Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT06456918
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2024-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ValidationTurkishVersionQualityofRecovery-15
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 510}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-09', 'studyFirstSubmitDate': '2024-06-09', 'studyFirstSubmitQcDate': '2024-06-09', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To validate the QoR-15', 'timeFrame': 'September 2019-September 2022', 'description': 'the survey was conducted on the day before the surgery (Pre), and on postoperative days 1 (P1), 7 (P7), and 30 (P30).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['major abdominal surgery, outcome, QoR-15, validation'], 'conditions': ['Major Abdominal Surgery', 'Patient-reported Outcome']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to perform a cross-cultural adaptation and psychometric evaluation of the Quality of Recovery 15 questionnaire in Turkey.', 'detailedDescription': "The QoR-15 was translated into Turkish through a rigorous process involving independent translations, consensus, back-translation, and review. The questionnaire was administered to patients undergoing elective major gastrointestinal surgery preoperatively and on postoperative days 1, 7, and 30. Reliability was assessed using Cronbach's α and intra-class correlation coefficient. Construct validity was evaluated through confirmatory factor analysis, and responsiveness was analyzed using Cohen's effect size and standardized response mean."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '510 patients who met the inclusion criteria of being over age of 18 and had a planned elective major gastrointestinal surgery were included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being over age of 18 and had a planned elective major gastrointestinal surgery\n\nExclusion Criteria:\n\n* under 18 years of age, had an alcohol or substance addiction problem, refused to participate in the study, had a previous major abdominal surgery'}, 'identificationModule': {'nctId': 'NCT06456918', 'acronym': 'ValidQoR-15', 'briefTitle': 'ValidationTurkishVersionQualityofRecovery-15', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Validation of the Turkish Version of the "Quality of Recovery 15 (QoR-15)" Questionnaire', 'orgStudyIdInfo': {'id': 'U1111-1309-0952'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients undergoing elective major gastrointestinal surgery', 'description': 'Patients had a planned elective major gastrointestinal surgery.', 'interventionNames': ['Procedure: Quality of Recovery 15 questionnaire']}], 'interventions': [{'name': 'Quality of Recovery 15 questionnaire', 'type': 'PROCEDURE', 'description': "return to daily life after surgery according to the patient's baseline or social norms", 'armGroupLabels': ['patients undergoing elective major gastrointestinal surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06230', 'city': 'Ankara', 'state': 'Altindag', 'country': 'Turkey (Türkiye)', 'facility': 'Mehmet Ali Koc', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Mehmet A Koc, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mehmet Ali Koç', 'investigatorAffiliation': 'Ankara University'}}}}