Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-01-24 @ 11:36 PM
Study NCT ID:
NCT02396927
Status:
UNKNOWN
Last Update Posted:
2017-02-28
First Post:
2015-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D HD Versus 2D HD in Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-26', 'studyFirstSubmitDate': '2015-03-12', 'studyFirstSubmitQcDate': '2015-03-23', 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of errors during the dissection of the Calot´s triangle', 'timeFrame': 'Expected duration: 20 minutes', 'description': 'The unedited videos of the operations will be assessed according to GERT (Generic Error Rating Tool) by three surgeons, blinded to which optical modalities is used during the operations as done in a previous pilot study.'}], 'secondaryOutcomes': [{'measure': 'Duration of the dissection of the Calot´s triangle', 'timeFrame': 'Expected duration: 20 minutes'}, {'measure': 'Duration of surgery', 'timeFrame': 'Expected duration: 1 hour'}, {'measure': 'The need for conversion to open surgery', 'timeFrame': 'intraoperative, expected duration of surgery: 1 hour'}, {'measure': 'Estimated blood loss in ml', 'timeFrame': 'intraoperative, expected duration of surgery: 1 hour'}, {'measure': 'Intraoperative complications', 'timeFrame': 'intraoperative, expected duration of surgery: 1 hour', 'description': 'e.g. leakage of bile, leakage of gallstone, injury to the bile ducts, injury to organs.'}, {'measure': 'Subjective assessment (Assessment of fatigue and perceived exertion)', 'timeFrame': 'an expected average of 15 minutes before and after the operation', 'description': 'The surgeon will fill out questionnaires and scales.'}, {'measure': 'Subjective assessment (optical modality and mental load assessment)', 'timeFrame': 'an expected average of 15 minutes after the operation', 'description': 'The surgeon will fill out questionnaires and scales.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['3D', 'Three-dimensional', 'laparoscopy', 'cholecystectomy'], 'conditions': ['Cholelithiasis', 'Gall Bladder Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD resolution in cholecystectomy in terms of error rating, performance time and subjective assessment.', 'detailedDescription': 'Conventional laparoscopy can be very challenging, especially with the requirement of converting the two-dimensional image of the operating field to a three-dimensional perception. This can potentially lead to a detrimental effect on the learning curve as well for the feasibility of the operation for the more inexperienced surgeon. In our hospital, the high frequency of cholecystectomy serves as a basis for the minimally experienced surgeons to explore whether three-dimensional laparoscopy provides a better ability for solving complex intraoperative tasks than the conventional laparoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective cholecystectomy (out-patient treatment)\n\nExclusion Criteria:\n\n* Previous upper abdominal surgery\n* ASA-score 3 or above'}, 'identificationModule': {'nctId': 'NCT02396927', 'briefTitle': '3D HD Versus 2D HD in Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Three-dimensional High-definition (3DHD) Laparoscopy Versus Two-dimensional High-definition (2DHD) Laparoscopy in Cholecystectomy: a Clinical Controlled Randomized Double Blinded Trial.', 'orgStudyIdInfo': {'id': '3D_vs_2D_chol'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '2D HD laparoscopy', 'description': 'Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 2DHD viewing mode', 'interventionNames': ['Device: 2D HD laparoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3D HD laparoscopy', 'description': 'Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 3DHD viewing mode', 'interventionNames': ['Device: 3D HD laparoscopy']}], 'interventions': [{'name': '3D HD laparoscopy', 'type': 'DEVICE', 'otherNames': ['Olympus 3D ENDOEYE FLEX'], 'description': 'Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.', 'armGroupLabels': ['3D HD laparoscopy']}, {'name': '2D HD laparoscopy', 'type': 'DEVICE', 'description': 'Placebo', 'armGroupLabels': ['2D HD laparoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK2730', 'city': 'Herlev', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Charlotte Fergo', 'role': 'CONTACT', 'email': 'sayakafergo@hotmail.com'}], 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'centralContacts': [{'name': 'Charlotte Fergo', 'role': 'CONTACT', 'email': 'charlotte.sayaka.fergo@regionh.dk'}], 'overallOfficials': [{'name': 'Charlotte Fergo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herlev Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Miss', 'investigatorFullName': 'Charlotte Fergo', 'investigatorAffiliation': 'Herlev Hospital'}}}}