Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT00999960
Status:
SUSPENDED
Last Update Posted:
2017-04-14
First Post:
2009-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Simulator
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'whyStopped': 'Decision of sponsor', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-13', 'studyFirstSubmitDate': '2009-10-21', 'studyFirstSubmitQcDate': '2009-10-21', 'lastUpdatePostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative time to perform the complete procedure', 'timeFrame': 'during the procedure'}], 'secondaryOutcomes': [{'measure': 'Operative time to complete each step of the procedure', 'timeFrame': 'each step of the procedure'}, {'measure': 'Intraoperative bleeding', 'timeFrame': 'during the procedure'}, {'measure': 'Transfusion rate', 'timeFrame': 'Hospital stay'}, {'measure': 'Complication rate', 'timeFrame': 'during the procedure'}, {'measure': 'Conversion rate', 'timeFrame': 'during the procedure'}, {'measure': 'Quantity of liquid obtained in drains', 'timeFrame': 'during the hospitalization'}, {'measure': 'Duration of urethral stenting', 'timeFrame': 'during the hospitalization'}, {'measure': 'Reintervention rate', 'timeFrame': 'during the patient participation'}, {'measure': 'Duration of hospital stay', 'timeFrame': 'during the patient participation'}, {'measure': 'Positive surgical margin', 'timeFrame': 'during the procedure'}, {'measure': 'PSA value', 'timeFrame': 'at 3,6 and 12 months after the procedure'}, {'measure': 'Continence rate', 'timeFrame': 'at 3, 6 and 12 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Laparoscopy', 'Prostate', 'Cancer', 'Learning', 'Simulation', 'Simulator'], 'conditions': ['Prostatic Neoplasms', 'Cancer of Prostate', 'Prostate Cancer', 'Prostate Neoplasms']}, 'descriptionModule': {'briefSummary': 'To evaluate the clinical impact of an online video simulator during the learning period of laparoscopic radical prostatectomy.', 'detailedDescription': 'Objectives: To compare two different approaches in learning laparoscopic radical prostatectomy , with or without using an online video simulator Design : Prospective randomized multicentric study\n\nMethods: 20 surgeons considered as naive concerning their experience in laparoscopic radical prostatectomy will be randomized into two groups :1 group will use the online video simulator, 1 group will use usual learning methods except the online video simulator.\n\nAll procedures will be recorded from the beginning till the end.A video review will be preformed concerning all the videos in order to identify the total operative time and time to perform each one of the operative steps of the procedure.Clinical , biological and histological data will be collected in order to compare the two arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgeon beginning his clinical experience in laparoscopic radical prostatectomy and having performed less then 30 procedures before being enrolled in the study\n* Surgeon who intends to begin laparoscopic radical prostatectomy clinical practice\n* Surgeons who usually perform enough cases to enroll at least 10 patients during the study inclusion time\n\nExclusion Criteria:\n\n* Surgeon who does not have access to high speed internet (\\>1024 Ko/s)\n* Surgeons who do not intend to begin laparoscopic radical prostatectomy in his clinical practice'}, 'identificationModule': {'nctId': 'NCT00999960', 'acronym': 'PERLE', 'briefTitle': 'Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Simulator', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'A Prospective Randomized Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Online Simulator', 'orgStudyIdInfo': {'id': 'AOR 07074-NI07008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1: without simulator', 'description': 'without simulator', 'interventionNames': ['Procedure: Laparoscopic Radical Prostatectomy (without a simulator)']}, {'type': 'EXPERIMENTAL', 'label': '2: with simulator', 'description': 'with simulator', 'interventionNames': ['Procedure: Laparoscopic Radical Prostatectomy (with a simulator)']}], 'interventions': [{'name': 'Laparoscopic Radical Prostatectomy (without a simulator)', 'type': 'PROCEDURE', 'description': 'without simulator', 'armGroupLabels': ['1: without simulator']}, {'name': 'Laparoscopic Radical Prostatectomy (with a simulator)', 'type': 'PROCEDURE', 'description': 'Learning with a simulator', 'armGroupLabels': ['2: with simulator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': "HOPITAL SAINT-LOUIS Service d'urologie", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'DESGRANDCHAMPS François, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}