Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT04694469
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2020-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Day-time and Night-time Operations of Supracondylar Humeral Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012892', 'term': 'Sleep Deprivation'}], 'ancestors': [{'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-04', 'studyFirstSubmitDate': '2020-12-30', 'studyFirstSubmitQcDate': '2021-01-04', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': 'one month', 'description': '30 days morbidity'}, {'measure': 'Operation duration', 'timeFrame': 'intraoperative', 'description': 'time between anesthesia induction and anesthesia emergence'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'one month', 'description': '30 days mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['supracondyler humerus fracture', 'night time operation', 'sleep deprivation', 'closed reduction and percutaneous pinning', 'CRPP'], 'conditions': ['Supracondylar Fracture', 'Morbidity']}, 'referencesModule': {'references': [{'pmid': '30151989', 'type': 'BACKGROUND', 'citation': 'Tessler MJ, Charland L, Wang NN, Correa JA. The association of time of emergency surgery - day, evening or night - with postoperative 30-day hospital mortality. Anaesthesia. 2018 Nov;73(11):1368-1371. doi: 10.1111/anae.14329. Epub 2018 Aug 27.'}, {'pmid': '21825947', 'type': 'BACKGROUND', 'citation': 'Chacko AT, Ramirez MA, Ramappa AJ, Richardson LC, Appleton PT, Rodriguez EK. Does late night hip surgery affect outcome? J Trauma. 2011 Aug;71(2):447-53; discussion 453. doi: 10.1097/TA.0b013e3182231ad7.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate that performing supracondylar humerus fracture operations during daylight hours may have better results than performing them at night.', 'detailedDescription': "Supracondylar humerus fractures are one of the most common traumatic fractures seen in children and their treatment usually requires immediate closed reduction and percutaneous pinning (CRPP). The presence of neurovascular complications associated with this fracture is considered an orthopedic emergency. For this reason, depending on the patient's operation time, the procedure should be performed at night under emergency conditions. Sleep deprivation, which is common in healthcare professionals, may affect patient safety due to disruptions in treatments and surgical procedures by reducing physician performance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'paediatric population with supracondylar humeral fractures', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 5 to 12 years\n* had supracondylar humeral fractures,\n* underwent CRPP\n* under general anaesthesia\n* American Society of Anesthesiologists (ASA) physical status I to III\n\nExclusion Criteria:\n\n* Surgical procedures outside the operating room\n* parental refusing the study protocol'}, 'identificationModule': {'nctId': 'NCT04694469', 'briefTitle': 'Comparison of Day-time and Night-time Operations of Supracondylar Humeral Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Comparison of Night-time and Daytime Operation on Outcomes of Supracondylar Humeral Fractures: A Prospective Observational Sudy', 'orgStudyIdInfo': {'id': '2019/266'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group Day', 'description': 'operated at 07:30 AM - 06:30 PM', 'interventionNames': ['Procedure: Closed reduction and percutaneous pinning (CRPP)']}, {'label': 'Group Night', 'description': 'operated at 06:30 PM - 07:30 AM', 'interventionNames': ['Procedure: Closed reduction and percutaneous pinning (CRPP)']}], 'interventions': [{'name': 'Closed reduction and percutaneous pinning (CRPP)', 'type': 'PROCEDURE', 'description': 'Operated for supracondylar humeral fractures', 'armGroupLabels': ['Group Day', 'Group Night']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'state': 'Fatih', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University, Faculty of Medicine', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Mehmet I. Buget, Assoc. Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology'}, {'name': 'Nur Canbolat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology'}, {'name': 'Chasan Memet Chousein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Unıversity, Istanbul Faculty of Medicine, Orthopedics and Traumatology'}, {'name': 'Ali Ersen, Assoc. Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Istanbul Unıversit Istanbul Faculty of Medicine, Orthopedics and Traumatology'}, {'name': 'Kemalettin Koltka, Assoc. Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator M.D.', 'investigatorFullName': 'Nur Canbolat', 'investigatorAffiliation': 'Istanbul University'}}}}