Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-03-01 @ 12:21 AM
Study NCT ID:
NCT02361918
Status:
COMPLETED
Last Update Posted:
2015-02-12
First Post:
2014-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Value of Procalcitonin, CRP, Drain Fluid Culture, Il-6 and Tnf-α in Anastomotic Leakage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-08', 'studyFirstSubmitDate': '2014-10-26', 'studyFirstSubmitQcDate': '2015-02-08', 'lastUpdatePostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive values of serum CRP, procalcitonin, drain fluid IL-6 and TNF-alpha levels in anastomotic leakage.', 'timeFrame': '5 day'}]}, 'conditionsModule': {'conditions': ['Anastomotic Leakage in Colon Surgery']}, 'descriptionModule': {'briefSummary': 'Evaluating predictive value of serum procalcitonin, C-Reactive Protein, drain IL-6 and TNF-alpha for anastomotic leakage in post-operative period.', 'detailedDescription': 'To search for a biomarker, which might be able to predict rectal anastomotic leakage before its clinical presentation. Serum procalcitonin, C-reactive protein, and drain fluid culture, IL-6 and TNF-α levels were evaluated in 50 consecutive patients with rectal cancer who underwent low anterior resection with colorectal anastomosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patient had colonic resection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient underwent to colonic resection and had drain\n\nExclusion Criteria:\n\n* other patients'}, 'identificationModule': {'nctId': 'NCT02361918', 'briefTitle': 'Predictive Value of Procalcitonin, CRP, Drain Fluid Culture, Il-6 and Tnf-α in Anastomotic Leakage', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Predicting Value of Serum Procalcitonin, C-reactive Protein, and Drain Fluid Culture, Fluid Il-6 and Tnf-α Levels in Anastomotic Leakage Following Rectal Resection', 'orgStudyIdInfo': {'id': 'CTF-EH0001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anastomotic leakage', 'description': 'Patient had anastomotic leakage', 'interventionNames': ['Procedure: Colon surgery']}, {'label': 'No anastomotic leakage', 'description': 'Patient had no anastomotic leakage', 'interventionNames': ['Procedure: Colon surgery']}], 'interventions': [{'name': 'Colon surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['Anastomotic leakage', 'No anastomotic leakage']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Engin HATIPOGLU', 'investigatorAffiliation': 'Istanbul University'}}}}