'name': 'Quality of life assessment', 'type': 'OTHER', 'description': 'EQ5D-5L and Stoma QoL', 'armGroupLabels': ['EthioTemp', 'Ethioperm', 'SweSto']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Addis Ababa', 'country': 'Ethiopia', 'facility': 'Tikur Anbessa Specialized Hospital', 'geoPoint': {'lat': 9.02497, 'lon': 38.74689}}], 'overallOfficials': [{'name': 'Åsa Everhov, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Ass professor', 'investigatorFullName': 'Åsa Hallqvist Everhov', 'investigatorAffiliation': 'Karolinska Institutet'}}}}