Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-02-26 @ 6:28 AM
Study NCT ID:
NCT02628093
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2015-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A ProspectiveTrial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kivanova@med.cornell.edu', 'phone': '646-9622342', 'title': 'Koianka Trencheva', 'organization': 'Weill Cornell Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'description': 'Since this is a standard of care procedures no adverse events were recorded. However all intraoperative and postoperative complications were documented as described in the protocol. All the complications that were collected are not qualifying as serous adverse event per protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'THUNDERBEAT', 'description': 'THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels\n\nTHUNDERBEAT: Tissue dissection and vessels ligation', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 3, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'LIGASURE', 'description': 'LIGASURE energy device will be used for dissection of tissue and ligation of vessels\n\nLIGASURE: Tissue dissection and vessels ligation', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 9, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Postoperative Rectal Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound hematoma incision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Time for Dissection of the Soft Tissues', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'THUNDERBEAT', 'description': 'THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels\n\nTHUNDERBEAT: Tissue dissection and vessels ligation'}, {'id': 'OG001', 'title': 'LIGASURE', 'description': 'LIGASURE energy device will be used for dissection of tissue and ligation of vessels\n\nLIGASURE: Tissue dissection and vessels ligation'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '172'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '175'}]}]}], 'analyses': [{'pValue': '0.214', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value threshold \\<0.05', 'groupDescription': "Because this was a pilot (exploratory) randomized study, no formal sample size calculation was required. Demographic, preoperative, and postoperative variables and the primary outcome were compared between groups (THUNDERBEAT and LigaSure) by the Wilcoxon rank-sum test for continuous variables and the chi-square test/Fisher's exact test for categorical variables, as appropriate. All p-values are two-sided with statistical significance evaluated at the 0.05 alpha level.", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Because this was a pilot (exploratory) randomized study, no formal sample size calculation was required.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 Surgical procedure', 'description': 'from the start of colon mobilization to specimen removal from the abdominal cavity', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Versatility Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'THUNDERBEAT', 'description': 'THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels\n\nTHUNDERBEAT: Tissue dissection and vessels ligation'}, {'id': 'OG001', 'title': 'LIGASURE', 'description': 'LIGASURE energy device will be used for dissection of tissue and ligation of vessels\n\nLIGASURE: Tissue dissection and vessels ligation'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value threshold \\<0.05', 'groupDescription': 'compared between groups by the Wilcoxon rank-sum test', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 Surgical procedure', 'description': 'Total/Composite score (composite of 5 variables:hemostasis;sealing;cutting;dissection;and tissue manipulation) was measured by a score system from 1 to 5 (1 being worst and 5 best) for each of the 5 variables,weighted by Coefficient of Importance with weight distribution as follow: hemostasis 0.275, sealing 0.275, cutting 0.2, dissection 0.15, and tissue Manipulation 0.1.). The final reported score is a weighted average.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Post Surgical Stay in the Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'THUNDERBEAT', 'description': 'THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels\n\nTHUNDERBEAT: Tissue dissection and vessels ligation'}, {'id': 'OG001', 'title': 'LIGASURE', 'description': 'LIGASURE energy device will be used for dissection of tissue and ligation of vessels\n\nLIGASURE: Tissue dissection and vessels ligation'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from Surgery date to the discharge date from the hospital up to 30 days', 'description': 'Length of post surgical stay in the hospital measured in days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dryness of the Surgical Field Average Score Mean/sd', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'THUNDERBEAT', 'description': 'THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels\n\nTHUNDERBEAT: Tissue dissection and vessels ligation'}, {'id': 'OG001', 'title': 'LIGASURE', 'description': 'LIGASURE energy device will be used for dissection of tissue and ligation of vessels\n\nLIGASURE: Tissue dissection and vessels ligation'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 Surgical Procedure', 'description': 'Measured by score from 1 to 5 where 1 means Heavy bleeding , hemostasis achieved with the instrument with more than 2 attempts, and 5 means No oozing at vessel or tissue site in entire surgical field .', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intraoperative Complication Related to the Energy Devices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'THUNDERBEAT', 'description': 'THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels\n\nTHUNDERBEAT: Tissue dissection and vessels ligation'}, {'id': 'OG001', 'title': 'LIGASURE', 'description': 'LIGASURE energy device will be used for dissection of tissue and ligation of vessels\n\nLIGASURE: Tissue dissection and vessels ligation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 Surgical procedure', 'description': 'Intraoperative adverse event occurrences during surgery due to the energy devices (THUNDERBEAT and LigaSure) measured as categorical variable "Yes" or "No"', 'unitOfMeasure': 'percentage of total in the group', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Delayed Thermal Injuries Related to Energy Devices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'THUNDERBEAT', 'description': 'THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels\n\nTHUNDERBEAT: Tissue dissection and vessels ligation'}, {'id': 'OG001', 'title': 'LIGASURE', 'description': 'LIGASURE energy device will be used for dissection of tissue and ligation of vessels\n\nLIGASURE: Tissue dissection and vessels ligation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value threshold \\<0.05', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'DAY 1 to DAY 30 Postsurgery', 'description': 'Delayed thermal injuries related to Energy devices that occur after surgery within 30 days of the surgical date, measured as categorical variables "Yes" or "No".', 'unitOfMeasure': 'percentage of total number in the group', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Operative Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'THUNDERBEAT', 'description': 'THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels\n\nTHUNDERBEAT: Tissue dissection and vessels ligation'}, {'id': 'OG001', 'title': 'LIGASURE', 'description': 'LIGASURE energy device will be used for dissection of tissue and ligation of vessels\n\nLIGASURE: Tissue dissection and vessels ligation'}], 'classes': [{'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000', 'lowerLimit': '113', 'upperLimit': '270'}, {'value': '170', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '265'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 Surgical Procedure', 'description': 'operative procedure time measured in minutes from the start of the incision to the last stitch in the closure of the surgical incision', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'THUNDERBEAT', 'description': 'THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels\n\nTHUNDERBEAT: Tissue dissection and vessels ligation'}, {'id': 'FG001', 'title': 'LIGASURE', 'description': 'LIGASURE energy device will be used for dissection of tissue and ligation of vessels\n\nLIGASURE: Tissue dissection and vessels ligation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '73 subjects were enrolled, and 60 of them were randomized into the two groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'THUNDERBEAT', 'description': 'THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels\n\nTHUNDERBEAT: Tissue dissection and vessels ligation'}, {'id': 'BG001', 'title': 'LIGASURE', 'description': 'LIGASURE energy device will be used for dissection of tissue and ligation of vessels\n\nLIGASURE: Tissue dissection and vessels ligation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '92'}, {'value': '63', 'groupId': 'BG001', 'lowerLimit': '29', 'upperLimit': '88'}, {'value': '59.5', 'groupId': 'BG002', 'lowerLimit': '29', 'upperLimit': '92'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index(BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.3', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '26.4', 'spread': '4', 'groupId': 'BG001'}, {'value': '26.3', 'spread': '4.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared.", 'unitOfMeasure': 'kgm^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ASA Class', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'description': 'American Society of Anesthesiologists Classification (ASA Class) and has 6 levels plus an indicator "E" for an emergency cases.ASA 1: A normal healthy patient, ASA 2: A patient with a mild systemic disease,ASA 3: A patient with a severe systemic disease that is not life-threatening, to ASA 6: A brain-dead patient whose organs are being removed with the intention of transplanting them into another patient.This trial enrolled patients with ASA 1 to 3.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-08', 'size': 91733, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-18T14:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2015-12-04', 'resultsFirstSubmitDate': '2019-11-22', 'studyFirstSubmitQcDate': '2015-12-09', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-31', 'studyFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Time for Dissection of the Soft Tissues', 'timeFrame': 'Day 0 Surgical procedure', 'description': 'from the start of colon mobilization to specimen removal from the abdominal cavity'}, {'measure': 'Versatility Score', 'timeFrame': 'Day 0 Surgical procedure', 'description': 'Total/Composite score (composite of 5 variables:hemostasis;sealing;cutting;dissection;and tissue manipulation) was measured by a score system from 1 to 5 (1 being worst and 5 best) for each of the 5 variables,weighted by Coefficient of Importance with weight distribution as follow: hemostasis 0.275, sealing 0.275, cutting 0.2, dissection 0.15, and tissue Manipulation 0.1.). The final reported score is a weighted average.'