Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT05695404
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2023-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Contribution of 3D Printing in Anatomical Lung Segmentectomies.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015412', 'term': 'Mastectomy, Segmental'}], 'ancestors': [{'id': 'D008408', 'term': 'Mastectomy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-12', 'studyFirstSubmitDate': '2023-01-02', 'studyFirstSubmitQcDate': '2023-01-12', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Surgeon's mental workload.", 'timeFrame': '1 day', 'description': 'measure of mental workload by the NASA-TLX score at the end of the surgery: It is a multidimensional rating scale that has six bipolar dimensions: mental demand (MD); physical demand (PD); time demand (TD); self performance (P); effort (E); and frustration (F). The dimensions thus reflect tasks (DM, PD, TD), performance (P), and behavioral factors (E and F). NASA-TLX is calculated through a self-questionnaire, using 20-point visual analogue scales anchored by very low and very high. The test provides a global load score between zero and 100 and by sub-dimensions, higher scores indicating higher mental loads of subjective perceptions.'}], 'secondaryOutcomes': [{'measure': "The surgeon's stress during surgery", 'timeFrame': '1 day', 'description': 'To assess stress, the surgeon wore a Holter device throughout the surgical procedure'}, {'measure': "Surgeon's attention to work by d2-R test", 'timeFrame': '1 day', 'description': "For the evaluation of the surgeon's attention to work at the end of the surgery, we used first d2-R test.\n\nScoring of the d2-R test included the following: concentration performance (CC), which represents the capacity of concentration; total number of target items processed, included the omitted ones (CCT), which informs about the speed of processing the test; percentage of errors (E%) which is defined as (total number of errors x 100)/CCT, and reflects performance accuracy.\n\nThese scores are standardized to standard score (NS), used by default for the computerized d2-R. The NS ranges from 20 to 80, with an average of 50. In the normal distribution scale of the d2-R test, 7% of the normative subjects scored under 35, 24% scored between 35 and 44, 38% scored between 45 and 55, 24% scored from 56 to 65 and 7% scored over 65. The scores are consider very weak, weak, mean, high and very high, respectively."}, {'measure': "Surgeon's attention to work by EncephalApp Stroop test.", 'timeFrame': '1 day', 'description': 'For the evaluation of the surgeon\'s attention to work at the end of the surgery, we used also EncephalApp Stroop test.\n\nThe task has two components: "off" and "on" states. In the "off " state, the surgeon views a pound signs (###) presented in red, green, or blue, one at a time and has to respond as quickly as possible by touching the matching color of the stimulus to the colors displayed at the bottom of the screen. In the "on" state the subject has to accurately select the color of the word presented, which is actually the name of the color in discordant coloring. The specific outcomes of the EncephalApp Stroop test were: the total time for five correct runs in the "off " state (OffTime) and in the "on" state (OnTime); the number of runs needed to complete the five correct "off" runs and five correct "on" runs.'}, {'measure': "The surgeon's overall satisfaction at the end of the surgery.", 'timeFrame': '1 day', 'description': 'To assess surgeon subjective satisfaction at the end of the surgery, we used a subjective satisfaction 5-point Likert scale'}, {'measure': 'Duration of the surgical procedure', 'timeFrame': '1 day', 'description': 'calculated from the skin incision to the completion of the segmentectomy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Segmentectomy', 'Thoracic surgery', '3D printed model', 'Mental workload', '3D reconstruction'], 'conditions': ['Thoracic Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of the present work was to evaluate if the presence on the operating field of a 3D printed personalized model of the pulmonary anatomy of a patient operated by full thoracoscopy for an anatomical segmentectomy, makes it possible to reduce the mental workload and the fatigue of the surgeon.', 'detailedDescription': 'Between 28.10.2020 and 05.10.2021, we successively included all anatomic segmentectomies performed by full thoracoscopy in our department, except for S6 segmentectomies, S4+5 left bisegmentectomy and patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery.\n\nWe performed a prospective randomized controlled pilot trial on 2 parallel arms:\n\n* The "Digital" arm\n* The "Digital+Object" arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all anatomic segmentectomies performed by full thoracoscopy in our department.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all anatomic segmentectomies performed by full thoracoscopy, except for S6 segmentectomies, S4+5 left bisegmentectomy and patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery.\n\nExclusion Criteria:\n\n* S6 segmentectomies\n* S4+5 left bisegmentectomy\n* Patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery.'}, 'identificationModule': {'nctId': 'NCT05695404', 'acronym': '3DiLUNG', 'briefTitle': 'Contribution of 3D Printing in Anatomical Lung Segmentectomies.', 'organization': {'class': 'OTHER', 'fullName': 'Institut Mutualiste Montsouris'}, 'officialTitle': 'Contribution of 3D Printing in Anatomical Lung Segmentectomies: a Prospective Randomized Controlled Pilot Trial.', 'orgStudyIdInfo': {'id': 'THOR-02-2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The "Digital" arm', 'description': "Surgeons had a virtual 3D reconstruction of the patient's pulmonary anatomy by the Visible Patient Planning (VP) software", 'interventionNames': ['Procedure: Segmentectomy']}, {'label': 'The "Digital+Object" arm', 'description': "Surgeons had at their disposal on the operating field, in a transparent sterile bag, the 3D printed model, made from the virtual 3D VP software of the patient's lung anatomy", 'interventionNames': ['Procedure: Segmentectomy']}], 'interventions': [{'name': 'Segmentectomy', 'type': 'PROCEDURE', 'description': 'Lung resection', 'armGroupLabels': ['The "Digital" arm', 'The "Digital+Object" arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Mutualiste Montsouris (thoracic surgery department)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Madalina Grigoroiu, dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Mutualiste Montsouris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Mutualiste Montsouris', 'class': 'OTHER'}, 'collaborators': [{'name': "Fondation de l'Avenir", 'class': 'OTHER'}, {'name': 'Paris cite university, 75006 Paris, France', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}