Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-23 @ 12:21 PM
Study NCT ID:
NCT02888158
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2016-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Training With and Without Robotic Assistance for Surgical Internes: a Randomized Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2016-08-30', 'studyFirstSubmitQcDate': '2016-08-30', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time (in minutes) required for the intern to perform a laparoscopic nephrectomy on an animal model (pig).', 'timeFrame': '6 months (3 months after a second training session on the Pelvic Trainer)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Surgical Training']}, 'referencesModule': {'references': [{'pmid': '25216348', 'type': 'RESULT', 'citation': 'Letouzey V, Huberlant S, Faillie JL, Prudhomme M, Mares P, de Tayrac R. Evaluation of a laparoscopic training program with or without robotic assistance. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:321-7. doi: 10.1016/j.ejogrb.2014.08.003. Epub 2014 Aug 20.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare two groups of gynecologic/urologic/visceral internes in terms of the time required to perform a laparoscopic surgical intervention (nephrectomy) on an animal model (pig).\n\nThe two groups of internes differ by the type of training they received: (1) Pelvic-Trainer training with robotic assistance versus (2) Pelvic-Trainer training without robotic assistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intern registered for specialization in surgery (urological, visceral or gynecology-obstetrics)\n\nExclusion Criteria:\n\n* The intern refuses to participate in the study\n* The internal is not available for training and/or evaluation'}, 'identificationModule': {'nctId': 'NCT02888158', 'acronym': 'LAPRA', 'briefTitle': 'Laparoscopic Training With and Without Robotic Assistance for Surgical Internes: a Randomized Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Laparoscopic Training With and Without Robotic Assistance for Surgical Internes: a Randomized Study', 'orgStudyIdInfo': {'id': 'AOI/2011/VL-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pelvic Trainer without robotic assistance', 'description': 'Interns randomized to this arm will have two Pelvic Trainer training sessions three months apart.\n\nIntervention: Pelvic Trainer', 'interventionNames': ['Other: Pelvic Trainer']}, {'type': 'EXPERIMENTAL', 'label': 'Pelvic Trainer with robotic assistance', 'description': 'Interns randomized to this arm will have two Pelvic Trainer training sessions three months apart but with robotic assistance.\n\nIntervention: Robotic assistance\n\nIntervention: Pelvic Trainer', 'interventionNames': ['Other: Robotic assistance', 'Other: Pelvic Trainer']}], 'interventions': [{'name': 'Robotic assistance', 'type': 'OTHER', 'description': 'Robotic assistance will be implemented during Pelvic Trainer training sessions.', 'armGroupLabels': ['Pelvic Trainer with robotic assistance']}, {'name': 'Pelvic Trainer', 'type': 'OTHER', 'description': 'The standard Pelvic Trainer simulator for surgical training.', 'armGroupLabels': ['Pelvic Trainer with robotic assistance', 'Pelvic Trainer without robotic assistance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier - Hôpital Gui de Chauliac', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Vincent Letouzey, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}