Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2026-01-29 @ 12:52 PM
Study NCT ID:
NCT00942461
Status:
COMPLETED
Last Update Posted:
2009-07-21
First Post:
2009-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammatory Response in Laparoscopic and Open Colectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'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'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'lastUpdateSubmitDate': '2009-07-20', 'studyFirstSubmitDate': '2009-07-20', 'studyFirstSubmitQcDate': '2009-07-20', 'lastUpdatePostDateStruct': {'date': '2009-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammatory reaction of the patients organism in laparoscopic vs open colorectal surgery for cancer', 'timeFrame': 'preoperative, intraoperative, 6h postop, 24h postop'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['a-defensins', 'TLRs', 'Inflammatory Cytokines', 'CRP', 'No metastases', 'No other obvious inflammation', 'No chronic diseases'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '21898023', 'type': 'DERIVED', 'citation': 'Tsimogiannis KE, Tellis CC, Tselepis AD, Pappas-Gogos GK, Tsimoyiannis EC, Basdanis G. Toll-like receptors in the inflammatory response during open and laparoscopic colectomy for colorectal cancer. Surg Endosc. 2012 Feb;26(2):330-6. doi: 10.1007/s00464-011-1871-2. Epub 2011 Sep 5.'}, {'pmid': '21567262', 'type': 'DERIVED', 'citation': 'Tsimogiannis KE, Telis K, Tselepis A, Pappas-Gogos GK, Tsimoyiannis EC, Basdanis G. Alpha-defensin expression of inflammatory response in open and laparoscopic colectomy for colorectal cancer. World J Surg. 2011 Aug;35(8):1911-7. doi: 10.1007/s00268-011-1140-5.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to measure and compare the inflammatory response in laparoscopic and open colon cancer surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* colorectal cancer\n\nExclusion Criteria:\n\n* metastases\n* stage 4 colorectal cancer\n* recurrent disease\n* chronic diseases\n* obvious inflammatory condition'}, 'identificationModule': {'nctId': 'NCT00942461', 'briefTitle': 'Inflammatory Response in Laparoscopic and Open Colectomy', 'organization': {'class': 'OTHER', 'fullName': 'G. Hatzikosta General Hospital'}, 'officialTitle': 'Contribution to the Study of Inflammatory Response in Laparoscopic vs Open Colon Cancer Surgery', 'orgStudyIdInfo': {'id': 'GH-1948-04'}, 'secondaryIdInfos': [{'id': 'GHDS-12345-4'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic Surgery group', 'description': 'Group of patients that are operated with laparoscopic approach', 'interventionNames': ['Procedure: Laparoscopic colectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open surgery Group', 'description': 'Group of patients operated with open approach', 'interventionNames': ['Procedure: Open colectomy']}], 'interventions': [{'name': 'Laparoscopic colectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic colectomy. Epidural anaesthesia used', 'armGroupLabels': ['Laparoscopic Surgery group']}, {'name': 'Open colectomy', 'type': 'PROCEDURE', 'description': 'Open colectomy. Epidural anaesthesia used', 'armGroupLabels': ['Open surgery Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45001', 'city': 'Ioannina', 'country': 'Greece', 'facility': 'G Hatzikosta General Hospital', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'G. Hatzikosta General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Ioannina', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Konstantinos E. Tsimogiannis, MD', 'oldOrganization': 'G. Hatzikosta General Hospital, Ioannina, Greece'}}}}