Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-01-07 @ 4:42 AM
Study NCT ID:
NCT03578068
Status:
UNKNOWN
Last Update Posted:
2018-07-05
First Post:
2018-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Translation and Validation of the French Version of the Postoperative Quality of Recovery Score QoR-15
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-22', 'studyFirstSubmitDate': '2018-05-28', 'studyFirstSubmitQcDate': '2018-06-22', 'lastUpdatePostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QoR-15F score Title: QoR-15F score Description: Time Frame: 24h befor surgery Outcome 2 Title: QoR-15F score Description: Time Frame: 24h after surgery', 'timeFrame': '24h after surgery', 'description': 'the score is calculated from the questionnaire 24 hours after the surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quality of Recovery', 'Postoperative', 'Surgery', 'French', 'Translation', 'Validation'], 'conditions': ['Recovery of Function']}, 'referencesModule': {'references': [{'pmid': '32303379', 'type': 'DERIVED', 'citation': 'Demumieux F, Ludes PO, Diemunsch P, Bennett-Guerrero E, Lujic M, Lefebvre F, Noll E. Validation of the translated Quality of Recovery-15 questionnaire in a French-speaking population. Br J Anaesth. 2020 Jun;124(6):761-767. doi: 10.1016/j.bja.2020.03.011. Epub 2020 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'After a surgery, the recovery of the previous health status of patients, such as walk, body care, sleep, diet, feeling of comfort, is one of the priorities of the perioperative medicine. The QoR-15 was designed to measure quality of recovery after surgery. It provided a valid, extensive and efficient evaluation of the postoperative quality of recovery. The primary objectives of this study is to translate the original QoR-15 questionnaire into French, and do a full psychometric evaluation of the French version. We will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, orthopedic, \\[…\\], gynecological surgery, in the University Hospital of Strasbourg. The secondary objectives will be to evaluate the quality of recovery of the patients who undergone surgery at Strasbourg University Hospital, and to evaluate the incidence of postoperative complications occurring within three months postoperatively and a possible association with the QoR-15F.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient operated at Strasbourg University Hospital for a minor, intermediate or major programmed surgery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient operated at Strasbourg University Hospital for a minor, intermediate or major programmed surgery\n* Patient agreeing to use his data for research purposes\n\nExclusion Criteria:\n\n* Patient operated on a surgery for which it is highly probable that the postoperative management does not allow him to propose the completion of the J1 questionnaire\n* Patient unable to express non-opposition to participation in the study\n* Patient expressing opposition to participating in the study'}, 'identificationModule': {'nctId': 'NCT03578068', 'acronym': 'QoR-15F', 'briefTitle': 'Translation and Validation of the French Version of the Postoperative Quality of Recovery Score QoR-15', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Translation and Validation of the French Version of the Postoperative Quality of Recovery Score QoR-15', 'orgStudyIdInfo': {'id': '7051'}}, 'contactsLocationsModule': {'locations': [{'zip': '67098', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric Noll, MD', 'role': 'CONTACT', 'email': 'eric.noll@chru-strasbourg.fr', 'phone': '33 3 88 55 23 37'}, {'name': 'Pierre Diemunsch, MD', 'role': 'CONTACT', 'email': 'pierre.diemunsch@chru-strasbourg.fr', 'phone': '33 3 88 12 70 76'}, {'name': 'Eric Noll, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pierre Diemunsch, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'François DEMUMIEUX, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Service D'Anesthesiologie - Reanimation Chirurgicale", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Eric Noll, MD', 'role': 'CONTACT', 'email': 'eric.noll@chru-strasbourg.fr', 'phone': '33 3 88 55 23 37'}, {'name': 'Pierre Diemunsch, MD, PhD', 'role': 'CONTACT', 'email': 'pierre.diemunsch@chru-strasbourg.fr', 'phone': '33 3 88 12 70 76'}], 'overallOfficials': [{'name': 'Eric Noll, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Strasbourg, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}