Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-05 @ 5:48 PM
Study NCT ID:
NCT03096769
Status:
COMPLETED
Last Update Posted:
2018-03-21
First Post:
2017-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ergonomics in Robotic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-20', 'studyFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2017-03-24', 'lastUpdatePostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Nordic Upper Body Questionnaire Score', 'timeFrame': 'Baseline, Immediately postoperative (approximately one hour)', 'description': 'The Nordic upper body questionnaire will be one measure of upper body musculoskeletal discomfort following robotic hysterectomy.'}, {'measure': 'Change in Body Part Discomfort Questionnaire Score', 'timeFrame': 'Baseline, Immediately postoperative (approximately one hour)', 'description': 'The Body Part Discomfort Questionnaire will be one measure of upper body musculoskeletal discomfort following robotic hysterectomy'}, {'measure': 'Surgical Task Load Index Score', 'timeFrame': 'Immediately postoperative (approximately one hour)', 'description': 'The surgical task load index score will be one measure of upper body musculoskeletal discomfort following robotic hysterectomy.'}], 'secondaryOutcomes': [{'measure': 'Change in measurement of console settings (in cm)', 'timeFrame': 'Baseline, up to 1 year', 'description': 'Comparison between surgeon- and ergonomist-derived console settings'}, {'measure': 'Change in measurement of console head angle (in degrees)', 'timeFrame': 'Baseline, up to 1 year', 'description': 'Comparison between surgeon- and ergonomist-derived console settings'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Musculoskeletal Strain', 'Ergonomics']}, 'descriptionModule': {'briefSummary': 'This study is designed to answer if an ergonomist can configure a daVinci robot console to improve surgeon discomfort. Adjustments to the robot console will be surgeon specific as they are tailored to their individual body type. Measurements will be taken at the time of console configuration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fellowship trained, specialty board certified gynecologic surgeon.\n* Robot used for hysterectomy until completion of vaginal cuff closure.\n\nExclusion Criteria:\n\n\\- Any non-robotic method to perform hysterectomy (laparotomy, non-robotic laparoscopic, vaginal approach).'}, 'identificationModule': {'nctId': 'NCT03096769', 'briefTitle': 'Ergonomics in Robotic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Ergonomics in Robotic Surgery', 'orgStudyIdInfo': {'id': '16-009275'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Study Arm', 'interventionNames': ['Other: Ergonomist']}], 'interventions': [{'name': 'Ergonomist', 'type': 'OTHER', 'description': 'The intervention consists of each surgeon meeting with an ergonomist where the ergonomist will adjust the console settings and chair height to an ergonomically optimal position.', 'armGroupLabels': ['Study Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'John A Occhino', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'John A. Occhino', 'investigatorAffiliation': 'Mayo Clinic'}}}}