Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT05794269
Status:
UNKNOWN
Last Update Posted:
2023-04-04
First Post:
2023-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Turkish Version of the QoR-15 for Emergency Laparotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-31', 'studyFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2023-03-20', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity of TQoR-15 questionnaire (24 hours)', 'timeFrame': 'At 24 hours after surgery', 'description': 'Evaluate the validity of the Turkish version of the QoR-15 to assess immediate postoperative recovery after emergency laparotomy (at 24 hours)'}, {'measure': 'Validity of TQoR-15 questionnaire (72 hours)', 'timeFrame': 'At 72 hours after surgery', 'description': 'Evaluate the validity of the Turkish version of the QoR-15 to assess immediate postoperative recovery after emergency laparotomy (at 72 hours)'}], 'secondaryOutcomes': [{'measure': 'Minimal important difference', 'timeFrame': 'At 24 and 72 hours after surgery', 'description': 'Estimate minimal important difference from the TQoR-15 questionnaire in the emergency laparotomy population.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Quality of Life', 'Anesthesia', 'Surgery', 'Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '23411725', 'type': 'BACKGROUND', 'citation': 'Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.'}, {'pmid': '36161615', 'type': 'BACKGROUND', 'citation': 'Kara U, Simsek F, Kamburoglu H, Ozhan MO, Alakus U, Ince ME, Eksert S, Ozkan G, Eskin MB, Senkal S. Linguistic validation of a widely used recovery score: quality of recovery-15 (QoR-15). Turk J Med Sci. 2022 Apr;52(2):427-435. doi: 10.55730/1300-0144.5330. Epub 2022 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'Patient perceived quality of recovery is an important outcome after surgery and should be measured in clinical trials. The QoR-15 was designed to measure quality of recovery postoperatively. It provided an efficient evaluation of the postoperative quality of recovery. The primary objectives of this study is validate the Turkish version of QoR-15 questionnaire for emergency laparotomy. The investigators will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients emergency laparotomy, in the University of Health Sciences, Gülhane Education and Training Hospital Ankara, Türkiye.', 'detailedDescription': 'Recovery from surgery is a complex process that can vary depending on the patient and the anesthesia used. Most clinical studies are interested in reducing perioperative morbidity and mortality, but few evaluate the overall recovery process. The QoR-15 questionnaire assess recovery after elective surgery. A Turkish translation of the QoR-15 score has been validated for use in scheduled surgery. This scale, regardless of the language in which it is translated, has been developed and validated in patients who have undergone scheduled surgery. Until now, no validated scoring tool has been available to assess recovery after emergency laparotomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients admitted for emergency laparotomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years old,\n* Turkish speaking,\n* Admitted for any type of emergency laparotomy (time to surgery \\< 72 hours)\n* Able to answer the questionnaire at hospital admission, alone or with the help of a third party\n* And agreeing to participate in the study.\n\nExclusion Criteria:\n\n* Patients with psychiatric or neurological pathologies that compromise cooperation with the protocol,\n* Patients admitted for revision surgery,\n* aged \\< 18 years old\n* not agreed to provide written informed consent to participate'}, 'identificationModule': {'nctId': 'NCT05794269', 'acronym': 'QoR-15T-EL', 'briefTitle': 'Turkish Version of the QoR-15 for Emergency Laparotomy', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi'}, 'officialTitle': 'Validation of the Turkish Version of QoR-15 (QoR-15T) Scale for Emergency Laparotomy', 'orgStudyIdInfo': {'id': '2023-20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Main Group', 'description': 'Each patient complete the Turkish version of the QoR-15 score (TQoR-15) at 3 times (before surgery, on Day 1, on Day 3).', 'interventionNames': ['Other: TQoR-15 questionnaire']}], 'interventions': [{'name': 'TQoR-15 questionnaire', 'type': 'OTHER', 'description': "The TQoR-15 questionnaire (Turkish version) consists of 15 questions concerning five domains (the patient's feelings, comfort, pain, dependence on the health care team and psychological well-being). Two to three minutes are required to complete all the questions. If the patient is not able to read the questionnaire himself, a third person can ask the patient the questions orally. Each item is scored from 0 to 10 and the total score is the sum of the score obtained for each item, i.e. a score from 0 to 150.", 'armGroupLabels': ['Main Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06010', 'city': 'Etlik', 'state': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Umut KARA', 'role': 'CONTACT', 'email': 'drumutkara@gmail.com', 'phone': '+905339392399'}], 'facility': 'SBÜ Gülhane Education and Training Hospital', 'geoPoint': {'lat': 39.98205, 'lon': 32.82459}}], 'centralContacts': [{'name': 'Umut KARA', 'role': 'CONTACT', 'email': 'drumutkara@gmail.com', 'phone': '+905339392399'}, {'name': 'Serkan ŞENKAL', 'role': 'CONTACT', 'email': 'senkalserkan@gmail.com', 'phone': '+905338142614'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Umut Kara', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi'}}}}