Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-28 @ 7:03 AM
Study NCT ID:
NCT01628250
Status:
COMPLETED
Last Update Posted:
2022-11-15
First Post:
2012-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Laparoscopic Complete Mesocolic Excision on Colon Cancer
Sponsor:
Organization:
Raw JSON
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CME and HMA are the two arms of the medial approach utilized.', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'D3 Laparoscopic Colectomy', 'description': 'Randomized group of patients receiving laparoscopic colectomy with D3-resection\n\nD3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications.', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 19}], 'seriousEvents': [{'term': 'vessel-related complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Surgical and medical procedures'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Histopathological Outcomes Obtained Through the Surgeries', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laparoscopic Complete Mesocolic Excision', 'description': 'Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision\n\nlaparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized.'}, {'id': 'OG001', 'title': 'D3 Laparoscopic Colectomy', 'description': 'Randomized group of patients receiving laparoscopic colectomy with D3-resection\n\nD3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.3', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '19.2', 'spread': '6.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days after the surgery', 'description': 'number of lymph nodes retrieved', 'unitOfMeasure': 'nodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Survival Rate', 'timeFrame': '3 years after the surgery', 'description': 'The follow up to the patients after the surgery to evaluate the oncological results of the technique', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Laparoscopic Complete Mesocolic Excision', 'description': 'Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision\n\nlaparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized.'}, {'id': 'FG001', 'title': 'D3 Laparoscopic Colectomy', 'description': 'Randomized group of patients receiving laparoscopic colectomy with D3-resection\n\nD3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Laparoscopic Complete Mesocolic Excision', 'description': 'Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision\n\nlaparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized.'}, {'id': 'BG001', 'title': 'D3 Laparoscopic Colectomy', 'description': 'Randomized group of patients receiving laparoscopic colectomy with D3-resection\n\nD3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications.'}, {'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': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '99', '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': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-26', 'studyFirstSubmitDate': '2012-06-20', 'resultsFirstSubmitDate': '2015-11-07', 'studyFirstSubmitQcDate': '2012-06-22', 'lastUpdatePostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-21', 'studyFirstPostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histopathological Outcomes Obtained Through the Surgeries', 'timeFrame': '14 days after the surgery', 'description': 'number of lymph nodes retrieved'}], 'secondaryOutcomes': [{'measure': 'Survival Rate', 'timeFrame': '3 years after the surgery', 'description': 'The follow up to the patients after the surgery to evaluate the oncological results of the technique'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Operation Finding', 'Complications', 'Pathology', 'Quality of Life', 'Neoplasms Recurrence']}, 'descriptionModule': {'briefSummary': 'Laparoscopic complete mesocolic excision is a concept that using laparoscopic surgery technique to perform a resection for colon cancer. Besides, the segment of the colon containing the tumor, the resection area should include an intact mesocolon as an envelope to encase the possible route for metastasis. The routes include blood vessels, lymphatic drain and etc. Such hypothesis predicts better histopathological and higher oncological results which turns into better survival rate and better quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with pathologically confirmed colon cancer\n* Signed consent\n\nExclusion Criteria:\n\n* History of malignancy\n* Intestinal obstruction or perforation\n* Evidence of metastasis by preoperative examinations\n* Deformity of spine\n* Emergency case\n* BMI \\> 29'}, 'identificationModule': {'nctId': 'NCT01628250', 'acronym': 'LCME', 'briefTitle': 'Laparoscopic Complete Mesocolic Excision on Colon Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Clinical Research on the Efficacy and Feasibility of Laparoscopic Complete Mesocolic Excision on Colon Cancer: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'SH-MIS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopic complete mesocolic excision', 'description': 'Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision', 'interventionNames': ['Procedure: laparoscopic complete mesocolic excision']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D3 laparoscopic colectomy', 'description': 'Randomized group of patients receiving laparoscopic colectomy with D3-resection', 'interventionNames': ['Procedure: D3-laparoscopic colectomy']}], 'interventions': [{'name': 'laparoscopic complete mesocolic excision', 'type': 'PROCEDURE', 'otherNames': ['laparoscopic CME', 'Complete Medial Approach (CMA)', 'Hybrid Medial Approach (HMA)'], 'description': 'laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized.', 'armGroupLabels': ['laparoscopic complete mesocolic excision']}, {'name': 'D3-laparoscopic colectomy', 'type': 'PROCEDURE', 'otherNames': ['D3 laparoscopic colectomy'], 'description': 'D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications.', 'armGroupLabels': ['D3 laparoscopic colectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Bo Feng, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Minimally Invasive Surgery Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bo Feng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research chair of MIS', 'investigatorFullName': 'Bo Feng', 'investigatorAffiliation': 'Ruijin Hospital'}}}}