Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT05675904
Status:
COMPLETED
Last Update Posted:
2023-01-09
First Post:
2022-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Textbook Outcome in Colon Carcinoma
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 564}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-05', 'studyFirstSubmitDate': '2022-12-17', 'studyFirstSubmitQcDate': '2023-01-05', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Textbook Outcome', 'timeFrame': 'September 2012- August 2016', 'description': 'analyse the achievement of Textbook Outcome in a series of patients undergoing scheduled colon cancer resection'}, {'measure': 'Overall survival', 'timeFrame': 'From surgery to 160 months', 'description': 'relationship between Textbook Outcome and overall survival'}, {'measure': 'disease-free survival', 'timeFrame': 'From surgery to 160 months', 'description': 'relationship between Textbook Outcome and disease-free survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Outcome Assessment', 'Cancer of Colon']}, 'descriptionModule': {'briefSummary': 'BACKGROUND:\n\nTextbook outcome (TO) is a multidimensional quality management tool that uses a set of traditional surgical measures to reflect an "ideal" surgical result for a particular pathology. The aim of the present study is to record the rate of TO in patients undergoing elective surgery for colon cancer.\n\nMATERIAL AND METHODS:\n\nRetrospective study of all patients undergoing scheduled colon cancer surgery at a Spanish university hospital from September 2012 to August 2016. Patients with rectal cancer were excluded. The variables included in the definition of TO were: R0 resection, number of isolated nodes ≥12, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days.\n\nThe main objective of this study is to analyse the achievement of TO in a series of patients undergoing scheduled colon cancer resection at the Doctor Balmis General University Hospital in Alicante, Spain. The investigators assess the relationship between TO and overall and disease-free survival, and analyse the indicators included in the definition of TO in colon cancer surgery in order to establish recommendations for its standardization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing elective colon cancer resection with confirmed histological diagnosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective colon cancer resection with confirmed histological diagnosis were eligible for the study\n\nExclusion Criteria:\n\n* Age under 18 years\n* Emergency surgery\n* Resections of the rectum or resections for pathologies other than cancer\n* Follow-up of less than two years (with the exception of patients who died)'}, 'identificationModule': {'nctId': 'NCT05675904', 'briefTitle': 'Textbook Outcome in Colon Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario de Alicante'}, 'officialTitle': 'Textbook Outcome in Colon Carcinoma: Implications for Overall Survival and Disease-free Survival.', 'orgStudyIdInfo': {'id': '12/2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Yes Textbook Outcome', 'description': 'Patients undergoing scheduled colon cancer surgery with a R0 resection, number of isolated nodes ≥12, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days', 'interventionNames': ['Procedure: Colon oncological resection']}, {'label': 'No Textbook outcome', 'description': 'Patients undergoing scheduled colon cancer surgery without any of the following items: R0 resection, number of isolated nodes ≥12, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days', 'interventionNames': ['Procedure: Colon oncological resection']}], 'interventions': [{'name': 'Colon oncological resection', 'type': 'PROCEDURE', 'description': 'Scheduled colon cancer surgery', 'armGroupLabels': ['No Textbook outcome', 'Yes Textbook Outcome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03010', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Universitario Dr. Balmis', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General Universitario de Alicante', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Physician', 'investigatorFullName': 'Candido Fernando Alcazar-Lopez', 'investigatorAffiliation': 'Hospital General Universitario de Alicante'}}}}