Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT04869995
Status:
COMPLETED
Last Update Posted:
2023-03-02
First Post:
2021-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behav'Robot: Understanding the Surgeon Behavior During Robot-assisted Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2021-04-28', 'studyFirstSubmitQcDate': '2021-04-28', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Elicitation of the surgeons' perception", 'timeFrame': '= interview duration (about 30 minutes)', 'description': "Elicitation of the surgeons' perception of practices and behavior changes when doing robot-assisted surgery."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Robotic Surgical Procedures']}, 'referencesModule': {'references': [{'pmid': '35393313', 'type': 'DERIVED', 'citation': "Cormi C, Parpex G, Julio C, Ecarnot F, Laplanche D, Vannieuwenhuyse G, Duclos A, Sanchez S. Understanding the surgeon's behaviour during robot-assisted surgery: protocol for the qualitative Behav'Robot study. BMJ Open. 2022 Apr 7;12(4):e056002. doi: 10.1136/bmjopen-2021-056002."}]}, 'descriptionModule': {'briefSummary': "Robot-assisted surgery is spreading since the last decade, but little is known about the impact of the use of the robot on surgeon practices and behavior in the operation theatre.\n\nInterviewing senior surgeons trained for doing robot-assisted surgery, this qualitative study is expected to provide new insights to understand the surgeons' behavioral changes when using a robot.\n\nThis study will contribute to improving training programs in robot-assisted surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants will comprise senior abdominal and pelvic cavity surgeons (i.e., visceral surgeons, gynecologist surgeons, and urologists) having completed their robot-assisted surgery training, and commonly doing laparoscopic surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Senior abdominal and pelvic cavity surgeons (i.e., visceral surgeons, gynecologist surgeons, or urologists).\n* Having completed a robot-assisted training\n* Commonly doing laparoscopic surgery\n\nExclusion Criteria:\n\n* Those who refuse to participate in the study'}, 'identificationModule': {'nctId': 'NCT04869995', 'briefTitle': "Behav'Robot: Understanding the Surgeon Behavior During Robot-assisted Surgery", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Troyes'}, 'officialTitle': "Behav'Robot: Understanding the Surgeon Behavior During Robot-assisted Surgery (a Qualitative Study)", 'orgStudyIdInfo': {'id': 'BehavRobot'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention', 'description': 'Senior abdominal and pelvic cavity surgeons (i.e., visceral surgeons, gynecologist surgeons, and urologists) having completed their robot-assisted surgery training, and commonly doing laparoscopic surgery.', 'interventionNames': ['Other: Interview']}], 'interventions': [{'name': 'Interview', 'type': 'OTHER', 'description': 'An individual semi-structured interview per surgeon, according to an interview guide.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Troyes', 'state': 'Grand Est', 'country': 'France', 'facility': 'Centre Hospitalier de Troyes', 'geoPoint': {'lat': 48.30073, 'lon': 4.08524}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Troyes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}