Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-27 @ 10:19 PM
Study NCT ID:
NCT06063395
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2023-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Size of the Operating Fields Depending on the Morphology of the Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2023-09-18', 'studyFirstSubmitQcDate': '2023-09-29', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mathematically model the working volume for abdominal aortic surgery as a function of the preoperative CT scan, the length and orientation of the incision and the morphometric characteristics of the patient, and thus predict surgical risk.', 'timeFrame': 'During surgery', 'description': 'To measure the dimensions of the working volume of an open abdominal aortic surgery using a camera to create an algorithm by associating them with the preoperative images and morphometric data of the patient.'}], 'secondaryOutcomes': [{'measure': 'Find a correlation between work volume and BMI du patient.', 'timeFrame': 'During surgery', 'description': 'Coefficient of determination R² which measures the quality of prediction of work volume as a function of patient BMI'}, {'measure': 'Validate the algorithm for predicting the volume of work in abdominal aortic abdominal aortic surgery.', 'timeFrame': 'During surgery', 'description': 'Difference in cubic centimetres between the volume of work and the predicted one'}, {'measure': 'Evaluation of how the algorithm helps to deal with surgery', 'timeFrame': 'During surgery', 'description': 'Evaluation questionnaire for surgeons'}, {'measure': 'Correlate results with surgical complications', 'timeFrame': 'During the procedure until patient discharge', 'description': 'Intra-hospital complications'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abdominal aorta', 'Open surgery', 'Vascular surgery'], 'conditions': ['Open Surgery on the Abdominal Aorta']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-centre, observational clinical study.\n\nPatients who have not expressed their non-opposition, who are of age and who are undergoing open surgery on the abdominal aorta by laparotomy will be included.\n\nThe aim is to mathematically model the working volume for abdominal aortic surgery as a function of the preoperative CT scan, the length and orientation of the incision and the morphometric characteristics of the patient, and thus predict the surgical risk.\n\nTo meet this objective, the dimensions of the working volume of open abdominal aortic surgery will be measured using a camera to create an algorithm by associating them with the preoperative images and morphometric data of the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient undergoing open surgery on the abdominal aorta by laparotomy.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age\n* Patient undergoing open surgery on the abdominal aorta by laparotomy.\n* Patient who has been informed of the terms of the study and who has not expressed non-opposition.\n\nExclusion Criteria:\n\n* Emergency surgery\n* Patient without preoperative CT scan'}, 'identificationModule': {'nctId': 'NCT06063395', 'acronym': 'ABORD-3D', 'briefTitle': 'Study of the Size of the Operating Fields Depending on the Morphology of the Patients', 'organization': {'class': 'NETWORK', 'fullName': 'Geprovas'}, 'officialTitle': 'Study of the Size of the Operating Fields Depending on the Morphology of the Patients', 'orgStudyIdInfo': {'id': '2023-A01613-42'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient undergoing open surgery on the abdominal aorta by laparotomy', 'interventionNames': ['Procedure: open surgery on the abdominal aorta by laparotomy']}], 'interventions': [{'name': 'open surgery on the abdominal aorta by laparotomy', 'type': 'PROCEDURE', 'description': 'Laparotomy aortic surgery for the management of an abdominal aortic aneurysm has several distinct stages which will not be altered by the performance of this study. The patient arrives in the operating room and is taken care of by the anesthetic team. The patient is then placed in the correct position for optimal surgical management and a skin cleansing procedure is carried out. A sterile drape is applied and the preoperative checklist in force in the establishment is completed. Initial dissection of the aneurysm and its proximal and distal control is left to the discretion of the principal surgeon. Once the aortic aneurysm has been controlled, the main surgeon places self-static retractors and then prepares to clamp the aorta. The surgeon initiates aortic clamping to create the aorto-biliac or bifemoral bypass. Once the bypass has been created, the operation is completed by closing the surgical approach and the skin incision. The bandage is then applied.', 'armGroupLabels': ['Patient undergoing open surgery on the abdominal aorta by laparotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67000', 'city': 'Strasbourg', 'state': 'France', 'country': 'France', 'facility': 'Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Nabil Chakfe', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpitaux Universitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Geprovas', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}