Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-04-11 @ 7:35 AM
Study NCT ID:
NCT00683293
Status:
COMPLETED
Last Update Posted:
2014-04-16
First Post:
2008-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial Comparing Conventional and Robot-assisted(Da Vinci®)Laparoscopic Interventions for Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'la.kots@ksa.ch', 'phone': '00418384141', 'title': 'Dimtri SARLOS', 'organization': 'Kantonsspital Aarau'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2008 to 2011', 'eventGroups': [{'id': 'EG000', 'title': '1 Conventional Laparoscopic Hysterectomy', 'description': 'Randomized group of patients receiving conventional laparoscopic hysterectomy\n\nConventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques', 'otherNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2 Robot-assisted Laparoscopic Hysterectomy', 'description': 'group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization', 'otherNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Conventional Laparoscopic Hysterectomy', 'description': 'Randomized group of patients receiving conventional laparoscopic hysterectomy\n\nConventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques'}, {'id': 'OG001', 'title': '2 Robot-assisted Laparoscopic Hysterectomy', 'description': 'group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'spread': '21', 'groupId': 'OG000'}, {'value': '106', 'spread': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after surgey', 'description': '•Mean Time to complete surgery from cut to suture', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Conventional Laparoscopic Hysterectomy', 'description': 'Randomized group of patients receiving conventional laparoscopic hysterectomy\n\nConventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques'}, {'id': 'OG001', 'title': '2 Robot-assisted Laparoscopic Hysterectomy', 'description': 'group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 Conventional Laparoscopic Hysterectomy', 'description': 'Randomized group of patients receiving conventional laparoscopic hysterectomy\n\nConventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques'}, {'id': 'FG001', 'title': '2 Robot-assisted Laparoscopic Hysterectomy', 'description': 'group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '2008 to 2011 All patients were recruited from our clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1 Conventional Laparoscopic Hysterectomy', 'description': 'Randomized group of patients receiving conventional laparoscopic hysterectomy\n\nConventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques'}, {'id': 'BG001', 'title': '2 Robot-assisted Laparoscopic Hysterectomy', 'description': 'group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'spread': '6', 'groupId': 'BG000'}, {'value': '46.3', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '46', 'spread': '5.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-11', 'studyFirstSubmitDate': '2008-05-21', 'resultsFirstSubmitDate': '2013-11-12', 'studyFirstSubmitQcDate': '2008-05-21', 'lastUpdatePostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-11', 'studyFirstPostDateStruct': {'date': '2008-05-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Surgery', 'timeFrame': 'after surgey', 'description': '•Mean Time to complete surgery from cut to suture'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'up to 2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Laparoscopic Hysterectomy', 'Robot-assisted Laparoscopic Hysterectomy', 'Robot-assisted Surgery'], 'conditions': ['Laparoscopic Technique no Switch to Open', 'Duration of Surgery', 'Intraoperative Complications', 'Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '22914470', 'type': 'RESULT', 'citation': 'Sarlos D, Kots L, Stevanovic N, von Felten S, Schar G. Robotic compared with conventional laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2012 Sep;120(3):604-11. doi: 10.1097/AOG.0b013e318265b61a.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs.', 'detailedDescription': 'During the last few years robot-assisted surgery has been introduced in many surgical specialties and experiences in gynaecological surgery are very limited.\n\nSeveral aspects like the wider range of motion of robot-instruments leading to more precision in surgery, the 3 dimensional optical system and the ergonomically designed console may offer some advantages. For better judgment these possible benefits as well as safety and outcome need to be evaluated and compared with conventional laparoscopic hysterectomy techniques. This randomized clinical trail intends to compare conventional with robot-assisted(da Vinci®-System) laparoscopic hysterectomy regarding specific parameters. The focus of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalisation and costs.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for laparoscopic hysterectomy\n* Patients BMI \\< 40\n* Signed consent\n\nExclusion Criteria:\n\n* Estimated uterus weight \\>400 g\n* No combination with other procedures\n* No underlying malignant condition'}, 'identificationModule': {'nctId': 'NCT00683293', 'briefTitle': 'Clinical Trial Comparing Conventional and Robot-assisted(Da Vinci®)Laparoscopic Interventions for Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Aarau'}, 'officialTitle': 'Laparoscopic Hysterectomy: a Clinical Randomized Trial Comparing Conventional and Robot-assisted(Da Vinci®)Techniques', 'orgStudyIdInfo': {'id': 'KSA-RobHyst'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Randomized group of patients receiving conventional laparoscopic hysterectomy', 'interventionNames': ['Procedure: Conventional Laparoscopic Hysterectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Randomized group of patients receiving robot-assisted laparoscopic hysterectomy', 'interventionNames': ['Procedure: Robot-assisted (Da Vinci®) laparoscopic hysterectomy']}], 'interventions': [{'name': 'Conventional Laparoscopic Hysterectomy', 'type': 'PROCEDURE', 'otherNames': ['- Minimal invasive hysterectomy,', '- Laparoscopic removal of uterus,', '- Minimal invasive removal of uterus'], 'description': 'Removal of uterus via standard laparoscopic techniques', 'armGroupLabels': ['1']}, {'name': 'Robot-assisted (Da Vinci®) laparoscopic hysterectomy', 'type': 'PROCEDURE', 'otherNames': ['- Robot-assisted(Da Vinci®)laparoscopic hysterectomy', '- Robot-assisted minimal invasive hysterectomy'], 'description': 'Removal of uterus by robot-assisted laparoscopic technique', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aarau', 'country': 'Switzerland', 'facility': 'Kantonsspital Aarau', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}], 'overallOfficials': [{'name': 'Dimitri Sarlos, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kantonsspital Aarau'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Aarau', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head Gynaecology and oncological Gynaecology', 'investigatorFullName': 'Dimitri Sarlos', 'investigatorAffiliation': 'Kantonsspital Aarau'}}}}