Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT01618994
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2012-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation Study for Robotic Surgery Simulator
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-08', 'studyFirstSubmitDate': '2012-06-11', 'studyFirstSubmitQcDate': '2012-06-12', 'lastUpdatePostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Time', 'timeFrame': 'At end of cervical amputation', 'description': 'As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation'}], 'secondaryOutcomes': [{'measure': 'Blood Loss', 'timeFrame': 'End of cervical amputation', 'description': 'As measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume'}, {'measure': 'Surgical Skill Rating', 'timeFrame': 'Within a month of the performed surgery', 'description': 'All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet'}, {'measure': 'Surgeon Console Biometrics', 'timeFrame': 'during surgery', 'description': 'As measured by controller movements and grip'}, {'measure': 'Novice Robotic Surgeon Data', 'timeFrame': 'Within a month of the performed surgery', 'description': 'Descriptive Operative data of surgeons who did not participate in robotic simulator training'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Robotic Simulator', 'EBL', 'Robotic Surgeons', 'Intuitive Surgical', 'simulation modules', 'benchmarks', 'Morristown Protocol', 'Study Surgeons', 'Control Surgeons', 'Expert Surgeons', 'dual-console daVinci system', 'blinded skill assessment'], 'conditions': ['Pelvic Organ Prolapse']}, 'descriptionModule': {'briefSummary': 'A study to determine whether completing a rigorous simulation protocol could provide novice robotic surgeons with actual advanced surgical skills in an operating room setting.', 'detailedDescription': 'Objective: To determine whether a group of surgeons otherwise naive to robotic techniques could demonstrate proficiency during their first robotic supracervical hysterectomy having only received simulator and pig lab training.\n\nPrimary outcome measure: As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation.\n\nSecondary Outcome measures:\n\n1. Blood loss- as measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume.\n2. Surgical skill rating- All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet.\n3. Surgeon console biometrics- As measured by controller movements and grips\n4. Novice robotic surgeon data: Descriptive Operative data of surgeons who did not participate in robotic simulator training.\n\nMethods: To create the simulator protocol, 5 robotic surgeons (each averaging \\>75 robotic cases per year) performed all 28 simulation modules available on the da Vinci Skills Simulator. To establish "expert benchmarks", they picked the 10 simulator modules they thought were most beneficial to robotic novices\', and they performed each of these 10 modules to the best of their ability \\>5 times. The data was used to create benchmarks in which all parameters of these 10 modules were taken into account (i.e. not just the time to completion). Thus the "Morristown Protocol" was established- whereby successful completion of the protocol required passing every parameter of all 10 simulator modules at the expert level.\n\nWe then recruited community board-certified OB-GYN\'s who were completely naive to robotics and offered them full robotic training free-of-charge as long as they could pass the "Morristown Protocol" as their very first step in the training process. These "study surgeons" were given 24/7 access to the da Vinci Skills Simulator and simply asked to complete the protocol at their own pace. Within a week of doing so, they went through the standardized Intuitive Surgical pig lab and then performed their first ever robotic surgery- a supracervical hysterectomy- as our main outcome measure. These cases were performed using the dual-console daVinci system with one of the senior authors on the other console ready to step in if necessary.\n\nTwo sets of comparative benchmarks for this surgical procedure has been established. Our "expert surgeons" each performed supracervical hysterectomies for the study- as did a group of "control surgeons". These "control surgeons" had full robotic privileges but were not averaging more than 2 cases per month and had never used the simulator. Operative time, EBL, and a blinded skill assessment (of videos) were compared for all cases among the 3 surgeon groups using t-tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Gynecologic surgeons with no robotic experience', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must not have performed a da Vinci assisted surgery\n\nExclusion Criteria:\n\n* prior experience on the da Vinci system or the robotic simulator'}, 'identificationModule': {'nctId': 'NCT01618994', 'briefTitle': 'Validation Study for Robotic Surgery Simulator', 'organization': {'class': 'OTHER', 'fullName': 'Atlantic Health System'}, 'officialTitle': 'Validation Study for Robotic Surgery Simulator', 'orgStudyIdInfo': {'id': 'R11-01-018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Expert Surgeons', 'description': 'Gynecologic robotic surgeons, each averaging \\>75 robotic cases per year', 'interventionNames': ['Procedure: Performing robotic supracervical hysterectomy']}, {'label': 'Study Surgeons', 'description': 'Gynecologic surgeons who are completely naive to robotics', 'interventionNames': ['Procedure: Performing robotic supracervical hysterectomy']}, {'label': 'Control Surgeons', 'description': 'Gynecologic surgeons with full robotic privileges but were not averaging more than 2 cases a month and had never used the simulator', 'interventionNames': ['Procedure: Performing robotic supracervical hysterectomy']}], 'interventions': [{'name': 'Performing robotic supracervical hysterectomy', 'type': 'PROCEDURE', 'description': 'All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy', 'armGroupLabels': ['Control Surgeons', 'Expert Surgeons', 'Study Surgeons']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}], 'overallOfficials': [{'name': 'Patrick Culligan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atlantic Health System'}, {'name': 'Charbel Salamon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atlantic Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlantic Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'Intuitive Surgical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}