Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-10 @ 7:48 AM
Study NCT ID:
NCT01664806
Status:
COMPLETED
Last Update Posted:
2013-03-25
First Post:
2012-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode Causing Thermal Injury at Port Site Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D000084462', 'term': 'Hyperthermia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thomas.robinson@Ucdenver.edu', 'phone': '303-724-2728', 'title': 'Dr. Thomas Robinson', 'organization': 'University of Colorado School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This is a pilot study with no funding so data is limited.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'No adverse events were discovered.', 'eventGroups': [{'id': 'EG000', 'title': 'Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts', 'description': "Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.\n\nCovidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.", 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Coag Mode 30 Watts Power', 'description': 'Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.\n\nCovidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Histologic Thermal Injury to Epigastric Port Site Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts', 'description': "Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.\n\nCovidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."}, {'id': 'OG001', 'title': 'Coag Mode 30 Watts Power', 'description': 'Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.\n\nCovidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at this port sites.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A sample size of convenience for feasibility.'}, {'type': 'SECONDARY', 'title': 'Histologic Evidence of Burn at the Umbilical Port Site Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts', 'description': "Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.\n\nCovidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."}, {'id': 'OG001', 'title': 'Coag Mode 30 Watts Power', 'description': 'Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.\n\nCovidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port site.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A sample size of convenience for feasibility.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts', 'description': "Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.\n\nCovidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."}, {'id': 'FG001', 'title': 'Coag Mode 30 Watts Power', 'description': 'Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.\n\nCovidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '40 patients were recruited at the University of Colorado Hospital.', 'preAssignmentDetails': 'Two screened patients were excluded because they refused entry into the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts', 'description': "Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.\n\nCovidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."}, {'id': 'BG001', 'title': 'Coag Mode 30 Watts Power', 'description': 'Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.\n\nCovidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy'}, {'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': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '18', 'groupId': 'BG000'}, {'value': '41', 'spread': '12', 'groupId': 'BG001'}, {'value': '44', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-18', 'studyFirstSubmitDate': '2012-08-10', 'resultsFirstSubmitDate': '2013-01-25', 'studyFirstSubmitQcDate': '2012-08-13', 'lastUpdatePostDateStruct': {'date': '2013-03-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-25', 'studyFirstPostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histologic Thermal Injury to Epigastric Port Site Skin', 'timeFrame': '1 day', 'description': 'Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at this port sites.'}], 'secondaryOutcomes': [{'measure': 'Histologic Evidence of Burn at the Umbilical Port Site Skin', 'timeFrame': '1 day', 'description': 'Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port site.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Electrosurgery', 'Radiofrequency energy', 'Monopolar instruments', 'Capacitive coupling', 'Thermal injury', 'Surgical complications'], 'conditions': ['Intraoperative Complications', 'Thermal Injury', 'Electrocoagulation']}, 'referencesModule': {'references': [{'pmid': '23739984', 'type': 'DERIVED', 'citation': 'Jones EL, Dunn CL, Townsend NT, Jones TS, Bruce Dunne J, Montero PN, Govekar HR, Stiegmann GV, Robinson TN. Blend mode reduces unintended thermal injury by laparoscopic monopolar instruments: a randomized controlled trial. Surg Endosc. 2013 Nov;27(11):4016-20. doi: 10.1007/s00464-013-3032-2. Epub 2013 Jun 6.'}]}, 'descriptionModule': {'briefSummary': "Monopolar radiofrequency energy is used to perform the laparoscopic cholecystectomy operation. The appearance of burns are common following laparoscopic cholecystectomy; particularly at the port site of the active electrode. Willson et al found that 9 out of 19 skin biopsies from the skin adjacent to the port site of the monopolar instrument's active electrode were found to have thermal injury by histology. \\[Willson et al. Surg Endosc (1997) 11:653\\] Authors have speculated that using different generator modes may lead to less capacitive coupling; \\[Wu et al Am J Surg (2000) 179: 67\\] although no data exists to support these speculations.\n\nThe investigators hypothesize that capacitive coupling electrosurgical injuries from monopolar instruments are occurring during laparoscopic cholecystectomy operations. The investigators hypothesize that use of blend modes will reduce the incidence of capacitive coupling thermal injuries during laparoscopic operations in comparison to coag modes.", 'detailedDescription': "SPECIFIC AIM:\n\nCompare incidence of skin burns caused by using coag versus blend monopolar instrument modes at the active electrode port site (epigastric port), and at the non-active electrode port sites (umbilical and right abdominal wall).\n\nOUTCOME MEASURE:\n\nHistologic evidence of thermal injury at the skin biopsy sites of the active electrode port, the camera port and the medial assistant port. Histology will be performed by a blinded pathologist.\n\nPOPULATION TO BE ENROLLED:\n\nSubjects undergoing elective laparoscopic cholecystectomy will be recruited in the principle investigators pre-operative clinic. All subjects will be 18 years and older.\n\nSTUDY DESIGN AND METHODS:\n\nWritten informed consent will be obtained in all subjects prior to enrollment. Subjects will be randomized on the day of surgery to undergo the laparoscopic cholecystectomy operation with either the coag or blend modes of using standard monopolar electrosurgery instruments. The randomization process will occur by using a random number generator. A total of 40 subjects will be recruited; 20 subjects per group. Shave skin biopsies will be performed at the edge of the incisions of the active electrode port, the camera port and the medial assistant port on the right abdominal wall. The incisions and skin will be otherwise opened and closed in the routine clinical manor.\n\nSTATISTICAL ANALYSIS The incidence of skin burns created using coag or blend modes will be compared individually at all three port sites using chi-squared or Fisher's exact test where appropriate. Baseline demographic data (e.g., gender, age, body mass index, operation time, blood loss, indication for operation and histology) will be compared in the two groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older planned to undergo elective laparoscopic cholecystectomy\n\nExclusion Criteria:\n\n* Patients undergoing urgent or emergent laparoscopic cholecystectomy operations'}, 'identificationModule': {'nctId': 'NCT01664806', 'briefTitle': 'Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode Causing Thermal Injury at Port Site Skin', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode and Thermal Injury to Tissue Adjacent to Port Sites', 'orgStudyIdInfo': {'id': '09-0049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Coag mode 30 Watts Power', 'description': 'Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.'}, {'type': 'EXPERIMENTAL', 'label': 'Covidien Triad monopolar generator', 'description': "Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform Elective laparoscopic cholecystectomy. which is the experimental arm of the study's mode.", 'interventionNames': ['Device: Covidien Triad monopolar generator']}], 'interventions': [{'name': 'Covidien Triad monopolar generator', 'type': 'DEVICE', 'description': 'Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.', 'armGroupLabels': ['Covidien Triad monopolar generator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Thomas Robinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}