Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2026-01-01 @ 4:17 AM
Study NCT ID:
NCT04907435
Status:
COMPLETED
Last Update Posted:
2021-05-28
First Post:
2021-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Simultaneous Laparoscopic and Open Operations for Synchronous Liver Metastases With Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-25', 'studyFirstSubmitDate': '2021-05-25', 'studyFirstSubmitQcDate': '2021-05-25', 'lastUpdatePostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'three years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Optimization of Treatment']}, 'descriptionModule': {'briefSummary': 'retrospective analysis of medical records of patients with synchronous liver metastatic colorectal cancer, who underwent simultaneous operations on the intestine and on the liver, from January 2011 to November 2020 at the Russian Scientific Center for Roentgenoradiology. 2 groups of 21 patients each were formed: group 1 included a patient with simultaneous laparoscopic operations, group 2 included a patient with simultaneous open operations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with synchronous metastatic liver lesions with colorectal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with synchronous metastatic liver lesions with colorectal cancer\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04907435', 'briefTitle': 'Comparison of Simultaneous Laparoscopic and Open Operations for Synchronous Liver Metastases With Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Federal State Budgetary Institution Russian Scientific Center of Roentgenoradiology of the Ministry'}, 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patient with simultaneous laparoscopic operations', 'interventionNames': ['Procedure: simultaneous operations']}, {'label': 'patient with simultaneous open operations', 'interventionNames': ['Procedure: simultaneous operations']}], 'interventions': [{'name': 'simultaneous operations', 'type': 'PROCEDURE', 'description': 'simultaneous operations', 'armGroupLabels': ['patient with simultaneous laparoscopic operations', 'patient with simultaneous open operations']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal State Budgetary Institution Russian Scientific Center of Roentgenoradiology of the Ministry', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Ivanova Olga', 'investigatorAffiliation': 'Federal State Budgetary Institution Russian Scientific Center of Roentgenoradiology of the Ministry'}}}}