}], 'secondaryOutcomes': [{'measure': 'Length of Post Surgical Stay in the Hospital', 'timeFrame': 'from Surgery date to the discharge date from the hospital up to 30 days', 'description': 'Length of post surgical stay in the hospital measured in days'}, {'measure': 'Dryness of the Surgical Field Average Score Mean/sd', 'timeFrame': 'Day 0 Surgical Procedure', 'description': 'Measured by score from 1 to 5 where 1 means Heavy bleeding , hemostasis achieved with the instrument with more than 2 attempts, and 5 means No oozing at vessel or tissue site in entire surgical field .'}, {'measure': 'Intraoperative Complication Related to the Energy Devices', 'timeFrame': 'Day 0 Surgical procedure', 'description': 'Intraoperative adverse event occurrences during surgery due to the energy devices (THUNDERBEAT and LigaSure) measured as categorical variable "Yes" or "No"'}, {'measure': 'Delayed Thermal Injuries Related to Energy Devices', 'timeFrame': 'DAY 1 to DAY 30 Postsurgery', 'description': 'Delayed thermal injuries related to Energy devices that occur after surgery within 30 days of the surgical date, measured as categorical variables "Yes" or "No".'}, {'measure': 'Operative Procedure Time', 'timeFrame': 'Day 0 Surgical Procedure', 'description': 'operative procedure time measured in minutes from the start of the incision to the last stitch in the closure of the surgical incision'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '34724584', 'type': 'DERIVED', 'citation': 'Milsom JW, Trencheva K, Momose K, Peev MP, Christos P, Shukla PJ, Garrett K. A pilot randomized controlled trial comparing THUNDERBEAT to the Maryland LigaSure energy device in laparoscopic left colon surgery. Surg Endosc. 2022 Jun;36(6):4265-4274. doi: 10.1007/s00464-021-08765-8. Epub 2021 Nov 1.'}]}, 'descriptionModule': {'briefSummary': 'Prospective randomized controlled study, at Colon and Rectal Surgery, WMC/NYPH. Subjects undergoing Laparoscopic Left Colectomy will be randomized into 1 of 2 groups based on the instrument used for tissue dissection and vessel ligation: Group 1 - THUNDERBEAT Group 2\n\n\\- Ligasure Population', 'detailedDescription': 'Prospective randomized controlled study, at Colon and Rectal Surgery, WMC/NYPH. Subjects undergoing Laparoscopic Left Colectomy will be randomized into 1 of 2 groups based on the instrument used for tissue dissection and vessel ligation: Group 1 - THUNDERBEAT Group 2\n\n\\- Ligasure Population: 60 subjects, with colon neoplasm or diverticulitis will be invited in the study after surgery is deemed necessary Study Procedures: This project will consist only of prospective data collection. No interventions will be done for research purpose. Data will be collected prospectively on: -Patients (before, during and after surgery) -The THUNDERBEAT and LigaSure instruments Data will be collected on data collection sheets and entered in a password protected database Primary Outcomes/Definitions- Overall time for dissection of the soft tissues necessary for specimen removal during colon resection, measured in minutes, from the start of colon mobilization to specimen removal from the abdominal cavity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that will be undergoing a Left Laparoscopic Colon Resection\n* Older than 18 years old\n* ASA 1 to 3\n* Elective surgeries\n* Patients who willingly provide informed consent\n\nExclusion Criteria:\n\n* Morbidly obese patients (BMI \\>35)\n* Patients with acute diverticulitis\n* Patients with multiple previous abdominal surgeries\n* Patients on anticoagulants\n* Patients who can not, tolerate a major surgery\n* Patients for whom electrosurgery is contraindicated\n* Patients who are pregnant\n* Patient with IBDs'}, 'identificationModule': {'nctId': 'NCT02628093', 'briefTitle': 'A ProspectiveTrial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'A Randomized Controlled Trial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery', 'orgStudyIdInfo': {'id': '1403014955'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'THUNDERBEAT', 'description': 'THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels', 'interventionNames': ['Device: THUNDERBEAT']}, {'type': 'OTHER', 'label': 'LIGASURE', 'description': 'LIGASURE energy device will be used for dissection of tissue and ligation of vessels', 'interventionNames': ['Device: LIGASURE']}], 'interventions': [{'name': 'THUNDERBEAT', 'type': 'DEVICE', 'description': 'Tissue dissection and vessels ligation', 'armGroupLabels': ['THUNDERBEAT']}, {'name': 'LIGASURE', 'type': 'DEVICE', 'description': 'Tissue dissection and vessels ligation', 'armGroupLabels': ['LIGASURE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical Center- NYPH', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jeffrey Milsom, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'WCMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Olympus', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}