Optimization of Health Expenditure in Liver Surgery

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ClinicalTrials.gov Identifier: NCT01715402

Recruitment Status : Enrolling by invitation

First Posted : October 29, 2012

Last Update Posted : February 6, 2017

Sponsor:

Collaborator:

Assistance Publique - Hôpitaux de Paris

Information provided by (Responsible Party):

Centre Hospitalier Universitaire, Amiens

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Hepatocellular Carcinoma Hilar Cholangiocarcinoma Intra Hepatic Cholangiocarcinoma Liver Metastasis	Procedure: liver surgery

Detailed Description:

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.

key measures to help them are the publication of national recommendations, assessment of actual practices and the incentive to activity.

Internationalwide recent and concordant data suggest that

quality and security of care, after an initial improvement, are going to stall
scientific recommendations are rarely validated by an impact analysis and are not applied
clinical data collected within an administrative framework are unreliable and too generalist
the evaluation, especially in the surgical field, is based on indicators sometimes irrelevant and often unclear

Study Design


Study Type :	Observational
Estimated Enrollment :	3000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Optimization of Health Expenditure in Major Surgery: Impact of a Mixed, Clinical and Ethnographic Approach in the Model of Liver Surgery
Actual Study Start Date :	September 2012
Estimated Primary Completion Date :	December 2017
Estimated Study Completion Date :	December 2018

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Cholangiocarcinoma

Genetic and Rare Diseases Information Center resources: Bile Duct Cancer Klatskin Tumor Intrahepatic Cholangiocarcinoma

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
operated patients this cohort includes patients who underwent a liver surgery whatever the pathology and whatever the surgical procedure	Procedure: liver surgery this intervention type includes hepatectomies; wedge; segmentectomies etc...

Outcome Measures

Primary Outcome Measures :

overall postoperative length of stay [ Time Frame: during the 3 months after the surgery ]
the overall postoperative length of stay is defined as the hospitalization between the surgery and patient's discharge.

This period includes the readmission for at least 24 hours in case of outcomes related to the surgery.

Secondary Outcome Measures :

peroperative outcomes [ Time Frame: during the surgical procedure ]
the peroperative outcomes are collected during the surgery and correspond to any event occured during the surgical intervention
postoperative outcomes [ Time Frame: after the surgery until postoperative month 3 ]
the postoperative outcomes correspond to any event occured after the surgical intervention. These outcomes include fistulae; bleeding...
construct of pronostic models [ Time Frame: after the postoperative month 3 ]
the construct of pronostic models include variables that affect the length of stay; morbidity and mortality
evaluation of PMSI indicators [ Time Frame: after the postoperative month 3 ]
this evaluation includes the analysis of PMSI indicators; their validity and the influence of centres on hepatectomies results

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

the population corresponds to patients operated in one of the thirteen hospitals.

These hospitals are distributed on the french territory to ensure that the recruitment is representative of the general population

Criteria

Inclusion Criteria:

elective liver surgery
older than 18
agreed to participate
surgical procedure included procedures registered as "HLFA003 - 007 ; 009 - 011 ; 017 - 020 ; HLFC002 à 004 ; 027 ; 032 ; 037" in the PMSI database

Exclusion Criteria:

emergency surgery
refused to participate

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01715402

Locations


France
Amiens North Hospital
Amiens, France
Bordeaux Hospital
Bordeaux, France
Beaujon University Hospital
Clichy, France
Lille Regional Hospital
Lille, France
Lyon Hospital
Lyon, France
Marseille Hospital
Marseille, France
Paoli calmette institute
Marseille, France
Saint Antoine Hospital
Paris, France
Strasbourg hospital
Strasbourg, France
Gustave Roussy institute
Villejuif, France
Paul Brousse Hospital
Villejuif, France

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Assistance Publique - Hôpitaux de Paris

Investigators


Principal Investigator:	Olivier FARGES, MD, phD	Beaujon University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cauchy F, Farges O, Vibert E, Boleslawski E, Pruvot FR, Regimbeau JM, Mabrut JY, Scatton O, Adham M, Laurent C, Grégoire 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.


Responsible Party:	Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:	NCT01715402 History of Changes
Other Study ID Numbers:	AOM 11060
First Posted:	October 29, 2012 Key Record Dates
Last Update Posted:	February 6, 2017
Last Verified:	February 2017

Keywords provided by Centre Hospitalier Universitaire, Amiens:


liver tumor carcinoma cholangiocarcinoma metastasis

Additional relevant MeSH terms:


Neoplasm Metastasis Carcinoma, Hepatocellular Cholangiocarcinoma Klatskin Tumor Neoplastic Processes Neoplasms Pathologic Processes Adenocarcinoma Carcinoma	Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Liver Extracts Hematinics

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