Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT04849702
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2021-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Clavien-Dindo and Comprehensive Complication Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-15', 'studyFirstSubmitDate': '2021-04-02', 'studyFirstSubmitQcDate': '2021-04-15', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '1 year'}, {'measure': 'Total in-hospital costs', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Length of ICU stay', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complication of Surgical Procedure', 'Colorectal Disorders', 'Clavien Dindo', 'Comprehensive Complication Index']}, 'descriptionModule': {'briefSummary': 'Our aim was to compare 2 postoperative complication scoring systems in predicting length of hospital stay and in-hospital costs after colorectal resections.', 'detailedDescription': 'Introduction: Postoperative complications are associated with prolonged hospital stay and rise in costs of treatment. The Comprehensive Complication Index (CCI) was developed as a scoring system that does not only take the most severe complication into account, but all complications after surgery. Our aim was to compare the Clavien-Dindo scoring system with the CCI in predicting length of hospital stay (LOHS) and in-hospital costs after colorectal resections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Data of patients in which complications occurring after surgical procedures, performed between October 2012 and September 2013, were recorded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Only patients that underwent a colorectal resection were included\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04849702', 'briefTitle': 'Comparison of the Clavien-Dindo and Comprehensive Complication Index', 'organization': {'class': 'OTHER', 'fullName': 'Jessa Hospital'}, 'officialTitle': 'Comparison of the Clavien-Dindo and Comprehensive Complication Index Systems for Grading of Surgical Complications After Colorectal Resections.', 'orgStudyIdInfo': {'id': '2020007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Postoperative complication after colorectal resection', 'description': 'Documentation of all postoperative complications after colorectal resections', 'interventionNames': ['Procedure: No intervention was compared']}], 'interventions': [{'name': 'No intervention was compared', 'type': 'PROCEDURE', 'description': 'No intervention was compared', 'armGroupLabels': ['Postoperative complication after colorectal resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Hasselt', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Jessa Hospital', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'overallOfficials': [{'name': 'Karel MC Smeyers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jessa hospital, Hasselt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jessa Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}