Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-01-01 @ 11:52 AM
Study NCT ID:
NCT00744159
Status:
COMPLETED
Last Update Posted:
2008-08-29
First Post:
2008-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Comparison of Immunological Benefit of Laparoscopic Colectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-28', 'studyFirstSubmitDate': '2008-08-27', 'studyFirstSubmitQcDate': '2008-08-28', 'lastUpdatePostDateStruct': {'date': '2008-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune factors', 'timeFrame': 'post OP 5th day'}], 'secondaryOutcomes': [{'measure': 'Post-operative complications', 'timeFrame': 'POD 7th days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colon cancer', 'laparoscopic colorectal surgery', 'cellular immunity', 'HLA-DR expression on monocyte'], 'conditions': ['Immunity']}, 'descriptionModule': {'briefSummary': 'This study aimed to clarify existence of immunological benefit of laparoscopic colon cancer surgery compared to open colon surgery.', 'detailedDescription': 'Patients with clinical stage Ⅲ left colon and upper rectal cancer were prospectively assigned to undergo LC (n=35) or OC (n=39). Factors related to cellular immunity of host (total lymphocyte count, CD4 lymphocyte, CD8 lymphocyte, CD4/CD8 ratio, HLA-DR expression on monocyte (mHLA-DR)) were examined preoperatively, on the 1st day of operation (POD1) and the 5th day of operation (POD5).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'hospital based cohort', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy proven of colon cancer\n* Preoperatively suspected as clinical stage III colon cancer\n* Lesion located Descending colon, sigmoid colon and upper rectal cancer\n\nExclusion Criteria:\n\n* Could not perform curative resection\n* Intestinal obstruction, perforation, intra-abdominal abscess\n* Severe medical illness\n* Immunopathy'}, 'identificationModule': {'nctId': 'NCT00744159', 'briefTitle': 'Prospective Comparison of Immunological Benefit of Laparoscopic Colectomy', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Prospective Comparative Study of Immunological Benefit Between Laparoscopic Colectomy and Open Colectomy', 'orgStudyIdInfo': {'id': 'IRB 2005-08-041'}, 'secondaryIdInfos': [{'id': '#CRS-106-14-1'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'OC', 'description': 'Open colorectal resection'}, {'label': 'LC', 'description': 'Laparoscopic colorectal resection'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center, Department of surgery', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Woo Yong Lee, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Woo Yong Lee/Associate Professor, Department of Surgery, Samsung Medical Center', 'oldOrganization': 'Samsugn Medical Center'}}}}