Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-24 @ 1:45 PM
Study NCT ID:
NCT06485102
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Differences of the Postoperative Outcome for Carotid Surgery Patients Treated by Either Male or Female Surgeons
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2024-01-29', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The impact of surgeons' gender, team gender and patients gender on postoperative apoplexy", 'timeFrame': '0-30 days', 'description': 'stroke \\[observed in a time frame of 30 days after the operation\\]'}, {'measure': "The impact of surgeons' gender team gender and patients gender on postoperative peripheral nerve lesions", 'timeFrame': '0-30 days', 'description': 'Impairment of peripheral cervial nerves \\[observed in a time frame of 30 days after the operation\\]'}, {'measure': "The impact of surgeons' gender team gender and patients gender on reinterventions", 'timeFrame': '0-30 days', 'description': 'Number of patients with surgical revision'}, {'measure': "The impact of surgeons' gender team gender and patients gender on procedure related death", 'timeFrame': '0-30 days', 'description': 'Number of patients who died following surgery'}], 'secondaryOutcomes': [{'measure': "The impact of surgeons' gender team gender and patients gender on procedure time", 'timeFrame': '0-30 days', 'description': 'Duration of surgery measured in minutes'}, {'measure': "The impact of surgeons' gender team gender and patients gender on the length of stay", 'timeFrame': '0-30 days', 'description': 'length of stay in days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carotid Artery', 'Apoplexy', 'Surgical outcome', 'Gender specific outcome', 'Surgeon gender'], 'conditions': ['Carotid Stenosis']}, 'descriptionModule': {'briefSummary': 'This research will focus on the differences of the postoperative outcome for carotid surgery patients treated by either male or female surgeons. Since 2012, in Germany, the surgical treatment of carotid stenosis has an established quality assurance, making the thematic especially suitable for testing the surgical results of either male or female surgeons.', 'detailedDescription': 'Data about physician gender having impact on the treatment quality of a patient first appeared in 1999, the publication being about patients with breast cancer. This discussion was resumed in 2016 when Y. Tsugawa et. al showed that female doctors have, in comparison to male doctors, better treatment results. Primary outcomes for the study were mortality and readmissions, which were lower if the treatment has been done by a female doctor. Until today, there are only a few reports about the role of physician gender, especially that of surgeons, in the treatment quality. Studies like the ones from Blohm et. al and Wallis et. al show that female surgeons have a better outcome and a lower mortality, 30 days after the surgery. Wallis et. al also showed that the correlation between male surgeons and female patients have the worst results\\].\n\nNone of the studies that were written until today focussed on carotid surgery. Since 2012, in Germany, the surgical treatment of carotid stenosis has an established quality assurance, with specific documentation and a standard surgical course of action. This is why we consider that this surgery is especially suitable for comparison of results, depending on surgeon genders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A retrospective data collection will be conducted for all the patients, that between jan. 2012 and dec. 2023, were operated because of a carotid stenosis in the University Clinic for Vascular and Endovascular Surgery in Augsburg. This stenosis may have been symptomatic or asymptomatic. The surgery must respect the latest quality assurance for that period.', 'genderDescription': "The impact of surgeons' gender on the postoperative outcomes. The impact of surgeons' team gender on the postoperative outcome. The connection between patients' gender and surgeons' gender regarding postoperative outcome.", 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 18 years\n* All the patients that had a carotid revascularisation between jan. 2012 and dec. 2023.\n\nExclusion Criteria:\n\n\\- No quality assurance'}, 'identificationModule': {'nctId': 'NCT06485102', 'briefTitle': 'Differences of the Postoperative Outcome for Carotid Surgery Patients Treated by Either Male or Female Surgeons', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Augsburg'}, 'officialTitle': 'Differences of the Postoperative Outcome for Carotid Surgery Patients Treated by Either Male or Female Surgeons', 'orgStudyIdInfo': {'id': 'CAROTIS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing surgery', 'description': 'A retrospective data collection will be conducted for all the patients, that between jan. 2012 and dec. 2023, were operated because of a carotid stenosis in the University Clinic for Vascular and Endovascular Surgery in Augsburg. This stenosis may have been symptomatic or asymptomatic. The surgery must respect the latest quality assurance for that period.', 'interventionNames': ['Procedure: Carotid Surgery in patients with symptomatic or asymptomatic stenosis']}], 'interventions': [{'name': 'Carotid Surgery in patients with symptomatic or asymptomatic stenosis', 'type': 'PROCEDURE', 'description': 'Carotid Surgery in patients with symptomatic or asymptomatic stenosis', 'armGroupLabels': ['Patients undergoing surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86156', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'University Hospital Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}], 'overallOfficials': [{'name': 'Alexander Hyhlik-Duerr, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Augsburg Vascular Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'anonymous study design'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Augsburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Epidemiology, Faculty of Medicine, University of Augsburg', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}