Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-25 @ 4:15 AM
Study NCT ID:
NCT01715402
Status:
UNKNOWN
Last Update Posted:
2017-02-06
First Post:
2012-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of Health Expenditure in Liver Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D018285', 'term': 'Klatskin Tumor'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-03', 'studyFirstSubmitDate': '2012-10-22', 'studyFirstSubmitQcDate': '2012-10-24', 'lastUpdatePostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall postoperative length of stay', 'timeFrame': 'during the 3 months after the surgery', 'description': "the overall postoperative length of stay is defined as the hospitalization between the surgery and patient's discharge.\n\nThis period includes the readmission for at least 24 hours in case of outcomes related to the surgery."}], 'secondaryOutcomes': [{'measure': 'peroperative outcomes', 'timeFrame': 'during the surgical procedure', 'description': 'the peroperative outcomes are collected during the surgery and correspond to any event occured during the surgical intervention'}, {'measure': 'postoperative outcomes', 'timeFrame': 'after the surgery until postoperative month 3', 'description': 'the postoperative outcomes correspond to any event occured after the surgical intervention. These outcomes include fistulae; bleeding...'}, {'measure': 'construct of pronostic models', 'timeFrame': 'after the postoperative month 3', 'description': 'the construct of pronostic models include variables that affect the length of stay; morbidity and mortality'}, {'measure': 'evaluation of PMSI indicators', 'timeFrame': 'after the postoperative month 3', 'description': 'this evaluation includes the analysis of PMSI indicators; their validity and the influence of centres on hepatectomies results'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['liver tumor', 'carcinoma', 'cholangiocarcinoma', 'metastasis'], 'conditions': ['Hepatocellular Carcinoma', 'Hilar Cholangiocarcinoma', 'Intra Hepatic Cholangiocarcinoma', 'Liver Metastasis']}, 'referencesModule': {'references': [{'pmid': '28991876', 'type': 'DERIVED', 'citation': 'Cauchy F, Farges O, Vibert E, Boleslawski E, Pruvot FR, Regimbeau JM, Mabrut JY, Scatton O, Adham M, Laurent C, Gregoire E, Delpero JR, Bachellier P, Soubrane O. Sensitizing Surgeons to Their Outcome Has No Measurable Short-term Benefit. Ann Surg. 2017 Nov;266(5):884-889. doi: 10.1097/SLA.0000000000002403.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to reduce the length of stay after liver surgery by taking account of objective quantitative clinical variables, subjective qualitative clinical variables and non clinical variables.', 'detailedDescription': 'a new dimension of the activity expected of physicians is to improve the safety of care on the one hand and the control of health care costs on the other.\n\nkey measures to help them are the publication of national recommendations, assessment of actual practices and the incentive to activity.\n\nInternationalwide recent and concordant data suggest that\n\n* quality and security of care, after an initial improvement, are going to stall\n* scientific recommendations are rarely validated by an impact analysis and are not applied\n* clinical data collected within an administrative framework are unreliable and too generalist\n* the evaluation, especially in the surgical field, is based on indicators sometimes irrelevant and often unclear'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the population corresponds to patients operated in one of the thirteen hospitals.\n\nThese hospitals are distributed on the french territory to ensure that the recruitment is representative of the general population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective liver surgery\n* older than 18\n* agreed to participate\n* surgical procedure included procedures registered as "HLFA003 - 007 ; 009 - 011 ; 017 - 020 ; HLFC002 à 004 ; 027 ; 032 ; 037" in the PMSI database\n\nExclusion Criteria:\n\n* emergency surgery\n* refused to participate'}, 'identificationModule': {'nctId': 'NCT01715402', 'briefTitle': 'Optimization of Health Expenditure in Liver Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Optimization of Health Expenditure in Major Surgery: Impact of a Mixed, Clinical and Ethnographic Approach in the Model of Liver Surgery', 'orgStudyIdInfo': {'id': 'AOM 11060'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'operated patients', 'description': 'this cohort includes patients who underwent a liver surgery whatever the pathology and whatever the surgical procedure', 'interventionNames': ['Procedure: liver surgery']}], 'interventions': [{'name': 'liver surgery', 'type': 'PROCEDURE', 'description': 'this intervention type includes hepatectomies; wedge; segmentectomies etc...', 'armGroupLabels': ['operated patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'facility': 'Amiens North Hospital', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Bordeaux Hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Clichy', 'country': 'France', 'facility': 'Beaujon University Hospital', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Lille', 'country': 'France', 'facility': 'Lille Regional Hospital', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Lyon Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Marseille Hospital', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Paoli calmette institute', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Paris', 'country': 'France', 'facility': 'Saint Antoine Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Strasbourg hospital', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy institute', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Paul Brousse Hospital', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Olivier FARGES, MD, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beaujon University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'collaborators': [{'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}