Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT07037693
Status:
COMPLETED
Last Update Posted:
2025-06-25
First Post:
2025-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prediction of Postoperative Outcomes After Rectal Resection by the Comprehensive Complication Index (CCI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012002', 'term': 'Rectal Diseases'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 958}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2025-06-06', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'Periprocedural', 'description': 'The predictive ability of the comprehensive-complication index and the Clavien-Dindo classification regarding the length of hospital stay after rectal resection will be compared through an area under the curve (AUC) analysis.'}], 'secondaryOutcomes': [{'measure': '30-day readmission rate', 'timeFrame': '30 days', 'description': 'The predictive ability of the comprehensive-complication index and the Clavien-Dindo classification regarding the 30-day readmission rate after rectal resection will be compared through an area under the curve (AUC) analysis.'}, {'measure': '90-day mortality', 'timeFrame': '90 days', 'description': 'The predictive ability of the comprehensive-complication index and the Clavien-Dindo classification regarding the 90-day mortality after rectal resection will be compared through an area under the curve (AUC) analysis.'}, {'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'The patients 5-year overall survival will be compared between patients with low comprehensive-complication index and high comprehensive-complication index. A high comprehensive-complication score was defined as a score above the median score of the patients with a Clavien-Dinco classification grad 3a complication.'}, {'measure': 'Comprehensive measure', 'timeFrame': '30 days', 'description': 'Evaluation of the comprehensive measure of the comprehensive-complications index through analysis of the number and severity of all complications for patients with multiple complications. Comparison of the range of the comprehensice complications-index score in patients with the same Clavien-Dindo classification.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Diseases']}, 'descriptionModule': {'briefSummary': 'Postoperative complications after rectal resection can worsen the short-term postoperative outcomes and the long-term survival. This study aims to compare the comprehensive complication index (CCI) and the commonly used Clavien-Dindo classification (CDC) in predicting postoperative outcomes after rectal resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with rectal resection at the Cantonal Hospital of St.Gallen between 2012 and June 2024.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with rectal resection at the Cantonal Hospital of St.Gallen between 2012 and June 2024.\n\nExclusion Criteria:\n\n* Missing CCI data\n* Missing CDC data\n* Incomplete 30-day follow-up\n* Decline to have their information included in the scientific data analysis\n* Age under 18 years'}, 'identificationModule': {'nctId': 'NCT07037693', 'briefTitle': 'Prediction of Postoperative Outcomes After Rectal Resection by the Comprehensive Complication Index (CCI)', 'organization': {'class': 'OTHER', 'fullName': 'Cantonal Hospital of St. Gallen'}, 'officialTitle': 'Prediction of Postoperative Outcomes After Rectal Resection by the Comprehensive Complication Index (CCI): A Retrospective Comparative Study', 'orgStudyIdInfo': {'id': 'CCI rectal resection'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CCI', 'interventionNames': ['Diagnostic Test: Comprehensive complication index (CCI)']}, {'label': 'CDC', 'interventionNames': ['Diagnostic Test: Clavien-Dindo-Classification (CDC)']}], 'interventions': [{'name': 'Comprehensive complication index (CCI)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Comprehensive complication index (CCI)', 'armGroupLabels': ['CCI']}, {'name': 'Clavien-Dindo-Classification (CDC)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Clavien-Dindo-Classification (CDC)', 'armGroupLabels': ['CDC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Sankt Gallen', 'state': 'St.Gallen', 'country': 'Switzerland', 'facility': 'HOCH Health Ostschweiz, Kantonsspital St.Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cantonal Hospital of St. Gallen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yanic Ammann', 'investigatorAffiliation': 'Cantonal Hospital of St. Gallen'}}}}